Report of the Technical Expert Group on

Patent Law Issues

December 2006
 INDEX

Contents Page

Executive Summary 2

1.0 Backdrop 4

2.0 Approach 2

3.0 Practices in Other Countries 10

4.0 Summary of Submissions and Presentations 15

5.0 Conclusions and Recommendations 2

Annexures I to V 8-53

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EXECUTIVE SUMMARY

1.0 Background

The Patents (Amendment) Bill, 2005, introduced in the Parliament in March, 2005 with the
objective of making the Patents Act compatible with India‘s international obligations, particularly
under the Agreement on Trade Related Aspects of Intellectual Property Rights (TRIPS
Agreement) had the benefit of detailed discussion in both the Houses. During the debate, the
issues regarding patentability of micro-organisms and the definition of 'pharmaceutical substance'
to mean ―a new chemical entity (NCE)‖ or ―new medical entity (NME)‖ were raised. The
Commerce and Industry Minister then assured the Parliament that he would refer these issues to
an Expert Committee for detailed examination and report the matter to the Parliament.
Accordingly, a Technical Expert Group on Patent Law Issues was set up by the Government of
India, Ministry of Commerce & Industry, Department of Industrial Policy & Promotion vide O. M.
No. 12/14/2005-IPR-III dated April 5, 2005.

2.0 Terms of Reference of the Group:

2.1 whether it would be TRIPS compatible to limit the grant of patent for pharmaceutical
substance to new chemical entity or to new medical entity involving one or more
inventive steps; and

2.2 whether it would be TRIPS compatible to exclude micro-organisms from patenting.

3.0 Approach

3.1 The Expert Group adopted a consultative approach to seek inputs from different stake
holders such as industry associations, non-governmental organizations, intellectual
property attorneys, etc. through written submissions, presentations, etc. The Group
studied the inputs received and also took into account other relevant literature to arrive
at their assessment. The Expert Group has arrived at specific recommendations and
conclusions as given below.

3.2 In making the recommendations the Group was guided by the need for access of
affordable medicines to Indian people at large, encouraging innovation by Indian
industry, its current capabilities in R&D, and balancing of India‘s obligations under
international agreements with the wider public interest.

4.0 New Chemical Entities

4.1 In the light of the above discussion, it would not be TRIPS compliant to limit granting of
patents for pharmaceutical substance to New Chemical Entities only. However, every
effort must be made to provide drugs at affordable prices to the people of India.
Further, every effort should be made to prevent the grant of frivolous patents and ‗ever-
greening‘. Detailed Guidelines should be formulated and rigorously used by the Indian
Patent Office for examining the patent applications in the pharmaceutical sector so that
the remotest possibility of granting frivolous patents is eliminated.

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5.0 Micro-organism

5.1 The group‘s conclusion is based on the requirements of Article 27.3 of the TRIPS as
articulated in 5.23 above and the provision of Indian Patent Act (Section 3 (j)).
However, strict guidelines need to be formulated for examination of the patent
applications involving micro-organisms from the point of view of substantial human
intervention and utility.

5.2 Excluding micro-organisms per se from patent protection would be violative of TRIPS
Agreement.

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1.0 Backdrop

1.1 The Patents (Amendment) Bill, 2005, introduced in the Parliament in March,
2005 with the objective of making the Patents Act compatible with India‘s
international obligations, particularly under the Agreement on Trade Related
Aspects of Intellectual Property Rights (TRIPS Agreement) had the benefit of
detailed discussion in both the Houses. During the debate, the issues regarding
patentability of micro-organisms and the definition of 'pharmaceutical substance'
to mean ―a new chemical entity (NCE)‖ or ―new medical entity (NME)‖ were
raised. The Commerce and Industry Minister then assured the Parliament that he
would refer these issues to an Expert Committee for detailed examination and
report the matter to the Parliament. Accordingly, a Technical Expert Group on
Patent Law Issues was set up by the Government of India, Ministry of Commerce
& Industry, Department of Industrial Policy & Promotion vide O. M. No.
12/14/2005-IPR-III dated April 5, 2005 (Annex-I).

1.2 The Technical Expert Group consisted of the following:

Dr. R.A. Mashelkar Chairman

Director General
Council of Scientific and Industrial Research
New Delhi

Prof. Goverdhan Mehta Member

Director
Indian Institute of Science
Bangalore

Prof. Asis Datta Member

Director
National Centre for Plant Genome Research
New Delhi

Prof. N.R. Madhava Menon Member

Director
National Judicial Academy
Bhopal

Prof. Moolchand Sharma Member

Director
National Law Institute University
Bhopal

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 1.3 Terms of Reference of the Group were:

1.3.1 whether it would be TRIPS compatible to limit the grant of patent for
pharmaceutical substance to new chemical entity or to new medical
entity involving one or more inventive steps; and

1.3.2 whether it would be TRIPS compatible to exclude micro-organisms from

patenting.
2 Approach

2.2 The Expert Group adopted a consultative approach to seek inputs from different
stake holders such as industry associations, non-governmental organizations,
intellectual property attorneys, etc. through written submissions, presentations, etc.
The Group studied the inputs received and also took into account other relevant
literature to arrive at their assessment. The Expert Group has arrived at specific
recommendations and conclusions as given below.

2.3 In making the recommendations, the Group was guided by the need for access of
affordable medicines to Indian people at large, encouraging innovation by Indian
industry, its current capabilities in R&D, and balancing of India‘s obligations under
international agreements with the wider public interest.

3 Practices in Other Countries

3.1 Patenting practices relating to new chemical entities and micro-organisms in

some countries are summarised in Annex-II.

4 Summary of Submissions and Presentations

4.1 A summary of the various submissions and presentations made to the Group is
presented in Annex-III.

5 Conclusions and Recommendations

5.1 Based on the interactions the Group had with various stakeholders and a detailed
examination of the critical legal and technical issues involved, perusal of related
literature, the Group has come to the following conclusions and
recommendations:

(a) New Chemical Entity

Terms of Reference: Whether it would be TRIPS compatible to limit the grant of patent for
pharmaceutical substance to new chemical entity or to new medical entity involving one or more
inventive steps:

5.2 The term "new chemical entity" appears for the first time in International
Intellectual Property agreements in the TRIPS Agreement of 1994, under Article
39.3:

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 "Members, when requiring, as a condition of approving the marketing of
pharmaceutical or of agricultural chemical products which utilize new
chemical entities, (emphasis added) the submission of undisclosed
test or other data, the origination of which involves a considerable effort,
shall protect such data against unfair commercial use. In addition,
Members shall protect such data against disclosure, except where
necessary to protect the public or unless steps are taken to ensure that
the data are protected against unfair commercial use."

5.3 According to the United States (US) Food and Drug Administration (FDA), a new
molecular entity (NME) or new chemical entity (NCE) means a drug that contains
no active moiety that has been approved by FDA in any other application
submitted under section 505(b) of the Federal Food, Drug, and Cosmetic Act.

5.4 The term "new medical entity" has neither been used nor defined in the
TRIPS Agreement.

5.5 Article 27 of the TRIPS Agreement elaborates the scope of patentable subject
matter as follows:

―1. Subject to the provisions of paragraphs 2 and 3, patents shall be

available for any inventions, whether products or processes, in all fields
of technology, provided that they are new, involve an inventive step and
are capable of industrial application. Subject to paragraph 4 of Article 65,
paragraph 8 of Article 70 and paragraph 3 of this Article, patents shall be
available and patent rights enjoyable without discrimination as to the
place of invention, the field of technology and whether products are
imported or locally produced.

2. Members may exclude from patentability inventions, the

prevention within their territory of the commercial exploitation of which
is necessary to protect ordre public or morality, including to protect
human, animal or plant life or health or to avoid serious prejudice to the
environment, provided that such exclusion is not made merely because
the exploitation is prohibited by their law.

3. Members may also exclude from patentability:

(a) diagnostic, therapeutic and surgical methods for the treatment

of humans or animals;
(b) plants and animals other than micro-organisms, and essentially
biological processes for the production of plants or animals other
than non-biological and microbiological processes. However,
Members shall provide for the protection of plant varieties either
by patents or by an effective sui generis system or by any
combination thereof. The provisions of this subparagraph shall
be reviewed four years after the date of entry into force of the
WTO Agreement.‖

5.6 Granting patents only to NCEs or NMEs and thereby excluding other categories of
pharmaceutical inventions is likely to contravene the mandate under Article 27 to
grant patents to all 'inventions'. Neither Articles 7 and 8 of the TRIPS Agreement

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 nor the Doha Declaration on TRIPS Agreement and Public Health can be used to
derogate from this specific mandate under Article 27.

5.7 Article 1 of the TRIPS Agreement requires compliance to the provisions of the
Agreement, while TRIPS plus provisions are optional. This would mean that
limiting grant of patents to pharmaceutical substances to new chemical entities
only, and excluding new forms of crystals, polymorphs, etc., if they satisfy the
criteria of patentability, is not consistent with TRIPS Agreement.

5.8 Section 2 (1) (j) of the Indian Patents Act defines ―invention‖ as a new product
or process involving an inventive step and capable of industrial application. The
term ―pharmaceutical substance‖ has also been defined in Section 2 (1) (ia) as
any new entity involving one or more inventive steps. The term ―inventive step‖
has been defined in Section 2 (1) (ja) as a feature of an invention that involves
technical advance as compared to the existing knowledge or having economic
significance or both and that makes the invention not obvious to a person skilled
in the art. Thus, a chemical to be patentable must be new, non-obvious and
have utility. However, Section 3 excludes certain inventions from being patented.
This, inter alia, includes the exclusions under Section 3 (d) as under:

―The mere discovery of a new form of a known substance which does not result
in the enhancement of the known efficacy of that substance or the mere
discovery of any new property or new use for a known substance or of the mere
use of a known process, machine or apparatus unless such known process
results in a new product or employs at least one new reactant.

Explanation: For the purposes of this clause, salts, esters, ethers, polymorphs,
metabolites, pure form, particle size, isomers, mixtures of isomers, complexes,
combinations and other derivatives of known substance shall be considered to be
the same substance, unless they differ significantly in properties with regard to
efficacy.‖

Thus, the new form of a known substance would not be patentable unless it differs
significantly in properties with regard to efficacy.

National Interest perspective

5.9 If the aim of limiting patents to new chemical entities is to prevent a

phenomenon loosely referred to as 'ever-greening', this can be done by a proper
application of patentability criteria as present in the current patent regime.

5.10 It is important to distinguish 'ever-greening' from what is commonly referred to

as 'incremental innovation'. While 'ever-greening' refers to an extension of a
patent monopoly, achieved by executing trivial and insignificant changes to an
already existing patented product, 'incremental innovations' are sequential
developments that build on the original patented product and may be of
tremendous value in a country like India. Therefore, such incremental
developments ought to be encouraged by the Indian patent regime.

5.11 Restricting patentability just to NCEs or NMEs could have both legal and scientific
ramifications. There is a perception that even the current provisions in the
Patents Act could be held to be TRIPS non-compliant. Drug discovery research is
still finding its feet in India. Though many companies are investing, it will at least

7
 be a decade before a critical mass is in place and results start accruing. Thus,
restricting patentability to just NCEs would mean that most of the pharmaceutical
product patents would be owned by MNCs.
5.12 In case of patenting of drugs, the protection to various forms of same substance
(salts, esters, ethers, polymorphs, metabolites, pure form, particle size, isomers,
mixture, etc.) is often seen as ‗ever-greening‘ (extending incremental protection
to a subsisting patent) and hence such protection is objected to.

5.13 In most countries, patenting of an invention for different forms of the same
substance is subjected to the test of novelty, non-obviousness (unexpected
effect) and utility before it is granted patent protection. Such a protection in the
form of incremental inventions in respect of known and new molecules or a
process potentially provides an added advantage to an inventor or a firm to
retain its market share or capture a space in the established market. However,
patenting an invention does not imply that a person can practice the invention;
he would have to exercise due diligence and ensure that the rights of others are
not infringed.

5.14 Many drug industry stakeholders feel that the use of the expression ―new
chemical entity‖ under the Patents Act would lead to many interpretations.
While some Indian drug industry representatives feel that limiting grant of
patents to new chemical entities will not be conducive to competitive growth,
some others feel that patent protection should only be given based on the strict
compliance of the patentability criteria. Many Indian industry representatives are
not in favour of widening the scope of patentability.

5.15 The group examined the current level and type of R&D innovations that the
Indian drugs and Pharma industry was undertaking. Annexure IV and V provide
some representative samples of international patents filed by the Indian
industry. It is clearly seen that most of them are based on incremental
inventions.

5.16 In the light of the above discussion, it would not be TRIPS compliant
to limit granting of patents for pharmaceutical substance to New
Chemical Entities only. However, every effort must be made to provide
drugs at affordable prices to the people of India. Further, every effort
should be made to prevent the grant of frivolous patents and ‘ever-
greening’. Detailed Guidelines should be formulated and rigorously
used by the Indian Patent Office for examining the patent
applications in the pharmaceutical sector so that the remotest
possibility of granting frivolous patents is eliminated.

(b) Micro-organisms:

Terms of Reference: Whether it would be TRIPS compatible to exclude micro-organisms from

patenting.
5.17 The Concise Oxford Dictionary, defines the term micro-organism as "Any of
various microscopic organisms, including algae, bacteria, fungi, protozoa and
viruses" and the Collins English Dictionary, defines this term as "Any organism,
such as a virus, of microscopic size.‖

5.18 The Institute of Science, UK describes micro-organism as an organism that can

be seen only under a microscope, usually, an ordinary light microscope. They are

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 usually of the order of microns (millionths of a metre) or tens of microns in linear
dimensions, and include bacteria, mycoplasma, yeasts, single celled algae and
protozoa. Multicellular organisms are normally not included, nor fungi, apart from
yeasts. Viruses are also not automatically included; many scientists do not
classify them as organisms, as they depend on cells to multiply. Hawker and
Linton in their book 'Micro-organisms, Function, Form and Environment' state
that the term micro-organism is derived from the minute size of the various
organisms. Viruses are included, though they are non-cellular particles, which are
not capable of independent life and can proliferate only in living cells. Brock in
his book 'Biology of Micro-organisms' describes micro-organisms, as a
microscopic organism consisting of a single cell or cell cluster, including the
viruses. Evans and Killington in their book 'Introduction to Microbiology, Heritage'
define Micro-organisms as microscopic life forms including microscopic fungi,
Protista, prokaryotes and viruses. Hawker, Linton, Folkes and Carlile in their book
'Biology of Micro-organisms' describe Micro-organisms as consisting of several
distinct groups of organism, most of whose members are of microscopic
dimensions.

5.19 Microbiological inventions include new products, processes, uses and

compositions involving biological materials. These inventions cover methods to
isolate and obtain new organisms, improve their character, modify them and find
their new and improved uses.

5.20 Patenting of new micro-organisms is based on their differences with the

characters and uses of micro-organisms as available in the prior art. Known
micro-organisms are restricted to new uses, wherever patent law permits such a
protection. The same is the case with genetically modified micro-organisms.
Genes and gene products are treated similar to chemical compositions. Patenting
of animal and human genes quite often attracts issues regarding public order
and morality.

5.21 Position of Micro-organisms in the Indian Patents Act, 1970 as amended up to

2005 is as follows:

Section 3 of the Patents Act specifies inventions which are not patentable. The
relevant provisions of that Section are as below:

3 ( c ): "the mere discovery of a scientific principle or the formulation of

an abstract theory or discovery of any living thing or non-living
substances occurring in nature."

3(j) : "plants and animals in whole or any part thereof other than micro-
organisms but including seeds, varieties and species and essentially
biological processes for production or propagation of plants and
animals."

The above provisions clearly identify micro-organisms as patentable subject

matter, provided they fulfil the prescribed criteria.

In the Dimminaco AG vs. Controller of Patents, the Calcutta High Court held in
2002 that a patent on a micro-organism is valid. The court ruled that the Act did
not preclude a living end product from being patented.

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 5.22 Article 27.3 of the TRIPS Agreement states that Members may also exclude from
patentability:

―(a) diagnostic, therapeutic and surgical method for the treatment of humans
or animals;
(b) plants and animals other than micro-organisms, and essentially biological
processes for the production of plants and animals other than non-biological
and microbiological processes. ―

5.23 Thus, Article 27.3 of the TRIPS Agreement clearly excludes plants and animals
from being patented, but regards micro-organisms as different from plants and
animals. While naturally occurring micro-organisms should not qualify for
patenting, micro-organisms involving human intervention and utility are
patentable subject matter under the TRIPS Agreement, provided they meet the
prescribed patentability criteria.

