Professional Documents
Culture Documents
Property Rights
1
Relevance of “Law relating to Intellectual Property
and Patents” for the students of Science and
Technology
2
Outcomes of Science and Technology
Outcomes: Aims:
- Scientific Knowledge - Improving life
- Technical Skills - Improving Society
- Creative Skills - Improving education
- Publications - Better Quality of Life
- Products and solutions - Addressing global challenges
- Services and related solutions, - Equitable and Sustainable
and many more Development (SDGs) 3
The Office of the Controller General of Patents, Designs & Trade Marks
(CGPDTM) generally known as the Indian Patent Office, is an agency under
the Department for Promotion of Industry and Internal Trade (DPIIT) which
administers the Indian law of Patents, Designs and Trade Marks. 4
What happens if you do not protect your inventions?
5
6
Why Intellectual Property Required?
7
What are the IPRs in India?
The Intellectual Property Rights (IPRs) in India mainly include encompassing trademarks,
copyrights, patents, trade secrets and design, etc. Each category of intellectual property
covers a different group of properties and work. It is necessary to choose the right
category to safeguard the work and the business property.
Copyright - Grants the protection of written or published works such as books, songs,
films, web content, and other artworks
Patents - The patent rights protect an invention, new business product, or the process
8
What are the IPRs in India?
Geographical indications (GI) - Geographical indications and appellations of origin
are signs used on goods that have a specific geographical origin and possess
qualities, a reputation or characteristics that are essentially attributable to that
place of origin. Most commonly, a geographical indication includes the name of the
place of origin of the goods.
Trade secrets - A trade secret is a company's process or practice that is not public
information, which provides an economic benefit or advantage to the company or
holder of the trade secret. Trade secrets must be actively protected by the company
and are typically the result of research and development.
9
Types of IPR
TRADEMARK PATENTS COPYRIGHTS
For Aesthetic Designs of For Specified place with the Confidential Business
Industrial Products products Information
10
Why is it important to register intellectual
property?
When an individual or an organization develops a new product, which
involves a lot of processes, content, resources etc., a lot of time and
money is invested. It is natural for the inventor or organization to have the
expectation of being able to own exclusive rights over the invention, while
excluding others from benefiting from it.
This exclusivity is provided through IP systems and IP laws.
There are several dangers if IPRs are not protected. For instance, not
protecting IP can result in getting benefits from the unprotected invention
in an unauthorized manner to anyone.
There is no law that can stop one from duplicating and seeking financial
benefits from someone else's innovation if IP is not filed.
11
Benefits of IPR
Intellectual property rights not only protect the ideas or concepts of business but also protect the
genuine business assets that are vital to the products and services. The advantages include:
• Enhances market value - Intellectual property rights can help you generate business through
the licensing, sale and even commercialization of the products and services protected under
IPRs.
• Turn ideas and thoughts into profit-making assets - Copyrighting or licensing the patents can
lead to a steady stream of royalties and additional income.
• Market your products and services - Intellectual property rights like trademark registration
can help you separate your products and services from others.
• Access or raise Capital - Through sale, licensing, or by using IPRs as collateral for debt
financing, an individual can monetize for debt financing. Intellectual property rights can be
used as an advantage while applying for government funding like grants, subsidies, and loans.
• Enhances export opportunities – A business that has registered IPRs will be able to use
brands and designs to market its products and services to other markets as well. A business
can also tap into the franchising agreements with overseas companies or export patented
products. 12
Case Study to build a perspective
• Novartis (for Glivec) Vs The Union of India
13
Thank you
14
Discussion on the Glivec Case Study
Facts:
1. In 1998, one of the largest international pharmaceutical
companies i.e. Novartis International AG filed an application as
per the TRIPS agreement before the Chennai Indian patent office
for the grant of a patent for an anticancer drug ‘Glivec’ which is
used to treat Chronic Myeloid Leukemia (CML) and
Gastrointestinal Stromal Tumours (GIST) invented from Beta
crystalline form of “Imatinib mesylate”. This drug is famously
used in the treatment of cancer and the same is patented in more
than 35 countries.
1
Discussion on the Glivec Case Study
Facts:
2. When Novartis filed its patent application, the grant used to be
restricted to methods or processes and not for products in India,
as defined under section-5 of Patent Act, 1970.
3. After the Patent (Amendment) Act, 2005, section-5 was
repealed and patents came to be granted for methods or
processes but also for products.
4. In 2005, patent application of Novartis for the drug Glivec was
taken into consideration and the same was rejected by Madras
Patent Office on the ground that the drug was anticipated by
prior publication and failed to satisfy the requirement of
novelty and non-obviousness
2
Discussion on the Glivec Case Study
Court Proceedings:
1. After that, Novartis filed two writ petitions in Madras High
Court in the year 2006 under Article-226 of Constitution of India
(Jurisdiction of the High Courts).
2. The appeals subsequently stated that the section-3(d) of Patent
Act, 1970 is unconstitutional because it is not in compliance with
TRIPS agreement and also violates Article-14 of Constitution of
India (equal protection of law) and the other against the order
passed by Madras Patent Office.
3. Madras High Court transferred the case to IPAB (Intellectual
Property Appellant Tribunal) in 2007. This appeal was finally
heard and dismissed by IPAB stating that the invention satisfied
the tests of novelty and non-obviousness but the patentability of
the product was hit by section-3(d) of the Patent Act, 1970.
3
Discussion on the Glivec Case Study
Court Proceedings:
4. The judgment given by IPAB is to prevent ever-greening of
already patented product by introducing minor changes and
to provide easy access to the citizens of India to life saving
drugs.
4. After that Novartis filed SLP (Special Leave Petition) in 2009
before the Supreme Court of India against the order passed by
IPAB under Article-136 of Constitution of India (for appeal to
the Supreme Court).
