Certificate course in Pharmaceutical Intellectual

Property Rights (CPIPR)

PATENT DETAILS:

This module is related to patents and related to the details about patent
document in general, anatomy of a patent document, types of patents and others.

Sub-unit Index Page numbers

I Anatomy of a patent document 1 - 12
II Patent families 13 - 17
III Types of patent 18 - 24
IV Patent searches 25
V Patent term and extensions 26 - 28
VI Patentability criteria 29 - 38
Novelty
Non-obviousness
Duty of disclosure
VII Patent agents and attorneys 39 - 40
VIII Patent infringement 41 - 43
- Sample US patent document 5 pages
Total 48 pages

Disclaimer: This module is intended for informational purpose only. No

legal information or advice is provided through this module.

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 Certificate course in Pharmaceutical Intellectual
Property Rights (CPIPR)

ANATOMY OF A PATENT DOCUMENT

A patent application is a request pending at a patent office for the grant of a

patent for the invention described and claimed by that application.

A patent specification is a document describing the invention for which a patent is

sought and setting out the scope of the protection of the patent. As such, a
specification generally contains a section detailing the background and overview
of the invention, a description of the invention and embodiments of the invention
and claims, which set out the scope of the protection. A specification may include
figures or drawings to aid the description of the invention, gene sequences and
references to biological deposits, or computer code, depending upon the subject
matter of the application.

The patent document is divided into several sections which provide different
types of information regarding the invention. In general, the patent document is
comprised of the following sections:
1. Title
2. Abstract
3. Background of the invention
4. Summary of the invention
5. Detailed description of the invention
6. Drawings
7. Claims

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Title of invention1:
Titles of inventions in patent documents form a useful secondary source of
information, provided that they are reasonably informative. They are as a rule
printed on the first page of patent documents and normally also included in the
entries in Official Gazettes.

Titles of inventions convey to the user of patent documents a first impression of

the main content of the invention.

Titles of inventions are of considerable importance to users who are desirous of

keeping abreast of patented developments in a particular art and who rely for that
purpose on the titles listed in Official Gazettes. The informative value of the titles
may also be very useful in Industrial Property Offices for indexing or preliminary
classifying purposes.

• The title of the invention should be meaningful.

• The title should clearly, concisely and as specifically as possible indicate
the subject to which the invention relates.
• If the patent document contains claims in different categories (product,
process, apparatus, use), this should be evident from the title.
• The word “patent,” personal names, fancy names, trade names,
trademarks or abbreviations or terms such as “etc.” which do not serve to
identify the invention should not be used in the title.

When wording titles of inventions, it should be borne in mind that the title belongs
to the bibliographic data, which in many cases will be transferred onto a
machine-readable data carrier. The title should therefore preferably only contain
characters and signs which can be read and printed by computer.

1
http://www.wipo.int/standards/en/pdf/03-15-01.pdf

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 Certificate course in Pharmaceutical Intellectual
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Abstract2:
The abstract is a short summary of an invention. It is a condensed version of a
patent where the essence of invention is provided.

Abstracts are used primarily for searching patents. They should be written in a
way to make the invention easily understood by those with a background in the
field. The reader should quickly be able to get a sense of the nature of the
invention so that they can decide whether they need to read the rest of the patent.

The abstract describes the invention and the way in which it can be used, but
does not discuss the scope of the claims.

Tips for abstract writing3:

1. A proper Abstract commences on a separate sheet that does not include either
other parts of the application or any other material. Preferably, an Abstract is
presented after the claims, which preferably follow the Specification.
2. A proper Abstract is between 50 and 150 words and does not exceed 15 lines
of text.
3. A proper Abstract avoids the legal phraseology commonly found in patent
claims, such as “means” and “said.” Instead, the language used should
encompass that which is new and be clear and concise. Thus, a proper abstract
also avoids phrases that can be implied, such as, “The disclosure concerns,”
“The disclosure defined by this invention,” “The disclosure describes,” etc.
4. A proper Abstract neither discusses purported merits or speculative
applications of a disclosed invention nor does it compare the invention with prior
art. Rather, a proper Abstract efficiently describes the disclosed subject matter
and encompasses what is believed to be novel. Accordingly, extensive
mechanical and design details of an apparatus should not be included.

2
http://inventors.about.com/library/weekly/aapatentabstracta.htm
3
http://patentablydefined.com/2009/09/28/patent-abstracts-common-problems-with-them-and-tips-for-
drafting-a-better-abstract/

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Background of the invention:
The background generally comprises two parts: an explanation of the field of
invention and a description of the prior art.
A paragraph(s) describing to the extent practical the state of the prior art or other
information disclosed known to the applicant, including references to specific
prior art or other information where appropriate. Where applicable, the problems
involved in the prior art or other information disclosed which are solved by the
applicant's invention should be indicated.

Summary of the invention:

The summary of the invention, which is distinct from the abstract, is meant to
discuss the invention rather than the disclosure as a whole. Often, the summary
will discuss advantages of the invention or how it solves the problems existing in
the art, such as those presented in the background of the invention.

Detailed description of the invention4:

The detailed description of the invention is the biggest section of a patent. Its
purpose is to adequately and accurately describe the invention. The specification
must include a written description of the invention or discovery and of the manner
and process of making and using the same, and is required to be in such full,
clear, concise, and exact terms as to enable any person skilled in the art or
science to which the invention or discovery appertains, or with which it is most
nearly connected, to make and use the same.
The specification must set forth the precise invention for which a patent is
solicited, in such manner as to distinguish it from other inventions and from what
is old. It must describe completely a specific embodiment of the process;
machine, manufacture, composition of matter or improvement invented, and must
explain the mode of operation or principle whenever applicable. The best mode
contemplated by the inventor of carrying out his invention must be set forth.

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There are generally two sections:
A general explanation of the invention and how to practice it:
The invention is described in its broadest sense, to show that the inventors have
a broad view of the scope of the elements. Often, preferred embodiments of the
invention are described. Such embodiments are generally more limited versions
of the broadest concept and are provided for support for a fall-back position of
narrower claims if the broader concept is not patentable. Definitions of key terms
are often provided and are extremely important in interpreting the scope of the
claims.