5.24 Universally, as practised by most patent offices, new micro-organisms isolated

for the first time from the natural surrounding can only be patented if they differ
in character from the known micro-organisms and find a new or improved use or
function. The issue has been discussed and debated in Europe for a number of
years. In many countries, including European countries, USA, Republic of Korea,
Japan and China, patenting of micro-organisms is not an issue. Claims to micro-
organisms have been allowed on the grounds that they are the products of
micro-biological processes.

National Interest perspective

5.25 Biotech industry is one of the fastest growing industries in the world, including in
India. India being one of the bio-diversity rich countries, it would, thus, be
prudent for us to protect biotechnological inventions as that would help Indian
biotechnology research compete globally attracting collaborations, FDI, contract
R&D, etc. to the best advantage of the Indian R&D and biotech industry.
India needs to reap the due benefits from its rich bio-resources with an enabling
provision for protection of intellectual property in bio-technological innovations
and inventions.

5.26 There have been instances of patenting of Indian biological materials by other
countries. It would, thus, be in our interest to document, protect and modify new
micro-organisms isolated from various parts of our country and find their new
and improved industrial uses. This step would help Indian biotech industry.

5.27 The group‘s conclusion is based on the requirements of Article 27.3 of the TRIPS
as articulated in 5.23 above and the provision of Indian Patent Act (Section 3
(j)). However, strict guidelines need to be formulated for examination of the
patent applications involving micro-organisms from the point of view of
substantial human intervention and utility.

5.28 Excluding micro-organisms per se from patent protection would be

violative of TRIPS Agreement.

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 Annex-I

Copy of Government of India, Ministry of Commerce & Industry,

Department of Industrial Policy & Promotion vide Order No.
12/14/2005-IPR-III dated April 5, 2005

ORDER

Subject:- Technical Expert Group on Patents law issues

A Technical Expert Group comprising the following persons has been constituted to study
certain patents law issues:

1. Dr. R.A. Mashelkar - Chairman

Director General
Council of Scientific and
Industrial Research
2, Rafi Marg,
New Delhi – 110 001

2. Prof. Goverdhan Mehta - Member

Director
Indian Institute of Science
Bangalore – 560 012

3. Prof. Asis Datta - Member

Director
National Centre for
Plant Genome
Research
JNU Campus
New Delhi – 110 067

4. Prof. Madhav Menon - Member

National Judicial Academy
Bhopal

5. Prof. Moolchand Sharma - Member

Director
National Law Institute University
Bhopal
Contd…..

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 -2-

2. The Group will have the following terms of reference:

a) whether it would be TRIPS compatible to limit the grant of patent for pharmaceutical
substance to new chemical entity or to new medical entity involving one or more
inventive steps; and

b) whether it would be TRIPS compatible to exclude micro-organisms from patenting.

3. The group will submit its report to the Department of Industrial Policy and Promotion.

4. The group will be serviced by the Department of Industrial Policy and Promotion.

Sd/-
(Rajeev Ranjan )
Director

Copy to:

All the members of the Group.

Copy also to

1. Prime Minister‘s Office

2. Cabinet Secretariat.
3. Office of CIM
4. Office of Secretary (IPP)
5. Ministries/Departments of Chemicals & Petro-chemicals, Health, Biotechnology, Science &
Technology, Commerce, Scientific and Industrial Research, Agricultural Research &
Education, Environment & Forests.

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 Annex - II

Patenting Practices in Other countries

Examination Guidelines for Patent Applications relating to
Biotechnological Inventions at the UK Patent Office

These Guidelines set out the practice within the UK Patent Office as it relates to
patent applications for biotechnological inventions. The 2000 Regulations came
into force on 28 July 2000 and implemented the provisions of Articles 1 to 11 of
the European Directive 98/44/EC on the legal protection of biotechnological
inventions.

In the UK, the Patents Regulations 2000 confirmed and clarified that inventions
concerning biological material, including gene sequences, may be legitimately the
subject of patent applications. In other words, these Regulations have
established beyond doubt the legitimacy of biotechnology patents in the UK.

―An invention shall not be considered unpatentable solely on the grounds that it
concerns (a) a product consisting of or containing biological material; or (b) a
process by which biological material is produced, processed or used‖

[Paragraph 1, Schedule A2 to the Patents Act 1977]

Universally, it is an established practice that a natural substance which has been

isolated for the first time and which had no previously recognized existence, does
not lack novelty because it has always been present in nature.

It is generally agreed, and it is particularly relevant in the field of biotechnology,

that a patent should not be granted merely because the applicant had been
involved in laborious and costly effort. If the goal is known and sufficient of the
theory and practice is known for the applicant to predict where he is going,
without there being an original step, then an obviousness objection would be
well founded.

Following the sequencing of various genomes, there is unlikely to be an inventive

step in identifying from within a sequenced genome any new gene, even those
without known homologues. It is obvious to trawl the genome for previously
unidentified genes, and any skilled worker would have some expectation of
success. In Genentech, an idea was considered obvious if ―the materials in
question were lying in the road and ready for a research worker to use‖, even if
the skilled man faced a number of obstacles in proceeding to his goal. However,
if overcoming these obstacles required ―a spark of imagination….beyond the
imagination properly attributable to him as a man skilled in the art‖ then there
may be some element of inventive step. The use of bioinformatics tools would
not seem to pose obstacles requiring a spark of imagination to overcome.

Paragraph 2 of Schedule A2 to the British Patents Act, 1977 permits biological

material which is isolated from its natural environment or produced by means of
a technical process to be the subject of an invention even if it previously
occurred in nature. Claims to micro-organisms per se have been allowed on the
grounds that they are products of microbiological processes. This applies even

13
when they are merely isolated from their natural surroundings, their isolation,
culture, characterization and the finding of a utility turning what would be a
discovery into an invention.

Claims for micro-organisms per se which have been isolated or obtained by

artificially induced random mutation, are allowed but generalizations from such
specific micro-organisms to novel species would not normally be permitted. On
the other hand, claims to genetically modified micro-organisms derived from
readily available known micro-organisms where the invention resides in the gene
introduced, may be claimed more generally. Also claims to mutants and variants
of a specified deposited micro-organism are allowed provided they possess the
same inventive property as the deposited micro-organism.

Patenting of Micro-organisms in China

Claims for micro-organisms per se are allowed in China. DNA sequences are
considered to be large chemical compounds, and may be patented as
compositions of matter. Although patent claims to naturally occurring DNA
sequences might be expected to trigger the ‗products of nature‘ rule, courts have
upheld patent claims covering ‗purified and isolated‘ DNA sequences as new
compositions of matter resulting from human intervention. An excised gene is
eligible for a patent as a composition of matter or as an article of manufacture
because that DNA molecule does not occur in that isolated form in nature; or
synthetic DNA preparations are eligible for patents because their purified state is
different from the naturally occurring compound.

Article 25 of the Chinese Patent Law states that:

For any of the following, no patent right shall be granted:

(1) Scientific discoveries;
(2) Rules and methods for mental activities;
(3) Methods for the diagnosis or for the treatment of diseases
(4) Animal and plant varieties;
(5) Substances obtained by means of nuclear transformations.

For processes used in producing products referred to in items (4) of the

proceeding paragraph, patent right may be granted in accordance with the
provisions of the Law.

Patenting of Micro-organisms in Europe

The European Union has defined ―'biological material" instead of "micro-

organism", as under [Article 2.1 (a)]

―Biological material means any material containing genetic information and

capable of reproducing itself or being reproduced in a biological system"

In Plant Genetic Systems application (T356/93) European Board of Appeal was

seized with the question as to what is meant by the term 'micro-organism' The
Board held that a micro-organism would include bacteria, yeast, fungi, algae,
protozoa, plasmids and viruses, but also animal or plant cells and generally all
unicellular entities with dimensions beneath the limits of human vision.

14
Article 53(b) of the European Patent Convention (EPC) provides that European
patents shall not be granted in respect of ‗plant or animal varieties or essentially
biological processes for the production of plants or animals; this provision does
not apply to microbiological processes or the products thereof‘.

In its decision of 16 June 1999 the Administrative Council inserted a new Chapter
VI entitled ‗Biotechnological inventions‘ in Part II of the EPC Implementing
Regulations. The new provisions entered into force on 1 September 1999 and
implemented the requirements of the EU Biotechnology Directive in European
patent law. The EPO has introduced four new rules, Rules 23b to 23e. Rule 23b
sets out general matters and defines the meaning of biotechnological inventions,
biological material, plant variety, and microbiological process. Rule 23c states
patentable biotechnological inventions, including:

 Biological material isolated from their environment, even if known in

nature. This particularly applies to genes that are isolated from their
natural environment by means of technical processes and made available
for industrial production.
 Plants or animals if the invention is not confined to a single variety

The provision clarifies the scope of Article 53(b) of EPC. It indicates that a plant
grouping characterized only by a particular gene, but not by its whole genome, is
not covered by the protection of new varieties and therefore is in principle
patentable. This also applies if such plant grouping comprises plant varieties.

Rule 23d sets out what is not patentable. This includes processes for cloning
human beings, processes for modifying the genetic identity of human beings,
using human embryos for commercial purposes and modifying the genetic
identity of animals such as may cause them suffering without substantial medical
benefit. The list is to be seen as giving concrete form to the concepts of ‗ordre
public‘ and ‗morality‘.

Rule 23e indicates what is and is not patentable with respect to the human body.
The human body and its elements cannot be patented. However, elements of the
body, when isolated from the body, may be patented.

Patenting of Micro-organisms in Japan

In 1997, the Japanese Patent Office (JPO) published its ‗Implementing Guidelines
for Inventions in Specific Fields‘. Inventions in the biotechnology field in the
Guidelines are divided into four types: genetic engineering, micro-organisms,
plants and animals. Inventions relating to genetic engineering include those of a
gene, a vector, a recombinant vector, a transformant, a fused cell, a
recombinant protein, and a monoclonal antibody. Inventions relating to micro-
organisms include micro-organisms per se as well as those relating to the use of
micro-organisms.

In Japan, micro-organism means yeast, molds, mushrooms, bacteria,

actinomycetes, unicellular algae, viruses, protozoa, etc. and further includes
undifferentiated animal or plant cells as well as animal or plant tissue cultures.

15
 Patenting of New Chemical Entity in US:

According to the United States (US) Food and Drug Administration (FDA), a new
molecular entity (NME) or new chemical entity (NCE) means a drug that contains
no active moiety that has been approved by FDA in any other application
submitted under section 505(b) of the Federal Food, Drug, and Cosmetic Act.

Patenting of Micro-organisms in USA

Art. 35 USC Sec 101 of the US patent law states: whoever invents or discovers
any new and useful process, machine, manufactures, or composition of matter,
or any new and useful improvement thereof, may obtain a patent thereof…‖

In USA, utility requirement in respect of biotech inventions are very strict. A

discovery that is not a creation does not meet the requirement of utility. A newly
discovered micro-organism existing in nature, a newly discovered plant per se
are discoveries because they do not involve creativity. Inventions that are
incapable of industrial application do not meet the requirement of utility.
Inventions of a gene, a vector, a recombinant vector, a transformant, a fused
cell, a recombinant protein and a monoclonal antibody whose utility is not
described in a specification or cannot be inferred, do not meet the requirement
of utility. An invention of a micro-organism per se, a plant per se or an animal
per se whose utility is not described or cannot be inferred does not meet the
requirement of utility.

According to the new ‗Utility Examination Guidelines‘ of the USPTO, if an isolated

DNA fragment has a specific, substantial, and credible utility, the DNA fragment
invention satisfies the requirement of utility and a patent can be granted for the
DNA fragment. Where a new use is discovered for the patented DNA fragment,
that new use may qualify for its own process patent. Of course, the later patent
is a dependent patent of the DNA fragment patent.

Patenting of Micro-organisms in Australia

The Australian patent law defines invention as "any new manner of

manufacture."

The question of patents for living organisms was considered at length in Ranks
Hovis McDougall Ltd.'s Application [1976 A OJP 3915] and the Court held that:

a) No objection can be taken to a claim to a new organism on the ground that it is

something living;
b) Any new variants claimed must have improved or altered useful properties and
not merely have changed morphological characteristics which have no effect on
the working of the organism; and
c) Naturally occurring micro-organisms per se are not patentable as they represent


An active moiety means the molecule or ion, excluding those appended portions of the molecule that
cause the drug to be an ester, salt (including a salt with hydrogen or coordination bonds), or other
noncovalent derivative (such as a complex, chelate, or clathrate) of the molecule, responsible for the
physiological or pharmacological action of the drug substance.
(Source: http://en.wikipedia.org)

16
a discovery and not an invention, but a claim to a pure culture in the presence of
some specified ingredients would satisfy the requirement of a technical
intervention.

The guidelines for a micro-organism in Australian Patent Law states, ―what is

discovered in nature without any practical application, is a mere chemical
curiosity‖' and is not patentable [Part 8.2.5.3 Australian Manual of Patent
Practice]. However, isolated micro-organisms are considered patentable.

Patenting Practices of Micro-organism in Brazil

Article 10 states that the following shall not be considered inventions or utility
models:

"all or part of natural living beings and biological materials found in nature or
isolated there from, including the genome or the germ plasm of any natural
living being and any natural biological process."

Article 18 states that the following should not be patentable:

"living beings, in whole or in part, except for transgenic micro-organisms meeting

the three requirements of patentability - novelty, inventive step and industrial
application - in accordance with Article 8 and which are not mere discoveries."

For the purposes of this law, transgenic micro-organisms mean organisms,

except for plants or animals in whole or in part, that due to direct human
intervention in their genetic composition express a characteristic that cannot
normally be achieved by the species under natural conditions.

17
 Annexe - III
Summary of Submissions and Presentations

Ranbaxy

New Chemical Entity (NCE):

As India‘s leading Pharmaceutical Company committed to R& D in the field of

drug development, we are of the opinion that incremental innovations in terms
of developing new forms, new derivatives and new delivery systems of existing
drug should be granted patent protection provided they are new, involve an
inventive step and have commercial utility. This will provide the necessary fillip to
development of Novel Drug Delivery System (NDDS) in our laboratories.

Restricting patentability to NCEs may appear to be an attractive solution in the

short –term to companies with a ‗Reverse –Engineering‘ mind–set, but will not
benefit hundreds of scientists working in our public & private R & D Centers, who
are just starting off on the difficult task of new drug discovery research.

Restriction of patentability to NCEs alone is likely to benefit only MNCs which

have the resources and the experience to develop NCEs. Indian companies that
have far less resources are better placed to benefit from early commercialization
of incremental innovations. A prerequisite to successful licensing deal for such
products is the protection of the IP in the form of a patent, preferably in the
country itself since products are being manufactured here.

Restricting patentability to NCEs is not compliant with Article 27.1 of TRIPS.

Patent Applications filed by Ranbaxy:

Strategic Direction
Segment 2004 2007 2012
Generics *** *** ***
NDDS * ** ***
NDDR ***

Global Sales US $ 1 Bn US $ 2Bn US $ 5 Bn

*Stars indicate importance/direction in the segment

AREAWISE PATENT FILING /GRANT TO RANBAXY

(Total number unique patent applications filed: 709)

India USA

Filed Granted* Filed Granted

Process 388 95 88 38

APIs 246 58 64 30
Dosage 142 37 24 08

18
 NDDS 75 21 18 08
NDDR 75 23 40 13
Herbal 06 - - -
Packaging 01 - - -
Total 545 139 146 59

*includes accepted patent

The firm emphasizes that NDDS products need patent protection since strength
of Indian scientists lie in innovations that improve existing products. Further,
NDDS programs are less expensive, have lower gestation periods and result in IP
that can be licensed. Example Cipro OD licensed by Ranbaxy to Bayer.

Ranbaxy has further tried to define ―efficacy‖ as the capacity of the drug to
produce a desired effect. In medical terms, clinical efficacy is the maximal effect
that can be produced by a drug. Any factor such as bioavailability that
substantially enhances a clinical outcome benefit would be deemed to be
included in the definition of efficacy. Any invention on derivatives or properties
that affect these factors should be deemed to be patentable, if it demonstrably
and significantly influences the efficacy. This would include inventions on
chemical modifications such as prodrugs, salts, polymorphs, etc. Such inventions
should be patentable provided they meet the stringent patentability criteria
under Section 3 (d) and 3 (e) and the invention is novel, non-obvious and
industrially useful.

Micro-organisms:

No comments.