4
Issues in the Case
5
The Judgement of the Honorable Supreme
Court of India
In April 2013, the two judge bench of Supreme Court of India
rejected the appeal filed by Novartis and upheld that the beta
crystalline form of Imatinib Mesylate is a new form of the known
substance i.e., Imatinib Mesylate, wherein the efficacy was well
known.
Supreme Court made it crystal clear that in the case of medicine
“Efficacy” in section-3(d) only means “Therapeutic Efficacy”
and states that all properties of drug are not relevant, the
properties which directly relate to efficacy in case of medicine is its
therapeutic efficacy.
Supreme Court in third issue ruled that about 30% increase in
bioavailability qualifies as increase in therapeutic efficacy
under section-3(d) of Patent Act, 1970 if evidence is provided
for the same.
6
Conclusion
7
ECO 500/ 600: Types of Intellectual Property Rights
8
Contents
9
Intellectual Property Rights (IPR)
10
Function of IPRs
11
Categories of IPRs
12
Types of IPRs
Patents
Undisclosed
information Copyrights
Plant
varieties &
farmers Trademarks
rights
IPRs
Biological Industrial
diversity designs
Protection of
Geographical
Integrated
indications
Circuits
of goods
design
13
Patents
• The patent holder has the legal right to exclude others from
commercially exploiting his invention for the duration of this
period
14
Patents
15
Copyright
• Copyright lasts for a certain time period after which the work
is said to enter the public domain
19
Trademark
20
Designs
• The Designs Act, 2000 and the Designs Rules, 2001 presently
govern the design law in India
21
Semiconductor Integrated Circuits Layout-
Design
22
Semiconductor Integrated Circuits Layout-
Design
• Semiconductor Integrated Circuit means a product having
transistors and other circuitry elements designed to perform
an electronic circuitry function
• The layout determines the size of the integrated circuit as well
as its processing power
25
Geographical Indications of Goods
26
Geographical Indications of Goods
27
Biological Diversity
30
Protection Of Plant Varieties And Farmers
Rights
• A plant variety represents a more precisely defined group of
plants, selected from within a species, with a common set of
characteristics
31
Protection Of Plant Varieties And Farmers
Rights
• According to the Act, the term 'variety' means - a plant
grouping except micro organism within a single botanical
taxon of the lowest known rank, which can be:
• defined by the expression of the characteristics resulting
from a given genotype of that plant grouping
• distinguished from any other plant grouping by expression
of at least one of the said characteristics
• considered as a unit with regard to its suitability for being
propagated, which remains unchanged after such
propagation; and includes propagating material of such
variety, extant variety, transgenic variety, farmers’ variety
and essentially derived variety
32
Protection Of Plant Varieties And Farmers
Rights
• The objectives of the Act are:
• to recognize and protect rights of farmers for their
contribution made at any time in conserving, improving and
making available plant genetic resources for the
development of new plant varieties
• to protect plant breeders’ rights to stimulate investment for
research and development both in the public and private
sector for development of new plant varieties
• to facilitate the growth of seed industry in the country that
will ensure the availability of high quality seeds and
planting material to the farmers
33
Undisclosed Information or Trade Secret
37
Thank You !
38
Novartis AG v. Union of India & Others
(Supreme Court of India, 1 April 2013)
Prepared by UNCTAD’s Intellectual Property Unit
Summary
On 1 April 2013, the Supreme Court of India confirmed the rejection by the Indian
Patent Office of a patent application filed by Swiss drug maker Novartis on the anti-
cancer medicament “Glivec”. The Supreme Court (hereinafter “the Court”)
considered that Glivec did not qualify as a patentable “invention” under Section 3 (d)
of the Indian Patents Act.
The facts
Glivec is based on the original drug “imatinib”. In 1992, Novartis filed a patent
application for “imatinib”, which also covered pharmaceutically acceptable salt forms
of “imatinib”. This patent was granted by the US Patent and Trademark Office
(USPTO). Novartis received US Food and Drug Administration (FDA) approval for
one salt form of imatinib, i.e. “imatinib mesylate”, in 2001. As opposed to the original
(“free base”) substance imitanib, the salt form (i.e. mesylate) is soluble in the human
body.
In 1997, Novartis filed a US patent application for a specific variation of imatinib
mesylate, i.e. its “beta crystalline form”, for which the USPTO eventually granted a
patent. The beta crystalline form enables oral administration of imatinib mesylate.
In 1998, Novartis also applied for product patent protection for the beta crystalline
form of imatinib mesylate in India. The Indian Patent Office rejected this application
in 2006, based inter alia on the failure by Novartis to show “significantly enhanced
efficacy” of the beta crystalline form over its original salt, i.e. imatinib mesylate, as
required under Section 3(d) of the Indian Patents Act. This consideration was
confirmed by the Indian Intellectual Property Appellate Board (IPAB) on 26 June
2009. Novartis appealed to the Supreme Court.
In order to meet the statutory requirement of enhanced efficacy under Section 3(d),
Novartis in 2005 conducted studies to show inter alia a 30% increase in
bioavailability of beta crystalline imatinib mesylate over the original substance
imatinib.
The legal issues:
Novartis claimed that the subject matter of its patent application, i.e. beta crystalline
imatinib mesylate, was based on two separate patentable inventions:
• The selection of the imatinib mesylate salt from the original substance
imitanib;
• The development of the specific beta crystalline form of imatinib mesylate.
Imatinib mesylate
The Court came to the conclusion that imatinib mesylate lacked novelty, as it was
already included in the claims to the original substance imatinib. 1 The Court based its
opinion on a number of scientific articles that describe not only the free base, i.e.
1
imatinib, but also its salt form, i.e. imatinib mesylate, and its anti-tumoral properties.
