Law

Intellectual Property Pharmaceutical Patents: Subject Matter Exclusions

Development Team

Role Name Affiliation

Principal Investigator Professor (Dr.) Ranbir Singh Vice Chancellor, National

Law University, Delhi

Paper Coordinator Mr. Yogesh Pai Assistant Professor of

Law, National Law

University, Delhi

Content Writer (CW) Ms. Lakshmi Kruttika Vijay Senior Associate, Anand

and Anand

Content Reviewer (CR) Prof. Prabuddha Ganguli MHRD IPR Chair

Professor, Tezpur

University

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Module Detail

Subject name Law

Paper name Intellectual Property

Module name/ Title Pharmaceutical Patents: Subject Matter Exclusions

Module Id Law/IP/#10

Pre- requisites 1. Patents, patentability, introduction to TRIPS, TRIPS

and public health

Objectives 1. To understand the nature of statutorily-defined and

judiciary-interpreted subject matter exclusions of

patents.

2. To study in detail the subject matter of patentability.

3. TRIPs vis-à-vis Patents Act 1970 : Pharmaceutical

Patents.

Key words Pharmaceutical patents, Section 3(d); TRIPs, patentable

inventions, discovery, increased efficacy, Traditional

Knowledge.

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Introduction

For any invention to be granted a patent, the invention must satisfy three

requirements: (1) novelty, (2) inventive step and (3) utility. However, this

examination presupposes one important step—it presumes that the innovation that the

patent is being sought for is, indeed, an invention. Section 3 and other provisions of

the Indian Patents Act, 1970 were amended in 2002 & 2005 to accommodate India’s

obligations as a signatory to the Agreement on Trade-Related Aspects of Intellectual

Property (TRIPS).

Section 3 finds its basis in Article 27 of the TRIPS, which states:

“Article 27 :Patentable Subject Matter

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

available for any inventions, whether products or processes, in all

fields of technology, provided that they are new, involve an inventive

step and are capable of industrial application. (5) Subject to paragraph

4 of Article 65, paragraph 8 of Article 70 and paragraph 3 of this

Article, patents shall be available and patent rights enjoyable without

discrimination as to the place of invention, the field of technology and

whether products are imported or locally produced.

2. Members may exclude from patentability inventions, the

prevention within their territory of the commercial exploitation of

which is necessary to protect ordre public or morality, including to

protect human, animal or plant life or health or to avoid serious

prejudice to the environment, provided that such exclusion is not

made merely because the exploitation is prohibited by their law.

3. Members may also exclude from patentability:

Learning Outcome: The aim of this module is to understand the nature of

statutorily-defined and judiciary-interpreted subject matter exclusions of patents. The

chapter also explores, where relevant, the legislative history of the amendments to Section

3. Each of the relevant subsections of Section 3 are discussed in turn using case law and

patent office documents as examples.

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

humans or animals;

(b) plants and animals other than micro-organisms, and essentially

biological processes for the production of plants or animals other than

non-biological and microbiological processes. However, Members

shall provide for the protection of plant varieties either by patents or

by an effective sui generis system or by any combination thereof. The

provisions of this subparagraph shall be reviewed four years after the

date of entry into force of the WTO Agreement.”1

Several scholars hold the view that the use of the term “technology” without

specific definition in Article 27.1 has given ratifying member countries a great deal of

freedom in determining the subject matter exclusions that can be implemented within

their respective national statutory framework for patent laws. 2 Certainly, the

amendments carried out in the Indian Patents Act, 1970—procedural, definitional and

substantive in nature—have had a great impact on the innovation that is patentable in

India. No industry has felt the impact of these amendments more than the

pharmaceutical industry.

Section 3 of the Indian Patents Act, 1970, at least in theory, helps discern whether

the subject matter of the innovation being claimed is patentable. Similar to the U.K.

