Patents Nayanika Majumdar

What is a
patent?
• A patent is an exclusive right granted for an invention. Patents
benefit inventors by providing them with legal protection of their
inventions.
• An invention is a product or a process that provides a new way of
doing something or offers a new technical solution to a problem
• A patent is a limited monopoly that is granted in return for the
disclosure of technical information.
• The applicant is required to disclose his invention so that it can be
used (or worked) by a ‘person skilled in the art’. In return, the State
(in the guise of the Patent Office) issues the applicant with a patent
that gives him the exclusive right to control the way that his patented
invention is exploited for a 20-year period
 History of patent laws in India
• 1856 - British Patent and Design Act - allowed inventors and creators to protect their inventions
• 1859 - the Indian Patents Act allowed local inventors and creators to register their patents in
India. This law gave them exclusive rights over their inventions within the country.
• The 1883 Indian Patents and Designs Act established a Central Office for registering designs in
India. This law also stipulated that all patents would be valid for 14 years,
• In 1888, the Indian Patents and Design Act was revised to improve enforcement measures against
infringement. The courts were given more power to order damages and fines against infringers
• The Indian Patents and Designs Act, 1911 replaced all the previous Acts. This Act brought patent
administration under the management of Controller of Patents for the first time
• Finally, in 1970, major amendments were made to the patent law by introducing the Indian Patent
Amendment Act. This Act introduced a post-grant opposition system, allowing applicants to
challenge an already granted patent on certain grounds. It also included provisions for
compulsory licensing, which allowed the government to grant licenses to produce and sell
patented products in public interest cases.
Justification for patents

• Natural rights
• Incentivizing / reward system
• Most popular - public benefit
• Patents role in generation or circulation of technical information – information function
• Patents act as incentive to disclose information that might have otherwise remained a
secret
• Also encourage information to be revealed in a way that is practically useful
• As the grant is awarded for a period of 20 years – investors will be more than willing to
fund research and development
Patentability
SUNN

• Article 27 TRIPS - patents shall be available for any inventions, whether products
or processes, in all fields of technology, provided that they are new, involve an
inventive step and are capable of industrial application
• S - Subject Matter
• U - Utility (industrial application)
• N – Novel (new)
• N - Non-obviousness (inventive step)
 Patentable under Patents Act, 1970
• Section 2(1)(m) - “patent” means a patent for any invention granted under this Act
• Section 2(1)(j) - “invention” means a new product or process involving an inventive
step and capable of industrial application
• Section 2(1)(ja) - “inventive step” means a feature of an invention that involves
technical advance as compared to the existing knowledge or having economic
significance or both and that makes the invention not obvious to a person skilled in
the art
• Section 2(1)(ac) - “capable of industrial application”, in relation to an invention,
means that the invention is capable of being made or used in an industry
Requirement for patentability

Patent

Industrial Non-
Novelty Application obviousness
 What is not patentable (Section 3 and 4)
• frivolous invention or which claims anything obviously contrary to well established natural laws
• contrary to public order or morality or which causes serious prejudice to human, animal or plant
life or health or to the environment
• mere discovery of a scientific principle or the formulation of an abstract theory
• mere discovery of a new form of a known substance which does not result in the enhancement
of the known efficacy of that substance or the mere discovery of any new property or new use
for a known substance or of the mere use of a known process, machine or apparatus unless
such known process results in a new product or employs at least one new reactant
• a substance obtained by a mere admixture resulting only in the aggregation of the properties of
the components thereof or a process for producing such substance
• mere arrangement or re-arrangement or duplication of known devices each functioning
independently of one another in a known way
• a method of agriculture or horticulture
• 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.
• plants and animals other than micro-organisms but including seeds, varieties and species +
biological processes for production or propagation of plants and animals;
• a mathematical or business method or a computer programme per se or algorithms;
• a literary, dramatic, musical or artistic work or any other aesthetic creation whatsoever including
cinematographic works and television productions;
• a mere scheme or rule or method of performing mental act or method of playing game;
• a presentation of information;
• topography of integrated circuits;
• an invention which, in effect, is traditional knowledge or which is an aggregation or duplication
of known properties of traditionally known component or component
• an invention relating to atomic energy falling within sub-section (1) of section 20 of the Atomic
Energy Act, 1962
 Industrial application
• Section 2(1)(ac)
• For an invention to be patentable it should be capable of industrial application
• Patent protection is not available for purely abstract or intellectual creations
• Invention is capable of industrial application if it can be used or made in ‘any kind
of industry
• Need to show – ‘useful purpose’ and the same is satisfied is a patent can disclose
practical application or concrete benefit
• Pertinent to note – capable of industrial application i.e. no need to show actual use
but the fact that it can be potentially used. Potential use must be plausible and not
speculative
 Requirement of novelty
• Section 2 (1)(l) - “new invention” means any invention or technology which has not
been anticipated by publication in any document or used in the country or elsewhere in
the world before the date of filing of patent application with complete specification,
i.e., the subject matter has not fallen in public domain or that it does not form part of
the state of the art;
• Novelty means “new as compared to prior art”
• To be patentable, an invention must be different from all published articles, known
techniques, and marketed products.
• When an invention is disclosed or anticipated by state of art – patent will not be
granted / if granted will be revoked
Novelty (contd.)

• Anticipation by:
(i) Use
(ii) Documentation
• State of the art – all matter that at the date of application has been made available to
public
• Novelty ascertained in light of a single prior art reference
• All elements of the invention must be present in the prior art reference
Circumstances that negate novelty i.e. anticipation

(a) Prior publication

(b) Public knowledge and public use
(c) Used in trade / offered for sale
(d) Public display
(e) Public working
(f) Traditional knowledge
Exceptions to anticipation (Section 29-33)
• Anticipation by previous publication - If the invention has been published prior to filing patent
application and the applicant can prove that the publication was obtained without consent
• Application by previous communication to government – communication to govt to investigate the
invention does not constitute anticipation
• Anticipation by public display - invention shall not be deemed to be anticipated if–
1. The invention was displayed at an industrial or other exhibition to which the provisions of the relevant
section have been extended by a notification in Official Gazette. Also the invention was displayed with
the consent of the true first inventor or the person deriving title from him.
2. The invention’s description was published as a consequence of its display in such exhibition.
3. The description of the invention was read by the first owner before a learned society and was hence,
with his consent, published in the society’s transactions.
• Anticipation by public working - An invention shall not be deemed to be anticipated if, within one year
before the priority date of the claim of the invention, the invention was publicly worked in India solely for
the purpose of reasonable trial because of the inherent nature of the invention
• Anticipation by use and publication after provisional specification – If the invention has been used
and published after filing a provisional application, then a complete specification filed shall not be deemed
to have been anticipated.
Inventiveness or non-obviousness
• Section 2(1)(ja) – (i) technical advancement or commercial success (ii) not obvious
to a person skilled in the art
• How to determine non-obviousness? (Pozzoli v. BDMO)
(i) identify the notional person skilled in the art and his general knowledge on
the subject
(ii) Identify the inventive claim
(iii) Identify the differences in the matter consisting of state of the art and
inventive concept
(iv) Would the difference be obvious to a person skilled in the art or do they
require a degree of invention
Biswanath Prasad Radhey Shyam vs
Hindustan Metal Industries
FACTS
• The old method of manufacturing utensils, particularly shallow dishes, was to turn scrap and polish them
on some sort of headstock without a tailstock, the utensils either being fixed to the headstock by
thermoplastic cement or held in the jaws of a chuck fixed to the headstock.
• This system was, fraught with risk to the workers as the utensils used to fly off from the headstock.
• Consequently, Purshottam Dass, one of the partners of Hindustan Metals, invented a device and method
for the manufacture of utensils, in 1951.
• HM got the alleged invention patented under the Indian Patent and Designs Act, 1911
• In September 1952, HM learnt that the defendant was using and employing the device and method of
manufacturing of dishes under the former's patent.
• The plaintiff served a notice upon the defendant to no avail and finally the plaintiff prayed for a
permanent injunction restraining the defendant from adopting, imitating, employing or in any manner
infringing the device of the plaintiff's patent.
• Defendant claimed that the method covered by the plaintiff's patent, namely, that of a lathe (headstock,
adapter and tailstock) has been known and openly and commonly used all over the country for several
decades before the plaintiff's patent
• The alleged invention of the plaintiff was not on the date of the patent, a manner of new manufacture
or improvement, nor did it involve any inventive step
• Defendant filed for revocation of patent and the plaintiff filed a counter to the same
• The trial court held as follows:
(i) The patent does not involve any inventive step having regard to what was known or used
prior to the patent.
(ii) The work of turning or scraping utensils of various designs has been going on at
Mirzapur and other places for many years before 1951.
(iii) The changes introduced by the patentee are of a minor nature.
(iv) The alleged invention was not on the date of the patent, a manner of new manufacture
or improvement. It did not involve any novelty
(v) The patent obtained by the plaintiff was liable to be revoked and the plaintiff was not
entitled to any damages.
• The Appellate Bench of HC held that - "In our opinion, the method of mounting patented by the
appellant did involve an inventive step and was a manner of new manufacture and improvement". In the result,
it allowed the appeals, set aside the judgment and decree of the learned trial Judge and decreed the plaintiff's suit
with costs.”
SC
• In order to be patentable - an improvement should be something more than a
mere workshop improvement and must independently satisfy the test of invention
or inventive step .
• To be patentable the improvement or the combination must produce a new result,
or a new article or a better or cheaper article than what was already existing .
• An invention must not be the obvious or natural suggestion of what was
previously known and if a person was able to make the invention based on the
knowledge existing on the priority date, the invention would lack inventive step .
• Whether the "manner of manufacture" patented, was publicly known, used and
practised in the country before or at the date of the patent ? If the answer to this
question is 'yes', it will negative novelty or 'subject matter'.
Held
• The court stated that the patented invention was merely an application of an old
invention, known for decades before 1951,
• The invention was a normal development of an existing manner of manufacture not
involving something novel which would be outside the probable capacity of a craftsman .
• The invention did not lie outside the Track of what was known before and it would have
been obvious to any skilled worker in the field in the light of existing knowledge .
• As the invention involved a mere addition of a lever and bracket, which did not involve a
substantial exercise of the inventive power or innovative faculty by the inventor, the Court
stated that the invention was obvious.
• Furthermore, as the invention was publicly used by the patent holder before the date of
filing of the patent application, the novelty of the invention was negated.
• In the light of its analysis, the court concluded that the invention lacked novelty and
inventive step.
• The judgement of the Appellate Bench was set aside and that of the trial Court restored
Business and software patents
 Bilski v. Kappos
• Petitioners Bernard L. Bilski and Rand Warsaw filed a patent application including eleven
claims on 10 April 1997 for a method of hedging risks in commodities trading on the energy
market.
• They proposed a fixed bill system for consumer energy contracts.
• Under this type of contract, consumers pay a fixed price for their future energy consumption
based on their past energy use.
• The key claims at issue were claim 1, describing the method of how to hedge risks and claim 4,
which reduces claim 1 into a simple mathematical formula.
• The patent examiner rejected all eleven claims on the grounds that “the invention is not implemented
on a specific apparatus and merely manipulates (an) abstract idea and solves a purely mathematical problem
without any limitation to a practical application”.
• The Board of Patent Appeals and Interferences affirmed the rejection, holding that the
application “involved only mental steps that do not transform physical matter and was directed
to an abstract idea” and therefore not eligible subject matter.
• The Federal Circuit heard the cases en banc and, in 2008, affirmed the rejection as well.
Some background
• Section 101 of the U.S. Patent Act states that “any new and useful process, machine, manufacture,
or composition of matter, or any new and useful improvement thereof, may be eligible for patent
protection.”
• In the context of business methods, the primary inquiry involves ascertaining the abstractness of
the claimed process.
• In Bilski, the Federal Circuit abandoned the “useful, concrete and tangible result” and fashioned a
“machine-or-transformation” test. Under this test, a process is patent-eligible if:
Ø the process is “tied to a particular machine or apparatus”; or
Ø the process “transforms a particular article into a different state or thing.”
• It confined the definition of the word “process” to the two categories in the above test, machine
or transformation, by using the doctrine of noscitur a sociis. Following this doctrine "an
ambiguous term may be given more precise content by the neighbouring words with which it is
associated.
• The Federal Circuit did not categorically exclude either business method patents or software
patents, however, the test would inevitably lead to those results.
 Supreme Court
• Unanimously affirmed the rejection of Bilski’s claims, but also refocused the question on the
language of the statute and the meaning of abstractness
• The Court further ruled that the doctrine of noscitur a sociis was not applicable to the term
“process” as it was legally defined in the statute.
• The Court opined that the machine-or-transformation test was not part of the statute but
that, nonetheless, this formulation might serve as a clue in determining eligibility under
Section 101.
• However, the machine-or-transformation test is not the sole test for determining whether an
invention is a patent-eligible process.
• The Court found no categorical prohibition against business method patents, as the statute
itself does not differentiate between business methods and other processes. The Court also
observed that the patent-eligibility inquiry is only a threshold test
• Justice Kennedy highlighted the four independent categories of patent−eligible subject
matter—“processes, machines, manufactures, and compositions of matter”—and recognized
the three judicial exceptions -laws of nature, physical phenomena, and abstract ideas
 Software Patents