In addition, Novartis, in patent infringement proceedings in Europe, had argued that
the imatinib patent encompassed claims to the salt mesylate. According to the Court, a
patent holder cannot claim a wide scope of an existing patent in infringement
litigation but then claim a narrow scope of the same patent in the context of
examining novelty of a salt derivative. 2 The scope of the original patent claims thus
defines the teachings that are pertinent for the novelty test.
2 See in particular para 143 of the Court’s decision: “[…] It is, of course, a fundamental princip le that
the construction of a claim is the sam e whether validity [i.e. regarding novelty] or infringement [i .e.
regarding scope of claims] is to be considered; no patentee is entitled to the luxury of an ‘elastic’
claim which has a narrow meaning in the former but a wide meaning in the latter . […]”
(emphasis by the Court).
3 See paras 124 and 158 of the decision.
4 Para. 180.
5 Paras 165, 171.
6 Para. 187.
7 Para. 189.
8 Ibid.
2
The Court in the end clarified that its decision did not imply a general rejection of
patentability of incremental inventions in the areas of chemical and pharmaceutical
substances.9 The Court did not say that increased bioavailability may never result in
enhanced therapeutic efficacy. And it left open the exact definition of “therapeutic
efficacy”, which could be applied narrowly to only cover curative effect, or more
broadly to encompass increased safety and less toxicity. 10
Points of significance
• Provisions like Section 3(d) of the Indian Patens Act provide an operational
tool for judges to prevent the patenting of incremental changes of existing
products.
• Efficacy may be used as a criterion for examining the notion of
“invention”/”patentable subject matter”. Alternatively, it may also be used in
the context of the novelty or inventive step examination.11
• In the absence of an express provision comparable to Section 3(d) of the
Indian Patents Act, judges may nevertheless have recourse to the criterion of
efficacy. In the case of product derivatives, similar chemical structures of the
original and the derivative product will usually set a presumption of
obviousness, which may only be rebutted by showing surprising effects of the
derivative such as enhanced efficacy.
• The interpretation of the term “efficacy” will be decisive in this context.
TRIPS leaves Members free to define efficacy in a broader sense (including
non-therapeutic/physical efficacy, such as improved methods of drug
administration) or in a narrow sense, as applied by the Indian Supreme Court
(limiting the definition to therapeutic efficacy). Many drug derivatives will
pass a broad test of physical efficacy, while failing a test of therapeutic
efficacy.
• Improved bioavailability does not necessarily result in improved therapeutic
efficacy.
• If the claims of an existing patent are interpreted widely to extend the scope of
the patent to the greatest possible extent (e.g. in infringement litigation), this
wide scope may be used by competitors to challenge the patentability of
follow-on patents on derivatives of the patented product.
Key words
Section 3(d), efficacy, therapeutic efficacy, bioavailability, patentable subject matter,
patentability, invention, novelty, inventive step, new forms, salts, derivatives,
incremental innovation.
9 Para. 191.
10 See Frederick M. Abbott, « The Judgement In Novartis v. India: What The Supreme Court Of India
Said”, Intellectual Property Watch of 4 April 2013 (http://www.ip-watch.org/2013/04/04/the-judgment-
in-novartis-v-india-what-the-supreme-court-of-india-
said/?utm_source=post&utm_medium=email&utm_campaign=alerts).
11 Para. 190 : « Thus, in whichever way section 3(d) may be viewed, whether as settin g up the
3
ECO 500/ 600: Types of Intellectual Property Rights
1
Contents
2. Characteristics of Patents
2
Patents
• A patent is an exclusive right granted for an invention
3
What does a patent offer?
• The patent owner has the exclusive right to prevent or stop others
from commercially exploiting the patented invention.
4
Characteristics of Patents
5
Characteristics of Patents
6
What all is not patentable in India
• An invention may satisfy the condition of novelty, inventiveness and usefulness but it may not
qualify for a patent under the following situations:
1. An invention that is frivolous or contrary to well established natural laws
2. 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
3. The mere discovery of scientific principle or the formulation of an abstract theory or
discovery of any living thing or non-living substance occurring in nature
4. *The mere discovery of a new form of a known substance which does not result in
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.
7
What all is not patentable in India
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 regards to efficacy
5. A substance obtained by mere admixture resulting only in the aggregation of the properties of
the components thereof
6. The mere arrangement or re-arrangement or duplication of known devices
7. A method of agriculture or horticulture
8. Any process for medicinal, surgical, curative, prophylactic (diagnostic, therapeutic) or other
treatment of human beings or any process for a similar treatment of animals
9. Plants and animals in whole or any part thereof and naturally occurring biological material
10. A mathematical or business method or a computer program per se or algorithms
11. A mere scheme or rule or method of performing mental act or method of playing game
8
What all is not patentable in India
12. A presentation of information
13. Topography of integrated circuits
14. An invention which, in effect, is traditional knowledge
15. Inventions relating to atomic energy
16. A literary, dramatic, musical or artistic work or any other aesthetic creation
9
Patent Filing Dates vs Priority Dates
• The terms filing date and priority date are often used interchangeably, but they are not the
same.
• The filing date is the date when a patent application is first filed at a patent office. The priority
date, sometimes called the “effective filing date”, is the date used to establish the novelty
and/or obviousness of a particular invention relative to other art.
• The priority date may be earlier than the actual filing date of an application. If an application
claims priority to an earlier parent application, then its priority date may be the same as the
parent application.
The term of every patent granted is 20 years from the date of filing of application. However, for
application filed under national phase under Patent Cooperation Treaty (PCT), the term of
patent will be 20 years from the international filing date accorded under PCT.
10
Patent Filing Dates vs Priority Dates
There are a number of situations where a patent application
may claim priority to an earlier application. These include:
• Continuation applications.
• Domestic applications based on foreign or international filings.
• Patent filings based on provisional patent applications. In this case, the
priority date for the full-length application is the date of the provisional
application filing.