Krishna & Saurastri, Trademarks & Patent Attorneys

New Chemical Entity (NCE):

a. It will not be TRIPS compatible to limit the grant of patent to pharmaceutical

substances to new chemical entity or to new medical entity involving one or
more inventive steps;

b. Both the above things will be against specific interests of Indian inventors
and a bonanza for multinational companies;

c. Time has come to re-examine entire IPR policy of India. Best policy will be to
ensure implementation of provisions of compulsory licensing provisions and
Section 66 in letter and spirit. With fear of misuse or mischievous use gone,
make scope of patentability as broad as possible by deleting ALL restrictive
provisions on patentability except Sections 3 (b), 3 (p), 4, 39. This will give a
real business impetus in investing in innovations, which will empower
individual Indian inventors, which shall result in national as well as personal
benefits.

d. Article 1 of the TRIPS Agreement clearly indicates that what has been
included in the Agreement is the compliance to minimum commitment is
mandatory. If anything is optional, it is giving more extensive protection
than has been stipulated in the Agreement. This clearly means that

19
 excluding pharmaceutical substances other than new entities, which may
include new forms of crystals, polymorphs etc, is not consistent with TRIPS
requirements if they satisfy the criteria of patentability.

e. In process patents regime, strength of Indian pharmaceutical companies was

in their capability to invent new processes. Now in product patent regime
also, this ability shall help them to reassert themselves. R&D in new
chemical entities requires a huge financial commitment, staying ability and
R&D capability, which very few Indian Pharma companies have. Even at
present, patents portfolio of most Indian pharma companies, except one
exception, is very poor as compared to the patents culture in similar
companies in developed countries. Strength of our pharma companies lies at
present in working around in presently generic products.

f. This may include finding out better forms which have some strategic
economic advantage such as better handling properties, better stability, etc.

g. It is also possible that a new efficient process of an economically generic

drug may be patented, but except for a new shape of crystals of the product
produced by that process, there is nothing that can help in detecting that
the patented process has been used by the infringer, in which case, although
pharmaceutical substance produced is not a new chemical entity, the new
crystal structure as a product claim shall have extraordinary strategic and
economic importance. However, denying a patent to this claim shall work to
disadvantage of such inventions, which are distinctly possible from Indian
inventors in generics.

h. When a new process is different and far more efficient, uses some reactants
not used in earlier prior-art processes, and same chemical entity with same
physical properties of its particles are produced, in such cases, even when
such a process may be patented, the only practical and effective way to
detect infringement will be given by only a product claim which claims
presence of this impurity in trace quantities. Limiting patentability to new
chemical entities only shall lead to denial of such a product claim from being
granted, which shall work against the interest mainly of Indian inventors.
They will find it circuitous and more expensive to prove that their process is
being infringed in absence of an express product claim being granted.

i. Many such examples are possible, and many unanticipated and unexpected
may arise in future, where the proposed restrictions on patentability may
turn out to be counterproductive.

j. This means that they will be producing inventions, which shall be in the
category other than "new chemical entities". By opting to exclude
pharmaceutical substances other than new chemical entities from patenting
in pharmaceutical area, we shall be offering bonanza to multinational
companies, because "new chemical entities‖ is their exclusive strength at
present and excluding all other pharmaceutical substances from patentability
will make their competitive position further exclusively protected. This
approach will hit Indian pharma companies. Loss of the multinationals will be
marginal.

k. The entire reason for excluding "New Forms" from being held patentable

20
 emerges from the fear of "Greening of Patents". This is basically not a
practical fear because even if a "New Form" is patented, this does not revive
patent protection to the off-patent form nor to that chemical entity. What
has expired as patent protection has expired. May be, the patentee can
exercise his exclusivity on the "New Form", which shall not include protection
to the chemical entity, but just the new form. But as long as the "Old Form"
is useful for its purpose, the patent on "New Form" can be ignored and not
used at all by the world. On the contrary, the' "New Form" has such a
significant improvement that its use is indispensable, in such a case why
should anyone have a grudge against its patentability and licensing it
lawfully'?

l. Restrictive provisions on patentability are mainly on account of fear of

misuse or mischievous use of exclusivity. This threat should not exist for us
due to very strong compulsory licensing provisions and defensive provision.
It shall be enough to give confidence that Sections 84 and 91 shall be
implemented in case of genuine cases without any delay. These provisions
protect the existing innovation based companies from possible crippling
effects of monopolies from arrival of new critical patents from patentees of
other countries. It is misconceived that they are useful only in national
emergencies or only If public demand is not satisfied. If read properly, these
sections are available not only in case of national emergencies; but even
when a patentee is producing the product to satisfy public demand, if an
already existing enterprise faces closure due to the new patent, compulsory
license is available to avert the closure (See section 84 (7) (a) (i)). The only
objection and that too valid one is that one has to wait for three years from
the date of sealing of the patent for application of this provision. This
problem, however, is solved by the very revolutionary provision of Section
91, where, if an enterprise has active R&D in the same field and the new
patent is related to their existing ongoing R&D, they get the right from the
date of sealing the patent. These two provisions between them avert any
threat to Indian business and shall herald an era of cooperative business
rather than competitive killer instinct based business.

m. To take benefit of the potential profits from licensing of new molecules,

Indian companies will have to start genuine work on several types of
molecules. Once R&D culture settles in Indian Pharma companies, this
avenue will also appear attractive and practical to them. This will mean a
genuine and substantial change in Indian pharma R&D, which shall bring
benefits to the Inventive individuals and companies for themselves and for
the country. In course of time, lead molecules may emerge even from India.

Micro-organism:

a. It will not be TRIPS compatible to exclude micro-organisms from patenting;

b. It may be pointed out here that we have fully exploited the permitted
exclusions under Section 3 of the Article 27. However, same provision very
specifically and expressly excludes permission to exclude micro-organisms
from patentability. With so clear express provisions, here is no way to
interpret that micro-organisms can be excluded from patentability.

21
 Shri V.R. Krishna Iyer

New Chemical Entity:

It is well within the TRIPS norms to limit patentability to new chemical entitites
in respect of pharmaceutical inventions

Micro-organism:

It was observed that micro-organisms, which occur in nature and which at best,
could be regarded, as discoveries cannot constitute patentable inventions. There
should be no patent protection in respect of such cases.

In clause 3(j), the expression "other than micro-organisms, but" should be

deleted. Alternatively, under proviso to section 1(3) of the Act, the
commencement of the provision should be deferred till a review of the question
of according patent protection to micro-organisms and non biological and micro
biological processes, as initiated by the WTO in 1999, is completed, and the
position is reviewed afresh by India. It is significant globally there is opposition
to such protection."

Biocon

New chemical Entity:

No Comments

Micro-organisms:

The following should be considered un-patentable:

a. Where the commercial exploitation would be contrary to morality or order

public;
b. Process for cloning human beings;
c. Use of human embryos for industrial or commercial purposes;
d. The human body, at the various stages of its formation and development;
e. Naturally occurring gene and DNA sequences and minor variations thereof;
f. Inherent utilities such as gene sequences coding for amino acids, peptides,
proteins.

Eric Hoehrenberg

New Chemical Entity:

Patent search carried out by the leading Brazilian patent law practice concerning
patents on salts, esters, polymorphs and similar ―incremental innovation‖ by
Indian companies in Brazil. There are 84 such patents from CIPLA, Dr. Reddy‘s
Labs, and Ranbaxy. It should be noted that many of these patents are also
pending at the European Patent Office. Thus, it seems that whatever rhetoric
may be used within India regarding such inventions, it is clear that leading
Indian companies view such innovations as indeed important enough to patent in
key markets outside of India. We would strongly suggest that patents on salts,

22
 esters etc. should indeed be granted if such products meet the internationally-
accepted conditions of novelty, involving an inventive step, and capable of
industrial application(TRIPS Article27(1)).

The EU and US have addressed the issue of patents on ―incremental‖ or

―adaptive‖ innovation as follows:

Article 35 under Section 101 of the US patent law states: ―whoever invents or
discovers any new and useful process, machine, manufactures, or composition of
matter, or any new and useful improvement thereof, may obtain a patent
thereof…‖

A report by the EU working Group on Pharmaceuticals and public health noted in

its 28 March 2000 report to the High-level Committee on health for policies and
Actions in the framework of the EU treaty of Amsterdam that: ―Innovation in
pharmaceuticals encompasses many different options, going from the
development of a completely new medicine for the treatment of a disease
otherwise incurable, to modifications of known formulations to improve benefits
for the patients, such as a less invasive administration route or a simpler
administration schedule.‖

Micro-organisms:

No Comments.

Indian Drug Manufacturers’ Association

New Chemical Entity:

Our submission is that the Parliament had only an NCE in mind when it approved
Section 2 and 3 particularly Section 3 clauses (d), (e) and (f);

The US FDA uses only term New Chemical Entity although their patent law is
very broad and unsuitable for a developing country like India.

Definition of New Chemical Entity in USA - US FDA Rule Sec. 505 (b) describes a
'new chemical entity' as ―. . . a drug that contains no active moiety that has been
approved by FDA in any other application submitted under section 505 (b) of the
Food, Drug and Cosmetic Act. . ..‖ The patentability criteria should be such so as
to

a. Avoid 'Me-Too' patents and ever-greening of patents. Patentability

criteria should not be too broad so as to give rise to ever-greening of
patents. We do not want to follow the US example where for example -
there are 28 new patents issued between 1995-2005 on the same one
drug Meningitis Vaccine, mostly for minor variations.

b. The definition of NCE should include 'salts', 'esters', 'metabolites',

'derivatives' etc. This will avoid multiplicity of patent applications and
gross abuse of patent monopolies and thus, would reduce litigation and
public exploitation.

23
 c. It should support the policy of the Government to bring down medicine
prices.

d. The new definition of patentable 'pharmaceutical substance' should be

supported by other provisions of the Patents Act particularly Sections 2
and 3.

Suggestion 1:

Section 2 (1) (ta):

Present Text: "pharmaceutical substance" means any new entity involving one or
more inventive steps;

Proposed text: Section 2 (1) (ta) - "pharmaceutical substance" means any new
chemical entity with a significant therapeutic advancement with one or more
inventive steps.

Explanation - For the purposes of this clause, salts, esters, ethers, polymorphs,
metabolites, pure form, particle size, isomers, mixtures of isomers, complexes,
combinations and other derivatives of known substance shall be considered to be
the same substance unless they differ significantly in properties with regard to
efficacy, and therefore, shall not be patentable.

Suggestion 2:

Present Text

Section 3 (d): 'the mere discovery of a new form of a known substance which
does not result in the enhancement of the known efficacy of that substance or
the mere discovery of any new property or new use for a known substance or of
the mere use of a known process, machine or apparatus unless such known
process results in a new product or employs at least one new reactant'.

'Explanation: For the purposes of this clause, salts, esters, ethers, polymorphs,
metabolites, pure form, particle size, isomers, mixtures of isomers, complexes,
combinations and other derivatives of known substance shall be considered to be
the same substance, unless they differ significantly in properties with regard to
efficacy'

Proposed text:

Section 3 (d): "the mere discovery of a new form of a known substance which
does not result in the enhancement of the known efficacy of that substance or
the mere discovery of any new property or new use for a known substance or of
the mere use of a known process, machine or apparatus unless such known
process results in a new product or employs at least one new reactant" and,
therefore, shall not be patentable.

24
Suggestion 3

Section 2 (1) (ja)

Present Text: "inventive step" means a feature of an invention that involves

technical advance as compared to the existing knowledge or having economic
significance or both and that makes the invention not obvious to a person skilled
in the art.

Proposed text:

Section 2 (1) (ja) - "inventive step" means a feature of an invention that involves
technical advance as compared to the existing knowledge or and having
economic significance or both and that makes the invention not obvious to a
person skilled in the art.

Suggestion 4:

Present Text:

Section 2 (1) (l): "new invention" means any invention or technology which has
not been anticipated by publication in any document or used in the country or
elsewhere in the world before the date of filing of patent application with
complete specification, i.e. the subject matter has not fallen in public domain or
that it does not form part of the state of the art.

Proposed Text:

Sec. 2 (1) (l): "new invention" means any invention or technology which has not
been anticipated by publication in any document or used in the country or
elsewhere in the world before the date of filing of patent application with
complete specification, i.e. the subject matter has not fallen in public domain or
that it does not form part of state of the art prior art.

Changes suggested:

(i) To use the term 'New Chemical Entity' instead of the term 'New Medical
entity‘ with a view to reduce litigation, public exploitation and ever-greening by
MNCs;

(ii) To drop words like "efficacy", "mere", "significant" from the text of Section 3
of the Patents Act.

(iii) The term 'Prior art' is preferred in Section 2(1)(l) instead of the phrase
‗state of the art';

(iv) In the definition of inventive step the conjunction 'or' between ....existing
Knowledge, having economic significance ....should be replaced with
‗and‘.

25
 Micro-organisms:

It is our submission that naturally occurring micro-organisms and other naturally

occurring allied biological materials should be considered non-patentable.

Suggested text of Section 3 (j)

Plants and animals in whole or any part thereof other than micro organisms
other than man-made or biotechnologically altered micro-organisms but including
seeds, varieties and species and essentially biological processes for production or
propagation of plants and animals.

Changes suggested:

(i) Micro-organisms should be made patentable as per TRIPS. However, in

Section 3(j) the relevant phrase 'micro-organisms' should be replaced with 'Man-
made or biotechnologically altered micro-organisms';

(ii) On the issue of patentability of micro-organisms, mandatory review of TRIPS

provisions by the TRIPS Council should be awaited;

Gene Campaign

New Chemical Entity:

No Comments.

Micro-organisms:

Patentability of micro-organisms should be for those micro-organisms which have

been produced by adequate human intervention and fulfil the criterion of
novelty, non-obviousness and industrial utility. Mere discovery and isolation will
not be considered sufficient human intervention.

Patents should not be granted on materials obtained from national and

international collections and depositories.

When a material is taken from a country, Article 15 of the Convention on

Biological Diversity should be respected. No patent should be granted without
prior informed consent and material transfer agreements.

When a patent is granted, the patent holder should be obliged to share the
economic benefits with the communities of the country from where the material
was obtained.

In view of the critical nature of the subject matter, patents involving micro-
organisms should not be granted on a broad basis (overarching patents with a
very wide scope).

Patents should be granted strictly based on patentability criteria with no

generalisation, that is, for the organism only with respect to that particular
function or property that constitutes the invention. The organism should remain
free for others to create inventions.

26
 Oxford Intellectual Property Research Centre, University of
Oxford, U.K.

New Chemical Entity:

No Comments.

Micro-organism:

The issue regarding protection to micro-organism is an independent one. The

world has now moved far beyond this debate and we ought, in view of the rapid
progress of our biotech industry, to grant protection to those micro- organism
that are new and non obvious. The above suggestions are confined to
addressing the TRIPS compliant legal options.

Drug Action Forum

New Chemical Entity:

We feel that there is an urgent need to restrict the definition of new chemical
entity. The definition of patentable ‗pharmaceutical substance‘ should be as
follows – ―Pharmaceutical substance means new drug molecule involving one or
more inventive step‖. And the definition of ‗patentable invention‘ should be as
follows – ―Invention means a basic product or process involving an inventive step
and capable of industrial application‖.

Micro-organisms:

No Comments.

National Working Group on Patent Law:

New Chemical Entity:

(i) The scope of 'invention' should be limited to basic novel product or process
involving inventive step and capable of industrial application;

(ii) The scope of 'pharmaceutical substance' should be limited to new molecular

entity with significant therapeutic advancement involving one or more
inventive steps;

(iii) There is lacuna about the definition of 'pharmaceutical substance'. Apart

from the definition there is no mention of this patentable subject matter
anywhere in the amended Patents Act 1970. Section 5 of the Act has been
omitted through the Patents (Amendment) Act 2005. We would suggest this
Section which could incorporate specifically 'pharmaceutical substance'
should be re-introduced with the following version:

27
 Section 5

Patents shall be available for basic novel inventions including pharmaceutical

substances as defined in Section 2 whether products or processes in all fields of
technologies excluding inventions stipulated under Section-3 provided that they
are new, involve an inventive step and are capable of industrial application.

To sum up our suggestions in regard to definitions of 'invention' and

'pharmaceutical substance' are in harmony with each other and clause (d)
including its explanation under Section 3 quoted above. We would emphasize
that basically the incrementally changed presentation must not be allowed for
patenting.

Micro-organism:

(i) Patenting of life forms may have at least two dimensions. Firstly, there is the
ethical question of the extent of private ownership that could be extended to
life forms. The second dimension relates to the use of IPRs' concept as
understood in the industrialized world and its appropriateness in the face of
the larger dimension of rights on knowledge, their ownership, use, transfer
and dissemination.

(ii) Micro-organisms as such occur in nature. If any micro-organism is discovered

it cannot be called invention, it falls in the category of discovery. Micro-
organism when genetically modified falls in the category of invention
because of human input. Genetically modified micro-organism may perform
any number of activities. If a researcher is able to research upon a particular
activity, and he is allowed patenting of his genetically modified micro-
organism this will result in blocking of further research on that micro-
organism. This is a peculiar situation arising out of patenting of micro-
organisms. In view of these circumstances it would not be appropriate even
to allow patenting of genetically modified micro-organism also as such.