Specific examples of how to practice the invention:

A patent application does not require examples, however in practice, examples
can often assist in showing patentability (e.g., enablement). The examples may
or may not have been performed by the inventors. "Working" examples present
completed undertakings. "Prophetic" examples are hypothetical undertakings and
are always written in the present or future tense. Typically, the examples
demonstrate practice of one or more specific embodiments of the invention.

Drawings:
A patent application or patent may contain drawings, also called patent drawings,
illustrating the invention, some of its embodiments (which are particular
implementations or methods of carrying out the invention), or the prior art. The
drawings may be required by the law to be in a particular form, and the
requirements may vary depending on the jurisdiction.

A patent application is required to contain drawings, if drawings are necessary to

understand the subject matter to be patented. Most patent applications contain
drawings. The drawings must show every feature of the invention as specified in
the claims. Omission of drawings may cause an application to be considered
incomplete and no application filing date.

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Claims of a patent:
Patent claims are the part of a patent or patent application that defines the scope
of protection granted by the patent. The claims define, in technical terms, the
extent of the protection conferred by a patent, or the protection sought in a patent
application. Thus, the claims are the heart of a patent since they define the limits
of exactly what the patent does, and does not, cover. That is, the patentee has
the right to exclude others from making, using or selling, only those things which
are described by the claims.

The claims of a patent come at the end of the document, right after the written
description (specification) of the invention. The claims are set forth as separately
numbered paragraphs in a single-sentence format. The first claim of an issued
patent is always numbered "1," with each claim thereafter following in an
ascending numerical sequence.

Each claim should have only one meaning which can be either broad or narrow,
but not both at the same time. In general a narrow claim specifies more details
than a broader claim.

Whether a patent will be granted is determined, in large measure, by the wording

of the claims in a patent application.

Claims continue to be important once a patent is granted, because questions of

patent validity and patent infringement are judged by the courts on the basis of
the claims.

Also, the fee to be paid for a patent application depends upon the number of
claims in the application.

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 Certificate course in Pharmaceutical Intellectual
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Important Characteristics of claims5
Three criteria to take note of when drafting your claims are that they should clear,
complete, and supported. Every claim must be one sentence, as long or as short
a sentence as required to be complete.

• Be Clear
The claim must be clear so that it does not cause the reader to speculate about
the claim. The claims should not contain words such as “thin, strong, weak, a
major part, such as, when required”. These words make the claim subjective.
Improper claims undermine the functioning of the patent system by making it
difficult for inventors and competitors to assess freedom to operate.

• Be Complete
Each claim should be complete, so that it covers the inventive feature and
enough elements around it to put the invention in the proper context.

• Be Supported in the specification

The claims have to be supported by the description. This means that all the
characteristics of your invention that form part of the claims must be fully
explained in the description. In addition, any terms used in the claims must be
either found in the description or clearly inferred from the description.

There are two basic types of claims:

• The independent claims, which stand on their own, and
• The dependent claims, which depend on a single claim or on several
claims and generally express particular embodiments as fall-back
positions. A dependent claim only has meaning when combined with a
preceding claim.

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Each independent claim consists of three parts: the preamble, a transitional word
or phrase, and the body.
1. Preamble:
The function of the preamble is to set forth the general technical environment of
the invention. For example, a claim to a pharmaceutical composition might have
the preamble "A pharmaceutical composition. . . . ."
The preamble is usually not considered to be a legally limiting constraint on the
invention. The limiting constraints are found later in the body of the claim.
2. Transitional phrase:
After the preamble, the next part of the claim is a transitional word or phrase. The
transitional word or phrase comes between the preamble and the body. There
are basically three transitions used: "comprising" or "which comprises,"
"consisting of," and "consisting essentially of."
3. Body:
The body of the claim follows the transitional phrase and lists the main elements
of the combination. It is here that the invention is particularly claimed. The body
of the claim of a machine invention, for example, lists the parts of the machine in
some sort of logical order so as to recite the mechanical interrelationship of the
parts of the machine. In another example, the claims to a chemical invention may
show a chemical formula or a representation of a chemical molecule. Finally, the
claims to a method invention will list the method steps generally in the order in
which they are to be carried out.

A chocolate composition containing cocoa butter, cocoa liquor and/or whole milk
powder and a sweetening agent wherein the sweetening agent contains between
5 and 100% of spray dried glucose.
- Preamble of the claim
- Transitional phase in the claim
- Body of the claim

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Depending upon the format of the claims, there are various types of claims:
1. Jepson claims
The Jepson format allows a patentee to use the preamble to recite "elements or
steps of the claimed invention which are conventional or known". When this
format is employed, the claim preamble defines not only the context of the
claimed invention, but also its scope. Jepson claims are "improvement claims".
The Jepson claim style is useful for inventions that are clearly improvements on
prior (patented) technologies – a dependent Jepson claim may reference the
invention of the parent claim as an improvement in a larger prior-art invention.

e.g. In a device comprising elements A, B, C and D the improvement comprising

element D being D.

2. Markush claims
A Markush-type claim recites alternatives in a format such as "selected from the
group consisting of A, B and C." The members of the Markush group (A, B, and
C in the example above) ordinarily must belong to a recognized physical or
chemical class or to an art-recognized class.

The risk of a Markush claim form is that if any one of the group is found to be old,
the entire claim is invalid. If the claim were written as separate claims, the
invalidity of one of the claims would not affect the others.

Markush group claims are frequently used in patent applications in the fields of
chemical engineering and biological and pharmaceutical engineering.

e.g. A pharmaceutical composition comprising drug ‘x’ and an antioxidant

selected from the group consisting of: 1) B; 2) C; 3) D; 4) E; 5) F and mixtures
thereof.

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3. Means-plus-function claims and step-plus-function claims
A means-plus-function claim is a claim including a technical feature expressed in
functional terms of the type "means for converting a digital electric signal into an
analog electric signal". A variant known as a "step-plus-function" claim style may
be used to describe the steps of a method invention ("step for converting... step
for storing...")