11
Patent Application Flow (Indian Patent Office)
12
Types of Patent Applications in India
A) PROVISIONAL APPLICATION
Indian Patent Law follows first to file system. A provisional application is an application which can
be filed if the invention is still under experimentation stage. Filing a provisional specification
provides the advantage to the inventor since it helps in establishing a ―priority date of the
invention. Further, the inventor gets 12 months’ time to fully develop the invention and ascertain its
market potential and to file the complete specification.
B) ORDINARY APPLICATION
An application for patent filed in the Patent Office without claiming any priority either in a
convention country or without any reference to any other earlier application under process in the
office. Such type of application is known an ordinary application.
A complete specification entails the following:
• Title
• A preamble to the invention.
• The technical field of the invention.
• Background of the invention.
• Objects of the invention.
• Statement of the invention.
• A brief description of the drawings
• A detailed description of the invention.
• Claims
• Abstract 13
Types of Patent Applications in India
C) CONVENTION APPLICATION
An application for patent filed in the Patent Office, claiming a priority date based on the same or
substantially similar application filed in one or more of the convention countries is known as a
convention application. In order to get convention status, an applicant should file the application in
the Indian Patent Office within 12 months from the date of first filing of a similar application in the
convention country.
F) PATENT OF ADDITION
When an invention is a slight modification of the earlier invention for which he has already applied
for or has obtained patent, the applicant can go for patent of addition if the modification in the
invention is new.
14
Types of Patent Applications in India
C) CONVENTION APPLICATION
An application for patent filed in the Patent Office, claiming a priority date based on the same or
substantially similar application filed in one or more of the convention countries is known as a
convention application. In order to get convention status, an applicant should file the application in
the Indian Patent Office within 12 months from the date of first filing of a similar application in the
convention country.
F) PATENT OF ADDITION
When an invention is a slight modification of the earlier invention for which he has already applied
for or has obtained patent, the applicant can go for patent of addition if the modification in the
invention is new.
15
The Patent Cooperation Treaty (PCT)/International
Patent System
• The Patent Cooperation Treaty (PCT) is an international treaty with more than 155 Contracting
States.
• The PCT makes it possible to seek patent protection for an invention simultaneously in a large
number of countries by filing a single “international” patent application instead of filing several
separate national or regional patent applications.
• The granting of patents remains under the control of the national or regional patent offices in
what is called the “national phase”.
• A PCT application is made to the receiving office (RO) situated in the home country, this
receiving office will forward the application made to the International Searching Authority
(ISA).
• The ISA will submit a search report along with a written report within 4 months to World
Intellectual Property Organisation (WIPO) for publication of invention in PatentScope (WIPO
database).
• The patent will finally enter the national phase of registration after a maximum of 30-31
months.
16
International Applications:
Paris Convention Vs PCT
• The Paris Convention allows inventors to first file an application in their home country. This
date of application would be considered as priority date and would set off a period of 12 months
within which individual applications have to be made to the countries where the applicant
decides to patent his invention.
• When PCT application is filed, the examination and search process is carried out by an
international authority and hence the procedure followed is uniform
17
Flow under the PCT Route
18
Section 3 (i) of the Indian Patent Act
any process for the medicinal, surgical, curative, prophylactic, diagnostic, therapeutic
or other treatment of human beings or any process for a similar treatment of animals to
render them free of disease or to increase their economic value or that of their products.
Case Study:
The Chinese University of Hong Kong and Sequenom, Inc. (the appellants) Vs
The Indian Patent Office
19
Thank You !
20
ECO 500/ 600: Substantive Patent Law Treaty
Dr. Feroz Khan Suri
Innovation and Incubation Centre for Entrepreneurship (IICE)
IISER Bhopal
1
Contents:
1. Summary of International Patent System
2. Prior Art
3. Novelty
4. Inventive Step
5. Industrial Applicability
6. Sufficiency of Disclosure
● Patents are granted by the national regimes and protected within the
boundaries of the national regime.
3
International Patent System: Summary
4
Susbtantive Patent Law
6
Prior Art
● In few countries, Prior art constitutes everything available to the public
anywhere in the world by any means compared to other countries,
where non-written (oral) disclosures or use outside their jurisdiction, do
not form part of the prior art.
● While many provide a general grace period, during which the disclosure
of the invention do not affect its patentability, others provide only for a
grace period limited to certain specific cases.
7
Prior Art
● The Indian Patents Act, 1970 defines "Prior art" as Publication in any
document or used in India or elsewhere in the world before the filing
date.
● What is a prior art search?
8
Prior Art
● How is a prior art search done?
● Short-listing of keywords
● Patentscope by WIPO
9
Novelty
● An invention is new if it is not comprised in the prior art. It results from
the comparison between existing prior art at the date of filing and the
claimed invention.
● Novelty ensures that nothing is withdrawn from public use that already
belongs to the public domain.
● Differences in the definition and application of the term "prior art" also
sets the requirement of novelty defined and applied in different ways
throughout the world.
10
Novelty
● In few systems, public use of the invention anywhere destroys novelty,
while in others, it depends on the place of use.
11
Novelty
12
Novelty
(c) Use of the invention during the period of the exhibition without the consent
of the inventor or his predecessor in title
(d) Description of the invention in a paper read by the inventor before a learned
society, or published with his consent in the transactions of such a society.
(e) Disclosures within one year before the filing (priority) date by public working
the invention for reasonable trial, by or with the consent of the applicant or
his predecessor in title.
13
Inventive Step
● An invention is considered to involve an inventive step or to be non-
obvious if, compared to the prior art, it is not obvious to a person skilled
in the art.
16
Novelty and Inventive Step (Explanation)
17
Industrial Applicability
● "Industrial applicability" or "utility" excludes from patentability,
inventions that have no utility in any field of industry or which do not
achieve the objective claimed by the invention or which may only be
used for private purposes.