Association of Biotechnology Led Enterprises

New Chemical Entity:

No Comments.

Micro-organisms:

The inventions to be considered patentable which have novelty, inventive steps

and commercial utility.

The following to be considered non-patentable:

 where the commercial exploitation would be contrary to morality or

ordre public
 Process for cloning human beings
 Use of human embryos for industrial or commercial purposes
 The human body, at the various stages and sequence and minor
variations thereof

28
  Naturally occurring gene and DNA sequence and minor variations
thereof.
 Inherent utilities such as gene sequences coding for amino acids,
peptide, proteins.

Indian Pharmaceutical Congress Association

New Chemical Entity:

The recent Patent Act disqualifies grant of patents for salts, esters, ethers,
polymorphs, metabolites, pure forms, particle size, isomers, mixture of isomers,
complexes, combinations and other derivatives of known substance and shall be
considered to be the same substance, unless they differ significantly in
properties with regard to efficacy. This may help to prevent ever greening of
patents.

This clause is akin to the Directive 2004/27/EC of the European Parliament and
Council of 31 March 2004, which provides guidelines for "generic medicinal
product". The Official Journal of European Union L 136/39 dated 30.4.2004
under Article 10 See 2.(b) "generic medicinal product" shall mean a medicinal
product which has the same qualitative and quantitative composition in active
substances and the same pharmaceutical form as the reference medicinal
product, and whose bioequivalence with the reference medicinal product has
been demonstrated by appropriate bioavailability studies. The different salts,
esters, ethers, isomers, mixtures of isomers, complexes or derivatives of an
active substance shall be considered to be the same active substance, unless
they differ significantly in properties with regard to safety and/or efficacy. In
such cases, additional information providing proof of the safety and/or efficacy
of the various salts, esters or derivatives of an authorized active substance must
be supplied by the applicant. The various immediate-release oral pharmaceutical
forms shall be considered to be one and the same pharmaceutical form.
Bioavailability studies need not be required of the applicant if he can
demonstrate that the generic medicinal product meets the relevant criteria as
defined in the appropriate detailed guidelines. This directive is aimed to avoid
ever greening of patents.

Micro-organisms:

No Comments.

Indian Pharmaceutical Alliance

New Chemical Entity:

It would be TRIPS compatible to limit the grant of patent to new chemical

entities or new medical entity involving one or more inventive steps.

Micro-organisms:

No Comments.

29
Affordable Medicines & Treatment Campaign

New Chemical Entity:

The terms ‘New chemical entity’ and ‘new medical entity’ are not inter
changeable terms and each term has its own legal meaning.

The specific terminology used in the patent legislation can make a significant
difference in expanding or alternatively restricting the scope of patentability,
directly affecting access to affordable drugs. Expanding the scope of
patentability will lead to greater number of drugs being patented adversely
affecting access to affordable drugs. On the other hand restricting that scope of
patentability will prevent trivial patenting of drugs leading to access to cheaper
generic drugs.

The term ―new chemical entity‖ is normally restricted only to mean a new
chemical substance, which is not known earlier. On the other hand the term
―new medical entity‖ is an expansive term which includes different forms of the
same chemical entity i.e. usage form, dosage form, salt form, etc. Hence all new
chemical entities are new medical entities but all new medical entities are not
new chemical entities.

The limiting the scope of patentability is absolutely necessary for India not only
to address the public health concerns but also for the survival of the domestic
pharmaceutical industry. To effectively limit the scope of patentability the
criteria of novelty, inventive step and industrial application should be defined as
per national interests. This is to be done by amending the definitions of
patentable criteria in the present Patents Act. Further, the definition of
pharmaceutical substance to be replaced with a new definition and this definition
should be then linked to the provisions and exclusions mentioned in Section 3 of
the Act.

It would be TRIPS compatible to limit the grant of patent to new chemical

entities.

Micro-organisms:

No Comments.

The International Association for the Protection of

Industrial Property (AIPPI) (India Group)

New Chemical Entity:

The AIPPI (Indian Group) felt that the current exclusions should follow the
TRIPS Agreement and the explanation to Section 3(d) should be deleted.

The Group felt that NCE is not a "patent" term but a "regulatory" term and it is
not appropriate to define the said term in the Act.

The Group felt that Section 3(d) which prevailed between the period 1 st January,

30
 2005 to 8th April 2005 was the best and that the word 'mere' ought to be
restored in the Section. The Group also felt that the Ordinance 2004 amended
Section 3(d) to ensure that what is not patentable is only mere new use. If a
second medical indication or therapeutic use of a known drug molecule passes
the test that it is not a mere new use- as per the Ordinance it would have been
patentable. The Patents Amendment Act, 2005 changed this position. Instead, it
contains a rather too long explanation on the exemption to patentability under
Section 3(d). According to this Section what is not patentable is:

a) The mere discovery of a new form of a known substance, which

does not result in the enhancement of the known efficacy of that
substance;
b) The mere discovery of any new property or new use for a known
substance; and
c) The mere use of a known process, machine or apparatus unless
such process results in a new product or employs at least one
new reactant.

Consequently, if a discovery of a new form of a known drug molecule results in

an enhancement of its known efficacy, it is patentable. However, the mere
discovery of a new use of a known substance is not patentable. The amended
Section 3(d) when read in conjunction with Section 3(i) would ensure that all
method of use inventions are non-patentable. A joint reading of the amended
Section 3(d) and Section 3(i) is capable of keeping a major portion of
pharmaceutical R&D outside the scope of patents.

If this cannot be done then at least the explanation to the said Section ought
to be deleted under the present Act so that the Section should go back to its
old form prior to the 1st of January, 2005.

The Group also felt that substantial and unexpected qualitative departure of
properties of the claimed NCE should qualify for inventiveness. When there is a
significant difference in effectiveness or utility compared to basic compounds,
salts, esters, derivatives, isomers, purified forms, complexes, hydrates,
crystalline forms, etc., should be considered as having inventive merit. The
Group made the following suggestions:

(i) The Explanation to Section 3 (d) of Patents Act should be

deleted.
(ii) 'New Chemical Entity' is not a patent term but only a regulatory
term and it is not appropriate to define it in the Patents Act.

Micro-organisms:

 An inconsistency exists between the actual laws which are based upon the
general principle that a living organism per se cannot be the subject matter of a
patent, and the state of science which nowadays makes it possible to describe
and repeat procedures for the modification of a living organism.
 Patent protection for particular biotechnological inventions exists in most
countries.
 Processes involving the industrial use of living organisms are generally
patentable.

31
 Micro-organisms per se and other biological materials, including plants, per se,
are patentable in many countries.
 Plants and even animals are also protectable in some countries by special rights.
 AIPPI re-affirms the principle that inventions relating to living organisms, be they
micro-organisms, plants, animals or parts thereof, or to other biological material
or to processes for obtaining or using them should be patentable on the sole
condition that they comply with the usual criteria of patentability. The Resolution
of Rio de Janeiro, which laid down this principle has been well accepted and has
had a positive influence on the ongoing work in WIPO.
 Resolution : A new Special Arrangement under Article 15 of the Paris
Convention should be made, providing for:
 deposition in a culture collection of the micro-organism (s)
described in a patent specification and not available to the public
as a requisite for grant of a patent;
 deposition in one culture collection approved under this
Arrangement as being sufficient to meet the requirements of all
States parties to this Arrangement;
 deposition on or before the filing of the first patent application
(with the possibility of formal details of deposition being
furnished, later within a prescribed period.
 The following suggestions are made:
(i) Exclusion of patenting of micro-organisms might be violative of
TRIPS. Only the scope of the term should be clarified.

(ii) The broadest definition for micro-organisms should be used. The

definition should be a guideline or directive rather than a statutory
definition.
(iii) Cell lines should not be excluded from patentability.

Lex Orbis

New Chemical Entity:

(i) It would be TRIPS violative if Indian Patent Law expressly excludes non-NCE
Pharmaceutical product inventions from patentability

(ii) The possibility of setting a high threshold with Section 3 (d) to justify the
exclusion of non-NCE pharmaceutical substances from patentability is to be
explored;

Micro-organisms:

(a) Article 27(3)(b) of TRIPS mandates WTO Members not to exclude "micro-
organisms", "non-biological" and "microbiological processes" from the scope of
patentability. Thus under Article 27(3) (b) of TRIPS, the Members are under
obligation to provide patents for micro-organisms.
(b) In order to bring the Indian law in compliance with the aforesaid TRIPS
provisions, a new clause to Section 3 was added in the Indian Patents Act (by
the Patents (Amendment) Act, 2002) which excluded from patentability, plants
and animals in whole or any part thereof other than micro-organisms but
including seeds, varieties and species and essentially biological processes for
production or propagation of plants and animals.

32
 (c) Thus TRIPS and the Indian law clearly provide that 'micro-organisms' are
patentable. As such, it will violate TRIPS if 'micro-organisms' per se are excluded
from the scope of patentability. The approach, therefore, has to be more
'definitional' and 'interpretative' than a blanket direct exclusion that attracts yet
another dispute at the WTO. The key question that follows is - whether it is
possible for India to adopt a very narrow and limited definition of 'micro-
organisms' to exclude everything other than "microscopic organisms including
ONLY algae, bacteria, fungi, protozoa and viruses. In the alternative, should
there be an expansive definition of 'micro-organism' to include within its scope all
'biological materials' containing genetic information and capable of reproducing
itself or being reproduced in a biological system (as in the Europe).
(d) It could be in India's national interests to make 'micro-organisms' patentable and
also to provide an expanded definition of 'micro-organism' so as to include in its
scope 'biological materials' including DNA fragments, genes, and proteins as
China provides.
(e) An alternative approach is to adopt the European approach (European Directive
(98/44/EC) and provide for a further broader definition of "Biological material" to
include "any material containing genetic information and capable of reproducing
itself or being reproduced in a biological system" and bring that under the scope
of patentable subject matter.
(f) An explanation to Section 3(j)- could be added with a balanced definition on the
following lines:

Explanation - for purposes of this clause, "micro-organism" means only

microscopic organisms including algae, bacteria, fungi, protozoa, viruses, DNA
fragments, genes, and proteins.

Crop Life

New Chemical Entity:

The discovery and development of a new molecule is an expensive proposition in

developed countries, a new drug cost about $1 billion for a new pesticide
molecule, the cost is about $ 300 million. In India, all this could be done at a
much lower cost.

Still, the cost would be huge, about $ 300 million (Rs. 1,350 Crore) for a new
drug; Indian companies at their current level of R & D spending (5-7 percent of
their turnover) are not in a position to undertake such a high level of investment

Besides, the risk is very high. But incremental innovations are well within their
reach. Our laws should promote these. This will enable our Scientists to put their
creativity to best use. When Indian companies can tap these opportunities
abroad (where these innovations are patentable), why not our own turf?

Patenting of incremental innovations should not be confused with the so called

ever greening of a patent. Such a situation could arise only when the patentee
having already enjoyed the 20-year term of his innovation, gets a further
extension. The Patent office will simply not allow this.

The patenting of a new dosage from, say, liquid of an existing medicine is a

totally impendent step. It does nothing to extend the patent term of the

33
medicine in its original form (solid) which on its expiry becomes open to
competitors to come up with generic versions.

In order to give desired incentive for innovations at all levels, the Patent Law
should provide for patenting of new forms, new uses and new formulations as
well as combinations of known compounds so long as these fulfil three fold
criteria of novelty, inventive step and capable of industrial application.

Micro-organisms:

No Comments.

Bradly Codon and Tapen Sinha

New Chemical Entity:

In the context of global and neglected diseases, uniformity of TRIPS obligations

relating to patented medicine impose unnecessarily high costs on users and poor
distribution of costs and benefits among producers and users of intellectual
property. Uniform rules can have disparate effects that worsen inequalities rather
than correct them. To achieve the correct balance between the rights of
producers and users of patented medicine, a broader range of factors must be
taken into account than are currently used in the WTO and UN contexts.

Micro-organisms:

No Comments.

Medicine San Frontiers, France

New Chemical Entity:

This submission approaches this question with an incremental approach-dividing

pharmaceutical product related inventions other than New Chemical Entities
(NCEs) into different categories, in particular new uses and new forms of known
compounds and examining the patentability or otherwise of those categories.

Based on the provisions of the TRIPS Agreement and taking the present Indian
legislation as a guide [especially Section 3(d)], it is argued that it is TRIPS
compatible to exclude, as the present Indian legislation does, new uses of
known compounds as new forms of known substances that fail to meet the
requisite threshold tests. The determination of where the threshold tests (for
example the meaning of 'mere' discovery, and the requirements for efficacy and
inventive step) will be set is critical in determining which other inventions, other
than NCEs will be patentable.

The logical end-point of a process of raising the thresholds required would be a

position where only NCEs would be regarded as patentable.

Micro-organisms:

No Comments.

34
 Organisation of Pharmaceutical Producers of India (OPPI)

New Chemical Entity:

Restricting Patentability to NCEs would have significant negative consequences

for the discovery and developments of future treatments for all disease areas
and also will be an area of concern to all investors, domestic and foreign because
of the precedent it sets for the treatment of Intellectual Property in India.

Micro-organisms:

A clear definition of micro-organism needs to be provided.

I.P. Institute, London:

New Chemical Entity:

1. Limiting the grant of patents to NCEs/NMEs and thereby excluding other

categories of pharmaceutical inventions the 'proposed exclusion‘ is likely to
contravene the mandate under Article 27 of TRIPS to grant of patents to all
'inventions'. Neither Articles 7 and 8 nor the Doha Declaration can be used to
derogate from this specific mandate under Article 27.

2. The proposed exclusion amounts to an unjustified differentially

disadvantageous treatment of pharmaceutical inventions and is therefore likely
to violate the 'non discrimination' mandate under Article 27.

3. It the aim of the proposed exclusion is to prevent a phenomenon loosely

referred to as 'ever-greening', this can be done by a proper application of
patentability criteria, as present in the current patent regime.

4. Lastly, it is important to distinguish the phenomenon of 'ever-greening' from

what is commonly referred to as 'incremental innovation'. While 'ever-greening'
refers to an undue extension of a patent monopoly, achieved by executing
trivial and insignificant changes to an already existing patented product,
'incremental innovations' are sequential developments that build on the original
patented product and may be of tremendous value in a country like India.
Therefore, such incremental development ought to be encouraged by the
Indian patent regime.

Micro-organisms:

India may not provide for a per se exclusion of ‗micro-organisms‘ from patentability.
However, should Indian policy imperatives require some limitation on the scope of
protection provided for ‗micro-organisms‘, the TRIPS agreement does provide some
latitude by which this might be achieved. It is suggested that

1. The term ‗micro-organism‘ could be defined in precise terms. However, this route
suffers from certain drawbacks and the TRIPS implications of such a solution are
not entirely clear.

35
2. The ‗discovery‘ exception could be strengthened by stipulating that mere isolation
or purification of a microorganism by known procedures will not render it
patentable. Rather, only truly ‗invented‘ microorganisms such as genetically
engineered ones would be granted patent protection. Here again, in the absence
of a WTO panel ruling on this or a related aspect of patent law, the extent to
which the ‗discovery‘ exception could be stretched without contravening TRIPS is
not absolutely certain.
3. In principle, the ‗morality‘ exception could be used to deny patents to micro-
organisms. However, this could not be done without, at the same time,
prohibiting any form of commercialisation of a micro-organism, a result that may
not fit well with the government‘s recent policy towards fuelling the growth of
the biotechnology industry.
4. The general patentability criteria (novelty, non obviousness, utility and written
description) could be tailored to specifically apply to patent applications claiming
micro-organisms. This could be in the form of examination guidelines to be
applied strictly by the patent office to ensure that only truly meritorious
inventions are granted patent protection.

On the various options, 2 and 4 may be best suited for India --- these options cater
appropriately to India‘s current policy imperatives (given its current socio-economic
realities), whilst at the same time remaining compliant with India‘s international
obligations under TRIPS.

K&S Partners

New Chemical Entity:

In general, the scope of protection granted in respect of a drug/chemical extends

to:
 The chemical that has been disclosed
 The application/use for which disclosed

It does not extend to

 Undisclosed derivatives, salts, esters etc which have a significant or
unexpected property or result
 Metabolites that may be formed upon ingestion of drug
 New use of the drug

Suggested approach:

In view of the above discussion regarding Section 3, it is suggested that the

Committee ought not to define the term "new chemical entity" or "new medical
entity".

However, should the Committee proceed to define this term, the following
workable definition is proposed:

Suggested definition:

"A new chemical entity is an entity that is new, not obvious to a person skilled in
the art in the form and for the application claimed".