Under US law, claim elements expressed in a means-plus-function format are

given a special interpretation, in that they are deemed to cover the corresponding
structure, material or acts described in the specification and equivalents thereof.

4. Omnibus claims
Omnibus claim is a claim including a reference to the description or the drawings
without stating explicitly any technical features of the product or process claimed.
European Patent Organization Omnibus claims are allowed under the EPC, but
only "when they are absolutely necessary". Under US patent law, omnibus claims
are categorically disallowed in utility patents.

e.g. A pharmaceutical composition as described in the description.

5. Product - by - process claims

A product-by-process claim is a product claim where the product is defined by its
process of manufacture.

e.g. Product ‘X’ obtained by the process comprising the steps of ……………….

6. Reach through claims

A reach-through claim is one that attempts to cover the basic research of an
invention or discovery. It is an "attempt to capture the value of a discovery before
it may be a full invention." Specifically, a reach-through claim is one in which

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"claims for products or uses for products when experimental data is provided for
screening methods or tools for the identification of such products."

7. Swiss type claims

In Europe, a Swiss-type claim or "Swiss type of use claim" is a formerly used
claim format intended to cover the first, second or subsequent medical use (or
indication of efficacy) of a known substance or composition.

Consider a chemical compound which is known generally, and the compound is

known to have a medical use (e.g. in treating diabetes). If it is later found to have
a second medical use (such as in treating pain), the discoverer of this property
will want to protect that new use by obtaining a patent for it.

However, the compound itself is known and thus could not be patented; In this
case, the only the particular method of treatment is new. However methods for
treatment of the human body are not patentable in many jurisdictions including
Europe. Such inventions can be claimed as swiss-type claims.

e.g. "Use of substance X in the manufacture of a medicament for the treatment of

condition Y".

Note:
Every type of claim may not be allowed in every jurisdiction. The claims in one
jurisdiction need to be drafted in another way in other jurisdiction.

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Claim construction6:
Claim construction is the art of translating patent claim jargon into plain English.
Claim construction simply means understanding the scope of the claim. A proper
interpretation of claim terms is essential for understanding the scope of a claim.

The interpretation of a claim is primarily based on the plain language of the claim
and on definitions, explicit or implicit, in the text of the patent document.

Claims often use terms, especially technical terms, that require a bit of detective
work to understand their meaning. The steps of investigation include identifying
terms that need defining (generally, words other than common English words),
looking in the text of the patent document for an explicit definition or use of the
term, look in the prosecution history for definition or use of the term, and
consulting a dictionary or expert in the field, if available.

An inventor may act as his own lexicographer; because of that, patent claims
may use terms as specifically defined in a patent specification. This may
complicate claim construction, as one must be knowledgeable of both the
specific disclosure and the technological context to which a term applies,
especially with regard to an accused infringing product.

Since patents provide the legal rights, the claim construction is a legal process in
which the scope of the claims is determined.

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http://www.patentlens.net/daisy/Telomerase/2380/2383.html

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PATENT FAMILIES:
A patent family is the same invention disclosed by a common inventor(s) and
patented in more than one country1.

Given the territorial character of patent protection, when an applicant wants to

protect an invention internationally, a patent application has to be filed in each of
the countries where protection is sought (either one by one or collectively through
supranational filing procedures). As a result, the first patent filing made to protect
the invention, the so-called priority filing, which is usually made in the home
country of the applicant, is followed by a series of subsequent filings and forms,
together with them, a patent family2.

In practice, however, it is not straightforward to identify all the members of a

patent family, at a certain point in time, and differences across information
sources arise from the use of diverse methodologies.

An international treaty, the Paris Convention, allows an applicant to file for a

patent on the same invention in other countries and claim the original (priority)
filing through PCT. When an applicant files on the same invention in multiple
countries, these applications and the subsequent publications are collectively
known of as a patent family.

A patent family will include all of the publications resulting from filings on the
invention. This may include multiple filings from a country because of the
different laws countries have defining how an invention may be patented. The
filings themselves may claim single or multiple priorities. The filing may claim one
or more prior filings related to the filing.

1
http://www.uspto.gov/main/glossary/#patentfamily
2
http://www.oecd.org/sti/innovationinsciencetechnologyandindustry/44604939.pdf

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Patent Families in Questel FamPat database3
It is a paid database service http://www.questel.com/

A FamPat family groups together all publications for patents of a single invention.

FamPat families are dynamic: their composition changes as new information is

received. Each patent is unique in the FamPat database. No single patent
number may appear in two distinct families.

FamPat family rules:

• Patents sharing the exact same priority number are grouped in the same
Fampat family

• Any national phase of a PCT application (WO) is included in the family of its
PCT parent

• Any national phase of an European patent (EP) is included in the family of its
EP parent

• Japanese applications that, when combined together, are equivalent to a

European or North American application, are grouped in the same family

• Non-US applications claiming priority to a US provisional application are

grouped with the respective US application(s)

• Any EP divisional application will be grouped with its parent EP.

3
https://www.questel.com/wp-content/uploads/2016/04/FamPat-Rules.pdf

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Derwent World Patents Index4
It is again a paid service available from Thomson Reuters.

DWPI is the world's most comprehensive database of enhanced patent

documents. DWPI contains over 34 million patent families covering more than 71
million patent documents worldwide. DWPI provides unparalleled access to the
world's patent literature with full coverage of agricultural and veterinary medicine,
electronic/electrical engineering, chemistry, pharmaceuticals and polymers.

INPADOC
This is free service.

INPADOC, which stands for International Patent Documentation Center, is an

international patent collection. The database is produced and maintained by the
European Patent Office (EPO). It contains patent families and legal status
information, and is updated weekly.

INPADOC was founded by the World Intellectual Property Organization (WIPO)

and the government of Austria under an agreement on May 2, 1972. A little less
than twenty years later, on January 1, 1990 or, according to another source, in
1991, it was integrated into the European Patent Office. An EPO sub-office was
then created in Vienna, Austria.

The INPADOC database, which is publicly accessible, provides information about

patent families, i.e. corresponding patent applications, i.e., patent applications in
different countries which claim the same priority and which normally disclose the
same invention. It also provides information concerning the legal status of patent
applications and patents in those countries which report status changes.