18
Industrial Applicability
● "Utility" vs. "industrial applicability"
● Novelty, inventive step and industrial application are the three steps
that are tests of patentability or the patentability criteria.
20
Patentability Criteria and Exclusions
● The Indian Patent Act, 1970 states the following Exceptions and
Limitations of the Rights.
1. The grant of a patent is subject to the following conditions:
a) Importation or manufacture of articles and usesof
processes by, or on behalf of the Govt. for its own use
b) Importation of medicines and drugs by the Govt. for its own use or
for distribution in dispensaries, hospitals or
other medical institutions maintained by, on behalf of or
specified by the Govt.
c) Use for purposes merely of experiment or research,
including the imparting of instructions to pupils.
23
Patentability Criteria and Exclusions
4. Compulsory licenses.
24
Sufficiency of Disclosure
● The disclosure must be such that it shows the way to safely and
repeatedly achieve the claimed result.
● The disclosure need not be in the description or in the claims only, but
may result from the whole patent specification. 25
Sufficiency of Disclosure
● In many legal systems, this has lead to the conclusion that the claims
must be supported by the description.
● In certain cases, the claims are drafted so broadly that the invention
cannot, even by using other parts of the specification, be carried out by
the person skilled in the art.
● The PCT states the manner of the description, it shall first state the
title of the invention as appearing in the request and shall:
26
Sufficiency of Disclosure
i. Specify the technical field to which the invention relates;
ii. Indicate the background art known to the applicant, useful for the
understanding, searching and examination of the invention;
iii. Disclose the claimed invention, so that the technical problem and its
solution can be understood, and state the advantageous effects, of
the invention with reference to the background art;
iv. Briefly describe the figures in the drawings, if any;
v. Set forth at least the best mode contemplated by the applicant for
carrying out the invention claimed;
vi. Indicate explicitly, if the capability of industrial exploitation is not
obvious from the description or nature of the invention;
27
Sufficiency of Disclosure
● Certain patent systems request a disclosure allowing a person skilled in
the art to carry out the invention, while other systems require the
application to disclose the best mode.
● This has led to the divergence in the definition and application of the
disclosure requirement
● As per the Indian Patents Act, 1970 disclosure requirements mean that
an application shall:
● Fully and particularly describe the invention and its operation or use
and the method by which it is to be performed;
● Disclose the best method of performing the invention, which is
known to the applicant.
28
Claims
● The claims define the invention, and scope of protection of the patent
as others may not commercially use what is covered by the claims, but
may use other information in the specification.
● The claims form the basis for the examination as to the patentability of
the invention.
• Two different aspects of claims: firstly, the drafting of the claims, and
secondly the interpretation of the claims.
30
Method of diagnosis and patentability in
India
30 November 2023
The Chinese University of Hong Kong and Sequenom, Inc. (the appellants) filed an appeal on
October 12, 2023, with the High Court of Madras, praying the court to set aside the order dated
March 31, 2021, passed by the respondent (the Indian Patent Office) in Patent Application
4812/CHENP/2012. The claimed invention entitled “Fetal Genomic Analysis From a Maternal
Biological Sample”. The respondent rejected the application of the appellants for a patent grant in
view of Section 3(i) of the Patents Act, 1970. The Controller relied upon paragraph [0007] of the
complete specification before holding that the claimed invention is a process of diagnosing that
the foetus is suffering from genetic or other diseases. The appellants contended that the
determination of the foetal fraction does not diagnose a disease and that, therefore, the claimed
invention is not a diagnostic method.
The appellant submitted that the object and purpose of the amendment to Section 3(i) is to
prevent the grant of patents to methods of diagnosis performed by a medical doctor on patients
so as to ensure that medical doctors are in a position to adopt the best methods of diagnosis and
treatment, without the apprehension that a patent infringement action would be initiated against
them. The appellants contended that the expression “diagnostic” in Section 3(i) should be
construed as limited to diagnostic methods practiced on the human body. The appellants pointed
out that the Manual of Patent Office Practice and Procedure published in 2010 (the 2010
Manual), at Paragraph 08.03.06.08, states that “methods of diagnosis practised on the human
and animal body is not patentable”, thereby indicating that diagnosis undertaken in vitro is patent
eligible.
The appellants submitted that the method envisages carrying out in vitro analysis of fragments of
nucleic acid molecules taken from a biological sample containing both the foetal and maternal
DNA and the determination of the foetal fraction by following the process set out in the amended
claims, including by using a computer program. The appellants submitted that such foetal fraction
is the proportion of cell-free DNA (cfDNA) originating from the foetus in the biological sample.
Dilating further, the appellant contended that the claimed invention is a non-invasive prenatal
screening test (NIPT), which does not uncover pathology. The appellants also contrasted NIPT
with invasive tests such as amniocentesis and chorionic villi sampling, which are diagnostic.
The appellant determined the foetal fraction and submitted that pathology could not be
uncovered without further testing. Section 3(i) also uses expressions such as “other treatment of
human beings” and “to render them free of disease”. The appellant contended that a method
would qualify as diagnostic only if it is intended for treating human beings to render them free of
disease. The appellant relied upon the order of the Enlarged Board of Appeal (the EBoA) in case
No. G 0001/04 (the EBoA opinion). The said opinion was also relied upon to contend that the
expression “diagnostic” is applicable only if all the following four method steps in diagnosis are
carried out: (i) the examination phase involving the collection of data, (ii) the comparison of such
data with standard/reference values, (iii) the finding of any significant deviation, i.e. a symptom,
during the comparison and (iv) the attribution of the deviation to a particular clinical picture, i.e.
the deductive medical or veterinary decision phase.