Patents Act, 1977, but unlike the Patents Act in the United States—Section 3 is an

exclusionary provision. It does not state what would be considered an invention, but

only what specific sort of subject matter would not qualify as invention under the

Patents Act. As the Supreme Court observed, “[Section 3] puts at one place provisions

of two different kinds: one that declares that certain things shall not be deemed to be

‘inventions’ [for instance clauses (d) & (e)]; and the other that provides that, though

resulting from invention, something may yet not be granted patent for other

considerations [for instance clause (b)].”3

The relevant parts of Section 3 of the Patents Act, 1970 that affect subject-matter

eligibility of pharmaceutical substances are reproduced below:

Section 3. What are not inventions: The following are not inventions within

the meaning of this Act:

(b) An invention the primary or intended use or commercial exploitation of

which could be contrary to public order or morality or which causes

serious prejudice to human, animal or plant life or health or to the

environment;

1 Article 27 of the Agreement on Trade-Related Aspects of Intellectual Property. 2 See generally WIPOStanding Committee on the Law ofPatentsExclusions from Patentability

andExceptions and Limitations toPatentees’ Rights: A Study Prepared byProfessor Lionel

Bently,Professor Brad Sherman,Professor Denis Borges Barbosa(with Ms Karin Grau-Kuntz),Professor

Shamnad Basheer(with Mr ShashwatPurohit and Mr Prashant Reddy),Professor Coenraad Visser

andProfessor Richard Gold(with Professor Yann Joly), available at

http://www.wipo.int/edocs/mdocs/scp/en/scp_15/scp_15_3-annex1.pdf. 3Novartis AGv. Union of India, (2013) 6 SCC 1, at para 92.

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(c) The mere discovery of a scientific principle or the formulation of an

abstract theory or discovery of any living thing or non-living substance

occurring in nature;

(d) The mere discovery of a new form of a known substance which does not

result in the enhancement of the known efficacy of that substance or the

mere discovery of any new property or new use for a known substance or

of the mere use of a known process, machine or apparatus unless such

known process results in a new product or employs at least one new

reactant.

Explanation.—For the purposes of this clause, salts, esters, ethers,

polymorphs, metabolites, pure form, particle size, isomers, mixtures of

isomers, complexes, combinations and other derivatives of known

substance shall be considered to be the same substance, unless they differ

significantly in properties with regard to efficacy;

(e) A substance obtained by a mere admixture resulting only in the

aggregation of the properties of the components thereof or a process for

producing such substance;

(j) Plants and animals in whole or any part thereof other than microorganisms

but including seeds, varieties and species and essentially biological

processes for production or propagation of plants and animals;

(p) An invention which in effect, is traditional knowledge or which is an

aggregation or duplication of known properties of traditionally known

component or components.

The statutory contours of subject-matter eligibility for pharmaceutical substances

are explained in this chapter.

Section 3 (b): Public Order, Morality or Prejudicial Subject Matter Not

Patentable

Section 3(b) of the Patents Act excludes any invention whose use or exploitation

would be contrary to public order, morality or prejudices animals, plants or the

environment. The use of Section 3(b) of the Patents Act appears to be rather limited.

One such case before the Patent Office involved an invention for a medicinal powder

prepared from the remains of bodies a week after they were buried.4 The Patent Office

rejected this application holding that exhumation for profit was against public

morality and public order.

Another, rather surprising use of Section 3(b) wasthe Intellectual Property

Appellate Board’s (hereinafter “the IPAB”) order inNovartis AG v. Union of India.

The IPAB opined that Novartis’ application for the patent that covered the patented

4See, Shamnad Basheer, “Grave Diggers, “Immoral Patents” and the NBRA”, July 30, 2008, available

at http://spicyip.com/2008/07/grave-diggers-immoral-patents-and-nbra.html.

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drug Glivec would result in “public disorder among other things” because of its

prohibitively high prices. Therefore, the IPAB held that the impugned patent

application ought to be struck down under Section 3(b) of the Patents Act.