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https://clarivate.com/products/derwent-world-patents-index/

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Features of INPADOC5
When using INPADOC via one of the commercial database host services, it
bears all the Espacenet features, plus the following:
• Standardization of applicant and inventor names;

• References to abstracts from Chemical Abstracts and Thomson Scientific

Abstracts are made within the patent family;

• By including the legal status database additional information is available

and additional family links can be established;

• National application numbers, international application numbers and

domestic relations are included in the family search

Patent families in the CAS Databases

This is a paid database.

Patent family information for chemical and chemical engineering patents from
1957 to the present is available in the CAplus database on STN.

For each CAplus "basic" patent, i.e., the patent document abstracted and
indexed by CAS, CAS has identified other closely related patent family members.

Closely related patent family members tend to have simple priority relationships
with the basic patent, such as citing the same priority application.

While most patent families consist of closely related patents "covered" by the
same abstract, there are some cases with more than one abstract associated
with a patent family. This may happen when related patents have somewhat

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http://www.epo.org/searching/essentials/patent-families/inpadoc.html

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different technical content or when family members have more complex
relationships such as multiple priorities from different countries or relationships
resulting from division, continuation, or continuation-in-part patents. Such
extended patent family relationships are also identified in the CAplus database.

CAS has covered patents of chemical, biochemical and chemical engineering

interest from 1907 to the present.

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TYPES OF PATENT

Based on the filing procedure there are several types of patent applications:
• Provisional Application
• Ordinary or non-provisional application
• Convention application
• PCT: International Application
• National Phase Application under PCT
• Patent of addition
• Divisional Application
• Continuation application
• Continuation-in-part application

In general, most of the countries recognize provisional application, convention

applications, PCT international application and national phase applications under
PCT.

The applications like continuation, continuation-in-part and patent of addition are

country specific.
e.g. Continuation application and continuation-in-part application are available
under US patent system and not under Indian or European patent system.

Patents of addition are not available in US patent system. These are available in
India.

We would study different types of patent applications in brief.

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Provisional Application
A provisional application is a temporary application which is filed when the
invention is not finalized and is still under experimentation.
Advantages of filing a provisional application:
• Applicant gets 12 months’ time to fully develop the invention and ascertain
its market potential
• Helps to establish “priority” right over the invention
• Enables the applicant to use the term "patent pending” on their product
• Less expensive to prepare and file the application
• Enables the applicant to file International applications and claim priority
within 12 months.
However, in order for the patent to be granted, a provisional application must be
followed by a complete specification within 12 months. Moreover, the provisional
application should be sufficiently detailed and must be drafted very carefully to
ensure that the priority rights are secured for your invention.

Ordinary or non-provisional application:

The first application for patent filed in the Patent Office without claiming priority
from any application or without any reference to any other application under
process in the Patent office is called an ordinary application.

Convention application:
When an applicant files a patent application, claiming a priority date based on the
same or substantially similar application filed in one or more of the convention
countries, it is called a convention application. In order to get a convention status,
an applicant should file the application before any of the patent offices within 12
months from the date of first application in the convention country.

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PCT: International Application
The Patent Cooperation Treaty or PCT is an international agreement for filing
patent applications. However, there is nothing called as a 'world patent'. The PCT
application does not provide for the grant of an international patent, it simply
provides a streamlined process for the patent application process in many
countries at the same time. Some of the benefits of the system are:
- It simplifies the process of filing patent applications i.e., an applicant can file a
single international patent application in one language with one receiving patent
office in order to simultaneously seek protection for an invention in up to 138
countries throughout the world.
- It provides internationally recognized priority date, which has an effect in each
of the countries designated.
- Delays the expenses associated with applying for patent protection in various
countries. PCT gives 30 to 31 months time to enter into various countries from
the priority date or international filing date whichever is earlier unlike the
convention method which gives only 12 months time to file for a patent
application in the country of interest from the priority date. Hence, the PCT route
allows the inventor more time to assess the commercial viability of his/her
invention.
- It provides an international search report. The results of this search are very
valuable to the applicant. They allow the applicant to make more informed
choices early in the patent process, and to amend the application to deal with
any conflicting material, before the major expenses of the national phase of the
patent process begin.
- Provides an option of an International Preliminary Examination Report that is
forwarded to the elected Offices and the applicant, the report containing an
opinion as to whether the claimed invention meets certain international criteria for
patentability.
- These reports give the applicant a fair idea about the patentability of the

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invention before incurring charges for filing and prosecution in each individual
country.

National Phase Application under PCT

The PCT-national phase must follow the international phase. The applicant must
individually 'enter into the national phase'. i.e. file a National phase application in
each county he wishes to enter. The applicant can enter the national phase in up
to 138 countries within 30-31 months (depends on the laws of the designated
countries) from the international filing date or priority date (whichever is earlier). If
the applicant does not enter the national phase within the prescribed time limit,
the International Application loses its effect in the designated or elected States.

Patent of addition:
Patent of addition is an application made for a patent in respect of any
improvement or modification of an invention described or disclosed in the
complete specification already applied for or has a patent.

In order to be patentable an improvement, should be something more than a

mere workshop improvement and must independently satisfy the test of invention.
The major benefit is the exemption of renewal fee so long as the main patent is
renewed. A patent of addition lapses with the cessation of the main patent.

Divisional Application:
A divisional application is one which has been "divided" from an existing
application. The applicant, at any time before the grant of a patent can file a
further application, if he so desires or if an objection is raised by the examiner on
the ground that the claims disclosed in the complete specification relates to more
than one invention. A divisional application can only contain subject matter in the
application from which it is divided (its parent), but retains the filing and priority
date of that parent. A divisional application is useful if a unity of invention

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objection is issued, in which case the second invention can be protected as a
divisional application.

Continuation application:
In certain offices a patent application can be filed as a continuation of a previous
application. Such an application is a convenient method of including material
from a previous application in a new application when the priority year has
expired and further refinement is needed.