Since the method involved in the claimed invention does not include clinical diagnosis, i.e. the
fourth method step set out above, the appellant contended that it is not a diagnostic method for
the purposes of section 3(i) of the Patents Act.
The respondent argued that the EPO Guidelines (March 2023) contain inter alia the following
guidance:
“The requirement that the final decision phase be included in the independent claim as an
essential feature is to be applied only if it is clear from the application/patent as a whole that the
inevitable result of the findings leads unambiguously to a particular diagnosis: this will have to be
decided by the division on a case-by-case basis.”
The court stated that if the process does not uncover pathology for any reason, it would not be
diagnostic for purposes of Section 3(i).The court mentioned thatthe claimed invention is per
se incapable of identifying the existence or otherwise of a disease, disorder or condition, and
further testing would be required for such purpose. In effect, it provides an indicator, foetal
fraction, which is relevant for further testing to arrive at a diagnosis. The court analyzed the word
“diagnostic” in Section 3(i) and concluded that the scope should not be unduly curtailed by
limiting it to in vivo or definitive diagnosis, nor should it be unduly expanded by implying the
words “relating to” diagnosis.
The court stated that the determination of foetal fraction is related to diagnosis but is not
“diagnostic”. The court stated that with a view to incentivize inventors in these cutting-edge
areas, albeit without compromising on the public policy exclusion from patent eligibility of
methods of diagnosis and treatment adopted by medical doctors, there is a case to consider
options such as restricting the scope of the expression “diagnostic” in Section 3(i) to in
vivo processes and counterbalancing by providing for compulsory licensing. The court has
allowed the appeal, and IN 4812 has proceeded to grant.
ECO 500/ 600: Indian Patent Office - Practice and
Procedures
Dr. Feroz Khan Suri
Innovation and Incubation Centre for Entrepreneurship
(IICE)
Contents
1. Procedures
2. Filing of an application
3. Written description
4. Types of Application
5. Publication
6. Forms for filing Patent Application
7. Claims
8. Timeline for Patent Application
Patent Process
● The General procedures for obtaining a patent is a multi-
stage process:
i. Filing of patent application.
ii. Publication after 18 months.
iii. Pre Grant Opposition /Representation by any person.
iv. Request for examination.
v. Examination: Grant or Refusal.
vi. Publication of Grant of patent.
vii. Post Grant Opposition to grant of patent.
viii. Decision By Controller.
Filing of an application
● A patent application can be filed either by true and first
inventor or his assignee, either alone or jointly with any
other person.
● The applicant is required to disclose the name, address
and nationality of the true and first inventor.
● An application for patent can be filed either in Hindi or
English.
● An application can be filed with Indian Patent Office
either with provisional or with complete specification
along with fee as prescribed in schedule I.
Written Description
● The Specification is a techno-legal document with full
scientific details of the invention and claims to the patent.
● A patent can be filed with provisional specification, if the
invention can be disclosed on paper, but has not attained
the final stage.
● In such a case, complete specification should be filed
within 12 months of the provisional application.
● It is useful in establishing a priority date for an invention.
● It provides the applicant with an opportuniy to assess and
evaluate the market potential for his invention.
Written Description
● Every Complete Specification shall:
a) Fully and particularly describe the invention and its
operation or use and the method by which it is performed;
b) Disclose the best method of performing the invention
which is known to the applicant for which he is entitled to
claim protection;
c) End with a claim or set of claims defining the scope of the
invention for which the protection is claimed;
d) Make reference to deposit of the biological material in the
international depository authority, if applicable;
e) Be accompanied by an abstract.
Written Description
● The disclosure must be such that a person skilled in the
art may be able to perform the invention.
● The Specification is to be submitted in Form-2 along with
the Application in Form-1 and other documents, in
duplicate, along with the prescribed fee in First Schedule.
● The first page of the Form 2 shall contain:
a) Title of the invention;
b) Name, address and nationality of each of the applicants
for the Patent;
c) Preamble to the description.
Types of Application
● India has 4 patent offices - Kolkata, New Delhi, Mumbai
and Chennai, each with a separate territorial jurisdiction.
● The different types of application are:
a) Provisional Application
b) Ordinary Application
c) Convention Application
d) PCT International Application
e) PCT National Phase Application
f) Patent of Addition
g) Divisional Application
Publication
● Every patent application is published after expiry of 18
months from its filing or priority date, whichever is
earlier.
● An application is not published if – (a) secrecy direction
is imposed or (b) has been abandoned u/s 9(1) or (c)
withdrawn 3 months prior to 18 months
● An applicant can request for early publication (within a
month) in Form 9 with the prescribed fee provided it does
not relate to Atomic energy or Defense purpose.
● Patent fess can be paid either at cash counter or online
through a comprehensive payment gateway.
Forms for filing Patent Application in India
● The list of documents required for filing of a Patent
Application are:
i. Covering letter-indicating the list of documents
ii. Application for Grant of Patent in Form 1 in duplicate
iii. Complete/Provisional specification in Form 2 in duplicate
iv. Statement and Undertaking in Form 3
v. Power of Attorney in Form 26
vi. Declaration of Inventor-ship in Form 5
vii. Request for examination: F18
viii. Requisite Statutory fees
Forms for filing Patent Application in India
(a) Application for grant of patent (b) Contains legal information such as name, contact details of the
applicant, inventors, priority date etc. To be accompanied by provisional or complete specification Provisional
Form 1 or complete specification
(a) Contains invention including Title, Field, background prior art, drawbacks of the known inventionsm
description, experimental results, Driwings, Abstract of theinvention, etc. Claims, in the complete
Form 2 specification are legal boundaries of invention
(a) Statement and undertaking foreign applications. (b) Information regarding the details of the invention if
filed abroad and the undertaking to inform the Patent Office as and when he files the same abroad.
Form 3
(a) Declaration as to inventorship. (b) The applicant discloses the names of all the inventors. This is generally
used when a complete specification is filed (within 12 months) after provisional specification.
