WHAT ARE NOT INVENTIONS

SECTION 3
(a) an invention which is frivolous or which claims anything
obviously contrary to well established natural laws;

 Eg. Machine giving more than 100% performance

 Newton’s laws of gravitation

(b) an invention the primary or intended use or commercial

exploitation of which could be contrary to public order or
morality or which causes serious prejudice to human, animal or
plant life or health or to the environment;
Eg.
 Gambling machine
 device for house-breaking
 Biological warfare material or device
 Terminator gene technology
 embryonic stem cell
 As per the section an invention would not be patentable if it is
immoral or against public order, harmful to human , animal or
plant life or harmful to environment
(c)the mere discovery of a scientific principle or the
formulation of an abstract theory or discovery of any
living thing or non-living substance occurring in
nature;

Eg. Extraction and isolation of biological materials is generally

considered the mere discovery of a naturally occurring substance
and is therefore barred under this provision.

 The IPO released Guidelines on the Examination of

Biotechnology Applications for Patents expressly state
that sequences isolated directly from nature are not
patentable. However only biological materials obtained which
are result of substantial human intervention are considered
patentable.
 (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.

 This section is the most controversial provision amongst all due

to its applicability across diverse fields of technology. The
interpretation of this section has been done by the authorities
in several pharmaceutical cases.
(e) A substance obtained by a mere admixture
resulting only in the aggregation of the properties of
the components thereof or a process for producing
such substance;

Eg. Paracetamol (Antipyretic) +Brufen (analgesic) = A drug

(antipyretic & analgesic)
• A soft drink that is only a mixture of sugar and some
colorants in water
But, a mixture resulting in synergistic properties of mixture of
ingredients may be patentable like Soap, Detergent, lubricant.

 A substance obtained by a mere admixture and any process in

its preparation under the existing practice a composition of
known components can be patented only if it exhibits synergy.
 However synergy cannot be properly defined and thereby there is
uncertainty .Thus, it is decided by the IPO on case to case basis.
(f) Mere arrangement or re-arrangement or duplication of
known devices, each functioning independently of one
another in a known way
e.g -
 A Bucket fitted with torch,

 An Umbrella with fan

 A Clock and radio in a single cabinet

 A flour-mill provided with sieving

(h) a method of agriculture or horticulture;

e. g. Cultivation of algae , Producing new form of a known plant,
preparation of an improved soil
However, Agricultural Equipment's are patentable.
Section 3 (i)
 Any process for the medicinal, surgical, curative,
prophylactic diagnostic, therapeutic or other
treatment of human beings.

 But in many case IPO has granted patent in vitro

diagnostic methods performed on tissues or fluids
which has been permanently removed from the body.
(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;

(p) an invention which in effect, is traditional

knowledge or which is an aggregation or
duplication of known properties of traditionally
known component or components.
SOME ADDITIONAL POINTS:

 Thereby discovery of anything that is occurring in the

nature is not patentable in India.

 Prohibited subjects have been mentioned under Section 3.

 However the microorganism and microbiological processes

are patentable. Genetically modified multicellular
organisms including plants, animals, human beings and
their parts are excluded from patentability in India .

 Gene sequence and DNA sequences are patentable.

 Human and embryonic stem cells cannot be patented.

 Methods of medical treatment are prohibited
from being patentable.
DIMMINACO A.G V. CONTROLLER OF
PATENT DESIGNS

 A landmark decision has been awarded by the

Calcutta High Court on 15th January, 2002 in respect
of patenting of inventions involving micro-organisms
in a case filed by Dimminaco A.G. against the decision
of the Controller General of Patents, Designs and
Trademark.
FACTS OF THE CASE
 The Appellant had filed a patent application for an
inventive process of preparing infectious Bursitis vaccine.
 This was useful in protecting poultry from infectious
Bursitis infection. However the process to prepare the
vaccine contained a living virus.

 The application was turned down by the Patent Office on

the ground that the process did not constitute an
invention under the Patent Act,1970. No reasons was
assigned for this decision.
 Dimminaco A.G appealed before the controller of Patent
and Designs but it upheld the decision of the IPO and
refused to grant patent.

 Hence the appellant approached the Calcutta High Court

 The Court took a serious note of the fact that
quasi-judiciary duties of the office had not been
adequately discharged as the IPO and the
controller of Patent and Design failed to cite
reasons for rejecting the application.
ISSUES INVOLVED
 Is there a statutory bar to accept the manner of
manufacture as patentable if the end product
contains a living organism?

 Will a process of preparing a vaccine that

contains a live virus considered to be ‘methods or
process of manufacture’ under the patent
Act,1970?