36
 Final comments:

 Defining "new chemical/medical entity" is unwarranted as far as patent is

concerned.
 New chemical entity should never be the basis for patentability.
 If the definition of "new chemical/medical entity" limits or conflicts with
TRIPS Art 27 then it would violate TRIPS.
 Patent Act is for inventors, R&D institutions.

Micro-organisms:

With regard to higher life forms such as animals (e.g. Harvard mouse), WTO
Members retain the discretion to grant or not to grant patent protection.
However, as per TRIPS there is no discretion with regard to micro-organism
since micro-organism should be patentable in all countries.

TRIPS makes it mandatory for the Members to grant patent protection for micro-
organism. Hence, a law that does not provide patent protection for micro-
organisms is TRIP-violative.

Isolated' Vs. 'Genetically modified micro-organisms:

TRIPS (Article 27.3) does not distinguish between 'isolated' and 'genetically
modified micro-organisms'. The only criteria for patentability of micro-organisms
is novelty, non-obviousness and industrial applicability, implying thereby that any
substance (including microbes) that is new, non-obvious with utility ought to be
granted patent protection.

Any Member country implementing laws drawing distinctions between isolated

and genetically modified micro-organism would be violative of TRIPS.

Alternative Law Forum

New Chemical Entity:

No comments

Micro-organism:

It is important to devise proper novelty and non-obvious tests for the patenting
of micro-organisms, use the flexibilities available within TRIPS to set up
appropriate tests of novelty and non-obviousness for determining the
patentability of micro-organisms so as to avoid the granting of patents which
offer no or little inventiveness and ultimately would amount to discoveries.
As TRIPS allows Member States to define the scope of micro-organisms, patents
over micro-organisms should be strictly limited to the scientific definition of the
term, i.e. virus, bacteria, fungi, protozoa and algae. Member States are free to
determine the scope of invention. Therefore, the Patents Act should exclude the
patenting of materials found in nature, even if isolated or purified from plants
and animals.

37
By providing a scientific definition of micro-organism, the Patents Act should
exclude patents over genes, proteins, DNA sequences, cells, seeds, etc.
The prior art and novelty tests should be constructed in such a way that micro-
organisms known to perform a definite function or process in an environment be
recognised as already existing or known, in case the new claim is over the micro-
organism performing similar functions or processes in another environment or
organism.

Centre for Study of Global Trade System and Development

New Chemical Entity:

1. Pharmaceutical products with annual sales totalling nearly $1 billion in
Canada have had their market monopolies extended by ever greening
strategies under the patented medicines (Notice of Compliance) Regulations.
2. Brand-name drug companies have employed strategies under the
Regulations to extend their exclusive marketing rights on blockbuster drugs.
3. Health Canada approved only 16 new active substances in 2003, yet brand-
name drug companies added 103 patents to health Canada‘s Patent Register
in that same year.
4. Under the Regulations, brand-name drug companies are allowed to list
patents for uses of a drug; even through the drug is not approved for that
use by Health Canada. Patents can be listed to restart the automatic stay
even years after the basic patent on the drug has expired.
5. Policymaker‘ concerns - Various policymakers have expressed concerns
about the Regulations. The Romanow Report of November 28,2002 referred
to ever greening as a particular concern affecting the cost of drugs.
6. A particular concern with current pharmaceutical industry practice is the
process of ―ever greening,‖ whereby manufacturers of brand name drugs
make variations to existing drugs to extend their patent coverage. This
delays the ability of generic manufacturers to develop cheaper products for
the marketplace and is a questionable outcome of Canada‘s patent law.
7. A number of examples illustrate the use of multiple-patent strategies to keep
generic products off the market in Canada and the U.S. has been employed
increasingly for block-buster drugs whose basic patents have expired, to
extend market exclusivity as long as possible.
8. It is important to ensure that such ever greening as in Canada does not
happen in India.

38
 ANNEXURE IV

PCT Applications filed by Indians in the field of drug and

pharmaceuticals (mostly pertaining to different forms of
same substance)
Sr.
PCT Application / Title Assignee
No.
(WO 2001/097775) CONTROLLED RELEASE ANTI-
1 AJANTA PHARMA LIMITED
INFLAMMATORY FORMULATION
(WO 2006/080029) EXTENDED RELEASE FORMULATION OF
2 ALEMBIC LIMITED
LEVETIRACETAM
(WO 2006/046256) EXTENDED RELEASE FORMULATION OF
3 ALEMBIC LIMITED
PRAMIPEXOLE DIHYDROCHLORIDE
(WO 2004/108117) EXTENDED RELEASE OSMO-
4 ALEMBIC LIMITED
MICROSEALED FORMULATION COMPRISING VENLAFAXINE
(WO 2000/009071) A NOVEL LIPOSOMAL FORMULATION
ALL INDIA INSTITUTE OF
5 USEFUL IN TREATMENT OF CANCER AND OTHER
MEDICAL SCIENCES
PROLIFERATION DISEASES
(WO 2006/123243) PHARMACEUTICAL DOSAGE FORMS OF AUROBINDO PHARMA
6
AN ANTIDEPRESSANT LIMITED
(WO 2006/111853) STABLE SOLID DOSAGE FORMS OF ACID AUROBINDO PHARMA
7
LABILE DRUG LIMITED
(WO 2006/109175) SOLID DOSAGE FORM OF AN AUROBINDO PHARMA
8
ANTIDIABETIC DRUG LIMITED
(WO 2006/087629) RAPIDLY DISINTEGRATING AUROBINDO PHARMA
9
COMPOSITION OF OLANZAPINE LIMITED
(WO 2006/082523) PHARMACEUTICAL SUSTAINED RELEASE AUROBINDO PHARMA
10
COMPOSITION OF METFORMIN LIMITED
(WO 2006/054175) STABLE DOSAGE FORMS OF ACID LABILE AUROBINDO PHARMA
11
DRUG LIMITED
(WO 2006/100602) IMMEDIATE RELEASE STABLE SOLID
12 AUROBINDO PHARMA LTD
DOSAGE FORMS OF AN ANTIHYPERTENSIVE DRUG
(WO 2006/035313) SOLID UNIT DOSAGE FORMS OF 5-HT1
13 AUROBINDO PHARMA LTD
AGONIST
(WO 2005/060942) EXTENDED RELEASE PHARMACEUTICAL
14 AUROBINDO PHARMA LTD
COMPOSITION OF METFORMIN
(WO 2006/021965) EUKARYOTIC BASED SYNERGISTIC BHARAT BIOTECH
15
FORMULATION FOR GASTRO-INTESTINAL DISORDERS INTERNATIONAL LIMITED
(WO 2002/069983) AMPHOTERICIN B AQUEOUS BHARAT SERUMS &
18
COMPOSITION VACCINES LTD.
(WO 2001/097796) CLEAR AQUEOUS ANAESTHETIC BHARAT SERUMS &
19
COMPOSITION VACCINES LTD.
(WO 2004/022699) LIQUID STABLE COMPOSITION OF BHARAT SERUMS AND
20
OXAZAPHOSPHORINE WITH MESNA VACCINES LTD.
(WO 2002/100438) ORAL CONTROLLED RELEASE DRUG
BLUE CROSS
21 DELIVERY SYSTEM WITH HUSK POWDER FROM LEPIDIUM
LABORATORIES LIMITED
SATIVUM SEEDS

39
Sr.
PCT Application / Title Assignee
No.
(WO 2005/123134) A CONTROLLED RELEASE DELIVERY CADILA HEALTHCARE
25
SYSTEM FOR METFORMIN LIMITED
(WO 2005/107716) CONTROLLED RELEASE PAROXETINE- CADILA HEALTHCARE
26
CONTAINING TABLETS BASED ON A CORE AND A COATING LIMITED
CADILA HEALTHCARE
27 (WO 2004/106322) POLYMORPHS OF ARIPIPRAZOLE
LIMITED
CADILA HEALTHCARE
28 (WO 2004/002445) NOVEL FLOATING DOSAGE FORM
LIMITED
(WO 2003/086343) FAST DISINTEGRATING ORAL DOSAGE CADILA HEALTHCARE
30
FORMS LIMITED
(WO 1999/049875) THE PROCESS FOR THE PREPARATION
CADILA
OF A STABLE FIXED DOSE PHARMACEUTICAL COMPOSITION
31 PHARMACEUTICALS (E.A.)
OF ANTI INFECTIVE AGENT/AGENTS AND MICRO
LTD.
ORGANISMS AS ACTIVE INGREDIENTS
(WO 2005/076748) THERAPEUTIC COMPOSITION AND
32 CHODAVARAPU, Janakiram
METHOD FOR PREPARING FROM DODONAEA SP
(WO 2001/032185) A PHARMACEUTICAL COMPOSITION
35 CONTAINING BISPHOSPHONIC ACID(S) OR SALT(S) CIPLA LTD.
THEREOF AND A PROCESS OF PREPARING THEREOF
(WO 2001/032143) A PHARMACEUTICAL COMPOSITION FOR
THE ADMINISTRATION OF WATER-INSOLUBLE
36 CIPLA LTD.
PHARMACEUTICALLY ACTIVE SUBSTANCES AND A PROCESS
FOR PREPARATION THEREOF
COUNCIL OF SCIENTIFIC
(WO 2006/067807) PHARMACEUTICAL COMPOSITION FOR
37 AND INDUSTRIAL
THE TREATMENT OF INVASIVE PULMONARY ASPERGILLOSIS
RESEARCH
COUNCIL OF SCIENTIFIC
(WO 2006/067537) A SYNERGISTIC ANTIPYRETIC
43 AND INDUSTRIAL
FORMULATION
RESEARCH
COUNCIL OF SCIENTIFIC
(WO 2004/087127) SYNERGISTIC HEPATOPROTECTIVE
47 AND INDUSTRIAL
COMPOSITION AND A METHOD THEREOF
RESEARCH
(WO 2004/084852) NONTOXIC DENTAL CARE HERBAL COUNCIL OF SCIENTIFIC
55 FORMULATION FOR PREVENTING DENTAL PLAQUE AND AND INDUSTRIAL
GINGIVITIS RESEARCH
(WO 2003/080847) CATIONIC AMPHIPHILES FOR COUNCIL OF SCIENTIFIC
56 INTRACELLULAR DELIVERY OF THERAPEUTIC MOLECULES AND INDUSTRIAL
ITS COMPOSITION, PROCESS AND USE THEREOF RESEARCH
(WO 2003/080081) SYNERGISTIC COMPOSITION OF TRANS- COUNCIL OF SCIENTIFIC
60 TETRACOS-15-ENOIC ACID AND APOCYNIN AND USE AND INDUSTRIAL
THEREOF RESEARCH
(WO 2003/080052) A USE OF TREATMENT FOR FUNGAL COUNCIL OF SCIENTIFIC
66 INFECTIONS WITH A SYNERGISTIC FORMULATION OF AND INDUSTRIAL
ANTIFUNGAL AGENTS RESEARCH
COUNCIL OF SCIENTIFIC
(WO 2001/074353) A SYNERGISTIC ANTI-MALARIAL
68 AND INDUSTRIAL
FORMULATION
RESEARCH
(WO 2001/072317) FORMULATION COMPRISING THYMOL COUNCIL OF SCIENTIFIC
73 USEFUL IN THE TREATMENT OF DRUG RESISTANT AND INDUSTRIAL
BACTERIAL INFECTIONS RESEARCH

40
Sr.
PCT Application / Title Assignee
No.
COUNCIL OF SCIENTIFIC
(WO 2001/072304) A NOVEL ANTI-MICROBIAL
74 AND INDUSTRIAL
COMPOSITION AND METHOD FOR PRODUCING THE SAME
RESEARCH
(WO 2004/032972) AN ORAL FORMULATION OF
DABUR RESEARCH
75 METHYLGLYOXAL AND ITS IMINO ACID CONJUGATES FOR
FOUNDATION
HUMAN USE
(WO 2002/094256) LYSINE AND/OR ANALOGUES AND/OR
78 POLYMERS THEREOF FOR PROMOTING WOUND HEALING DATTA, Debatosh
AND ANGIOGENESIS
(WO 2003/066612) NOVEL POLYMORPHIC FORMS OF
BICYCLIC ANTIDIABETIC AGENTS: PROCESS FOR THEIR DR. REDDY'S
79
PREPARATION AND PHARMACEUTICAL COMPOSITIONS LABORATORIES LIMITED
CONTAINING THEM
(WO 2003/013480) IMPROVED ENTERIC FORMULATION OF DR. REDDY'S
80
FLUOXETIN LABORATORIES LTD.
(WO 2002/069936) PHARMACEUTICAL COMPOSITION OF DR. REDDY'S
81
IBUPROFEN LABORATORIES LTD.
(WO 2000/063192) NOVEL POLYMORPHIC FORMS OF AN
DR. REDDY'S RESEARCH
82 ANTIDIABETIC AGENT: PROCESS FOR THEIR PREPARATION
FOUNDATION
AND PHARMACEUTICAL COMPOSITIONS CONTAINING THEM
(WO 2000/063191) NOVEL POLYMORPHIC FORMS OF AN
DR. REDDY'S RESEARCH
83 ANTIDIABETIC AGENT: PROCESS FOR THEIR PREPARATION
FOUNDATION
AND A PHARMACEUTICAL COMPOSITION CONTAINING THEM
(WO 2001/035943) DEXTROSE AND INSULIN FLUID
84 GANGAL, Hanamaraddi, T.
FORMULATION FOR INTRAVENOUS INFUSION
(WO 2006/090268) PROCESSES FOR THE PREPARATION OF GLENMARK
85 ALFUZOSIN AND SALTS THEREOF AND NOVEL CRYSTALLINE PHARMACEUTICALS
FORMS OF ALFUZOSIN LIMITED
(WO 2005/046648) EXTENDED RELEASE PHARMACEUTICAL
GLENMARK
87 DOSAGE FORMS COMPRISING ALPHA-2 AGONIST
PHARMACEUTICALS LTD.
TIZANIDINE
(WO 2004/089935) NOVEL CRYSTALLINE FORMS OF S-
90 HETERO DRUGS LIMITD
OMEPRAZOLE MAGNESIUM
(WO 2006/103688) A NOVEL CRYSTALLINE FORM OF
95 HETERO DRUGS LIMITED
RUPATADINE FREE BASE
(WO 2004/089952) NOVEL CRYSTALLINE FORMS OF
96 HETERO DRUGS LIMITED
ABACAVIR SULFATE
(WO 2004/089281) NOVEL POLYMORPHS OF TOLTERODINE
100 HETERO DRUGS LIMITED
TARTRATE
(WO 2004/087688) NOVEL CRYSTALLINE FORMS OF
101 HETERO DRUGS LIMITED
GATIFLOXACIN
(WO 2004/085416) NOVEL CRYSTALLINE FORMS OF (S)-
102 HETERO DRUGS LIMITED
CITALOPRAM OXALATE
(WO 2004/083191) NOVEL CRYSTALLINE FORMS OF
103 HETERO DRUGS LIMITED
LAMOTRIGINE
(WO 2004/083183) NOVEL CRYSTALLINE FORMS OF
104 HETERO DRUGS LIMITED
ARIPIPRAZOLE
(WO 2004/076443) AMORPHOUS FORM OF LOSARTAN
105 HETERO DRUGS LIMITED
POTASSIUM
106 (WO 2004/076417) NOVEL CRYSTALLINE FORMS OF HETERO DRUGS LIMITED