Continuation applications utilize the parent application's disclosure and claim the
benefit of the parent application. In order for a continuation application to be
granted the filing date of the parent application it must: (1) be filed while the
parent application is pending, (2) have at least one inventor in common with the
parent application, and (3) have claims that are fully supported by the parent
application's disclosure.

Continuation-In-Part (CIP) Applications

CIP applications contain the parent application's disclosure plus additional
disclosure. Claims that are supported by the parent application's disclosure may
obtain an effective filing date of the parent application; however claims that are
supported by the additional disclosure may not obtain the effective filing date.

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Types of patents in USA1:
Based on nature of invention, three different types of patents are available in US
patent system.
1. Utility Patent:
Issued for the invention of a new and useful process, machine, manufacture, or
composition of matter, or a new and useful improvement thereof, it generally
permits its owner to exclude others from making, using, or selling the invention
for a period of up to twenty years from the date of patent application filing,
subject to the payment of maintenance fees. Approximately 90% of the patent
documents issued by the USPTO in recent years have been utility patents, also
referred to as "patents for invention."

2. Design Patent:
Issued for a new, original, and ornamental design for an article of manufacture, it
permits its owner to exclude others from making, using, or selling the design for a
period of fourteen years from the date of patent grant. Design patents are not
subject to the payment of maintenance fees.

3. Plant Patent:
Issued for a new and distinct, invented or discovered asexually reproduced plant
including cultivated sports, mutants, hybrids, and newly found seedlings, other
than a tuber propagated plant or a plant found in an uncultivated state, it permits
its owner to exclude others from making, using, or selling the plant for a period of
up to twenty years from the date of patent application filing. Plant patents are not
subject to the payment of maintenance fees.

Further, there are three different types of patents in US patent system.

1
http://www.uspto.gov/web/offices/ac/ido/oeip/taf/patdesc.htm

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4. Reissue Patent:
Issued to correct an error in an already issued utility, design, or plant patent, it
does not affect the period of protection offered by the original patent.

5. Defensive Publication (DEF):

Issued instead of a regular utility, design, or plant patent, it offers limited
protection, defensive in nature, to prevent others from patenting an invention,
design, or plant. The Defensive Publication was replaced by the Statutory
Invention Registration in 1985-86.

6. Statutory Invention Registration (SIR):

This document replaced the Defensive Publication in 1985-86 and offers similar
protection.

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SEARCHING PATENTS

Why Perform a Patent Search1?

The reasons for performing a patent search are many. The most obvious is to
determine whether you can get a patent or if your invention has already been
patented. Other reasons include:
• getting a general idea of how an application and patent is structured to
help in the preparation or your own application
• learning more about a new field
• for market information
• competitor tracking
• technology tracking

The various free sites available for patent searches are:

Source Website
General sites for patent searches
Espacenet http://worldwide.espacenet.com/?locale=en_EP
Google patents http://www.google.com/?tbm=pts
Freepatentsonline http://www.freepatentsonline.com/
Patent lens http://www.patentlens.net/patentlens/quick.html
Specific sites for patent searches
Patentscope http://patentscope.wipo.int/search/en/structuredSearch.jsf
The site is for patent searches of PCT.
USPTO http://patft.uspto.gov/
The site is for patent searches in applications and granted
patents in US.

1
http://www.lib.utexas.edu/engin/patent-tutorial/index.htm

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TERM OF A PATENT
The term of a patent is the maximum period during which it can be maintained
into force. It is usually expressed in number of years either starting from the filing
date of the patent application or from the date of grant of the patent. In most
patent laws, renewal annuities or maintenance fees have to be regularly paid in
order to keep the patent in force. Otherwise the patent lapses before its term.

The term of a patent or specific "claims" in a patent may also be curtailed by

judgment of a court, as where a claim or patent is held "invalid" under the
relevant law, and thus no longer enforceable.

Significant international harmonization of patent term across national laws was

provided in the 1990s by the implementation of the WTO's Agreement on Trade-
Related Aspects of Intellectual Property Rights (TRIPs Agreement).

Article 33 of the TRIPs Agreement provides that the "The term of protection
available for patents shall not end before the expiration of a period of twenty
years counted from the filing date."

Consequently, in most of the countries, the term of patent is 20 years from the
filing date of the application.

Term of every patent in India is 20 years from the date of filing of patent
application, irrespective of whether it is filed with provisional or complete
specification.

However, in case of applications filed under PCT the term of 20 years begins
from International filing date

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Patent term in US
- All patents that were in force on June 8, 1995, or that issued on an application
that was filed before June 8, 1995, have a term that is the greater of the “twenty-
year term” or seventeen years from the patent grant.
- A patent granted on an international application filed before June 8, 1995, and
which entered the national stage before, on or after June 8, 1995, will have a
term that is the greater of seventeen years from the date of grant or twenty years
from the international filing date or any earlier filing date.
- A patent granted on an international application filed on or after June 8, 1995
and which enters the national stage will have a term which ends twenty years
from the filing date of the international application.
- A continuation or a continuation-in-part application claiming benefit of an
international application filed designating the United States will have a term
which ends twenty years from the filing date of the parent international
application.

The patent term will additionally be adjusted to compensate for delays in the
issuance of a patent. The reasons for extensions include:
• Delayed response to an application request for patent.
• Exceeding 3 years to consider a patent application.
• Delays due to a secrecy order or appeal.

Patent term in Europe

The European Patent Convention requires all jurisdictions to give a European
patent a term of 20 years from the actual date of filing an application for a
European patent or the actual date of filing an international application under the
PCT designating the EPO. The actual date of filing can be up to a year after the
earliest priority date. The term of a granted European patent may be extended
under national law if national law provides term extension to compensate for pre-
marketing regulatory approval.

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Patent term for pharmaceutical products:
The standard term of a patent is 20 years from the date of filing. However, the
time required for a pharmaceutical product to pass through research and
development, and clinical trials to obtain regulatory approval can often be more
than 10 years. This effectively shortens the life of the patent leaving the patentee
with little or no monopoly over the pharmaceutical product by the time it reaches
market.

Extensions of term for pharmaceutical patents are in recognition of the longer

time required for testing, development and regulatory approval processes of new
pharmaceutical products, which means that pharmaceutical patents invariably
have a shorter effective life than other patents.