The IPAB’s observation has been heavily criticized by at least one

commentator.5On appeal, the Supreme Court of India did not address this issue and

therefore it is unclear whether high prices can result in public disorder.However, the

IPAB’s ruling is confusing, because the subject matter of Novartis’ invention does

not, examined in, fall within the concept of “invention” that the Patent Office deems

as unpatentablesubject matter under Section 3(b). The Manual of Patent Office

Practice and Procedure (hereinafter “MPOPP”) provides useful illustrations to

indicate which inventions are patentable or barred under this provision. The MPOPP

states that inventions such as ‘methods of adulteration of food” or “method of

counterfeiting notes” are not patentable under Section 3 (b) of the Patents Act.6

However, it also clarifies that if the primary intention of the claimed invention does

not seek to cause “serious prejudice to human, animal or plant life or health or to the

environment, such subject matter may be considered to be an invention.” As an

example for this proposition it cites the invention of a pesticide. Thus,

notwithstanding the IPAB’s ruling in Novartis AG, Section 3(b) is directed at

discerning morally objectionable patent subject matter, rather than the subsequent

patent abuse.7

Section 3(c): Naturally Occurring Subject Matter Not Patentable

As the U.S. Supreme Court succinctly held in Gottschalk v. Benson, “Phenomena

of nature, though just discovered, mental processes, and abstract intellectual concepts

are not patentable, as they are the basic tools of scientific and technological work.”8

This statement has been at least Section 3(c) bars the patent eligibility of any living

subject matter that occurs in nature. Given that the subject matter examined under this

provision is one deemed to be naturally occurring, it is worth underscoring that the

Patents Act uses the term “discovery” rather than “invention” to describe such an

application.

5See, Shamnad Basheer, “Breaking News: Indian IP Tribunal Denies Patent to Novartis’ Glivec”, July

3, 2009, available at http://spicyip.com/2009/07/breaking-news-novartis-loses-glivec.html. 6The Office Of Controller General Of Patents, Designs & Trademarks, “Manual of Patent Office

Practice and Procedure Version 01.11” (modified March 23, 2011), pp. 81–82, available at

http://www.ipindia.nic.in/ipr/patent/manual/HTML%20AND%20PDF/Manual%20of%20Patent%20Of

fice%20Practice%20and%20Procedure%20-

%20pdf/Manual%20of%20Patent%20Office%20Practice%20and%20Procedure.pdf [hereinafter

“MPOPP”]. 7See, Shamnad Basheer, “Breaking News: Indian IP Tribunal Denies Patent to Novartis’ Glivec”, supra

n. 5. 8Gottschalk v. Benson, 409 U.S. 63, 68 (1972).

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Section 3(d): New Forms of Known Substances Require to Show Enhanced

Efficacy

The understanding, application and import of Section 3(d) of the Patents Act has

been the focus of litigation, scrutiny as well as debate across all sectors. In 2005,

India—after much postponement—was made to amend the Patents Act, 1970 to

comply with its TRIPs obligations. The most important of these amendments was the

introduction of product patents for pharmaceuticals. However, there were concerns

that such amendment would affect India (i) negatively impact the Indian generic

industry by reducing its market share and allowing multinational pharmaceutical

innovator companies to monopolize the market, and (ii) the interests of the public

would be compromised because of the high prices at which such patented medicines

would be sold.9

To allay these fears, India introduced Section 3(d) in the Patents Act, 1970

through the Patents (Amendment) Act, 2005. Section 3(d) states:

The mere discovery of a new form of a known substance which does not result

in the enhancement of the known efficacy of that substance or the mere

discovery of any new property or new use for a known substance or of the

mere use of a known process, machine or apparatus unless such known

process results in a new product or employs at least one new reactant.

Explanation.—For the purposes of this clause, salts, esters, ethers,

polymorphs, metabolites, pure form, particle size, isomers, mixtures of

isomers, complexes, combinations and other derivatives of known substance

shall be considered to be the same substance, unless they differ significantly in

properties with regard to efficacy;

In 2013, the Supreme Court clarified and interpreted Section 3(d) in the seminal

case Novartis AG v. Union of India[hereinafter “Novartis”]. There are several

conditions stated within Section 3(d) that must be satisfied before the provision is

applied to bar a subject matter’s patentability. Since this provision is rather unique to

the Indian patent regime, the Supreme Court’s interpretation of Section 3(d) is

discussed phrase-by-phrase below.