Form 5
(a) Request for examination of a patent application. (b) This form can be filed anytime with in 48 months of
filing an application. It can be filed even at the time of filing the patent application. Without filing this form
Form 18 the patent specification will not be examined.
(a) Request for expecdited examination of a patent application can be filed if, (b) The applicant indicates India
as the competent International Searching Authority or elects India as an International Preliminary Examining
Form 18A Authority in the corresponding international application; or the applicant is a startup.
(a) Form of authorization of a Patent Agent. (b) This form is required when the applicant is authorizing a
patent agent to act before the patent office on his/her behalf.
Form 26
(a) Request for early publication. (b) This form is required to be filled if the applicant wants that his
application is published before 18 months of filing.
Form 9
Claims
● Claims define the contours of rights, if and when a patent
is granted for an invention.
● It defines the scope of legal protection. It should cover all
aspects of the protection sought together adequately
distinguishing the prior art from the claimed invention.
● A Claim usually consists of three parts: (a) Preamble (b)
Transitional phrase; and (c) Body.
● While, the introductory phrase identifies the category of
invention and sometimes the purpose, the transition
phrase may be words and phrases such as Comprising of,
Including, Consisting of, Consisting essentially of etc.
Timeline for Patent Application in India
● A patent application examination is not automatic after its
filing, but only after receipt of the request of examination
in Form 18 or Form 18A (for expedited examination).
● Request for Examination can be filed within 48 months
from the date of priority or filing, whichever is earlier.
● Expedited application can be filed if :
a) India is the competent International Search Authority or
elected as an International Preliminary Examining
Authority in the corresponding international application;
b) the applicant is a startup
Timeline for Patent Application in India
● After examination, a report - First Examination Report
(FER) is issued to the applicant by the Patent Office.
● Thereafter, applicant has to comply with the requirements
within 6 months of the FER (extendable by 3 months).
● In case, the application is found to be in order for grant,
the patent is granted – a letter patent is issued, provided
no pre-grant opposition is filed or pending.
● If the requirements are not complied within the prescribed
time, applicants can request an opportunity of being heard
at least 10 days prior to expiry of the statutory period,
before the application is refused.
Timeline for Patent Application in India
● A representation for pre-grant opposition can be filed, on
Form 7A within six months from the date of publication
of the application 11A or before the grant of patent.
● There is no fee for filing representation for pre-grant
opposition and any person can file this.
● The time for filing post-grant opposition is 12 months
from the date of publication of the grant of patent in the
official journal of the patent office.
● The post grant opposition has to be filed in the prescribed
Form 7 along with prescribed fees as in First schedule by
the person interested and not by any other person.
Timeline for Patent Application in India
Filing of Complete Specification
following provisional specification Within 12 months of filing the provisional specification
(Form 2)
Statement and undertaking regarding Within 6 months from the date of filing of application
foreign applications (Form 3)
Request for examination (Form 18) Forty eight months from the date of filing or priority, whichever is earlier
With the complete specification or within one month from the date of filing of
Declaration of Inventorship (Form 5)
the complete specification
Time for replying to the First 6 months from the date of issuance of the FER, extendable upto 3 months, Total
Examination report (FER) 9 months.
Pre-grant opposition (Form 7A) After publication of the application and any time before the grant of patent
Post-grant opposition (Form 7) One year from the date of publication of grant of patent
1. PARTS OF A CLAIM
a. THE PREAMBLE
b. TRANSITIONAL PHRASE
c. THE BODY
4
THE PREAMBLE
THE PREAMBLE
Examples:
1.Object of the invention: to cook rice
AN APPARATUS FOR COOKING
2. Object of the invention: Cooking all kinds of
grains
AN APPARATUS FOR COOKING GRAINS
3. Object of the invention: to also cook
vegetables or other foodstuffs
AN APPARATUS FOR COOKING
6
THE PREAMBLE
Examples:
1. Object of the invention: making tea
A METHOD FOR MAKING TEA
2. Object of the invention: making beverages
arising from plant-based substances
A METHOD FOR MAKING PLANT-BASED
BEVERAGES
3. Object of the invention: making any warm
beverages
A METHOD FOR MAKING WARM
BEVERAGES
7
THE PREAMBLE
EXAMPLES:
1. Object of the invention: treating malaria
A COMPOSITION FOR TREATING MALARIA
2. Object of the invention: non-motorized vehicles
A NON-MOTORIZED LAND VEHICLES
3. Object of the invention: mounting telephones
A DEVICE FOR MOUNTING A TELEPHONE
8
TRANSITIONAL PHASE
EXAMPLE 1
1. An apparatus, comprising:
a plurality of printed pages;
a binding configured to hold the printed pages
together; and
a cover attached to the binding.
10
TRANSITIONAL PHASE
CLOSED PHRASE (consisting of)
- limits the scope of the claim to nothing
more than the
specifically recited elements
- claim covers only elements named and
nothing more
11
EXAMPLE 1
1. An apparatus, consisting:
a plurality of printed pages;
a binding configured to hold the printed pages
together; and
a cover attached to the binding.
12
TRANSITIONAL PHRASE
For example:
1. A chemical compound consisting of:
50% A component;
25% B component; and
25% C component.
For example:
1. An apparatus for holding items, comprising:
at least one leg; and
a top configured to support at least one leg.
14
For example:
1. An apparatus for holding items, comprising:
four legs;
16 screws; and
a top.
15
Example
CLAIM:
1. A game device, comprising:
a handle;
a head portion; and
a protrusion.
16
Example
CLAIM:
1. A game device, comprising:
a handle;
a head portion connected to the
handle; and
a protrusion being secured to the
handle.