Following countries provide patent term extensions for regulatory delays:

• Japan
• Australia
• Europe
• US
• Russia

However, many countries specially developing and semi-regulated countries do

not provide any patent term extensions for pharmaceutical products:
• India
• China
• Brazil
• Mexico

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PATENTABILITY CRITERIAS
What is patentable?
The three basic criteria for patentability of any invention are
Novelty: The invention must be new.
Inventive step: The invention must be non-obvious.
Industrial applicable: The invention must be useful.

Further, the disclosure of the invention also must meet some criteria for being
eligible for patent protection.

Novelty:
Novelty is a patentability requirement. An invention is not patentable if the
claimed subject matter was disclosed before the date of filing or before the date
of priority if a priority is claimed, of the patent application.

In some countries, such as the United States, Canada, Australia and Japan, a
grace period exists for protecting an inventor or their successor in title from
authorized or unauthorized disclosure of the invention before the filing date. That
is, if the inventor or the successor in title publishes the invention, an application
can still be validly filed which will be considered novel despite the publication,
provided that the filing is made during the grace period following the publication.
The grace period is usually 6 or 12 months. This type of novelty bar is sometimes
known as a relative novelty bar.

In other countries, including European countries, any act that makes an invention
available to the public, no matter where in the world, before the filing date or
priority date has the effect of barring the invention from being patented.
Examples of acts that can make an invention available to the public are written
publications, sales, public oral disclosures and public demonstrations or use.
This is known as an absolute novelty requirement.

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Local novelty (as is currently the requirement in New Zealand) only regards
publications, uses or sales that have taken place within that jurisdiction to be
novelty destroying. Local novelty by publication is now largely extinct under New
Zealand practice. This leaves only “local novelty by use”, which is rather limited,
even to the point of irrelevance. Therefore, to all intents and purposes, New
Zealand patent law already appears to operate on a de facto absolute novelty
basis.

The grace period should not be confused with the priority year defined by Paris
Convention for the Protection of Industrial Property. The priority year starts when
the first filing in a Contracting State of the Paris Convention is made, while the
grace period starts from the pre-filing publication.

The concept of prior art:

The most important part of patent application process is prior art examination.
Each of the world’s patent offices examines a filed application based upon
standards similar to the utility, novelty and non-obviousness as these three are
the main ingredients which are required for granting patent.

Prior art (also known as state of the art, which also has other meanings, or
background art, in most systems of patent law, constitutes all information that
has been made available to the public in any form before a given date that might
be relevant to a patent's claims of originality. If an invention has been described
in the prior art, a patent on that invention is not valid.

The standard method for researching the novelty of an invention is to perform a

prior art search. A prior art search is generally performed with a view to proving
that the invention is "not new" or old. No search can possibly cover every single
publication or use on earth, and therefore cannot prove that an invention is "new".
A prior art search may for instance be performed using a keyword search of large

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patent databases, scientific papers and publications, and on Google. However, it
is impossible to guarantee the novelty of an invention, even once a patent has
been granted, since some obscure little known publication may have disclosed
the invention as claimed.

Search is done in two steps

• Firstly search is in order to establish the state of the art with respect to the
invention.
• Secondly, the novelty, inventive step and industrial applicability (utility) are
examined.

Prior art in the system of patent law, constitutes all information that has been
made available to the public in any form before a given date that might be
relevant to a patent's claims of originality. Under U.S. patent laws, defining what
prior art is pertinent is often critical. The patent statutes define what constitutes
prior art for purposes of anticipating an invention or the claims of a patent
application or patent. Unless the alleged prior art can be brought within one of
the definitions set forth in the statutes, it is not pertinent and will not be
considered.

Searching prior arts:

• Free online sites for patent searches:
USPTO http://patft.uspto.gov/
Espacenet http://www.epo.org/searching/free/espacenet.html
PCT http://patentscope.wipo.int/search/en/search.jsf
Google patent http://www.google.co.in/?tbm=pts
Freepatentsonline http://www.freepatentsonline.com/

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• Free online sites for non-patent searches:
Google http://www.google.co.in/
Pubmed http://www.ncbi.nlm.nih.gov/pubmed/advanced

• Paid databases for patent and non patent searches:

Scifinder by CAS
Orbit by Questel

Further, various journal publications in the respective domains can be used as

prior art references. e.g. Chemistry journals like
1. Journal of Biological Chemistry
2. Journal of the American Chemical Society
3. Journal of Chemical Physics
4. Journal of Physical Chemistry B
5. Tetrahedron Letters
6. Journal of Applied Polymer Science
7. Langmuir
8. Chemical Physics Letters
9. Chemical Communications
10. Journal of Physical Chemistry A
11. Acta Crystallographica, Section E, Structure Reports online
12. Macromolecules
13. Journal of Organic Chemistry
14. Journal of Chromatography A
15. Journal of Agricultural and Food Chemistry
16. Bioorganic & Medicinal Chemistry Letters
17. Tetrahedron
18. Organic Letters

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Types of prior art searches1
Novelty
A "novelty search" is a prior art search that is often conducted by patent
attorneys, patent agents or professional patent searchers before an inventor files
a patent application. A novelty search helps an inventor to determine if the
invention is novel before the inventor commits the resources necessary to obtain
a patent. The search may include searching in databases of patents, patent
applications and other documents such as utility models and in the scientific
literature. A search of this type is also conducted by patent examiners during
prosecution of the patent application.

Validity
A "validity search" is a prior art search done after a patent is issued. The purpose
of a validity (or invalidity) search is to find prior art that the patent examiner
overlooked so that a patent can be declared invalid. This might be done by an
entity infringing, or potentially infringing, the patent, or it might be done by a
patent owner or other entity that has a financial stake in a patent to confirm the
validity of a patent.

Clearance
A clearance search is a search of issued patents to see if a given product or
process violates someone else's existing patent. If so, then a validity search may
be done to try to find prior art that would invalidate the patent. A clearance
search is a search targeting patents being in force and may be limited to a
particular country and group of countries, or a specific market.