Alice Corp. v. CLS Bank International

• The patent at issue disclosed a computer- implemented scheme for mitigating
“settlement risk” i.e the risk that only one party to a financial transaction will
pay what it owes, by using a third- party intermediary.
• Similar to an escrow, which has been used in finance since time immemorial
• The patents in question described how the escrow function could be performed
by a general-purpose computer. However, they did not describe how such a
computer would work, and did not include any source code or specifications
• Alice alleged that CLS Bank International and CLS Services Ltd. began using
similar technology in 2002 and therefore CLS Bank had infringed Alice's
patents.
• CLS Bank filed suit against Alice in 2007, seeking a declaratory judgment that
the claims of Alice were invalid. Alice counterclaimed infringement.
Conundrum in the courts
• The District Court held that all the claims of Alice were not eligible to be
patented because they are directed to the abstract idea of "employing a neutral
intermediary to facilitate simultaneous exchange of obligations in order to
minimize risk".
• A divided panel of the United States Court of Appeals for the Federal Circuit
reversed the order holding that it was not 'manifestly evident' that Alice's claims
are directed to an abstract idea.
• In 2013, the members of the Federal Circuit vacated that decision and set the case
for argument and again found the claims too abstract in a decision that had the
judges produce seven different opinions.
• The panel as a whole could not agree on a single standard to determine whether a
computer- implemented invention is patent eligible or an ineligible abstract idea.
Supreme Court

Ø SCOTUS had to answer the question- Is implementing an idea on a computer

enough to transform a non-patentable, abstract idea into patentable subject
matter?
Ø The keen interest of the software industry and patent professionals in the issue
was illustrated by the filing of 52 amicus curiae briefs urging the Supreme Court to
decide the issue of software patent eligibility.
Ø A software implementation of an escrow arrangement was not patent eligible
because it is an implementation of an abstract idea.
Ø Escrow is not a patentable invention, and merely using a computer system to
manage escrow debts does not rise to the level needed for a patent
• The Supreme Court articulated a two-step process (formulated in the Mayo case) for
assessing patent-eligible subject matter in the context of computer-related inventions-
1. In the first step the court must determine whether the patent claim under
examination contains an abstract idea, such as an algorithm, method of
computation, or other general principle. If the answer is affirmative, the court
must proceed to the next step.
2. In the second step of analysis, the court must determine whether the patent adds
to the idea "something extra" that embodies an "inventive concept.”
• The Court described the second step as a search for an “inventive concept” to ensure that the
patent amounts to “significantly more” than an abstract idea.
• The Court held that Alice's claims did no more than require a generic computer to
implement this abstract idea of intermediated settlement by performing generic computer
functions, which is not enough to transform an abstract idea into a patent-eligible
invention.
 Journey of the Patents Act, 1970
The 1999 Amendment
• Even though India was given exemptions from implementing pharmaceutical/agrochemical product
patents until 2005, it was mandated to set up a mailbox facility for such product patent applications
filed during the TRIPS transition period and to assign each application a filing date.
• Another obligation under TRIPS was the provision dealing with the grant of EMRs for mailbox
applications that met specified conditions during the transition period.
• India initially tried to implement the mailbox facility and grant EMRs by way of a presidential order
but failed to pass the law dealing with mailbox facility and EMRs.
• This prompted the United States to utilize the WTO's dispute resolution mechanism to address India's
failure to enact the mailbox and EMR regime into a law.
• The WTO's Appellate Body held in December 1997 that India's failure to make timely amendments to
its patent laws had resulted in its non-fulfilment of obligations covered by Article 70.8(a) of the
TRIPS Agreement.
• Finally, in March 1999, the amendment was passed by the Indian parliament; India formally
implemented the mailbox procedure for pharmaceutical product patent applications and gave it
retroactive application from January 1, 1995.
The 2002 Amendment Act
• The 2002 Act amended the 1970 law to ensure that the terms of all patents granted in
India would expire twenty years after their application filing date.
• Before this amendment, Indian process patents granted in the field of pharmaceuticals
lasted for only five years from sealing, or seven years from the date of the patent,
whichever was less, while the term of all other types of patents was fourteen years from
the date of the patent.
• The 2002 amendment brought into force other changes aimed at bringing India's
patents law in tune with the TRIPS Agreement, including new definitions of invention
and inventive step, and new exclusions from patentable subject matter like business
methods, algorithms, and traditional knowledge.
• The amendment also reversed the burden of proof provision involving cases of process
patent infringement and streamlined the compulsory licensing framework. The 2002
amendment also paved the way for patentability of microorganisms
2005 Amendment
• The last step in India’s implementation of the changes required to make its patent
law TRIPS compliant happened by way of the 2005 amendment.
• Through this amendment, Indian law, for the first time since 1970, allowed patent
protection to substances capable of being used as pharmaceuticals, food, and
agro-chemicals.
• Deletion of section 5 from the Patents Act opened the doors to product patents
in the country
Novartis v Union of India