41
Sr.
PCT Application / Title Assignee
No.
TRANDOLAPRIL
107 (WO 2004/074350) BICALUTAMIDE POLYMORPHS HETERO DRUGS LIMITED
(WO 2004/100682) A NOVEL COMPOSITION OF COMPLEX
108 METAL SALT OF GARCINIA ACID, A PROCESS FOR INDFRAG LIMITED
PREPARING THE SAME AND USE THEREOF
(WO 2004/100968) A SYNERGISTIC COMPOSITION FOR THE
109 INDUS BIOTECH PVT. LTD.
TREATMENT OF DIABETES MELLITUS
(WO 2006/109318) NOVEL POLYMORPH OF 3-HYDROXY-3- IPCA LABORATORIES
110
(3‘-SULFAMYL-4‘-CHLOROPHENYL)PHTHALIMIDINE LIMITED
111 (WO 2002/043707) PHARMACEUTICAL FORMULATION KHAN, Abdul Rehman
(WO 2005/102289) CLARITHROMYCIN EXTENDED RELEASE
129 LUPIN LIMITED
FORMULATION
(WO 2005/030178) EXTENDED RELEASE FORMULATION OF
138 LUPIN LTD.
BETA-LACTAM ANTIBIOTICS
(WO 2005/065682) RABEPRAZOLE CONTAINING
149 LYKA LABS LIMITED
FORMULATION
(WO 2006/054316) METHOD(S) OF PREPARATION,
MAGENE LIFE SCIENCES
150 STABILIZATION, COMPOSITION, AND ADMINISTRATION OF
PRIVATE LIMITED
GAMMA-LINOLENIC ACID FOR BRAIN TUMORS
(WO 2005/115423) USING ORGANIC AND/OR INORGANIC
POTASSIUM AND ITS SALTS TO TREAT AUTOIMMUNE AND
151 MEDASANI, Munisekhar
OTHER HEALTH DISORDERS AND METHODS OF
ADMINISTERING THE SAME
(WO 2005/092356) A NOVEL HERBAL COMPOSITION FOR
MEENAKSHISUNDARAM,
152 TREATING HIV/AIDS AND FUNGAL INFECTIONS SECONDARY
Palaniappan
TO HIV
MEGA LIFESCIENCES PVT.
153 (WO 2006/123354) ORAL PHARMACEUTICAL COMPOSITION
LTD.
(WO 2005/115090) A HERBAL COMPOSITION HAVING
154 POTENT ANTIMICROBIAL AND WOUND HEALING MEHTA, Dilip, Sukhlal
PROPERTIES
(WO 2006/048894) NOVEL CRYSTALLINE FORMS OF
MOREPEN LABORATORIES
155 ATORVASTATIN CALCIUM AND PROCESSES FOR PREPARING
LIMITED
THEM.
(WO 2004/084855) KERATOLYTIC COMPOSITION WITH
156 MUNISEKHAR, Medasani
ANTI-ALLERGIC ANTI-INFLAMMATORY PROPERTIES
(WO 2006/082598) NOVEL CRYSTALLINE FORMS OF
159 NATCO PHARMA LIMITED
RIZATRIPTAN BENZOATE
(WO 2006/054314) POLYMORPHIC FORMS OF IMATINIB
161 NATCO PHARMA LIMITED
MESYLATE
(WO 2006/040779) CONTROLLED RELEASE GASTRIC
162 NATCO PHARMA LIMITED
FLOATING MATRIX FORMULATION CONTAINING IMATINIB
(WO 2005/105036) CONTROLLED RELEASE MUCOADHESIVE
163 MATRIX FORMULATION CONTAINING TOLTERODINE AND A NATCO PHARMA LIMITED
PROCESS FOR ITS PREPARATION
(WO 2005/077933) NOVEL POLYMORPHIC FORM OF
164 IMATINIB MESYLATE AND A PROCESS FOR ITS NATCO PHARMA LIMITED
PREPARATION
(WO 2005/053659) AN IMPROVED PHARMACEUTICAL
165 NATCO PHARMA LIMITED
FORMULATION CONTAINING TAMSULOSIN SALT AND A

42
Sr.
PCT Application / Title Assignee
No.
PROCESS FOR ITS PREPARATION

(WO 2004/098573) AN IMPROVED AND STABLE

PHARMACEUTICAL COMPOSITION CONTAINING
166 NATCO PHARMA LIMITED
SUBSTITUTED BENZIMIDAZOLES AND A PROCESS FOR ITS
PREPARATION
(WO 2001/039836) A RAPID ACTING FREEZE DIRED ORAL
167 NATCO PHARMA LIMITED
PHARMACEUTICAL COMPOSITION FOR TREATING MIGRAINE
(WO 2001/035926) AN IMPROVED PHARMACEUTICAL
168 COMPOSITION FOR TREATING MALE ERECTILE NATCO PHARMA LIMITED
DYSFUNCTION
(WO 2001/064163) AN IMPROVED HERBAL COMPOSITION
NATURAL REMEDIES
169 HAVING ANTIALLERGIC PROPERTIES AND A PROCESS FOR
PRIVATE LIMITED
THE PREPARATION THEREOF
(WO 2004/032899) ANTIBIOTIC FORMULATION FOR ORCHID CHEMICALS &
170
INTRAMAMMARY ADMINISTRATION IN MILKING ANIMALS PHARMACEUTICALS LTD.
(WO 2004/019901) SUSTAINED RELEASE PHARMACEUTICAL ORCHID CHEMICALS &
172
COMPOSITION PHARMACEUTICALS LTD.
(WO 2004/016251) SUSTAINED RELEASE PHARMACEUTICAL ORCHID CHEMICALS AND
173
COMPOSITION OF A CEPHALOSPORIN ANTIBIOTIC PHARMACEUTICALS LTD.
(WO 2004/016250) SUSTAINED RELEASE PHARMACEUTICAL
174 ORCHID HEALTH CARE
COMPOSITION OF A CEPHALOSPORIN ANTIBIOTIC
(WO 2004/014390) NOVEL PHARMACEUTICAL COMPOSITION
175 ORCHID HEALTH CARE
OF CEFTIOFUR
(WO 2001/052897) THERAPEUTIC ANTI-INFLAMMATORY
176 AND ANALGESIC COMPOSITION CONTAINING SELECTIVE PANACEA BIOTEC LIMITED
COX-2 INHIBITORS
(WO 2001/039749) FAST DISSOLVING COMPOSITION WITH
177 PANACEA BIOTEC LIMITED
PROLONGED SWEET TASTE
(WO 2001/022791) CONTROLLED RELEASE COMPOSITIONS
178 PANACEA BIOTEC LIMITED
COMPRISING NIMESULIDE
(WO 2005/065685) CONTROLLED RELEASE
179 PHARMACEUTICAL COMPOSITION COMPRISING AN ACID- PANACEA BIOTEC LTD.
INSOLUBLE AND A BIOADHESIVE POLYMER
(WO 2005/065641) NON-DISINTEGRATING ORAL SOLID
180 PANACEA BIOTEC LTD.
COMPOSITION OF HIGH DOSE OF WATER SOLUBLE DRUGS
(WO 2005/065640) COMPOSITIONS OF BUCCAL DOSAGE
181 FORMS FOR EXTENDED DRUG RELEASE AND THE PROCESS PANACEA BIOTEC LTD.
OF PREPARING SUCH COMPOSITIONS
(WO 2000/013696) COMPOSITION FOR IMPROVING MENTAL
182 PANDITA, Maharaj, Krishen
CAPABILITIES IN MAMMALS
(WO 2004/108114) ANTI-FUNGAL COMPOSITION AND A
183 PATEL, Dinesh, Shantilal
PROCESS FOR ITS MANUFACTURE
(WO 2000/072884) A NOVEL FORMULATION OF N-(4-NITRO-
184 PATEL, Dinesh, Shantilal
2-PHENOXYPHENYL)METHANESULFONAMIDE
(WO 2006/046257) AN AYURVEDIC COMPOSITION AND
185 PROCESS FOR PREPARING THE COMPOSITION TO ACT AS PAWAR, Geeta, Pandurang
ANTI SNAKE-VENOM
(WO 2006/117616) POLYMORPHIC FORM I OF RANBAXY LABORATORIES
187
LUMEFANTRINE AND PROCESSES FOR ITS PREPARATION LIMITED

43
Sr.
PCT Application / Title Assignee
No.
(WO 2006/103551) CONTROLLED RELEASE FORMULATIONS RANBAXY LABORATORIES
188
OF OXYCODONE LIMITED
(WO 2006/100574) AMORPHOUS CEFDITOREN PIVOXIL
RANBAXY LABORATORIES
189 GRANULES AND PROCESSES FOR THE PREPARATION
LIMITED
THEREOF
(WO 2006/085208) STABLE SOLID DOSAGE FORMS OF RANBAXY LABORATORIES
190
AMLODIPINE AND BENAZEPRIL LIMITED
(WO 2006/085168) SOLID ORAL DOSAGE FORMS OF RANBAXY LABORATORIES
191
ZIPRASIDONE CONTAINING COLLOIDAL SILICONE DIOXIDE LIMITED
(WO 2006/077492) SUSTAINED RELEASE ORAL DOSAGE RANBAXY LABORATORIES
192
FORMS OF GABAPENTIN LIMITED
(WO 2006/072921) SWEETENER COMPOSITION OF STEVIA
RANBAXY LABORATORIES
194 EXTRACT AND MALTOL AND PROCESSES OF PREPARATION
LIMITED
THEREOF
(WO 2006/072878) ORAL DOSAGE FORMS OF SERTRALINE
RANBAXY LABORATORIES
195 HAVING CONTROLLED PARTICLE SIZE AND PROCESSES FOR
LIMITED
THEIR PREPARATION
(WO 2006/070248) METHODS FOR THE PREPARATION OF
RANBAXY LABORATORIES
196 STABLE PHARMACEUTICAL SOLID DOSAGE FORMS OF
LIMITED
ATORVASTATIN AND AMLODIPINE
(WO 2006/064304) ACID ADDITION SALTS OF MUSCARINIC RANBAXY LABORATORIES
197
RECEPTOR ANTAGONISTS LIMITED
(WO 2006/059217) STABLE SOLID DOSAGE FORMS OF
RANBAXY LABORATORIES
198 AMLODIPINE BESYLATE AND PROCESSES FOR THEIR
LIMITED
PREPARATION
(WO 2006/046114) OSMOTIC DOSAGE FORMS PROVIDING
RANBAXY LABORATORIES
199 ASCENDING DRUG RELEASE, AND PROCESSES FOR THEIR
LIMITED
PREPARATION
RANBAXY LABORATORIES
200 (WO 2006/046105) OXCARBAZEPINE DOSAGE FORMS
LIMITED
(WO 2006/046100) PHARMACEUTICAL COMPOSITION OF RANBAXY LABORATORIES
201
ALENDRONIC ACID LIMITED
(WO 2006/046096) A POLYMORPHIC FORM OF NARWEDINE RANBAXY LABORATORIES
202
AND ITS USE IN THE SYNTHESIS OF GALANTAMINE LIMITED
(WO 2006/040643) POLYMORPHIC FORMS OF EFAVIRENZ RANBAXY LABORATORIES
203
AND PROCESSES FOR THEIR PREPARATION LIMITED
(WO 2006/035293) POLYMORPHIC FORMS OF QUETIAPINE RANBAXY LABORATORIES
204
HEMIFUMARATE LIMITED
(WO 2006/035291) CRYSTALLINE FORMS OF CEFDINIR RANBAXY LABORATORIES
205
POTASSIUM LIMITED
(WO 2006/035286) PROCESS FOR PREPARATING
RANBAXY LABORATORIES
206 ENANTIOMERICALLY PURE FLUVASTATIN SODIUM AND A
LIMITED
NOVEL POLYMORPHIC FORM THEREOF
(WO 2006/035277) NOVEL PROCESSES FOR PREPARING
RANBAXY LABORATORIES
207 AMORPHOUS ROSUVASTATIN CALCIUM AND A NOVEL
LIMITED
POLYMORPHIC FORM OF ROSUVASTATIN SODIUM
(WO 2006/030303) ORAL EXTENDED RELEASE DOSAGE
RANBAXY LABORATORIES
208 FORM COMPRISING A HIGH DOSE BIGUANIDE AND A LOW
LIMITED
DOSE SULFONYLUREA

44
Sr.
PCT Application / Title Assignee
No.
(WO 2006/025029) EXTENDED RELEASE COMPOSITION OF RANBAXY LABORATORIES
209
DIVALPROEX LIMITED
RANBAXY LABORATORIES
211 (WO 2006/018807) CRYSTALLINE FORMS OF CEFDINIR
LIMITED
(WO 2006/003587) SOLID ORAL DOSAGE FORMS OF RANBAXY LABORATORIES
212
AZABICYCLO DERIVATIVES LIMITED
(WO 2005/123721) AMORPHOUS AND POLYMORPHIC FORMS RANBAXY LABORATORIES
213
OF CANDESARTAN CILEXETIL LIMITED
(WO 2005/123137) LYOPHILIZED PHARMACEUTICAL
RANBAXY LABORATORIES
214 COMPOSITION COMPRISING MOXIFLOXACIN
LIMITED
HYDROCHLORIDE
(WO 2005/107717) ORAL DOSAGE FORM FOR THE RANBAXY LABORATORIES
215
EXTENDED RELEASE OF BIGUANIDE AND SULFONYLUREA LIMITED
(WO 2005/099672) A MODIFIED RELEASE PHARMACEUTICAL
RANBAXY LABORATORIES
216 FORMULATION COMPRISING AMOXICILLIN AND
LIMITED
CLAVULANATE
(WO 2005/092886) PROCESS FOR THE PREPARATION OF RANBAXY LABORATORIES
217
AMORPHOUS FORM OF TIAGABINE LIMITED
(WO 2005/092852) PROCESS FOR THE PRODUCTION OF RANBAXY LABORATORIES
219
ATORVASTATIN CALCIUM IN AMORPHOUS FORM LIMITED
(WO 2005/090301) CRYSTALLINE FORM OF ATORVASTATIN RANBAXY LABORATORIES
220
HEMI CALCIUM LIMITED
(WO 2005/087198) PROCESSES FOR THE PREPARATION OF
RANBAXY LABORATORIES
221 SOLID DOSAGE FORMS OF AMORPHOUS VALGANCICLOVIR
LIMITED
HYDROCHLORIDE
(WO 2005/084636) A PROCESS FOR THE PREPARATION OF
RANBAXY LABORATORIES
222 CONTROLLED-RELEASE PHARMACEUTICAL COMPOSITION OF
LIMITED
METOPROLOL
(WO 2005/082330) CO-PRECIPITATED AMORPHOUS
RANBAXY LABORATORIES
223 CEFDITOREN PIVOXIL AND DOSAGE FORMS COMPRISING
LIMITED
THE SAME
(WO 2005/082329) PROCESS FOR THE PREPARATION OF
RANBAXY LABORATORIES
224 SOLID DOSAGE FORMS OF VALSARTAN AND
LIMITED
HYDROCHLORTHIAZIDE
(WO 2005/077392) HERBAL FORMULATION COMPRISING
RANBAXY LABORATORIES
225 EXTRACTS OF WITHANIA, TINOSPORA AND PICRORHIZA AS
LIMITED
A PEDIATRIC TONIC
(WO 2005/077332) STABLE SUSTAINED-RELEASE ORAL
RANBAXY LABORATORIES
226 DOSAGE FORMS OF GABAPENTIN AND PROCESS FOR
LIMITED
PREPARATION THEREOF
(WO 2005/066196) AMORPHOUS FORM OF FINASTERIDE RANBAXY LABORATORIES
227
AND PROCESSES FOR ITS PREPARATION LIMITED
(WO 2005/051489) FAST DISSOLVING SOLID ORAL DOSAGE RANBAXY LABORATORIES
228
FORMS OF GALANTHAMINE LIMITED
(WO 2005/049003) EXTENDED RELEASE DOSAGE FORMS OF RANBAXY LABORATORIES
229
BUPROPION HYDROCHLORIDE LIMITED
(WO 2005/044238) MODIFIED RELEASE SOLID DOSAGE RANBAXY LABORATORIES
230
FORM OF AMPHETAMINE SALTS LIMITED
(WO 2005/040134) PROCESS FOR THE PREPARATION OF RANBAXY LABORATORIES
231
AMORPHOUS ROSUVASTATIN CALCIUM LIMITED