5.1 “Mere discovery”

The phrase “mere discovery of a new form of a known substance” has been

discussed and debated at great length in the Supreme Court’s judgment in Novartis. In

that case, the petitioners argued that the term “discovery” used in the section is

distinct from the concept of “invention” defined in Sections 2(1)(j) and 2(1)(ja).10 The

court held that read in the context of the Patents Act the submission of the petitioners

could be accepted.11 However, the court emphasized that owing to Section 3(d)’s

uniqueness, the provision ought to be viewed separate from the rest of the subsections

9Combined discussion on the Statutory Resolution regarding disapproval of Patents (Amendment)

Ordinance, 2004 (No.7 of 2004) and the Patents (Amendment) Bill, 2005 (Resolution Negatived and

Bill Passed), March 23, 2005, available at

http://164.100.47.132/LssNew/psearch/Result14.aspx?dbsl=1866&ser=&smode=t#175*25. 10Novartis v. Union of India, (2013) 6 SCC 1, at para 99–101. 11Id., at para 102.

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in Section 3 that deal with patentability and instead read in the context of its

legislative history.12 This legislative history, according to the court, suggests that

Section 3(d) should be read with the opening words of Section 3, that is “The

following are not inventionswithin the meaning of this Act”. Thus the court held that

Section 3(d) was especially meant to be an extension of the definition of “invention”

as defined in Section 2(1)(j) and Section 2(1)(ja) of the Patents Act.

Therefore, the Novartis judgment has deemed Section 3(d)— read with Sections

2(1)(j) and 2(1)(ja) of the Patents Act—as setting a higher “invention threshold” than

the standard existing prior to the amendments in 2005. 13 Thus, any analysis of

pharmaceutical subject matter for novelty and inventive step for their patentability

must be carried out with reference to Section 3(d) of the Patents Act.

5.2 “New Form”

New form is a rather uncontroversial phrase when read in light of the Explanation

to Section 3(d). The Explanation lists “salts, esters, ethers, polymorphs, metabolites,

pure form, particle size, isomers, mixtures of isomers, complexes, combinations and

other derivatives” as new forms of known substances. These new forms may be

considered inventions under the Patents Act if they satisfy the criterion of enhanced

efficacy over the known substance. It is important to note that in a challenge on the

grounds of Section 3(d), the onus is on the challenger to first show how the claimed

invention is a mere new form of a known substance.14

5.3 “Known Substance”

It has now been established that for pharmaceutical patents, an examination of the

claimed invention’s inventive step and novelty should include an analysis of Section

3(d) where the claimed subject matter is a new form of a known substance.

The word “known” has been construed broadly by the Supreme Court in Novartis.

The court referred to its previous decision in the case Monsanto Company v.

CoramandalIndag Products where it interpreted the phrase “publicly known” as not

necessarily limited to being widely used to the knowledge of the consuming public;

instead, here it held that “[i]t is sufficient if it is known to the persons who are

engaged in the pursuit of knowledge of the patented product or process either as men

of science or men of commerce or consumers.”15Noting this wide construction of the

term “publicly known”, the court implicitly held that the phrase known must be given

at least equal accord.

In light of the ruling in the Novartis decision, a “known substance” appears to be

any substance whose existence is not confidential and is known to technical,

commercial or administrative personnel or members of the consuming public.16

12 Id. at paras 102–104. 13Id. at para 104. 14F. Hoffmann La Roche v. Cipla Ltd., C.S. (O.S.) 89 of 2008 & C.C. 52 of 2008, at para 117 (Sept. 7,

2012), available at http://lobis.nic.in/dhc/MAN/judgement/10-09-2012/MAN07092012S892008.pdf. 15(1986) 1 SCC 642, at para 6. 16Novartis v. Union of India, (2013) 6 SCC 1, at paras 163.