• Revolves around section 3(d) of the Patents Act, 1970 and its interplay with
clauses (j) and (ja) of section 2(1)
• Landmark judgement that deals with evergreening of patents and elaborates upon
the threshold for inventive step in relation to pharmaceutical products
• “Evergreening” is a term used to label practices that have developed in certain
jurisdictions wherein a trifling change is made to an existing product, and claimed
as a new invention.
• Glivec is and anti-cancer drug used to treat Chronic Myeloid Leukemia (CML) and
Gastrointestinal Stromal Tumours (GIST) 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 USPTO
• Novartis received US Food and Drug Administration (FDA) approval for one salt form of
imatinib, i.e. “imatinib mesylate”, in 2001.
• 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.
• 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.
Supreme Court
• After the application was made and before it was taken up for consideration, a number
of amendments were introduced in the Indian Patents Act, 1970, which brought about
fundamental changes in the patent law of the country.
• Novartis was aware of these changes in the law and still chose to bring its claim within
the four corners of the changed law
• Supreme Court stipulated the twin test of invention and patentability to stipulate the
circumstances of the grant of a patent. It said – “It is, therefore, fundamental that for grant
of patent the subject must satisfy the twin tests of “invention” and “patentability”. Something may be
an “invention” as the term is generally understood and yet it may not qualify as an “invention” for the
purposes of the Act. Further, something may even qualify as an “invention” as defined under the Act
and yet may be denied patent for other larger considerations as may be stipulated in the Act”
• Earlier Section 3(d) –
• “Section 3. What are not inventions.– The following are not inventions within the
meaning of this Act,—
(d) the mere discovery of any new property or mere 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.”
Section3 (d) post amendment –
“Section 3. What are not inventions.– The following are not inventions within the meaning
of this Act,—
(d) the mere discovery of a new form of a known substance which does not result in the
enhancement of the known efficacy of that substance or the mere discovery of any new
property or new use for a known substance or of the mere use of a known process,
machine or apparatus unless such known process results in a new product or employs at
least one new reactant.
• We have, therefore, no doubt that the amendment/addition made in section 3(d) is
meant especially to deal with chemical substances, and more particularly
pharmaceutical products. The amended portion of section 3(d) clearly sets up a
second tier of qualifying standards for chemical substances/pharmaceutical
products in order to leave the door open for true and genuine inventions but, at
the same time, to check any attempt at repetitive patenting or extension of the
patent term on spurious grounds. (i.e. evergreening)
• In case of chemicals and especially pharmaceuticals if the product for which
patent protection is claimed is a new form of a known substance with known
efficacy, then the subject product must pass, in addition to clauses (j) and (ja)
of section 2(1), the test of enhanced efficacy as provided in section 3(d) read with
its explanation.
• The test of efficacy would depend upon the function, utility or the purpose of the product under
consideration. Therefore, in the case of a medicine that claims to cure a disease, the test of
efficacy can only be “therapeutic efficacy”.
• With regard to the genesis of Section 3(d), and more particularly the circumstances in
which Section 3(d) as amended to make it even more constrictive than before, “therapeutic
efficacy” of a medicine was to be judged strictly and narrowly
• Each of the different forms mentioned in the explanation have some properties inherent to that
form, e. g., solubility to a salt. These forms, unless they differ significantly in property with regard
to efficacy, are expressly excluded from the definition of “invention”. Hence, the mere change of
form with properties inherent to that form would not qualify as “enhancement of efficacy” of a
known substance.
• Imatinib Mesylate did not qualify the test of “invention” set out in Section 2(1)(j) and Section
2(1)(ja) of the Patents Act, 1970 being a known substance.
• Beta crystalline form of Imatinib Mesylate being a pharmaceutical substance and moreover a
polymorph of Imatinib Mesylate, directly ran into Section 3(d) + explanation and did not
showcase enhanced efficacy.
• Held - The beta crystalline form of Imatinib Mesylate, failed in both the tests of
invention and patentability as provided under clauses (j), (ja) of Section 2(1) and Section
3(d) respectively, the appeals filed by Novartis AG failed and were dismissed
Micro-
organisms and
the Indian
patent regime
What was the scenario?
• Before the developments that we will study about took place-
• Patent protection was not granted to microorganisms as product
claims, but only to the process claims in which microorganisms was
used as a medium in inventions
• Then came the case of Diamond v. Chakravarty
Ø The case was heard in the US Supreme Court in 1980.
Ø It entailed the patentability of genetically modified organisms
(GMOs).
Diamond v. Chakravarty
• Ananda Mohan Chakrabarty, a microbiologist, developed a bacterium called
Pseudomona Putida, while working with General Electric.
• The bacterium could break down crude oil which made it suitable for treating
future oil spills.
• No naturally occurring bacteria showed this property, and it could be used in the
field of bioremediation or biodegradation of oil
• n 1972, Chakrabarty filed a patent application.
• Chakrabarty's 36 patent claims were of three types: (1) process claims for the
method of producing the bacteria; (2) claims for an inoculum comprised of a
carrier material floating on water and the new bacteria; and (3) claims to the
bacteria themselves.
• The patent examiner allowed the claims falling into the first 2 categories, but
rejected those belonging to the third based on: first, that micro- organisms are a
"product of nature" and second, that as living things they are not patentable
subject-matter under § 101 of Title 35 U.S.C, which states that:
“Whoever invents or discovers any new and useful process, machine, manufacture, or
composition of matter, or any new and useful improvement thereof, may obtain a patent
therefor, subject to the conditions and requirements of this title.”
• Chakrabarty appealed to the Patent Office Board of Appeals, the Board affirmed
the examiner on the second ground.
• The Court of Customs and Patent Appeals reversed the above holding and held
that “the fact that microorganisms…are alive…(is) without legal significance in patent law.”
• Sidney A. Diamond, Commissioner of Patents and Trademarks, appealed to the
Supreme Court.
• Justice Warren E. Burger observed that that 35 U.S.C. 101 empowered
researchers to patent a living, human-made organism as a “production” or
“synthesis of issue”
• SC noted that “laws of nature, actual events, and conceptual ideas” were
not patentable. However, this was unimportant to Chakrabarty's case since
he was endeavouring to patent a human-made organism that he had
produced himself
• The Supreme Court held on 16 June 1980 that a live, human- made
microorganism is patentable subject-matter under §101 and that the
respondent's microorganism constitutes a "manufacture" or "composition
of matter" within that statute.
• The patent was granted on 31 March 1981.
Indian scenario
• Article 27(3)(b) of the TRIPS 1994 provides that microorganisms and non-
biological and microbiological processes are patentable. It says that “Members may
also exclude from patentability, plants and animals other than micro-organisms, and essentially
biological processes for the production of plants or animals other than non-biological and
microbiological processes.”
• The Indian Patents Act, 1970 added microorganisms under the purview of
patentability through the Patents (Amendment) Act, 2002, in compliance with the
TRIPS.
• According to Section 3(j) of the Patents Act, 1970, a plant, animal, seeds and
biological processes, apart from microorganisms are not patentable. Thus S 3(j)
allows for patentability of micro-organisms
• Section 3(c) vs. Section 3(j)
Nuziveedu Seeds Ltd. & Ors v.
Monsanto Technology LLC
FACTS
• Monsanto deals with Bt. Trait1 licensing business in India. Nuziveedu is a private sector seeds
company in India.
• Monsanto applied to the Indian Patent Office in 2001 claiming a patent. The patent included
the nucleic acid sequence and the consequent process to insert the nucleic acid sequence in
plant cells. The patent was granted
• Monsanto claimed that its invention comprised of:
Øidentification of desired gene (Cry2Ab) from the DNA of BT (Bacillus Thuringiensis)
bacteria, which is found naturally in the soil;
Ømaking (synthesizing) nucleic acid sequence by copying the Cry2Ab for insertion into a
plant cell; and
Øthe method of inserting the said nucleic acid sequence into a plant cell.
• The final granted patent had two sets of claims: one set claiming the isolated, purified and
modified gene sequences, and the second set claiming methods of inserting the gene
sequences into plant cells.
• Claims with respect to transgenic plants, hybrid varieties and seeds that formed part of the
patent application were rejected during prosecution by the Indian Patent Office.
• Monsanto is the owner of the Indian Patent No.214436, which is an invention titled
"Methods For Transforming Plants To Express Bacillus Thuringiensis Deltaendotoxins”
• Monsanto claims that the patent is a biotech invention containing the infusion of Bt
gene into the cotton genome.
• The Bt. bacterium eradicates pests afflicting the cotton plant. Monsanto states that the
patent does not cover plants per se, but does cover components that can be termed
microbiological processes and microorganisms, thus patentable under the Patents Act.
• It claimed that using the patented technology, it created a large number of donor Bt.
cotton seeds and distributed them to seed companies, (including Nuziveedu under
different agreements).
• The licensees agreed to payment of royalties for the use of such donor seeds to get the
desirable genetic trait into their own specific hybrid varieties.
• Disputes arose with respect to payment of fee.
• The Nuziveedu group refused to pay license fee in terms of the agreements with
Monsanto, claiming that legally they were obliged to pay no more and Monsanto could
not claim anymore than, the "trait value” fixed by the State governments.
• Monsanto claimed to be the lawful owner and the patentee of the said patent and claims
entitlement to rights granted under the Patents Act, 1970.
• Nuziveedu, on the other hand, refuted that - the claim for enforcement of patents is liable to be
rejected as the subject patent is solely concerning an unpatentable matter (by reason of Section 3
(j))
• Nuziveedu submitted that the crops with the Bt. Trait3 are referred to as genetically modified
crops ("GM crops"), because they acquire an insect resistant trait through genetic modification.
In a laboratory Bt. Trait genes can be inserted only into a variety through a biotechnology
process, which after transformation is called as a transgenic variety.
• However, this by itself is not a variety which can be grown by farmers.
• Nuziveedu contended that they used the Donor Seeds transferred by Monsanto in their breeding
process for improving their varieties with the Bt. Trait.
• They argued that the gene or the method of transformation was not transferred to them and
only seeds of the transgenic variety were given. Nuziveedu also reiterated that the donor seeds
of the transgenic variety supplied by the Monsanto group could not be used by farmers unless
they were used as a donor variety by them
• Monsanto, in its suit, sought for an ad interim injunction against Nuziveedu, claiming that
cause of action arose on account of the Nuziveedu companies continuing to "market and sell"
Genetically Modified Hybrid Cotton Planting Seeds despite termination of the sub-license
agreements.
• Monsanto alleged violation of their intellectual property rights vis-à-vis the registered patent
and the trademarks
Single Judge Bench:
• The Single judge decision by the Delhi High Court stated that the licence was terminated by
Monsanto and patent protection could be enforced till the suit was disposed
• Rejected all the claims for invalidity and rejection of patent.
• Nuziveedu was allowed to use the patented technology and during the pendency of the suit, the
trait value compensation was to be paid by the Nuziveedu as fixed by the Government Policies.
Division Bench

• Main issue - whether the process described in Monsanto’s nucleotide sequence in

its Claims which were granted patent, resulting in isolation of the Cry2Ab gene, its
synthesization and insertion into the plant cell, resulting in donor transgenic seeds
and plants fall within the exceptions covered under Section 3(j) of the Patents Act.
• In claim 25 of their patent, Monsanto specifically claimed a man-made DNA
construct that does not exist in nature and does not otherwise form a part of a
plant as existing in nature. Monsanto elaborates how this DNA construct, which
when inserted into a plant confers the trait of insect tolerance to the plant and
how plants without this DNA construct do not exhibit the trait of insect tolerance
• Monsanto argued that products of biotechnology are not excluded from patenting
under Section 3(j) of the Patents Act.
• Although section 3(j) also excludes a “part of a plant”, in its ordinary sense, this exclusion
applies to what is ordinarily or naturally a part of a plant;
• Therefore, the DNA construct or nucleotide sequence of claims not being ordinarily
part(s) of a plant, (as they are a result of invention) were inserted into plants, were
patentable.
• Nuziveedu’s refrain was on the text of Section 3 (j); it emphasized that the Bt. Trait has
not been and cannot be utilised in isolation.
• It sows seeds of its proprietary cotton variety alongside the Transgenic Bt. Cotton seed.
The Transgenic Bt. Cotton seed and Nuziveedu‟s seeds yield different plants, which are
cross-pollinated at the flower stage.
• Nuziveedu integrates the trait provided to them in the form of seed of the transgenic
plant by Monsanto, as per their sub-license agreement.
• On insertion of a trait, it cannot be removed from that variety. There is no technology
available to remove or segregate the Bt. Trait from its proprietary varieties or restore them
to their original status without the Bt. Trait.
Section 3(j)

• The mechanism adopted by Parliament was to spell out what was not patentable i.e.,
plants, seeds, plant varieties, - whole or part and then exclude micro-organisms, but clarify
that the exclusion would not apply to "seeds, varieties and species and essentially
biological processes for production or propagation of plants and animals".
• Therefore, the principal provision (Section 3) provides for non-patentability of matters
spelt out - i.e.
(i) plants, animals in whole or part thereof;
(ii) excluding micro-organisms
(iii) but including seeds, varieties and species and essentially biological processes for
production or propagation of plants and animals
Were the subject matter of the patent micro-
organisms?