1
http://en.wikipedia.org/wiki/Prior_art

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Inventive step or non-obviousness:
In addition to the novelty requirement, the inventive step (non-obviousness)
requirement is another internationally recognized requirement of patentability
under patent law.

Human beings constantly create new inventions2. Some of those may be truly
innovative. Many, however, differ from known art only in minor details and could
easily have been conceived by other inventors without any inventive activity.
Thus, the objective of the inventive step (non-obviousness) requirement is to
prevent inventions involving only trivial accomplishments from obtaining a patent
that confers rights to exclude others from exploiting the patented invention. In
other words, only truly inventive achievements over the existing art, and not
developments that a person with ordinary skill could easily deduce from what
already exists, should be rewarded with an exclusive right.

The inventive step and non-obviousness reflect a same general patentability

requirement present in most patent laws, according to which an invention should
be sufficiently inventive i.e., non-obvious in order to be patented. In other words,
the nonobviousness principle asks whether the invention is an adequate distance
beyond or above the state of the art.

The expression "inventive step" is predominantly used in Europe, while the

expression "non-obviousness" is predominantly used in United States patent law.
Although the basic principle is roughly the same, the assessment of the inventive
step and non-obviousness varies from one country to another.

The purpose of the inventive step, or non-obviousness, requirement is to avoid

granting patents for inventions which only follow from "normal product design and
development", in order to eventually achieve a proper balance between the

2
http://www.wipo.int/scp/en/novelty/documents/5prov.pdf

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incentives provided by the patent system, namely encouraging innovation, and
the social cost of the patent system, namely conferring temporary monopolies.

In general, an invention is considered to involve an inventive step (be non-

obvious) if, having regard to the prior art, that invention is not obvious to a person
skilled in the art on the filing date (or the priority date).

A person having ordinary skill in the art to which the invention pertains means a
hypothetical person3:
• who has ability to use ordinary technical means for research and
development (including experimentation, analysis, manufactures, etc.);
• who has ability to exercise ordinary creativity in selecting materials and
modifying workshop ; and
• who is able to comprehend as his/her own knowledge all technical matters in
the state of the art in the field to which a claimed invention pertains at the time
of filing of a patent application.

In addition, a person skilled in the art is supposed to be able to comprehend as

his/her own knowledge all technical matters in the field of technology relevant to
a problem to be solved by the invention.

The definition of a person skilled in the art again differs from one jurisdiction to
another. However in general, the person skilled in the art is the one who has
technical knowledge in the domain of the invention.
e.g. For an application of new drug, a chemist working in the drug discovery lab
may be a person skilled in the art.

3
http://www.jpo.go.jp/iken_e/pdf/feedback_120530_2.pdf

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Relatively good arguments for proving inventive step or non-obviousness for an
invention are:
• Unexpected (good) results
• A clear technical advantage over prior art
• Synergistic effect
• Against technical teaching
• Long felt need for a solution to the problem
• Commercial success
• Competitors wants licenses

It can be said that an invention is new (novel) when it differs from the prior art.
Not much difference is required; a small difference is sufficient. Simply, an
invention Z’ is new when is different from the prior art Z.

It can be said that an invention is non-obvious (or possesses inventive level)

when it is sufficiently different from the prior art. A certain degree of difference is
required; a simple difference is not sufficient. Therefore, an invention A is non-
obvious when it is significantly different from the prior art Y.

The common understanding is that a single prior art reference revealing the
description, organization and functioning in substantially the same manner as
that of the claimed invention will anticipate it whereas inventive step is analyzed
in combination of one or more prior arts extrapolating the state of the art.

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Duty of disclosure:
An essential part of filing and prosecuting a patent application in many
jurisdictions including US is the duty of disclosure, which requires the disclosure
of all known information which is material to patentability 4 .The complete
specification must describe the method of performing the invention known to the
applicant, including that, which he may have acquired during the period of
provisional protection prior to the date of filing the complete specification.

The duty of disclosure requires disclosure of all information relevant or related to

the invention, and extends to each individual who is involved with the preparation,
filing and/or prosecution of the patent application. This includes the inventors, the
assignee, and all individuals who work for the inventors or assignee and who
assist in the preparation or prosecution of the application. The duty of disclosure
exists throughout prosecution, until the application issues as a patent, and may
be discharged by disclosing all relevant information to the attorney or agent who
is handling prosecution of the application. In addition to patents and publications,
the duty of disclosure extends to related patent applications pending in the
Patent Office and Office Actions issued in these pending applications and
corresponding foreign applications.

In India, sufficiency of disclosure is checked by the Examiner while examining a

patent application. The Examiner will look for whether:
a. the specification is properly titled.
b. the subject matter is fully and particularly described in the specification.
c. the claims define the scope of the invention properly.
d. the Specification describes the best method of performing the invention or not.
e. the source and geographical origin, in case of inventions related to biological
materials, has been disclosed.
f. approval obtained from Biodiversity Authority, wherever applicable.

4
http://www.evanlawgroup.com/duty_of_disclosure.html

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g. accession number and other details of the depository are given, if applicable
Indian scenario for duty of disclosure:
A patent applicant in India has the duty to disclose information regarding
corresponding applications filed in other countries. At the time of filing a patent
application in India, the applicant must file a Form 3 (Appendix III) under Section
8 of the Patents Act, 1970 dealing with the duty of the applicant to disclose the
information.

The Applicant has the following obligations under Section 85:

(1) File Form 3 with information regarding corresponding applications at the
time of filing the Indian application or within 6 months from the date of
filing the application in India. This applies to PCT National Phase
Applications as well;
(2) Undertake to keep the Controller of Patents informed of every other
application filed outside India subsequent to the filing of the Indian
application; and’
(3) At any time during the prosecution of the application in India, if the
examiner requires, furnish details regarding the prosecution of
corresponding applications in other countries.

Often Examiners ask applicants to submit the search and examination reports of
corresponding foreign applications. This can become an onerous task if the
applicant has filed patent applications in numerous countries.

http://www.ipoef.org/AM/Template.cfm?Section=Programs&Template=/CM/ContentDisplay.cfm&Conten
tID=15238

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PATENT ATTORNEY:
A patent attorney is an attorney who has the specialized qualifications necessary
for representing clients in obtaining patents and acting in all matters and
procedures relating to patent law and practice. The term is used differently in
different countries, and thus may or may not require the same legal qualifications
as a general legal practitioner.