17
Example
CLAIM:
1. A game device having a handle,
a throat portion and a head portion
connected to the throat portion,
wherein the improvement comprises
a protrusion being secured to the
handle.
19
Example
CLAIM:
1. A game device, comprising a handle
and a head portion connected to the handle,
characterized in that, a protrusion is
secured to the handle.
21
4. MEANS-PLUS-FUNCTION CLAIMS
FOR EXAMPLE:
Example
CLAIM:
1. A game device, comprising a
handle and a head portion connected to
the handle, characterized in that, an
anti-slippage means is secured to the
handle.
24
5. CLAIM PUNCTUATION
EXAMPLE 2
Preamble, transitional phrase:
Element (#1);
Element (#2);
Element (#3), characterized in that,
Element (#4)
26
1. An apparatus, comprising:
a plurality of printed pages;
a binding configured to hold the printed pages
together; and
a cover attached to the binding.
27
1. An apparatus, comprising:
a plurality of printed pages;
a binding configured to hold the printed pages
together;
a cover attached to the binding,
characterized in that, the cover is detachable from
the binding.
28
Example
CLAIM:
1. A game device, comprising a
handle and a head portion connected to
the handle, characterized in that, an
anti-slippage means is secured to the
handle.
30
Example
CLAIM:
1. A game device, comprising a
handle and a head portion connected to
said handle, characterized in that, an
anti-slippage means is secured to said
handle.
31
Claim1.
An apparatus (10), comprising:
a plurality of printed pages (11);
a binding (12) configured to hold the printed pages (11)
together; and
a cover(13) attached to the binding (12).
32
Claim 1.
An apparatus, comprising:
a plurality of printed pages;
a binding configured to hold the printed pages together;
and
a cover attached to the binding, wherein the cover is
detachable from the binding.
33
CLAIM SETS
1. INDEPENDENT CLAIM
BROADEST CLAIM
STAND ALONE AND DOES NOT NEED A LIMITATION FROM
ANOTHER CLAIM IN ORDER TO BE COMPLETE
PATENT APPLICATION MAY HAVE MORE THAN ONE (1)
INDEPENDENT CLAIM
2. DEPENDENT CLAIM
DEPENDS ON ANOTHER EITHER AN INDEPENDENT CLAIM OR
DEPENDENT CLAIM
MUST NOT EXTEND THE SCOPE OF THE SCOPE OF PROTECTION
OF THE INVENTION DEFINED IN THE INDEPENDENT CLAIM/S
“FALL BACK’ DURING EXAMINATION
35
Example
CLAIM:
1. A game device having a handle,
a throat portion and a head portion
connected to the throat portion,
wherein the improvement comprises
a protrusion secured to the handle.
Example version 1
CLAIMS:
1. A game device, comprising a handle
and a head portion connected to the
handle, characterized in that, an anti-
slippage means is secured to the handle.
1. Apparatus Claims
2. Method Claims
3. “Use” Claims
4. Composition Claims
5. Product-by-Process Claims
6. Biotechnology Claims
7. Software Claims
8. Omnibus Claims
9. Design Claims
38
1. Apparatus Claims
Protect an apparatus or device
Recite in the preamble what the apparatus
“is” and/or “what it does”
Recite in the claim's body the essential
inventive elements
39
Example:
1. An apparatus for supporting a camera,
comprising:
a pivotal mounting configured to hold the
camera; and
a set of legs arranged to support the pivotal
mounting.
40
2. Method Claims
Recite a sequence of steps that complete a
task or accomplish a result
Active Steps may be recited in order of
performance, but are usually interpreted as
being performed in any order unless otherwise
specified
41
3. “Use” Claims
Similar to method claims
1. The use of substance X as an
insecticide …
2.The use of a transistor in an amplifying
circuit …
3.May be interpreted as method claims
4.Not allowed in all jurisdictions
43
4. Composition claim
For example:
Claim for a zinc electroplating solution might be:
1. A copper electroplating solution comprising:
an alkaline solution of copper sulfate, from 30-
50 grams per liter;
sulphuric acid, from 2-4 times the copper
acetate solution; and
an aqueous solution of a PH-modifying
substrate in an amount sufficient to adjust the PH
to a value of from 3.5-5.
46
For example:
1. A pharmaceutical composition comprising
synergistic amounts of a hyaluronan or a salt thereof,
and an interleukin-1 (IL-1) receptor antagonist (IL-1ra),
wherein said IL-1ra comprises all or an IL-1 inhibitory
fragment of an amino acid having a sequence of SEQ
ID NO:2, or a sequence which is at least about 70%
homologous to said amino acid sequence.
47
5. Product-by-Process Claims
Claims a product defined in terms of a process of
manufacture
Some jurisdictions treat as product claims
Other jurisdictions treat as method claims
Verify that a product-by-process claim is the best
approach for protecting an invention before
employing this type of claim
48
Example
1. A metalic salt obtained by a process
comprising the steps of ...
49
6. Biotechnology Claim
Relates to all practical uses of living
organisms
Either commercial or therapeutic uses
May include c DNA, recombinant DNA, DNA
fragments, protein, monoclonal antibodies,
anti sense DNA and RNA, Recombinant
vectors and Expression vectors
50
7. Software Claims
Used where the claimed invention pertains to
computer software and/or hardware
Can use device and method claims to cover
software inventions
Can also use specialized claim formats to provide
an additional scope of protection
52
8. Omnibus Claims
Refer to the description or the drawings without
providing any specific limitations.
Simple to write:
1. An apparatus for harvesting corn as
described in the description.
2. A juice machine as shown in Figure 4.
Not all patent offices allow omnibus claims.
Include an omnibus claim where possible
But pin your strategy on other claim types
55
9. Design claim
Only one claim is typically permitted
56
For example:
A design of an umbrella…
Claim might be:
1. The ornamental design
Fig. 1
for an umbrella substantially
as shown.
57