• The discussion about the subject patent discloses that the nucleic acid sequence
which is the invention in question (the Cry2AB gene) has no existence of its own;
it is of use, after introgression at a particular place, none else.
• Even thereafter, the seed material has to undergo further steps of hybridization to
suit local conditions. Therefore, these products are not "microorganisms" and
consequently excluded from the exclusion clause in Section 3 (j).
Held
• The future propagation of the transgenic plants and the subsequent transfer of the Bt. Trait in
such plants and consequently, the transgenic seeds, will be a process of nature, and no step of
human intervention can impede such transfer of the sequence.
• Therefore, it would be contrary to law and Parliamentary intent to enable Monsanto to have
patent rights over the nucleic sequence once it is been duly introgressed and hybridized into the
transgenic plants.
• The moment the DNA containing the nucleotide sequence is hybridized to produce the transgenic
seeds/plants; the seeds/plants fall within the purview of the PV Act. The process of creation of
such seeds/plants were also excluded from patentability as they squarely fell within the meaning
of an "essentially biological process" exempted from patentability under section 3(j), as well.
ØThe subject matter, the concerned nucleotide sequence over which Monsanto had patent rights
and the process was held unpatentable by reason of Section 3 (j) of the Patents Act.
ØSingle judge’s directions to Monsanto to continue with its obligations under the sub-license
agreements, including consequential orders with respect to payment and receipt of trait value,
are upheld.
ØMonsanto was allowed to apply for registration under the PV Act
Supreme Court

• 8th January 2019, the SC remanded the matter to the division bench holding that
the Delhi HC was wrong in deciding the validity of the patent merely on the basis
of prima facie examination.
• It held that the question of validity of a patent is a mixed question of fact and law
and therefore evidence and expert testimony were to be considered.
Dimminaco A.G. v. Controller of Patents & Designs
• Patent Application filed by the appellant involved an invention relating to a process for
preparation of infectious Bursitis Vaccine.
• The vaccine would essentially protect the contagious Bursitis infection which was found in
poultry.
• However, the process for the preparation of this vaccine contained a living virus in the end
product
• The said Patent Application was examined by the Patent Office and was decided that it did not
constitute an invention under the Patent Act
• Dimminaco appealed to the Controller of Patents and Designs.
• The Assistant Controller of Patents & Designs further held that a vaccine with living organism
cannot be considered a substance
• It was held that the subject matter of the specification does not constitute an invention and
the patent application was, therefore, rejected
• Erstwhile Section 5 – “…. but claims for the methods or processes of manufacture shall be
patentable.”
Calcutta HC
• The court noted that in the instant case, the application was refused mainly on the ground
that the end product contained a living organism. Therefore, it was held that it could be
called a manner of manufacture
• The dictionary meaning of manufacture was referred to. It was observed that the process
of preparing a vendible commodity containing a living substance is not excluded from the
purview of the word, ‘manufacture’.
• Furthermore, the end product was novel, capable of industrial application and was useful
for protecting poultry against contagious Bursitis infection, thus making the process an
invention.
• Court held that the controller erred in denying patent protection to the vaccine just
because it contained a live virus
• The court further allowed the appeal and directed the petitioner’s patent application to be
reconsidered within two months of the publication/delivery of the judgement.
Vendibility test
• To decide whether in a particular case, the process of manufacture involved in the invention
ought to be patented or not, the vendibility test was used in this case.
• Vendibility test is satisfied if the invention results in the production of some vendible item or
it improves or restores former conditions of a vendible item or its effect is the preservation
and prevention form deterioration of some vendible product
• A vendible product is one that can be passed on from one person to another by way of
commercial transactions of sale and purchase.
• The vendibility test therefore is satisfied if either of the following conditions are met-
1. The invention results in the production of some vendible product; or
2. It improves/restores former conditions of a vendible product; or
3. Its effect is the preservation / prevention from deterioration of some vendible product.
• The process claimed for a patent, i.e., the manufacture of a vaccine, led to a vendible product.
• The court also noted that the dictionary meaning of the word manufacture does not exclude
the process of preparing a vendible commodity which contains a living substance
• Therefore, the process was an invention and as a result, patentable.
Harvard College
v Canada
(Commissioner
of Patents)
• The President and Fellows of Harvard College (Harvard) applied for a Canadian patent
for technology for creating transgenic non-human mammals that are prone to cancer.
• The patent application particularly described a process for producing mice that have
cancer-promoting genes (oncomice).
• Since oncomice have a heightened susceptibility to cancer and tumour development, they
are useful for animal carcinogenic studies, such as tests for evaluating suspected
carcinogens or cancer-protective agents.
• The technology in Harvard’s patent application entailed injecting cancer-promoting genes
(oncogene) “spliced” onto pieces of bacterial DNA (plasmids) into fertilized mouse eggs.
• The eggs were implanted into a female host mouse, and permitted to develop to term.
• The offspring of the host mouse were tested for the presence of the oncogene; those that
contain the oncogene are called “founder” mice.
• Founder mice were mated with mice that have not been genetically altered. Fifty percent
of these offspring have the oncogene in all of their cells.
• Harvard sought to protect the process by which the oncomice are produced, and also the
genetically modified mice.
• Commissioner of Patents (Commissioner) allowed the claims to the process to be
patented, but refused to grant claims to the mice.
• Although the Canadian Patent Office had previously regularly granted patents for genes,
proteins, cells and DNA sequences, it was unwilling to grant a patent for a “higher” life
form.
• The Commissioner determined that the transgenic mouse was not an “invention” because
it was not “reproducible” that is, the development of the eggs in the host mouse relied on
the laws of nature to produce the mammalian end product.
• The inventors did not have full control over all of the characteristics of the resulting
mouse.
• This decision was upheld by the Federal Court, Trial Division, but was overturned by a
majority of the Federal Court of Appeal.
• The majority of the Court, in directing the Commissioner of Patents to issue a patent,
stated that the Patent Act does not explicitly exclude living organisms such as non-human
mammals from the definition of "invention.”
 Majority opinion
• A majority of five judges of nine determined that the claims for the oncomice were not patentable,
while four judges vigorously dissented from this conclusion
• The majority opinion sidestepped the question of whether "lower" or single-celled organisms fit within
the Act, but reasoned that the subject-matter categories "art, process, machine, manufacture or
composition of matter" recited in the Act are exhaustive rather than illustrative, and that transgenic
animals cannot fit the common definition of the categorical language
• the majority explored the definitions of "manufacture" and "composition of matter" found in the Act.
The court concluded that higher life forms do not fit within either of these term
• the majority further concluded that the structure of the Patent Act reflects no legislative consideration
of the moral questions posed by the case at hand.
• the majority was of the view that the patenting of higher life forms under the current Canadian patent
regime would be a "radical departure" from the traditional patent regime and would therefore require
"an unequivocal direction from Parliament”
• the existence of the Plant Breeders’ Rights Act served as some indication of Parliament's intention to
provide another means outside the Patent Act to promote innovation in the field of biotechnology.
 Minority Opinion (Dissent)
• Even though Parliament may not have anticipated the Patent Act's application to higher life
forms when they wrote the Act, this invention is nonetheless a "profound and far-reaching"
"scientific accomplishment" - the kind of thing the Patent Act was meant to apply to.
• Most western jurisdictions, including the United States, Europe and Japan have issued patents
on the Harvard mouse, or on related subject-matter.
• Under Canadian law before the decision in Harvard College, various life forms have been held
to be patentable. Therefore, it is not "life" per se which is unpatentable.
• There is no rational dividing line to be drawn between lower life forms and higher life forms in
terms of patentability.
• Moreover, there is no patentable distinction between the fertilized, genetically altered
oncomouse egg (considered patentable by the Patent Office) and the resulting oncomouse,
which grows from that patentable egg
Association for Molecular Pathology et al. v. Myriad
Genetics et al.
FACTS
• Myriad Genetics, Inc. had discovered the precise location and sequence of two
human genes, mutations of which can increase the risks of breast and ovarian
cancer.
• In relation to this discovery, Myriad was granted several patents.
• These patents would give Myriad the exclusive right to isolate an individual's
BRCA1 and BRCA2 genes as well as the exclusive right to synthetically create
BRCA cDNA. 1
• In the present case, three claims were relevant: (i) those concerning the isolated
genes, (ii) the diagnostic method and (iii) the screening methods identifying
potential drug candidates.
 Facts (contd.)

• The patents covered the act of isolating the genes and the creation of cDNA, giving Myriad
exclusive rights to control those processes for 20 years.
• When scientists at other institutions began offering BRCA testing after Myriad had
discovered the genes, Myriad ordered them to stop, asserting that the testing infringed
Myriad's patents
• Petitioners - Association for Molecular Pathology filed suits against these claims, holding that
they were invalid under 35 U.S.C. §101
• The plaintiffs in the case included medical and scientific societies, individual researchers,
physicians and genetic counselors, individuals at risk of breast or ovarian cancer who were
unable to obtain some or all BRCA testing, and advocacy groups seeking to advance women’s
health and cancer prevention.
• Each of the plaintiffs alleged harm from the existence and assertion of the BRCA patents
 District Court and Court of Appeals
• The Federal District Court granted summary judgment against Myriad, finding that Myriad's
patents were invalid because they covered products of nature.
• On appeal, the Court of Appeals for the Federal Circuit reversed, holding that both isolated
DNA strands and cDNA may be patented. It held that isolated DNA as well as methods for
screening cancer therapeutics can be patent eligible.
• The BRCA genes, when isolated and extracted from the cellular nucleus, were chemically and
structurally distinct from any DNA found in the human body. Accordingly, such isolated and
purified genes would constitute man-made products of “human ingenuity” and thus eligible for
patent protection
• However, methods for comparing DNA were held to be patent ineligible.
• The patents claimed by Myriad Genetics would, if upheld, give it the exclusive right to isolate
BRCA1 and BRCA2 genes, or any strand of 15 or more nucleotides within them, and the
exclusive right to create BRCA cDNA
 Supreme Court
• The Court’s unanimous decision, largely reversing the Federal Circuit, was issued on June
13, 2013.
• Court, began by explaining that Myriad’s discovery of the BRCA genes — even if it
involved substantial time, expense, and skill — was not “an act of invention
• Myriad merely identified the “exact” or “precise” location and sequence of the BRCA
genes. Court thus reduced Myriad’s contribution, from a major discovery to a mere
refinement of existing knowledge
• The Court also established that the isolation per se did not constitute a new composition
of matter.
• The Court, however, found that cDNA was a non-naturally occurring molecule and that
its creation is the creation of something new. cDNA therefore was considered not to be
a product of nature and thus patent eligible under 35 U.S.C. §101.
 D'Arcy v Myriad Genetics Inc [2015] HCA 35.
• The High Court of Australia unanimously decided that the claims by Myriad Genetics did not define
a manner of manufacture.
• The Court found that, while formulated as claims to a product (i.e. a nucleic acid molecule), the
substance of the invention was the information embodied in the nucleotides of the molecule. The
Court decided that the information was an inherent part of the molecule and not created by human
action.
• The High Court, however, in arriving at its decision, looked not only at the form of the claims but at
their substance and breadth. The substance of the invention was determined to be the sequence of
nucleotides which, in a cellular environment, can ultimately be translated into the BRCA1 polypeptide
which the Court concluded ‘can properly be described as ‘information’. Used in that sense, “…the
information stored in the sequence of nucleotides coding for the mutated or polymorphic BRCA1
polypeptide is the same information as contained in the DNA of the person from which the nucleic
acid was isolated”.
• The Court was also concerned with the scope of the claims which could raise the risk of a chilling
effect upon legitimate innovative activity outside the formal boundaries of the monopoly
Patent Filing
and
Prosecution
Process
(i) Filing
(ii) Publication of Application
(iii) Examination
(iv) Pre-grant opposition
(v) Grant
(vi) Publication of grant of patent
(vii) Post-grant opposition
Application (Section 7)
• Every application for a patent shall be for one invention only and shall be made in the
prescribed form and filed in the patent office
• Every international application under the Patent Cooperation Treaty for a patent, as may
be filed designating India, shall be deemed to be an application under this Act, if a
corresponding application has also been filed before the Controller in India.
• The filing date of an application referred to in 7(1A) shall be the international filing date
accorded under the PCT
• Every application shall state that the applicant is in possession of the invention and shall
name the person claiming to be the true and first inventor;
• Where the person so claiming is not the applicant or one of the applicants, the
application shall contain a declaration that the applicant believes the person so named to
be the true and first inventor
Specification (Section 10)
Every complete specification shall
(a) fully and particularly describe the invention and its operation or use
and the method by which it is to be performed;
(b) disclose the best method of performing the invention which is known
to the applicant and for which he is entitled to claim protection; and
(c) end with a claim or claims defining the scope of the invention for
which protection is claimed.
(d) be accompanied by an abstract to provide technical information on the
invention
 Publication of application (Section 11A) and
request for examination (Section 11B)