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5.4 “Enhancement of the Known Efficacy”

The known substance is used as a reference point to determine whether the new

form is an invention within the meaning of the Patents Act. The known substance

must have a “known efficacy”. This known efficacy are usually results arising out of

clinical testing, pharmacological effects or in vitro and in vivo results made known

through documents such as a patent specification.17

At its very roots, a new form of a known substance is considered an invention

under the Patents Act, 1970 if it can be shown that the new form exhibits better

efficacious properties over the efficacy of the known substance used as comparison.

In other words, the claimed invention must exhibit enhanced efficacy over the

substance from which it is derived. The same term “efficacy” is used in the

Explanation to Section 3(d) and therefore is key to the interpretation of the provision.

In Novartis,the Supreme Court held that “efficacy” in the context of Section 3(d)

“can only be ‘therapeutic efficacy’”.18 The court proceeded to construe therapeutic

efficacy “strictly and narrowly”.19 It laid down the following rules:

A mere change of form of properties inherent to the structure of the known

substance and the claimed invention will not meet the threshold of enhanced

efficacy under Section 3(d);20

Not all advantageous or beneficial properties are relevant when considering

the efficacy of a claimed invention through the lens of Section 3(d).21 Notable

illustrations of advantageous properties that would not meet the 3(d) standard

include “physico-chemical properties” such as “(i) more beneficial flow

properties, (ii) better thermodynamic stability, and (iii) lower

hygroscopicity”.22

Importantly, the Court left the door open on whether increased bioavailability

could result in enhanced efficacy.23

5.5. Conclusion: What is not an invention under Section 3(d)?

The Novartis decision helped clarify to a large extent the interpretation of the first

phrase in Section 3(d). However, there are several other categories which are not

considered inventions under this provision of the Patents Act. The MPOPP lists these

categories out for easy reference—“the mere discovery of any new property of a

known substance; the mere discovery of new use for a known substance; the mere use

17Id., at paras 163–73. 18Id., at para 179. 19Id. 20Id., at para 181. 21Id., at para 179. 22Id., at para 187 23 Id., at paras 188–89. See also, Bioavailability, THE FREE DICTIONARY BY FARLEX,

http://medical-dictionary.thefreedictionary.com/Bioavailability (Bioavailability is “[t]he degree to

which a drug or other substance becomes available to the target tissue after administration.”)

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of a known process unless such known process results in a new product or employs at

least one new reactant; [and] the mere use of a known machine or apparatus.”24

Section 3(d) was introduced to curb “evergreening” by pharmaceutical companies,

that is, the extension of a patent holder’s the exclusionary rights under Section 48 of

the Patents Act. 25 The provision is rather confusingly worded, but the Supreme

Court’s interpretation has provided some clarification on the manner in which Section

3(d) should be understood by applicants, challengers and other authorities.

Section 3(e): Admixtures Not Patentable

Section 3(e) characterisesany “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” as not being an invention within the meaning of the

Patents Act.

In other words,an invention is not patentable under Section 3 (e) if the

composition is an aggregation of the properties of its components without any

synergistic or enhanced effect. This synergistic effect “has to be something more

surprising than what was known.”26Therefore, to prove that an invention is a mere

admixture, it must be shown that the admixture“has no enhanced effect or does a new

function different from that of its constituents”.27

Section 3(j): Most Living Things Not Patentable

The Patents Act excludes all plants, animals and their parts from patentability.