45
Sr.
PCT Application / Title Assignee
No.
(WO 2005/026140) PROCESS FOR THE PREPARATION OF RANBAXY LABORATORIES
232
CRYSTALLINE FORMS OF ORLISTAT LIMITED
(WO 2005/021000) SOLID ORAL DOSAGE FORMS OF RANBAXY LABORATORIES
233
GATIFLOXACIN LIMITED
(WO 2005/011666) STABLE SUSTAINED RELEASE ORAL RANBAXY LABORATORIES
234
DOSAGE FORM OF GABAPENTIN LIMITED
(WO 2005/009432) NEW DOSAGE REGIMEN IN CASE OF
RANBAXY LABORATORIES
235 CONCURRENT INTAKE OF GABAPENTIN WITH FOOD AND AN
LIMITED
INCREASED ORAL BIOAVAILABILITY THEREWITH
(WO 2004/105735) CONTROLLED RELEASE
RANBAXY LABORATORIES
236 PHARMACEUTICAL COMPOSITIONS OF TOLTERODINE AND
LIMITED
PROCESSES FOR THEIR PREPARATION
RANBAXY LABORATORIES
237 (WO 2004/104010) CRYSTALLINE FORM OF CEFDINIR
LIMITED
(WO 2004/103361) A PHARMACEUTICAL DOSAGE FORM OF RANBAXY LABORATORIES
238
CITALOPRAM LIMITED
(WO 2004/099229) PROCESS FOR THE SYNTHESIS OF BASE
ADDITION SALTS OF 2,3-0-ISOPROPYLIDENE-1-0-
RANBAXY LABORATORIES
239 SUBSTITUTED-5,6-DIDEOXY-5-N- (4-(2-HYDROXY-2-
LIMITED
OXOETHYL)-PHENYLAMINOCARBONYL) AMINO-L-
GULOFURANOSIDES
(WO 2004/098572) BIPHASIC RELEASE OF GLIPIZIDE FROM RANBAXY LABORATORIES
240
MONOCOMPARTMENT OSMOTIC DOSAGE FORM LIMITED
(WO 2004/082589) NASALLY ADMINISTRABLE,
RANBAXY LABORATORIES
241 BIOAVAILABLE PHARMACEUTICAL COMPOSITION OF
LIMITED
LORATADINE
RANBAXY LABORATORIES
242 (WO 2004/076442) POLYMORPHS OF LOSARTAN
LIMITED
RANBAXY LABORATORIES
243 (WO 2004/076440) POLYMORPHS OF S-OMEPRAZOLE
LIMITED
(WO 2004/075881) STABLE PHARMACEUTICAL
RANBAXY LABORATORIES
244 COMPOSITION OF RABEPRAZOLE AND PROCESSES FOR
LIMITED
THEIR PREPARATION
(WO 2004/075826) EXTENDED RELEASE, MULTIPLE UNIT
RANBAXY LABORATORIES
245 DOSAGE FORMS OF PHENYTOIN SODIUM AND PROCESSES
LIMITED
FOR THEIR PREPARATION
(WO 2004/075825) DOSAGE FORMS OF AMLODIPINE AND RANBAXY LABORATORIES
246
PROCESSES FOR THEIR PREPARATION LIMITED
(WO 2004/064834) CO-PRECIPITATED AMORPHOUS RANBAXY LABORATORIES
247
LOSARTAN AND DOSAGE FORMS COMPRISING THE SAME LIMITED
(WO 2004/056354) CONTROLLED RELEASE RANBAXY LABORATORIES
248
PHARMACEUTICAL COMPOSITIONS OF TAMSULOSIN LIMITED
(WO 2004/056336) CONTROLLED RELEASE, MULTIPLE UNIT RANBAXY LABORATORIES
249
DRUG DELIVERY SYSTEMS LIMITED
(WO 2004/054550) AN EXTENDED RELEASE RANBAXY LABORATORIES
250
PHARMACEUTICAL COMPOSITION OF PHENYTOIN SODIUM LIMITED
(WO 2004/052345) COATING COMPOSITION FOR TASTE
RANBAXY LABORATORIES
251 MASKING COATING AND METHODS FOR THEIR APPLICATION
LIMITED
AND USE

46
Sr.
PCT Application / Title Assignee
No.
(WO 2004/045622) PHARMACEUTICAL DOSAGE FORMS OF RANBAXY LABORATORIES
252
BIGUANIDE-SULFONYLUREA COMBINATIONS LIMITED
(WO 2004/045584) BUPROPION HYDROCHLORIDE SOLID RANBAXY LABORATORIES
253
DOSAGE FORMS LIMITED
(WO 2004/039352) AMORPHOUS FORM OF LOSARTAN RANBAXY LABORATORIES
254
POTASSIUM LIMITED
(WO 2004/010979) PROCESSES FOR THE PREPARATION OF RANBAXY LABORATORIES
255
ORAL DOSAGE FORMULATIONS OF MODAFINIL LIMITED
(WO 2004/004692) PROCESSES FOR THE PREPARATION OF RANBAXY LABORATORIES
261
ORAL DOSAGE FORMULATIONS OF MODAFINIL LIMITED
(WO 2003/103635) EXTENDED RELEASE FORMULATION OF RANBAXY LABORATORIES
262
DIVALPROEX SODIUM LIMITED
(WO 2003/103634) SUSTAINED RELEASE ORAL DOSAGE RANBAXY LABORATORIES
263
FORMS OF GABAPENTIN LIMITED
(WO 2003/084514) CONTROLLED RELEASE
RANBAXY LABORATORIES
264 PHARMACEUTICAL COMPOSITIONS OF CARBIDOPA AND
LIMITED
LEVODOPA
(WO 2003/049716) STABLE TOPICAL FORMULATION OF RANBAXY LABORATORIES
265
CLARITHROMYCIN LIMITED
(WO 2003/039527) CONTROLLED RELEASE TABLETS OF RANBAXY LABORATORIES
268
METFORMIN LIMITED
(WO 2003/028704) EXTENDED RELEASE PHARMACEUTICAL RANBAXY LABORATORIES
269
COMPOSITION CONTAINING METFORMIN LIMITED
(WO 2003/026610) PROCESS FOR THE PREPARATION OF RANBAXY LABORATORIES
270
FAST DISSOLVING DOSAGE FORM LIMITED
(WO 2003/017981) CONTROLLED RELEASE FORMULATION RANBAXY LABORATORIES
271
OF CLARITHROMYCIN OR TINIDAZOL LIMITED
RANBAXY LABORATORIES
272 (WO 2002/094774) OXCARBAZEPINE DOSAGE FORMS
LIMITED
(WO 2002/067943) ORAL PHARMACEUTICAL COMPOSITION RANBAXY LABORATORIES
273
OF CEFPODOXIME PROXETIL LIMITED
(WO 2002/047607) PROCESS FOR THE PREPARATION OF A RANBAXY LABORATORIES
275
FAST DISSOLVING DOSAGE FORM LIMITED
(WO 2002/024203) CONTROLLED RELEASE FORMULATIONS RANBAXY LABORATORIES
276
FOR ORAL ADMINISTRATION LIMITED
(WO 2002/017885) CONTROLLED RELEASE FORMULATION RANBAXY LABORATORIES
277
OF ERYTHROMYCIN OR A DERIVATIVE THEREOF LIMITED
(WO 2002/005816) A BIOAVAILABLE DOSAGE FORM OF RANBAXY LABORATORIES
278
LORATADINE LIMITED
(WO 2001/095886) BIOAVAILABLE DOSAGE FORM OF RANBAXY LABORATORIES
279
ISOTRETINOIN LIMITED
(WO 2001/019349) EXTENDED RELEASE FORMULATION OF RANBAXY LABORATORIES
280
ETODOLAC LIMITED
(WO 2000/071124) AMORPHOUS FORM OF FEXOFENADINE RANBAXY LABORATORIES
282
HYDROCHLORIDE LIMITED
283 (WO 2002/011716) LIQUID FORMULATION OF METFORMIN RANBAXY SIGNATURE LLC
(WO 2002/022158) SELFEMULSIFIABLE FORMULATION
RPG LIFE SCIENCES
286 HAVING ENHANCED BIOABSORPTION AND
LIMITED
IMMUNOSUPPRESSION ACTIVITIES

47
Sr.
PCT Application / Title Assignee
No.
(WO 2004/012701) NOVEL pH DEPENDENT ROBUST ENTERIC
288 POLYMERIC CONTAINER, AN IMPROVEMENT OVER EXISTING SCITECH CENTRE
ENTERIC DOSAGE FORMS.
(WO 2005/046567) SYNERGISTIC FORMULATION OF
293 ANTIOXIDANTS AND ANTIMYCOBACTERIAL AGENTS: A SHELGAONKAR, Meena
METHOD OF MAKING THE SAME
(WO 2003/011257) COMPOSITION AND PROCESS THE
294 MANUFACTURE OF SOLUBLE CONTAINERS WITH IMPROVED SINGH, Jasjit
GEL-STRENGTH
(WO 2006/097938) STABLE LIQUID SUSPENSION
STRIDES ARCOLAB
295 FORMULATION COMPRISING TIBOLONE AND PROCESS FOR
LIMITED
PRODUCING THE SAME
(WO 2005/120517) STABLE LIQUID SUSPENSION
STRIDES ARCOLAB
296 FORMULATION COMPRISING SYNTHETIC STEROIDS AND
LIMITED
PROCESS FOR PRODUCING THE SAME
(WO 2005/120459) PHARMACEUTICAL COMPOSITION
CONTAINING A STABLE AND CLEAR SOLUTION OF ANTI- STRIDES ARCOLAB
297
INFLAMMATORY DRUG IN SOFT GELATIN CAPSULE AND LIMITED
PROCESS FOR PRODUCING THE SAME
(WO 2003/101378) PHARMACEUTICAL FORMULATION IN A
STRIDES ARCOLAB
298 DRUG DELIVERY SYSTEM AND PROCESS FOR PREPARING
LIMITED
THE SAME
(WO 2003/070156) ORALLY ADMINISTRABLE
STRIDES ARCOLAB
299 PHARMACEUTICAL FORMULATION COMPRISING EPHEDRINE
LIMITED
HYDROCHLORIDE AND PROCESS FOR PREPARING THE SAME
(WO 2003/070155) ORALLY ADMINISTRABLE STRIDES ARCOLAB
300
PHARMACEUTICAL FORMULATION LIMITED
(WO 2003/070154) ORALLY ADMINISTRABLE
PHARMACEUTICAL FORMULATION COMPRISING STRIDES ARCOLAB
301
PSEUDOEPHEDRINE HYDROCHLORIDE AND PROCESS FOR LIMITED
PREPARING THE SAME
(WO 2002/092078) ORAL CONTROLLED RELEASE
PHARMACEUTICAL COMPOSITION FOR ONE-A-DAY THERAPY SUN PHARAMCEUTICAL
302
FOR THE TREATMENT AND PROPHYLAXIS OF CARDIAC AND INDUSTRIES LIMITED
CIRCULATORY DISEASES
(WO 2006/123358) STABLE ORAL PHARMACEUTICAL SUN PHARMACEUTICAL
303
COMPOSITION INDUSTRIES LIMITED
SUN PHARMACEUTICAL
304 (WO 2006/123357) PHARMACEUTICAL COMPOSITION
INDUSTRIES LIMITED
(WO 2005/115092) MICRONIZED ORAL PHARMACEUTICAL SUN PHARMACEUTICAL
305
COMPOSITION INDUSTRIES LIMITED
SUN PHARMACEUTICAL
306 (WO 2005/101982) A STABLE OPHTHALMIC COMPOSITION
INDUSTRIES LIMITED
(WO 2005/065047) STABLE ORAL COMPOSITION SUN PHARMACEUTICAL
307
CONTAINING DESLORATADINE INDUSTRIES LIMITED
(WO 2005/062722) FEXOFENADINE CONTAINING SUN PHARMACEUTICAL
308
PHARMACEUTICAL FORMULATION INDUSTRIES LIMITED
(WO 2005/046566) STABLE GABAPENTIN CONTAINING SUN PHARMACEUTICAL
309
COMPOSITION INDUSTRIES LIMITED

48
Sr.
PCT Application / Title Assignee
No.
(WO 2004/087648) STABILIZED PHENYTOIN CONTAINING SUN PHARMACEUTICAL
310
COMPOSITION INDUSTRIES LIMITED
(WO 2004/087043) STABLE OPHTHALMIC FORMULATION SUN PHARMACEUTICAL
311
CONTAINING AN ANTIBIOTIC AND A CORTICOSTEROID INDUSTRIES LIMITED
(WO 2004/082590) A LOW DOSE CORTICOSTEROID SUN PHARMACEUTICAL
312
COMPOSITION INDUSTRIES LIMITED
(WO 2003/026637) DOSAGE FORM FOR TREATMENT OF SUN PHARMACEUTICAL
314
DIABETES MELLITUS INDUSTRIES LIMITED
(WO 2003/011256) ORAL CONTROLLED RELEASE SUN PHARMACEUTICAL
318
PHARMACEUTICAL COMPOSITION OF A PROKINETIC AGENT INDUSTRIES LIMITED
(WO 2006/025070) NEBIVOLOL AND ITS
TORRENT
PHARMACEUTICALLY ACCEPTABLE SALTS, PROCESS FOR
319 PHARMACEUTICALS
PREPARATION AND PHARMACEUTICAL COMPOSITIONS OF
LIMITED
NEBIVOLOL
(WO 2004/012700) DOSAGE FORM COMPRISING HIGH DOSE
TORRENT
HIGH SOLUBLE ACTIVE INGREDIENT AS MODIFIED RELEASE
325 PHARMACEUTICALS
AND LOW DOSE ACTIVE INGREDIENT AS IMMEDIATE
LIMITED
RELEASE
(WO 2004/012699) MODIFIED RELEASE COMPOSITION
TORRENT
COMPRISING COATED MICRO MATRIX PARTICLES
329 PHARMACEUTICALS
CONTAINING THE HIGH SOLUBLE ACTIVE INGREDIENT AND
LIMITED
A RELEASE CONTROLLING AGENT
TORRENT
(WO 2003/104192) CONTROLLED RELEASE FORMULATION
330 PHARMACEUTICALS
OF LAMOTRIGINE
LIMITED
(WO 2006/095363) INJECTABLE PREPARATIONS OF
TROIKAA
331 DICLOFENIC AND ITS PHARMACEUTICALLY ACCEPTABLE
PHARMACEUTICALS LTD
SALTS
(WO 2006/008753) CRYSTALLINE AND AMORPHOUS FORM
UNICHEM LABORATORIES
332 OF RANOLAZINE AND THE PROCESS FOR MANUFACTURING
LIMITED
THEM
(WO 2006/100686) NOVEL POLYMORPH FORM G OF
333 FLUVASTATIN SODIUM AND PROCESS FOR THE USV LIMITED
PREPARATION THEREOF
(WO 2006/011154) A NOVEL POLYMORPH OF (1-BENZYL-4-
[(5,6-DIMETHOXY-1-INDANONE)-2-YL] METHYL PIPERIDINE
334 USV LIMITED
HYDROCHLORIDE (DONEPEZIL HYDROCHLORIDE) AND A
PROCESS FOR PRODUCING THEREOF
(WO 2006/001031) 1-BENZYL-4- ` (5,6-DIMETHOXY-1-
335 INDANONE)-2-YL! METHYL PIPERIDINE OXALATE USV LIMITED
(DONEPEZIL OXALATE) AND ITS POLYMORPHS
(WO 2001/087228) SUSTAINED RELEASE PHARMACEUTICAL
336 COMPOSITION CONTAINING GLIPIZIDE AND METHOD FOR USV LTD.
PRODUCING SAME
(WO 2006/054315) NONAQUEOUS LIQUID PARENTERAL
337 VENUS REMEDIES LIMITED
ACECLOFENAC FORMULATION
(WO 2006/011001) CONTROLLED RELEASE COMPOSITIONS
338 WOCKHARDT LIMITED
OF DIVALPROEX SODIUM
(WO 2006/010995) CONTROLLED RELEASE COMPOSITIONS
339 WOCKHARDT LIMITED
OF DIVALPROEX SODIUM

49
 ANNEXURE V
MOMSEN LEONARDOS & CIA

Brazilian Application # (PCT international

application and / or European Patent granted) Current
S.NO. subject matter of the invention claimed, status Owner

Pending
1 P10308062 (WO03072564) — Citalopram, purified base application Cipla LTD

P10213398 (WO03033508) — Alendronate, amorphous Pending

2 form application Cipla LTD

P10308063 (WO03072563) - Amorphous Pending

3 pharmaceutically acceptable salt&of.citalopram application Cipla LTD

P10308603 (WO03080589) - Purified citalopram Pending

4 hydrochloride or hydrobromide application Cipla LTD

Pending
5 P10308060 (WO03072562) - Amorphous citalopram base application Cipla LTD

P10211488 (WO03011826) - Crystalline forms of Pending

6 atorvastatin calcium application Dr. Reddy‘s Lab. Ltd

P10113732 (WO0220553) - Novel polymorphic form of

17- beta -(N-ter.butyl carbamoyl)-4-aza-5- alpha - Pending
7 androst-1-en-3-one application Dr. Reddy‘s Lab. Ltd

P1001 0683 (WO0063192) - Novel Polymorphic an Forms Pending Dr. Reddy‘s Research
8 of Antidiabetic Agent application Foundation

PI0116571 (WO002051819) - Novel oxazolidinone Pending Dr. Reddy‘s Research

9 Compund application Foundation

Dr. Reddy‘s Research

P19812770 - Novel antiobesity and hypocholesterolemic Pending Foundation INC. - Reddy-
10 compounds application Cheminor
Dr. Reddy‘s Research
Pending Foundation INC. - Reddy-
11 P19711098 (CA2258949) - Novel antidiabetic comPounds application Cheminor
P10114196 (WO0226737) - Novel
polymorphic/pseudopolymorphic forms of 5-[4-[2[N-
methyl-N-(2-pyridyl)amino]ethoxy]benzyl] thiazolidine- Pending Dr. Reddy‘s Research
12 2,4-dione maleate application Foundation

P10117054 (WO021 02777) - Novel polymorph of Pending

13 Fexofenadine and Fexofenadine hydrochloride application Dr. Reddy‘s Lab. Ltd

PI0214675 - Novel antidiabetic, hypolipidemic, antiobesity Pending

14 and hypocholesterolemic compounds application Dr. Reddy‘s Lab. Ltd
Dr. Reddy‘s Research
P19812772 (WO9919313)- Beta -aryl- alpha - Pending Foundation INC. - Reddy-
15 oxysubstituted alkylcarboxylic acids application Cheminor
P10212990 (WO03027118)— Pharmaceutically acceptable Pending
16 salts of 20(S)-campothecins application Dr. Reddy‘s Lab. Ltd
Dr. Reddy‘s Research
P (EP0847397B1) - Water-soluble C-ring analogues of Pending Foundation INC. - Reddy-
17 20(S)-camptothecin application Cheminor

Regularly filed pending pharmaceutical patent applications filed by Indian corporation in Brazil and its corresponding
European Patents (granted by the EPO) or international applications filed via the Patent Cooperation Treaty (WIPO-PCT)
for salts, esters, polymorphs, hydrates, isomers and metabolites of known substances. According to the patent owners,
these pending applications and issued patents do not claim mere discoveries; frivolous patents‖; ‗evergreening‖ or ihe
same known substance.‖

C Momsen, Leonardos & Cia, 2005.