• An application is not ordinarily open to the public in the prescribed period

• Can be published at the request of the applicant by the Controller at any time before the
expiry of the prescribed period.
• Every application to be published on the expiry of the prescribed period unless
withdrawn, abandoned, or under a secrecy direction
• No application for a patent shall be examined unless the applicant / interested person
makes a request for such examination within the prescribed period
• In case the applicant / interested person does not make a request for examination of the
application for a patent within the prescribed period the application shall be treated as
withdrawn by the applicant
 Examination (Section 12)
• When a request for examination has been made in respect of an application for a patent
in the prescribed manner - the application and specification and other documents
related thereto shall be referred at the earliest by the Controller to an examiner for
making a report in respect of the following–
(a) whether the application and the specification and other documents relating
thereto are in accordance with the requirements of the Act
(b) whether there is any lawful ground of objection to the grant of the patent
(c) the result of investigations made under section 13; and
(d) any other matter which may be prescribed
Search for anticipation by previous publication and
by prior claim (Section 13)
The examiner to whom an application for a patent is referred shall make
investigation for the purpose of ascertaining whether the invention so far as claimed
in any claim of the complete specification:
(a) has been anticipated by publication before the date of filing of the applicant’s
complete specification in any specification filed in pursuance of an application
for a patent made in India and dated on or after the 1st day of January, 1912;
(b) is claimed in any claim of any other complete specification published on or after
the date of filing of the applicant’s complete specification, being a specification
filed in pursuance of an application for a patent made in India and dated before
or claiming the priority date earlier than that date.
Pre-grant opposition (Section 25(1))
• Section 25(1) of the Indian Patent Act, 1970 along with Rule 55 of Patents Rules, 2003 deals with pre-grant
opposition in India.
• The opposition can be filed by any person in writing, any time after the publication of the patent
application and before it is granted.
• Section 25(1) clauses (a) to (k) of the Patent Act lays down an exhaustive list of the grounds based on
which the patent application can be opposed.
1. Wrongful obtainment: The invention or any part thereof was wrongfully obtained from the
opponent.
2. Prior publication: The invention was published before the priority date (earliest filing date which
discloses the invention). This objection is subject to Section 29 of the Act, which talks about situations
where the publication does not constitute an anticipation of the product or process.
3. Prior claim: The invention was previously claimed in another Indian patent application, which was
published on or after the priority date of the applicant’s claim but whose priority date is earlier than
that of the applicant.
4. Prior knowledge or use: The invention is known or used before the priority date. In the case of a
process that is being patented, it is deemed to have been publicly known or used if a product made by
that process was imported, before the first date of filing of the application.
5. Obviousness: The invention is obvious and does not involve any inventive step. This means
that no advancements have been to the existing use or literature on the subject.
6. Non-patentable subject matter: The subject of the application is not considered to be an
invention under the Patent Act or falls in the category of “non-patentable inventions”.
7. Insufficient description: The patent specification does not properly explain the invention or
the method of performing it.
8. Non-disclosure: The applicant has failed to disclose all the details which were required under
Section 8 of the Act.
9. False disclosure: The applicant has provided materially false information.
10. Time limit: The conventional application was not filed within the specified period of 12
months from the date of the first patent application made in a conventional country.
11. Biological material: The specification failed to disclose the origin or source of the biological
material, if any, used in making the invention or has mentioned the incorrect source.
12. Traditional knowledge: The invention was anticipated taking into consideration the
knowledge possessed by indigenous communities anywhere in the world.
Grant of a patent (Section 43)
• Where an application for a patent has been found to be in order for grant of the patent and
either—
(a) the application has not been refused by the Controller by virtue of any power vested in
him by this Act; or
(b) the application has not been found to be in contravention of any of the provisions of the
Act,
the patent shall be granted as expeditiously as possible to the applicant with the seal of the patent
office and the date on which the patent is granted shall be entered in the register.
• On the grant of patent, the Controller shall publish the fact that the patent has been granted
and thereupon the application, specification and other documents related thereto shall be open
for public inspection.
Post-grant opposition (Section 25(2))
• At any time after the grant of patent but before the expiry of a period of one year
from the date of publication of grant of a patent, any person interested may give
notice of opposition to the Controller in the prescribed manner
• Section 2(t) of the Patents Act defines “Person interested” as including a person
engaged in, or in promoting, research in the same field as that to which the invention
relates
• The grounds for opposition of patent are same wrt pre-grant or post grant opposition
REVOCATION OF PATENTS (Section 64)
• Subject to the provisions contained in the Patent Act, a patent whether granted before
or after the commencement of the Act, may be revoked on a petition of any person
interested or of the Central Government or on a counter-claim in a suit for
infringement of the patent by the High Court
Patent Infringement
• Section 48 of the Patents Act deals with rights of a patentee
Ø a patent granted under the Act will confer upon the patentee—
(a) where the subject matter of the patent is a product, the exclusive right to
prevent third parties, who do not have his consent, from the act of making,
using, offering for sale, selling or importing that product in India;
(b) where the subject matter of the patent is a process, the exclusive right to
prevent third parties, who do not have his consent, from the act of using that
process, and from the act of using, offering for sale, selling or importing the
product obtained directly by that process in India.
• Sections 104–115 of the Patents Act, 1970 deal with patent infringement.
Types of patent infringement
Literal infringement
• A product is said to be literally infringing if all elements of a patent claim are present in
the product, and a process is said to be literally infringing if all steps in a claim are present
in the process.
• In other words, all the claims in the patent specification match the features of the
infringing product or process.
Non-literal infringement
• Non-literal infringement is the type of patent infringement where the infringer makes an
equivalent product or process to the patented product or process and uses, sells, markets,
offers for sale, or imports the same without permission of the patentee during the term
of such a patent.
How to deduce non-literal infringement
Doctrine of Equivalents
• Under the doctrine, a product or process that does not literally infringe
upon the express terms of a patent claim may nonetheless be found to
infringe if there is 'equivalence' between the elements of the accused
product or process and the claimed elements of the patented invention
• The doctrine is applicable only in cases where the variation or difference
between the infringing product or process and the patented claim is
insignificant, insubstantial, and not essential to the patented claim.
• The triple test – substantially the same function, in substantially the same way
and to yield the same result – is applied primarily to products or devices.
• Whereas for process patents, the essential elements of the given process; the
necessary steps of that process; and the manner in which the essential elements
interact at each step must be substantially similar to the patented process or
method to sustain a claim of infringement.
• Thus, the doctrine of equivalents permits an expansion of patent rights beyond
the literal scope of the patent claims.
• One purpose of the doctrine of equivalents is to protect patentees from those
who seek to evade liability for infringement by making only insubstantial changes
to a patented invention.
Purposive construction
• Earlier followed Doctrine of Pith and Marrow - If an alleged infringing product
contains all the essential elements of the patented invention, it may be deemed to
infringe the patent, even if there are differences in non-essential elements. This doctrine
ensured - essence of the invention is protected, preventing infringers from making
minor modifications to evade liability while still capturing the core innovation
• Catnic Components Ltd. v. Hill & Smith Ltd. (1982) – the court moved away
from the pith and marrow doctrine to ‘purposive construction’ doctrine
• Under this new approach, the court focused on the purpose of the patent claim and
how a person skilled in the relevant field would interpret it.
• The court held that a patent claim should be given a purposive construction
• The question was whether a person with practical knowledge would understand that
strict compliance with a particular descriptive word or phrase in the claim was intended
to be an essential requirement of the invention.
Court stipulated -
• Whether persons with practical knowledge and experience of the kind of work in
which the invention was intended to be used, would understand that strict
compliance with a particular descriptive word or phrase appearing in a claim was
intended by the patentee to be an essential requirement of the invention so that
any variant would fall outside the monopoly claimed, even though it could have no
material effect upon the way the invention worked.
• No plausible reason has been advanced why any rational patentee should want to
place so narrow a limitation on his invention. On the contrary, to do so would
render his monopoly for practical purposes worthless, since any imitator could
avoid it and take all the benefit of the invention by making simple changes.
Kirin-Amgen Inc and Others v. Hoechst Marion
Roussel Limited and Others
FACTS
• Erythropoietin (EPO) is produced in the kidneys in minute quantities.
• It was discovered that EPO had a useful property - that it stimulated production of red blood
cells and as a result it was very valuable for the therapeutic treatment of anaemia.
• Amgen invented a process of producing EPO by recombinant DNA technology. For this
invention Amgen was granted a European Patent
• Essentially, Amgen had discovered a way of inserting the genetic code for the expression of
EPO into a host cell.
• The cell would then take the genetic code for EPO and express the protein as part of its
natural function. Amgen’s patent was directed to this invention.
• Transkaryotic Therapies Inc (TKT) also developed a different method of producing EPO. It
discovered a way to "switch on" a cell’s natural ability to express EPO. This method was
unknown at the priority date of the Amgen patent.
• TKT’s EPO was marketed as Dynepo (GA-EPO).
• Hoechst Marion Roussel Limited (a subsidiary of TKT) started importing EPO
into the UK.
• Amgen issued proceedings for infringement of its patent.
• The key Amgen claims in issue can be summarized as:
(1) a DNA sequence for use in securing the expression of EPO in a host cell,
(26) EPO which is the product of the expression in a host cell of a DNA
sequence according to claim 1, and
(19) EPO which is characterized by being the product of eucaryotic expression
of an exogenous DNA sequence with further characteristics that made it
different from pre-existing EPO.
Main issue
• Only Claims 19 and 26 were alleged to have been infringed because TKT did not
make any of its EPO using Amgen’s DNA sequencing.
• However, Claim 26 could not be understood without interpretation of Claim 1.
• The principal issue in the case was whether TKT's EPO fell outside the claims of
Amgen's patent suit because of the difference in the way it was made.
TKT’s claims
• TKT claimed that its method was not within Claim 19 or 26 and accordingly could not
infringe them.
• In addition, it claimed that Claim 19 was bad for insufficiency and further Claim 26 was
anticipated (i.e. not new) because the product which it claimed- EPO, was known and
formed part of the state of the art at the priority date.
• According to the House of Lords the first step in determining any infringement of the
patent was to correctly construe the claims of the patent.
• The claims of the patent required interpretation based on Article 69 of the European
Patent Convention (EPC)
• Article 69 stated - the extent of the protection conferred by a European Patent or a
European Patent Application shall be determined by the terms of the claims.
Nevertheless, the description and drawings shall be used to interpret the claims.
Construction
• Until the Patents Act 1977, which gave effect to the European Patent Convention
("EPC") there was nothing in any UK statute about the extent of protection conferred by
a patent. It was governed by the common law, the terms of the royal grant and general
principles of construction.
• Protocol on the Interpretation of Article 69 sates that:
• Article 69 should not be interpreted in the sense that the extent of the protection conferred by a
European patent is to be understood as that defined by the strict, literal meaning of the wording used in
the claims, the description and drawings being employed only for the purpose of resolving an ambiguity
found in the claims. Neither should it be interpreted in the sense that the claims serve only as a guideline
and that the actual protection conferred may extend to what, from a consideration of the description and
drawings by a person skilled in the art, the patentee has contemplated. On the contrary, it is to be
interpreted as defining a position between these extremes which combines a fair protection for the patentee
with a reasonable degree of certainty for third parties
Held
• After construing Claim 1 and Claim 19 the House of Lords found that none of these
claims were infringed.
• Essentially, on the evidence presented before it, the House of Lords found that a
reasonable person skilled in the art would have understood the claims to be concerned
with the protection of Amgen’s method of producing EPO.
• The person skilled in the art would not have understood the claims to be directed to
TKT’s method of production.
• Accordingly, the House of Lords found there to be no infringement. As TKT’s method
of production was not within the scope of Claim 1 it was also not within the scope of
Claim 26 as this was dependent upon Claim 1.
• Therefore, Amgen’s claim for infringement was dismissed.
Invalidation or claims
Claim 19 and 26 were product by process claims
• Anticipation
• HOL - Found that Claim 26 was attempting to claim EPO. This claim could not be allowed
because EPO was a known product at the priority date and thus formed the state of the art.
• The EPO produced by Amgen’s method was no different from the EPO that had been isolated
before from urine even though it appeared that Amgen had convinced the European Patent Office
that its EPO was different
• Insufficiency
• The specification did not give the person skilled in the art any idea as to whether the EPO he was
making would fall within Claim 19 or not.
• Further, the use of the reference to Amgen’s EPO being a higher molecular weight than naturally
occurring EPO was artificial so as to allow the claim to be granted by the European Patent Office.
• As a result the specification did not enable the person skilled in the art to perform the invention as
provided in Claim 19. Accordingly Claim 19 was invalid for insufficiency.
 Product by process claims
• It was a past practice in the UK to allow product-by-process claims.
• A product-by-process claim is a claim which claims the end product if that product is made by a
patented process.
• Up until the enactment of the Patents Act 1977 the scope of protection conferred by a patent was
undefined. Thus a product-by-process claim had the advantage that a patentee could pursue not
only the user of its patent process but any person who dealt in the resulting product.
• The EPC in Article 64(2) removed the requirement for product-by-process claims as it expressly
states that products directly obtained from a patented process are protected. The result of Article
64 is that the European Patent Office will reject product-by-process claims except in the limited
situation where the product is new (new in the sense of never being discovered).
• The UK enacted this provision in Sec 60(1)(c) Patents Act 1977.
• The UK continued to accept product-by-process claims even after the enactment of the Patents
Act 1977. As a result HOL stated that this practice of accepting product by- process claims must
cease to bring the UK into line with EPC
F. Hoffman-La Roche Ltd & Anr v. Cipla Ltd
• Case deals with an application seeking ad-interim injunction, restraining
the defendant from manufacturing, offering for sale, selling and
exporting the drug Erlotinib, for which the plaintiff holds a patent.
• Facts
• Hoffman La Roche (plaintiff) has a patent for a small drug molecule,
medically termed as a 'Human Epidermal Growth Factor Type-
1/Epidermal Growth Factor Receptor' (Her/Egfr) inhibitor, popularly
known as 'Erlotinib’.
• It is claimed that this drug marked a major breakthrough and
innovation in the treatment of cancer; it is used to destroy some types
of cancer cells while causing little harm to normal human cells.
• This drug is administered in the form of a tablet. The tablet
formulation of Erlotinib is sold by the plaintiff under the trademark
and name of 'Tarceva’.
• Erlotinib was approved in the year 2007 by the Indian patent office.
• The patent was valid on the basis of amendment of 2005 (product patent).
• The patented item was launched in 2006 was available in the Indian market under
the name of “Tarceva”.
• The announcement regarding the launch of Tarceva by Roche Scientific Company
(India) Pvt. Ltd., a wholly owned subsidiary of the Roche Group in India, was
given wide publicity by the media due to its importance in the cancer treatment.
• Cipla – the defendant is also engaged in manufacture and marketing of
pharmaceutical and health care products in India and the plaintiffs learnt of its
plans to launch a generic version of the drug Tarceva (Erlotinib) in India and
export the same to various countries.
• Infringement suit was filed and damages asked.
Single judge bench (Delhi HC)
• The court dismissed Cipla’ contentions about lack of inventive step.
• However, the court looked at two competing public interests, that is, the public interest in
granting an injunction to affirm a patent during the pendency of an infringement action,
as opposed to the public interest in access for the people to a life saving drug
• Court held that the balance has to be tilted in favor of the latter.
• The damage or injury that would occur to the plaintiff in such case is capable of
assessment in monetary terms.
• However, the injury to the public which would be deprived of the defendant's product,
which may lead to shortening of lives of several unknown persons, who are not parties to
the suit, and which damage cannot be restituted in monetary terms, is irreparable.
• Refused to grant injunction
Further developments