 Whether it will be construed as invention under

the Patent Act,1970
CONTENTION OF THE APPELLANT
Contention of the Appellant was that the
preparation of infectious bursitis vaccine is an
invention because of the following reasons:

1. The process involved an inventive step and

invented the vaccine that protects poultry
against the bursitis infection.
2. Patent Act, 1970 did not bar the patenting of
end product using a process involving live virus.
3. The claim is only for the process for preparing
the vaccine.
DECISION

 The court held that there is no statutory bar to accept

the manner of manufacture to be patentable if the
end product contains a living organism provided the
process claimed in the patent application is new and
novel process for preparation of the vaccine that
involved chemical steps under specific scientific
conditions. Therefore the court held that it was a
new process and was patentable under the Patent
Act.
 In other words since the end product is a new article,
the process relating to its manufacture was held to be
an invention and thereby patentable.
 The court also held that since the manner of
manufacture is not been defined under the Act the
dictionary meaning would prevail thereby
manufacture includes the process of preparing a
inventible commodity which contains a living
organism.
 The court rejected the IPO’s understanding of
lyophilizing i.e. the process of freezing the micro
organism/ living organism. The court held that in the
lyophilizing nothing is killed or destroyed. The
biological activity of the material is retained and not
wasted.
 Thereby as a manner of practice patents must be
granted by various patent offices to patent processes
where living beings are involved.
 CONCLUSION
 The judgement opens up new opportunities for
obtaining patents in India on microorganism
related inventions which were previously not
granted.
 Further, the importance of definitions in the Act
has been clearly brought out. The law cannot be
left to the interpretation of individuals. There has
to be a consistent interpretation which should
follow some logic.
 F. HOFFMAN LA ROUCHE AND ANR V.
CIPLA LTD 2009 (40) PCT 125 (DEL) (DB)

 The court in this case observed that S.3(d) discourages

evergreening of patent which is the practice of making
trifling changes in the existing product and claiming
new invention.

 S.3(d) prevents grant of patent unless the derivatives

or other forms differ significantly in regard to
properties in regard to the efficacy.
NOVARTIS AG AND ORS V. UOI AND
ORS (2015)
 Discussed the meaning of efficacy in detail.

 Efficiency means the ability to produce a desired

or intended result.

 The test of efficiency in the context of S.3(d)

would be different depending upon the result of
the product unless consideration is desired or
intended to produce

 It would depend upon function, utility or purpose

of the product under consideration.
 Eg. If it is a medicine if it claims to cure the
disease, the test of efficiency can only be
therapeutic efficiency.
FACTS :
 Novartis AG developed drug which cured blood cancer
called Gleevec on which patent was claimed.

 Novartis claimed grant of patent on imatinib mesylate

in beta crystalline form.

 In India prior to this case product patent was not

granted.

 A mailbox application for grant of patent was made by

Novartis AG.
 Novartis had EMR which was granted in the year
2003 and thereby the application made for grant
of patent was scrutinized in 2005.

 IPO rejected the patent application on the

ground that the application claimed patent on an
already known substance without any change in
the efficiency as required under S.3(d).

 Novartis then file a Writ Petition before the

Madras High Court against the decision of IPO of
rejecting the application
CONTENTIONS - NOVARTIS
 The Patent Controller has erred in rejecting the patent
application.

 S.3 (d) is vague, ambiguous and contrary to the

requirements of the TRIPS Agreement therefore it is
violates of right to equality.

 India has failed to comply with the mandate to amend

the domestic laws as required under the TRIPS
Agreement.
 There is ambiguity in reference to what constitutes
increase in the efficiency and significant enhancement as
required under S.3(d).
CONTENTIONS OF THE GOVT
 High Court is not the appropriate forum to decide
Novartis’s claim of the domestic laws not being
compliant with the TRIPS Agreement. (the same
was held by the Madras High Court)
JUDGMENT
 The controversy in relation to evergreening of
pharmaceutical patent is thereby settled by the
landmark judgment.

 The Honorable Supreme Court upheld the decision

of rejection of the patent application by IPO as the
substance on which Novartis claimed patent did not
qualify the efficiency test laid down under S. 2(1)(j)
and Section 2(1)(ja) of the Patent Act,1970.

 It also upheld the decision of the Madras High

Court that S.3(d) of the Patent Act,1970 is
constitutional.
 The judgment sought to draw a balance between
public good with monopolistic pricing, innovation
with affordability.

 The Honorable Supreme Court wanted to ensure

that generic drugs are available at a low cost so
that can be beneficial for the people at large,
more specifically the poor population of India.

 The decision also gave boost to the generic drug

industry.