50
 Brazilian Application # (PCT international
application and / or European Patent granted) Current
S.NO. subject matter of the invention claimed, status Owner

P1991 5835 (WO00321 91) - Stable pharmaceutical

composition containing 5-[[4-[3-Methyl-4- oxo-3,4-
dihydro-2- quinazolinyl]methoxyjphenyl -methyl] Pending NOVO NORDISK A/S and
18 thiadiazolidine -2,4-dione application Reddy's Research Foundation

P10213380 (WO03033481, WO03033456) - Propionic Pending

19 acid derivatives application Dr. Reddy‘s Lab. Ltd

P10010139 (WO0066572) - Antiobesity and

hypocholesterolemic compounds, their derivatives, their
analogs, their tautomeric forms, their stereoisomers, their
polymorphs, their pharmaceutically acceptable salts, their
pharmaceutically acceptable solvates and
pharmaceutically acceptable compositions containing Pending Dr. Reddy‘s Research
20 them application Foundation

P19914438 (WO0026200) - Improved process for the Pending Dr. Reddy‘s Research
21 preparation of antidiabetic compounds application Foundation

P10213350 (WO03033481, WO03033456) - Propionic Pending

22 acid derivatives application Dr. Reddy‘s Lab. Ltd

P 7155 (WO0050414) - Hypolipidemic, antihyperglycemic,

antiobesity and hypocholesterolemic compounds, their
derivatives, their analogs, theft tautomeric forms, their
stereoisomers, their polymorphs, their pharmaceutically
acceptable salts, their pharmaceutically acceptable
solvates and pharmaceutically acceptable compositions Pending Dr. Reddy‘s Research
23 containing Them. application Foundation

P19914493 (WO00i 5638) - Improved process for the

preparation of 5-[4-[[3-Methyl-4-oxo-3,4-
dihydroquinazolin-2-yl]methoxy] benzyl] thiazolidine-2, 4- Pending Dr. Reddy‘s Research
24 dione application Foundation

PI10108064 (WO0157026)- Derivatives of

Andrographolide, their stereoisomers, their polymorphs,
their pharmaceutically acceptable salts, and their Pending
25 pharmaceutically acceptable solvates application Dr. Reddy's Lab. Ltd

PI0114031 (WO0218390) - Method for the preparation of

hydrates of Olanzapine, process for conversion of Pending
26 olanzapine reffered to as form-I application Dr. Reddy's Lab. Ltd

Regularly filed pending pharmaceutical patent applications filed by Indian corporation in Brazil and its corresponding
European Patents (granted by the EPO) or international applications filed via the Patent Cooperation Treaty (WIPO-PCT)
for salts, esters, polymorphs, hydrates, isomers and metabolites of known substances. According to the patent owners,
these pending applications and issued patents do not claim mere discoveries; frivolous patents‖; ‗evergreening‖ or ihe
same known substance.‖

C Momsen, Leonardos & Cia, 2005.

51
 Brazilian Application # (PCT international
application and / or European Patent granted) Current
S.NO. subject matter of the invention claimed, status Owner

PI0212772 (WO03027072) - cost effective and industrially Pending

27 advantageous process for the preparation of repaglinide application Ranbaxy Lab. Ltd.

PI0312728 (WO2004014337) - Dispersible tablets of Pending

28 cephalexin application Ranbaxy Lab. Ltd.

Pending
29 PI0215686 (WO03084541) - Carboximide derivatives application Ranbaxy Lab. Ltd.

PI0106752 (WO0195886) - Bioavilable pharmaceutical

composition of 13-cis vitamin A acid (also known as 13- Pending
30 cis retinoic acid and isotretinoin) application Ranbaxy Lab. Ltd.

pi0111193 (WO0190049) - Novel amorphous form of Pending

31 sertraline hydrochloride application Ranbaxy Lab. Ltd.

PI0306928 (WO03059330) - Stable pharmaceutical Pending

32 compositions comprising ACE inhibitor(s) application Ranbaxy Lab. Ltd.

PI0110926 (WO0187831) - Novel amorphous form of Pending

33 omeprazole salts application Ranbaxy Lab. Ltd.

PI0108958 (WO0164183) - Once daily tablet formulation

for oral administration in humans for the controlled Pending
34 release of ciprofloxacin application Ranbaxy Lab. Ltd.
PI0308989 (WO03082241) - Pharmaceutical composition
which includes micronized clarithromycin and exhibits
improved dissolution characteristics relative to a
pharmaceutical composition that includes :unmicroflized Pending
35 clarithromycin application Ranbaxy Lab. Ltd.

P10212931 (WO03028704) - Extended Pending

36 releasepharmaceutical composition containing metforrnin application Ranbaxy Lab. Ltd.

P10308990 (WO03082248) - Pharmaceutical composition

which includes erythromycin A or a derivative thereof and Pending
37 alginic add application Ranbaxy Lab. Ltd.

P10012866 (EP1 204637B1) - Process for the preparation Pending

38 of isotretinoin, in a single step. application Ranbaxy Lab. Ltd.

P102 (EP1423097) - Controlled release formulation of Pending

39 clarithrornycin or tinidazol application Ranbaxy Lab. Ltd.

P10209842 (WO02094828) - Process for the preparation Pending

40 of imipenem application Ranbaxy Lab. Ltd.

Regularly filed pending pharmaceutical patent applications filed by Indian corporation in Brazil and its corresponding
European Patents (granted by the EPO) or international applications filed via the Patent Cooperation Treaty (WIPO-PCT)
for salts, esters, polymorphs, hydrates, isomers and metabolites of known substances. According to the patent owners,
these pending applications and issued patents do not claim mere discoveries; frivolous patents‖; ‗evergreening‖ or ihe
same known substance.‖

C Momsen, Leonardos & Cia, 2005.

52
 Brazilian Application # (PCT international
application and / or European Patent granted) Current
S.NO. subject matter of the invention claimed, status Owner

P10012864 (WO0108633)- Process for the production of Pending

41 an improved torn, of Form I celiprolol hydrochloride application Ranbaxy Lab. Ltd.

P10209843 (WO02094742) - Cost effective and

industrially advantageous process for the preparation of Pending
42 amorphous cilastatin sodium. application Ranbaxy Lab. Ltd.

P1021 0426 (WO02100323) - Methyl analog of Pending

43 simvastatin application Ranbaxy Lab. Ltd.

P10112597 (WO0205816) - Bioavailable oral dosage form Pending

44 of loratadine of specific particle size and surface area. application Ranbaxy Lab. Ltd.

P10016400 (WO0144144 ) - Process for the preperaUon

of sodium salts of statins, namely Compactin, Lovastatin Pending
45 and Pravastatin application Ranbaxy Lab. Ltd.

P10311642 (WO03103635). Extended release Pending

46 pharmaceutical composition comprising divaiproex application Ranbaxy Lab. Ltd.

P10215685 (WO03O84928) Alpha,ornega- dicarboximide Pending

47 derivatives application Ranbaxy Lab. Ltd.
PI0113102 (WO0211716) - Liquid formulation of Ranbaxy Lab. Ltd.
metformin Pending
48 application
PI0112598 (WO0206289) - Process for the preparation of Ranbaxy Lab. Ltd.
highly pure crystalline form of cefuroxime axetil
Pending
49 application
PI0311195 (WO03097614) - Process for the preparation Ranbaxy Lab. Ltd.
of Rosuvastatin Pending
50 application
PI0309853 (WO03092660) - Monocompartment osmotic Ranbaxy Lab. Ltd.
controlled drug delivery system Pending
51 application
PI0114100 (WO0224203) - Pharmaceutical composition in Ranbaxy Lab. Ltd.
the form of an oral controlled release solid dosage form
Pending
52 application
PI0112024 (WO0200615) - Process for the preparation Pending Ranbaxy Lab. Ltd.
and isolation of the hypolipaemic active substance application
lovastatin in substantially pure form
53
PI0214209 (WO03042215) - Cost effective and Pending Ranbaxy Lab. Ltd.
industrially advantageous process for the preparation of application
imipenem of high purity
54
PI0212807 (WO03026610) - Process for the preparation Pending Ranbaxy Lab. Ltd.
of fast dissolving dosage form, such as tablet, which application
disintegrates quickly in the mouth
55
PI0207640 (WO02067943) - Stable pharmaceutical Pending Ranbaxy Lab. Ltd.
composition of cefpodoxime proxetil application
56

Regularly filed pending pharmaceutical patent applications filed by Indian corporation in Brazil and its corresponding
European Patents (granted by the EPO) or international applications filed via the Patent Cooperation Treaty (WIPO-PCT)
for salts, esters, polymorphs, hydrates, isomers and metabolites of known substances. According to the patent owners,
these pending applications and issued patents do not claim mere discoveries; frivolous patents‖; ‗evergreening‖ or ihe
same known substance.‖

C Momsen, Leonardos & Cia, 2005.

53
 Brazilian Application # (PCT international
application and / or European Patent granted) Current
S.NO. subject matter of the invention claimed, status Owner
PI0209844 (WO02094773) - Cost effective and Pending Ranbaxy Lab. Ltd.
industrially advantageous process for the preparation of application
imipenem of high purity
57
PI0310074 (WO03097059) - Polymorphic forms of phenyl Pending Ranbaxy Lab. Ltd.
oxazolidinone derivatives application
58
PI0112826 (WO0206278) - Substituted phenyl Pending Ranbaxy Lab. Ltd.
oxazolidinones application
59
PI0010923 (WO0071116) - Process for the preparation of Pending Ranbaxy Lab. Ltd.
amorphous atorvastatin calcium and hydrates application

60
PI0212390 (WO03018544) - Efficient and industrially Pending Ranbaxy Lab. Ltd.
advantageous process for the preparatiobn of pure application
cilastatin.
61
PI0011490 (WO0077006) - Process for the preparation of Pending Ranbaxy Lab. Ltd.
the esters of 1,8-disubstituted-1,3,4,9-tetrahydropyrano application
(3,4-b)-indole-1-acetic acid

62
PI9912318 (WO0005205) - Novel piperazine derivatives Pending Ranbaxy Lab. Ltd.
substituted on one nitrogen by an aromatic system and application
on the other nitrogen by (2,5-dioxopyrrolidin)-1-yl)
alkanes or (2,6-dioxopiperidin-1-yl) alkanes
63
PI0209845 (WO02094774) - Dosage forms of Pending Ranbaxy Lab. Ltd.
oxcarbazepine for pral administration application
64
PI0207895 (WO02072565) - Improved and industrially Pending Ranbaxy Lab. Ltd.
advantageous process for the preparation of citalopram application

65
PI0007489 (EP1144425B1) - Substituted pentose and Pending Ranbaxy Lab. Ltd.
hexose monosaccharide derivative application

66
PI0007553 (EP1147119B1) - 2,3-O-isopropylidene Pending Ranbaxy Lab. Ltd.
derivatives of monosaccharides as cell adhesion inhibitors application

67
PI0115865 (WO0244151) - 1,4-disubstituted piperazine Pending Ranbaxy Lab. Ltd.
derivatives application
68
PI0012981 (WO0110419) - Gastro-retentive oral drug Pending Ranbaxy Lab. Ltd.
delivery system structurally comprised of a highly porous application
matrix comprising a drug
69
PI0309298 (WO03086362) - Stable bupropion Pending Ranbaxy Lab. Ltd.
hydrochloride tablet application
70
PI0208504 (WO02076376) - Stable pharmaceutical Pending Ranbaxy Lab. Ltd.
composition of pravastatin application
71

Regularly filed pending pharmaceutical patent applications filed by Indian corporation in Brazil and its corresponding
European Patents (granted by the EPO) or international applications filed via the Patent Cooperation Treaty (WIPO-PCT)
for salts, esters, polymorphs, hydrates, isomers and metabolites of known substances. According to the patent owners,
these pending applications and issued patents do not claim mere discoveries; frivolous patents‖; ‗evergreening‖ or ihe
same known substance.‖
C Momsen, Leonardos & Cia, 2005.

54
 Brazilian Application # (PCT international
application and / or European Patent granted) Current
S.NO. subject matter of the invention claimed, status Owner
PI0309113 (WO03084514) - Controlled released Pending Ranbaxy Lab. Ltd.
pharmaceutical composition of carbidopa and levodopa application

72
Pending
PI0212388(WO03018522)- Industrially advantageous application
process for the preparation of beta-
73 ionylidencacetaldehyde Ranbaxy Lab. Ltd
Pending
PI9910723 (WO9961022)-A stable oral pharmaceutical application
composition containing a substituted pyridylsulfinyl
74 benzimidazole Ranbaxy Lab. Ltd
Pending
PI0113661 (WO0217923)- Pharmaceutical composition application
for tropical delivery comprising a cyclooxygenase-2
75 enzyme inhibitor. Ranbaxy Lab. Ltd
Pending
PI9917219 (WO0056266)-Coating composition for the application
76 film coating of pharmaceutical cores Ranbaxy Lab. Ltd
Pending
PI0208513 (WO02076375) Proceass for the preparation application
77 of benazepril Ranbaxy Lab. Ltd
Pending
PI0110970(EP1287003B1)- Process for the preparation of application
a pure and pharmacopoeial amorphous form of
78 cefuroxime axetil Ranbaxy Lab. Ltd
Pending
application
PI9913696 (WO0015198)- Pharmaceutical composition in
the form of tablets or capsules provides a combination of
79 temporal and spatial control of drug delivery Ranbaxy Lab. Ltd
Pending
application
PI0116570 (WO02051408)- Derivatives of specially
80 substituted azole compounds Ranbaxy Lab. Ltd
Pending
application
PI0009177(EP1165051B1)-Process of mixing of crysatlline
cefuroxime axetil with amorphous cefuroxime axetil for
the preparation of a bioavailable oral dosage form
81 comprising amorphous cefuroxime axetil Ranbaxy Lab. Ltd
Pending
application
PI0110925(EP1283821B1)- Cost effective and industrially
advantageous process for the selective methylation of a
82 hydroxy group at the 6 position of erythromycin A Ranbaxy Lab. Ltd
Pending
application

PI0208999(WO02083634)-Improved and cost effective

83 process for the industrial preparation of cefpodoxime acid Ranbaxy Lab. Ltd

Regularly filed pending pharmaceutical patent applications filed by Indian corporation in Brazil and its corresponding
European Patents (granted by the EPO) or international applications filed via the Patent Cooperation Treaty (WIPO-PCT)
for salts, esters, polymorphs, hydrates, isomers and metabolites of known substances. According to the patent owners,
these pending applications and issued patents do not claim mere discoveries; frivolous patents‖; ‗evergreening‖ or ihe
same known substance.‖

C Momsen, Leonardos & Cia, 2005.

55
 Brazilian Application # (PCT international
application and / or European Patent granted) Current
S.NO. subject matter of the invention claimed, status Owner

PI0211691 (WO03014060)- Cost effective and industrially Pending

84 advantageous process for the preparation of tolterodine application Ranbaxy Lab. Ltd.

PI0215709 (WO03091261)- Process for the preparation of Pending

85 cefdinir or an industrial scale application Ranbaxy Lab. Ltd.

Regularly filed pending pharmaceutical patent applications filed by Indian corporation in Brazil and its corresponding
European Patents (granted by the EPO) or international applications filed via the Patent Cooperation Treaty (WIPO-PCT)
for salts, esters, polymorphs, hydrates, isomers and metabolites of known substances. According to the patent owners,
these pending applications and issued patents do not claim mere discoveries; frivolous patents‖; ‗evergreening‖ or ihe
same known substance.‖
C Momsen, Leonardos & Cia, 2005.

56