• Roche’s appeal to a higher bench of the Delhi High Court against the March 2008
order was dismissed
• On the substantive legal issues, the two-judge bench felt that Cipla had done
enough to demonstrate a potentially credible challenge to the validity the patent,
including raising sufficient doubt over whether it had complied with full disclosure
requirements.
• Roche’s subsequent agitation of the matter on special leave before the Supreme
Court was also denied as the case moved to trial
2012 Single judge bench

• Justice Singh answers two questions in his decision:

(i) whether Roche’s IN ’774 patent stands to be revoked, and
(ii) whether the Cipla’s manufacture of Erlocip infringes Roche’s IN
’774 patent
Wrt (i) Cipla fails to establish a case for revocation.
We are more concerned with (ii)
• Plaintiff claims - no evidence or process stated by Defendant to show that Erlotinib Hydrochloride in
Polymorph B form can be made without using claimed Erlotinib Hydrochloride.
• A Polymorphic form of a compound will infringe the basic compound patent' which in this case is the suit
patent. It is also a well settled principle that the aforesaid holds true irrespective of the fact that the
Polymorphic form' in question is covered by a separate Polymorph' patent.
• Defendant has at least shown on record that the plaintiffs' product which is being manufactured and sold as
Tarceva is Polymorphic B version of the compound
• The defendants contend - A separate patent application was filed in USA for Polymorph B i.e. US'221 and
other countries. Separate application for product - IN/507/DEL was also filed in India for Polymorph B
form of Erlotinib Hydrochloride.
• Clear admissions have been made that the suit patent is related to Polymorph A+B
• In India the plaintiffs' application for Polymorph B was IN-507/DEL filed on 14th May, 2002.
• The Polymorph B patent application IN'507 of Plaintiffs has been rejected in India. The Plaintiffs cannot be
better off after Polymorph B patent is rejected. First - Plaintiffs consider Polymorph B as a new invention &
file an application for getting a patent. Thereafter, when the said application is rejected by the Controller, the
Plaintiffs argue that the second product is covered by the first patent.
Court’s analysis
• Court had to test as to whether the impugned product was infringing the patented
subject matter especially when there is a patent claim on the subject and there is a product
which may not strictly covered within the patent claim but contains something else as well
in form of variant or reactants.
• Court applied the Catnic rule and said - Courts have evolved the rule of the purposive
construction of the patent claim so that in the cases wherever the need be, the claim in
the invention is not construed too narrowly which was never the intention of the inventor
and not the purpose of the said invention so that the maximum benefit should be given
to the inventor by not interpreting the patent claim in a pedantic manner and giving the
same an effect which was the real purpose for which the product was invented in
furtherance of the practical approach.
Construction in case of variants

• Wrt a variant - which would have material bearing upon the working of the invention, the
rule of purposive construction is not applicable as in those cases the variant would be
excluded from the ambit of the patented claim and thereby there will be no infringement
of patent.
• The following enquiry needs to be made:
i) That one has to show by an evidence as to what is missing in the patented claim
and the product in question is a minor variant;
ii) That there could not have been intention of the patentee to exclude such minor
variant from the ambit of invention;
iii) That the said minor variant could have no material effect on the way in which the
invention worked.
Application of the construction to the present case

• The specification of IN'774 clearly indicates that the said plaintiffs did not intend to
include the Polymorphic version B in the suit patent IN'774.
• The plaintiffs have attempted to establish infringement on the basis of what has been
written by the defendant on its packaging of the drug which is Erlotinib Hydrochloride
and what has been declared by the defendant before the authority.
• The claim of the plaintiffs is premised on the right of the plaintiffs in the patent of a
chemical compound, therefore the infringement of the same has to be established by
corresponding chemical analysis of the defendant's product and not by mere comparison
of the labels, strips or what is written thereon to show that there is an infringement.
Held

• The plaintiffs have not been able to provide any evidence as to whether the
Polymorphic version if at all is included with in the same patent claim
• If so, then what is the role of the reactants with which the claimed compound is
reacted in order to arrive at the Polymorphic version and whether the properties
and characteristic of the Polymorphic version corresponds with that of the suit
patent. This has not been established either
• Consequently, the plaintiffs have not been able to discharge such onus of proof
upon the plaintiffs in relation to establishment of such facts which would aid
towards establishment of the infringement of the patent
Further progression
• Division bench judgement (2015)
• Cipla alleged that their product Erlocip is a Polymorph B form of the compound Erlotinib
Hydrochloride and since the patent application for the Polymorph B of Erlotinib Hydrochloride is
rejected, Cipla is free to make polymorph B form.
• The Division Bench of the Delhi High Court held that the relevant Patent was clearly not limited
to any polymorphic form of Erlotinib Hydrochloride, but to Erlotinib Hydrochloride itself.
• The bench further stated that this compound may exist in various polymorphic structures;
however, any such structures will be subsumed within this patent. Along these lines, as Cipla’s
Erlocip is certainly one specific polymorphic form of the Erlotinib Hydrochloride compound
(Polymorph B), it will infringe the Patent
• The Division Bench set the correct legal principles for establishing infringement i.e. mapping the
infringer product with the patented claims.
• The court refused to grant injunction since Roche’s patent was due to expire in 2016 imposed
damages on Cipla instead
 Defences to patent infringement