The titles patent agent and patent lawyer are also used in some jurisdictions. In
some jurisdictions the terms are interchangeable, while in others the latter is
used only if the person qualified as a lawyer.

In US, patent agents and patent attorneys are distinct as follows:

A patent attorney is an individual who (1) is a lawyer, (2) holds a university
degree in an approved technical field or who is a state registered engineer, and
(3) has passed the Patent Bar Examination. A patent agent only qualifies under
items (2) and (3) above.

Both patent attorneys and patent agents are registered with the USPTO, and are
fully authorized to prepare patent applications and obtain patents for their clients.
Patent agents usually charge much less for their services.

In Europe, requirements for practicing as patent attorney before national patent

offices should be distinguished from those needed for practicing before the
European Patent Office (EPO). On the national level, the requirements are not
harmonized across the European Union, except that the EU makes sure that
respective professional qualifications are mutually recognized to some degree.

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In India, a person registered to practice before Indian Patent Office is called a
"Registered Patent Agent" or simply "Patent agent". The Indian Patent Law
specifically does not mention the designation of "Patent Attorney".

A patent agent is a person authorized to interact with the patent office on behalf
of his client. He can file a patent application, prosecute the patent application
and appear before the patent office or appellate board on behalf of his client.

Eligibility criteria to appear in the Indian Patent Agent Exam are simple and as
follows:
• Minimum 21 years of age.
• Indian Nationality.
• Degree in science, engineering or technology from any University
established under law for the time being in force] in the territory of India or
possesses such other equivalent qualifications as the Central Government
may specify in this behalf.

The qualifying examination shall consist of the following papers namely:

Paper Details Marks

Paper I Patents Act and Rules 100 marks

Paper II Drafting and interpretation of 100 marks

patent specifications and others
Viva Voce 50 marks
A candidate shall be required to secure a minimum of fifty marks in paper I and
paper II and shall be declared to have passed the examination only, if he obtains
an aggregate of sixty percent of the total marks.

Indian patent office maintains the question papers of previous papers at the
weblink: www.ipindia.nic.in/ipr/patent/patent_agent/exam_paper.htm

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PATENT INFRINGEMENT
Patent infringement is the commission of a prohibited act with respect to a
patented invention without permission from the patent holder. Permission may
typically be granted in the form of a license.

The definition of patent infringement may vary by jurisdiction, but it typically

includes using or selling the patented invention. In many countries, a use is
required to be commercial (or to have a commercial purpose) to constitute patent
infringement.

The scope of the patented invention or the extent of protection is defined in the
claims of the granted patent. In other words, the terms of the claims inform the
public of what is not allowed without the permission of the patent holder.

Patents are territorial, and infringement is only possible in a country where a

patent is in force. For example, if a patent is filed in India, then anyone in India is
prohibited from making, using, selling or importing the patented item, while
people in other countries may be free to make the patented item in their country.

The scope of protection may vary from country to country, because the patent is
examined by the patent office in each country or region and may have some
difference of patentability, so that a granted patent is difficult to enforce
worldwide.

Elements of patent infringement:

Typically, a party (other than the patentee or licensee of the patentee) that
manufactures, imports, uses, sells, or offers for sale patented technology without
permission/license from the patentee, during the term of the patent and within the
country that issued the patent, is considered to infringe the patent.

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The test varies from country to country, but in general it requires that the
infringing party's product (or method, service, and so on) falls within one or more
of the claims of the patent. The process employed involves "reading" a claim
onto the technology of interest. If all of the claim's elements are found in the
technology, the claim is said to "read on" the technology; if a single element from
the claim is missing from the technology, the claim does not literally read on the
technology and the technology does not infringe the patent with respect to that
claim.

In response to allegations of infringement, an accused infringing party will

generally assert one or more of the following:
• it was not practicing the patented invention;
• it was not performing any infringing act in the territory covered by the
patent;
• the patent has expired;
• the patent (or the particular claim(s) alleged to be infringed) is invalid,
because the invention in question does not meet patentability or includes
a formal defect, rendering the patent invalid or unenforceable;
• it has obtained a license under the patent;
• the patent holder is infringing patent rights belonging to the accused
infringing party, and the party may resolve the dispute in settlement or
cross-licensing.

Indirect infringement:
In certain jurisdictions, there is a particular case of patent infringement called
"indirect infringement." Indirect infringement can occur, for instance, when a
device is claimed in patent and a third party supplies a product which can only be
reasonably used to make the claimed device.

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Induced infringement:
It is that which enables the direct infringer to practice the patented intention. This
type of infringement can take the form of helping the direct infringer to assemble
the patented product; providing instructions that detail how to produce the
patented invention; preparing instructions for consumer use; or licensing plans or
a process which enable the licensee to produce the patented product or process.
The test for induced infringement is whether the inducer has demonstrated active
aiding and abetting of the direct infringer's infringing activities.

Contributory infringement:
A contributory infringement is one which offers to sell or sells a component of a
patented machine, manufacture, combination or composition, or a material or
apparatus for use in practicing a patented process, constituting a material part of
the invention, knowing the same to be especially made or especially adapted for
use in an infringement of such patent, and not a staple article of commerce
suitable for substantial noninfringing use.

Infringement under doctrine of equivalence (DOE):

The doctrine of equivalents is a legal rule in most of the world's patent systems
that allows a court to hold a party liable for patent infringement even though the
infringing device or process does not fall within the literal scope of a patent claim,
but nevertheless is equivalent to the claimed invention.
One way of determining whether a difference is "insubstantial" or not is called the
"triple identity" test. Under the triple-identity test, the difference between the
limitation in the accused device and the limitation literally recited in the patent
claim may be found to be "insubstantial" if the limitation in the accused device:
1.Performs substantially the same function
2.In substantially the same way
3.To yield substantially the same result
as the limitation literally recited in the patent claim.

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