• Research exception
• Section 47(3) - the grant of a patent is subject to the condition that any product or
process, in respect of which the patent is granted, may be made or used by any person
for the purpose merely of experiment or research including the imparting of
instructions to pupils
• Patent rights should not hamper the "bona fide" experiments and scientific processes.
• This exception permits third parties to carry out experimental or scientific activities
relating to the subject matter of the patent without infringing the patent holder's rights.
•Bolar exception
• Section 107-A - —For the purposes of the Act, the following are not considered
infringement-
(a) any act of making, constructing, using, selling or importing a patented invention
solely for uses reasonably related to the development and submission of
information required under any law for the time being in force, in India, or in a
country other than India, that regulates the manufacture, construction, use, sale
or import of any product;
(b) importation of patented products by any person from a person who is duly
authorised under the law to produce and sell or distribute the product
Why the exemption
• Pharmaceutical products must meet regulatory requirements for authorization to be
placed on the market.
• The patent status of the originator product can impede the competitor from being able to
start work to meet regulatory requirements in order to be able to place the product on the
market once the originator patent expires.
• Unless such work is permitted during the patent term, by an exception.
• Without the Bolar exception, or a broad experimental use exception that includes acts to
provide information for regulatory approval, the competitor will not be able to prepare
for regulatory approval until the patent expiry.
• Since obtaining the marketing approval for a generic medicine takes time, the patent
monopoly for the originator is practically extended further in time than originally
conceived
What does the Bolar exemption do?
• The Bolar exemption to patent rights allows the manufacturers of generic drugs to
undertake steps reasonably related to the development and submission of information
required for obtaining marketing approval anywhere in the world in respect of a patented
product without the consent of the patentee.
• Some countries permit the generic drug manufacturers to use the technology of a
patented drug to generate data and to demonstrate bioequivalence that would assist in the
regulatory or marketing approval of the generic product, while the patent is still in force.
• This provision allows the generic producers to market and manufacture their goods as
soon as the patent term expires.
• The exemption under Section 107A of the Act does not allow for the use of patented
drug to obtain the license to manufacture and distribute the generic drug before the
expiry of the term of patent.
Exhaustion
• The Doctrine of Exhaustion refers to the exhaustion of the exclusive rights of the
patent holder once the patented invention is sold without any restriction.
• The first unrestricted sale of a patented item exhausts the patentee's further
control over that particular item.
• The rationale behind the patent holder exhausting their rights once they have sold
the patented product is that, by first sale of the patent invention the patent holder
has already used the exclusive rights to prevent others from making, using, selling,
offering for sale in the territory of patent grant or importing an invention into the
territory of patent grant and therefore has already reaped the benefits conferred
by a patent.
Invalidity of patents

• If a patent is found to be invalid then the patentee may not have an infringement claim
• Section 107 - In any suit for infringement of a patent, every ground on which it may be
revoked under section 64 shall be available as a ground for defence.
• In bifurcated patent litigation systems (such as Germany), claims of infringement and
validity of a patent are decided independently of each other in separate court proceedings
at different courts.
• Bifurcation creates situations in which a patent is held infringed that is subsequently
invalidated
• In non-bifurcated systems (Such as UK, India), infringement and validity are decided
jointly in the same proceedings at a single court.
Remedies for patent infringement

• Section 108
(1) The reliefs which a court may grant in any suit for infringement include an
injunction (subject to such terms, if any, as the court thinks fit) and, at the
option of the plaintiff, either damages or an account of profits. [injunction;
damages and compensation]
(2) The court may also order that the goods which are found to be infringing and
materials and implement, the predominant use of which is in the creation of
infringing goods shall be seized, forfeited or destroyed, as the court deems fit
under the circumstances of the case without payment of any compensation.
[seizure and destruction of infringing goods and materials]
Compulsory licensing

• Compulsory licensing - when a government allows a third party to produce a patented

product or process without the consent of the patent owner
• Article 31 of TRIPS (which pertains to use without authorization of the right holder) lays
down the set of conditions that govern the use of compulsory licensing by WTO
members, the most important of which are the following:
(a) The entity applying for a compulsory license should have been unable to obtain a
voluntary license from the right holder on "reasonable" commercial terms;
(b) If a compulsory license is issued, adequate remuneration must be paid to the patent-
holder; and
(c) A compulsory license must be granted mainly to supply the domestic market.
Doha Declaration (Available here)
• WTO member governments adopted the Declaration on the TRIPS Agreement and Public Health by
consensus at the WTO’s Fourth Ministerial Conference in Doha, Qatar, on 14 November 2001.
• Its purpose is to respond to the concerns that have been expressed that the TRIPS Agreement might
make some drugs difficult to obtain for patients in poor countries.
• On compulsory licensing, the declaration makes it clear that each member is free to determine the
grounds upon which the licences are granted
• The declaration makes it clear that the TRIPS Agreement should be interpreted and implemented in a
manner that supports WTO members’ right to protect public health and, in particular, to promote
access to medicines for all.
• The TRIPS Agreement does refer to national emergencies or other circumstances of extreme urgency
in connection with compulsory licensing. But this is only to indicate that in these circumstances there is
no need to try to obtain a voluntary licence before resorting to compulsory licensing.
• The declaration makes it clear that each member has the right to determine what constitutes a national
emergency or other circumstance of extreme urgency, and that public health crises can fit the bill
• Under the Indian Patent law, Compulsory licenses are dealt with under the Chapter XVI of the Indian Patent
Act, 1970.
• Section 83 – General Principles
Ø patents are granted to encourage inventions and to secure that the inventions are worked in India on a
commercial scale + to the fullest extent that is reasonably practicable without undue delay;
Øpatents are not granted to enable patentees to enjoy a monopoly for the importation of the patented article;
Øthe protection and enforcement of patent rights contribute to the promotion of technological innovation
and to the transfer and dissemination of technology, to the mutual advantage of producers and users of
technological knowledge in a manner conducive to social and economic welfare;
Øpatents granted do not impede protection of public health and nutrition and should act as instrument to
promote public interest;
Øpatents granted do not in any way prohibit Central Government in taking measures to protect public health;
Øthe patent right is not abused by the patentee or person deriving title or interest on patent from the patentee,
and the patentee or a person deriving title or interest on patent from the patentee does not resort to practices
which unreasonably restrain trade or adversely affect the international transfer of technology; and
Øpatents are granted to make the benefit of the patented invention available at reasonably affordable prices
Purpose

that patented inventions are worked on a

commercial scale in the territory of India
without undue delay and to the fullest
extent that is reasonably practicable
General purpose for
granting CL (S. 89)
that the interests of any person for the time
being working or developing an invention in
the territory of India under the protection
of a patent are not unfairly prejudiced
Grounds for applying for a CL (S. 84(1))
• When - At any time after the expiration of three years from the date of the grant
of patent,
• Who - any person interested may make an application to the Controller for grant
of compulsory licence on patent
• Grounds:
(a) that the reasonable requirements of the public with respect to the patented
invention have not been satisfied, or
(b) that the patented invention is not available to the public at a reasonably
affordable price, or
(c) that the patented invention is not worked in the territory of India
Reasonable Requirements (S. 84(7))
The reasonable requirements of the public shall be deemed not to have been satisfied—
(a) if, by reason of the refusal of the patentee to grant a licence or licences on reasonable terms,—
i) an existing trade or industry or the development thereof or the establishment of any new trade or industry in
India or the trade or industry of any person or class of persons trading or manufacturing in India is prejudiced;
ii) the demand for the patented article has not been met to an adequate extent or on reasonable terms;
iii) a market for export of the patented article manufactured in India is not being supplied or developed;
iv) the establishment or development of commercial activities in India is prejudiced;
(b) if, by reason of conditions imposed by the patentee upon the grant of licences under the patent or upon the
purchase, hire or use of the patented article or process, the manufacture, use or sale of materials not protected
by the patent, or the establishment or development of any trade or industry in India, is prejudiced;
(c) if the patentee imposes a condition upon the grant of licences under the patent to provide exclusive grant
back, prevention to challenges to the validity of patent or coercive package licensing, or
(d) if the patented invention is not being worked in the territory of India on a commercial scale to an adequate
extent or is not being so worked to the fullest extent that is reasonably practicable, or
(e) if the working of the patented invention in the territory of India on a commercial scale is being prevented or
hindered by the importation from abroad of the patented article by— (i) the patentee or persons claiming under
him; or (ii) persons directly or indirectly purchasing from him; or (iii) other persons against whom the patentee is
not taking or has not taken proceedings for infringement.
Considerations for the Controller while granting CL (s. 84(6))
In considering the application filed, the Controller shall take into account the following:
(i) the nature of the invention, the time which has elapsed since the sealing of the
patent and the measures already taken by the patentee or any licensee to make full
use of the invention;
(ii) the ability of the applicant to work the invention to the public advantage;
(iii) the capacity of the applicant to undertake the risk in providing capital and working
the invention, if the application were granted;
(iv) as to whether the applicant has made efforts to obtain a licence from the patentee
on reasonable terms and conditions and such efforts have not been successful
within a reasonable period as the Controller may deem fit:
Provided that this clause shall not be applicable in case of national emergency or other
circumstances of extreme urgency or in case of public non-commercial use or on
establishment of a ground of anti-competitive practices adopted by the patentee,
Procedure for granting CL (S. 87)
• The licence is granted by the controller under the Act.
• When an application for compulsory licensing is made and the controller is satisfied with
the grounds, the applicant will be asked to serve a notice to the patentee or any other
person interested in the patent. The application will then be published in the official
journal.
• In case of any objection, the patentee or any other interested person may give the notice
of such opposition or objection to the controller within the time prescribed by the
controller.
• The notice of opposition must contain the grounds of objection with respect to the
application made by the applicant for grant of a compulsory licence.
• The controller is under an obligation to notify the applicant about such opposition and is
given an opportunity to be heard by both the parties i.e., the applicant and the opponent,
before deciding the application.
Revocation of patent (S. 85)

• Where, in respect of a patent, a compulsory licence has been granted, the Central
Government or any person interested may, after the expiration of two years from
the date of the order granting the first compulsory licence, apply to the Controller
for an order revoking the patent on the ground that the patented invention has
not been worked in the territory of India or that reasonable requirements of the
public with respect to the patented invention has not been satisfied or that the
patented invention is not available to the public at a reasonably affordable price.
• Every application for revocation shall ordinarily be decided within one year of its
being presented to the Controller.
India’s first Compulsory License

Bayer v Union of India

2013 Indlaw IPAB 20
Facts

• “Sorafenib”, an active pharmaceutical compound used for the treatment of liver

and kidney cancer was patented by Bayer Corporation, Germany, in India
• Sorafenib is marketed worldwide under the brand name Nexavar.
• CIPLA started producing and marketing the generic version of Sorafenib in 2008
under a brand name ‘Soranib’ and the description of ‘Sorafenib Tablets 200mg’.
• Bayer filed a suit for infringement against CIPLA
• During the ongoing dispute between CIPLA and Bayer, another generic
manufacturer, Natco Pharma Limited, filed a request for compulsory license
against Bayer's patent on Sorafenib before the Controller of Patents.
• The Controller found that Natco Pharma was deserving of a compulsory license
as Bayer had failed to meet the requirements of S. 84 of the Patents Act, 1970.
• The Controller drafted the terms and conditions of the compulsory license as
follows:
Ø A price of Rs. 8,800/- (per 120 tablets) was fixed.
Ø NATCO was directed to sell the patented drug at this price and also pay a
standard royalty at the rate of 6% calculated at the net price /manufacture.
Ø NATCO could sell the drug only in India and had to supply the drug to at least
600 needy patients each year free of charge.
• Bayer appealed the Controller’s decision before the Indian Intellectual Property
Appellate Board (IPAB).
IPAB’s analysis
• Reasonable requirements
• Sub-sections (a),(b) and (c) of S.84(1) are separated by the disjunctive ‘or’ and therefore,
even if one condition is satisfied, the Controller will be well within his rights to order
compulsory licence.
• If there is no working, then reasonable requirements will not be satisfied. If the price is
not affordable then, again, the reasonable requirements cannot be satisfied. If it is not
worked on a commercial scale, then again the reasonable requirements would not be
deemed to be satisfied.
Affordability
• The reasonably affordable price necessarily has to be fixed from the view point of the
public. The word, ‘afford’ itself indicates whether the public can afford to buy the drug
• The question to be considered - was Rs.280,000/- per month reasonably affordable
• Working of the Patent
• IPAB did not clarify whether the term ‘working of the patent’ meant
manufactured in India or imported into India but it found that the patent was not
being worked in India.
• The IPAB agreed that there could be certain situations in which a drug could only
be imported and not manufactured in India and such import would satisfy the
requirement of the drug being worked in India.
• However, IPAB held that such import must be on a commercial scale to an
adequate extent and at a reasonably affordable price.
• Further, the IPAB rejected the argument advanced by the appellant that its Patient
Assistance Program contributed to the working of the invention. This argument
was rejected on the ground that philanthropic efforts did not contribute to
working on a commercial scale.
• Public interest requirement
• The IPAB held that the public interest was paramount and efforts made by the
appellant to make the drug available to the public subsequent to the filing of the
application seeking a compulsory license are not disallowed.
• The provisions favour public interest and not the interests of either the patentee
of the compulsory license applicant.
• The IPAB held that patents are granted for the benefit of the public and therefore
must be easily attainable and affordable by the public.
• Further, the IPAB noted that the patentee was allowed a gestation period of three
years from the date of grant of the patent to work the patent in India.
• The CIPLA issue
• The IPAB held that ‘patented invention’ can only mean that which is made available to the public by the
patentee or the patentee’s licensee.
• If it were otherwise it would mean a monopoly is granted to a person who does not make an effort to
ensure the invention reaches the public
• While CIPLA’s presence in the market is relevant, the law is clear that the requirements to be satisfied for
the grant of CL are to be decided wrt the patentee alone.
• The IPAB further stated that the patentee is expected to furnish technical knowledge and render
assistance to licensees since the invention is the patentee’s property. It was undisputed that Bayer had not
shared any technical knowledge with CIPLA.
• The patentee should make sure that the invention is worked adequately and commercially.
• The Controller had also taken into account the fact that CIPLA entered the market only in 2010 Bayer
had approximately two years to work the invention on a commercial scale to an adequate extent.
• CL confirmed. Royalty increased from 6% to 7%
Further Developments
• The Bombay High Court confirmed the findings of the IPAB.
• The major legal question that arose before the Bombay High Court therefore was,
whether the supplies by infringers of the patented drug (Cipla in the instant case) have to
be taken into account to determine the satisfaction of the reasonable requirement test?
• The High Court dismissed Bayer’s petition challenging the grant of Compulsory License.
• The Court’s decision was rendered on the basis of the fact that even after taking into
account Cipla’s supplies, the public requirement would not be met.
• The Court held that it had no reason to overturn the Compulsory License granted to
Natco by the Controller

• Bayer filed a special leave petition against the Bombay High Court’s decision with the
Supreme Court of India, which however dismissed the petition and upheld the
compulsory license
Patents and
other forms of
IP
Traditional knowledge and patents
• Traditional knowledge (TK) is considered to be the collective property owned by the
entire community. It is res communis (owned by the entire society).
• TK is shaped by the contributions of several people over a long period of time. It is
deeply entrenched in the lives of the people, and TK cannot be severed from the
lives of the community.
• The TK is a collective right that belongs to the community that has developed this
knowledge over time. It consists of practices, instructions, and knowledge that have
been passed on from generation to generation within an indigenous community.
• WIPO (World Intellectual Property Organisation) defines traditional knowledge as
the knowledge, skills, practices, and know-how that are developed, sustained, and
passed on from generation to generation within a community, often forming part of
its cultural or spiritual identity.
How does law counter the overlap?
• Indian patent laws do not permit the protection of traditional knowledge under Section 3
(p) of the Indian Patent Act, 1970.
• An invention which in effect, is traditional knowledge or which is an aggregation or
duplication of known properties of traditionally known components is not an invention
and cannot be patented.
• Patent applications based on TK which contravene the provisions of law may be denied
pursuant to Section 15 or in pre-grant opposition pursuant to clauses (d), (f), and (k) of
section 25(1), and patents granted may be revoked in opposition pursuant to
clauses (d), (f) and (k) of section 25(2) of the Patents Act, 1970.
• The Patent Act 1970 includes provisions requiring TK to be disclosed and is the origin of
the invention in question. Section 10(4)(ii)(D) of the Act provides for the disclosure in
the specification of the source and geographical origin of all biological material used for
the invention.
TKDL

• Traditional Knowledge Digital Library is a joint project of the Government of

India through the Council for Scientific and Industrial Research (CSIR) and the
Ministry of AYUSH to collect information on traditional knowledge existing in
India as a single repository, in different languages and formats. TKDL acts as a
guide for patent examiners prior to art at International Patent Offices (IPOs).
• TKDL has proved to be a powerful tool in defending illegitimate rights over
existing TK information and exclusive IP rights over these TK
WIPO Treaty on Intellectual Property, Genetic Resources
and Associated Traditional Knowledge
• The WIPO Treaty on Intellectual Property, Genetic Resources and Associated Traditional
Knowledge (the Treaty) was adopted by the Member States of WIPO on May 24, 2024, and it
came into force three months after.
• The Treaty aims to enhance the efficacy, transparency and quality of the patent system with regard
to genetic resources and traditional knowledge associated with genetic resources ( “associated
TK”), and prevent patents from being granted erroneously for inventions that are not novel or
inventive with regard to genetic resources and associated TK.
• Patent disclosure requirement
• The Treaty establishes a mandatory patent disclosure requirement – this requires patent applicants
to disclose the country of origin of the genetic resources and/or the Indigenous Peoples or local
community providing the associated TK, if the claimed inventions are ‘based on’ genetic resources
and/or associated TK.
• If such information is unknown, the source of the genetic resources or associated TK should be
disclosed. If none of the above information is known, the patent applicant would be required to
declare so. Patent offices should provide certain guidance, though they would have no obligation
to verify the authenticity of the disclosure.
• Sanctions
• A failure to disclose the required information would be subject to appropriate, effective, and
proportionate measures. Patent applicants would have the opportunity to rectify a failure to
disclose the required information unless there has been fraudulent conduct or intent.
• Where there has been fraudulent intent in regard to the disclosure requirement, post grant
sanctions or remedies may be provided for.
• Fraud aside, no Party to the Treaty should revoke, invalidate, or render unenforceable a patent
solely on the basis of an applicant’s failure to disclose the required information.

• Non-retroactivity
• Subject to existing national laws on disclosure, the Treaty includes a non-retroactivity clause, i.e. no
obligations of the Treaty should be imposed in relation to patent applications filed prior to the
entry into force of the Treaty

Indian Ministry of commerce press release acknowledging its significance -

https://pib.gov.in/PressReleaseIframePage.aspx?PRID=2021716
Protection for plant varieties

• Article 27.3 (b) of the TRIPS agreement reads:

Member countries may exclude plants and animals other than micro-organisms, and
essentially biological processes for the production of plants or animals other than non-
biological and microbiological processes. However, Members shall provide for the
protection of plant varieties either by patents or by an effective sui generis system or by any
combination thereof.
• India decided to exclude patents for plants and plant varieties but exercised the sui generis
option.
• Wrt the sui generis system for effective protection of plant varieties - India enacted The
Protection of Plant Varieties and Farmers’ Rights’ Act, 2001, for plant variety protection
Patent and Plant Varieties Protection

• Section 3 (j) of The Patents Act, 1970 bars seeds, varieties and species of plants and
biological processes for production and propagation of plants from being included
within the meaning of inventions.
• Protection of Plant Varieties and Farmers' Rights Act, 2001 is - An Act to provide for
the establishment of an effective system for protection of plant varieties, the rights of
farmers and plant breeders and to encourage the development of new varieties of
plants.
• It is an attempt by the Indian Government to recognize and protect the rights of
both commercial plant breeders and farmers in respect of their contribution
Objectives of the PV Act

• The four major underlying objectives of the Act are:

(i) To recognize and protect the rights of farmers for their contribution made in
conserving, improving and making plant genetic resources available for
development of new varieties.
(ii) To protect plant breeders’ rights, to stimulate investment for research and
development, both in public and private sector, for the development of new plant
varieties.
(iii) To facilitate the growth of seed industry in the country, to ensure the availability of
high quality seeds and planting material to farmers.
(iv) To give effect to Article 27.3(b) in Part II of the TRIPs Agreement.
 Analysis of the overlap and exclusion in
Monsanto
• Monsanto (Citing Harvard College v. Canada) - Plant Breeders' Rights Act was passed not out of
recognition that higher life forms are not a patentable subject matter under the Patent Act , but
rather out of recognition that plant varieties deserve some form of intellectual property protection
despite the fact that they often do not meet the technical criteria of the Patent Act.
• It is evident that Parliamentary intent was to exclude from patenting plants, seeds or part thereof
excluding micro-organisms "but including essential biological processes".
• This meant that process or products, that otherwise meet the test of patentability (i.e. novelty,
inventive step and industrial application) are nevertheless as a matter of public policy, ineligible for
patent protection.
• The mechanism adopted by Parliament was to spell out what was not patentable i.e., plants, seeds,
plant varieties, - whole or part and then exclude micro-organisms, but clarify that the exclusion
would not apply to seeds, varieties and species and essentially biological processes for production
or propagation of plants and animals
Benefit Sharing

• Section 2(b) “benefit sharing”, in relation to a variety, means such

proportion of the benefit accruing to a breeder of such variety or such
proportion of the benefit accruing to the breeder from an agent or a
licensee of such variety, as the case may be, for which a claimant shall
be entitled as determined by the Authority under section 26;
• Section 26 deals with determination of benefit sharing by Authority
Patents ; Trade Secrets; and confidential info
• Trade Secrets
• A trade secret means information that:
a. Derives independent economic value, actual or potential, from not being generally known to,
and not being readily ascertainable by proper means; and
b. is the subject of efforts that are reasonable under the circumstances to maintain its secrecy.
The latter distinguishes patent protection from trade secret protection.
Whereas patent protection is granted in exchange for disclosing the invention to the public, trade
secret protection is granted to those who take reasonable steps to keep their invention secret.
• https://www.youtube.com/watch?v=7ug8tHiR98w&t=99s
• Confidential Info
• Trade Secrets Bill 2024