The statutorily provided exception to this rule is that microorganisms and

microbiological processes are patentable under the Patents Act.In 2013, thePatent

Office issued Guidelines for Examination of Biotechnology Applications for Patent

that attempted to harmonize this statutory exception under Section 3(j) with Section

3(c) of the Patents Act which (as explained above) excludes discoveries.The

Guidelines explain that the only logical interpretation from a conjunctive reading of

these provisionsis that modified microorganisms (distinct from naturally-occurring

microorganisms) are patentable subject matter under the Act.28

24MPOPP, supra n. 6, at p. 87. 25Novartis v. Union of India, (2013) 6 SCC 1, at para 84 (citing the debate in the Lok Sabha during the

passing of the Patents (Amendment) Bill, 2005). 26Ajantha Pharma v. Allergan Inc., at para 54, ORA/21/2011/PT/KOL & M.P. Nos. 60/2011, 2/2012,

59-61/2012, 72/2012, 73/2012, 127/2012, 128/2012, 134/2012, 135/2012, 12/2013 AND 15/2013 in

ORA/21/2011/PT/KOL, available at 27 See, La Renon Health Care Pvt. Ltd. v.Kibow Biotech, at para 27, Order No. 262 of 2013

(ORA/29/2011/PT/MUM & M.P. Nos. 90/2012 & 130/2012 in ORA/29/2011/PT/MUM, Nov. 13,

2013), available at http://www.ipab.tn.nic.in/262-2013.htm; Order No. 173 of 2013 at para 103,

Ajantha Pharma Limited v. Allergan Inc., ORA/21/2011/PT/KOL & M.P. NOS.60/2011, 2/2012, 59-

61/2012, 72/2012, 73/2012, 127/2012, 128/2012, 134/2012, 135/2012, 12/2013 and 15/2013 in

ORA/21/2011/PT/KOL (Aug. 8, 2013), available athttp://www.ipab.tn.nic.in/173-2013.htm (though, it

is notable that the IPAB did not have any findings about the applicant’s challenge under Section 3 (e)). 28See, “The Guidelines for Examination of Biotechnology Applications for Patent”, (March 2013), at

p.15, available at

http://nopr.niscair.res.in/bitstream/123456789/20283/1/JIPR%2018%284%29%20323-329.pdf.

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Apart from the Guidelines,authorities and courts have determined the ambit of this

provision. In the patent application 3098/DELNP/2006, the applicant sought a patent

for an invention relating to a “method for expression of apoliprotein in plants.” The

method in the original application included a step which defined the growth of cells

into mature plants. Since growth is a natural biological process, the Patent Office

through its examination report and decision objected to this portion of the claim as

being unpatentable under Section 3(i) of the Patents Act. This objection influenced

the applicant into amending and restricting the claim to the expression of apiloprotein

in the plant cell.29

In another case, Speaking Roses International Inc. v. Controller-General of

Patents, the Bombay High Court was asked to decide whether an invention claiming a

system and method for a photo-etched image on an organic product would fall within

the purview of the Section 3(j) exclusion. Here, the court ruled that because the

invention claimed a mere “mechanical process” and not a biological one, there was no

bar to the patenting of this subject matter under Section 3 (j) of the Patents Act.30Thus

Section 3(j) bars the patentability of any naturally-occurring subject matter.

Section 3(p): Patentable Subject Matter Cannot Be Traditional Knowledge

In the context of pharmaceuticals—unlike the other subsections of this

provision—Section 3(p) draws the important distinction between what can be

protected under the patents regime and what is already known and entitled to

protection under other realms of intellectual property law. Specifically, Section 3(p)

bars the patentability of any invention known in the public domain as traditional

knowledge.

The Patent Office has had an opportunity to examine patent applications under

Section 3(p) of the Patents Act. One such illustration is the Patent Office’s decision in

the application 1576/DEL/2006 entitled “A novel herbal composition effective against

skin disorders and to a process for the preparation thereof”. The claimed invention

was a product whose components included Neem, Rasaut and Chaksu extracts and the

process for the preparation of such extracts. During the examination of the patent

application, the Patent Office raised the objection—among other objections—that the

claimed invention was not patentable underSection 3(p) of the Patents Act in view of

traditional knowledge. Despite amendments by the applicant to overcome these

objections, the Patent Office’s views on the patentability of the application remain

unchanged. In her ruling, the Assistant Controller held that the claimed composition

had no inventive step or enhanced efficacy over the prior art, that is the traditional

knowledge documents. “In absence of any inventive feature in the claims, [the Patent

Office held that the] claimed composition is considered to be aggregation of known

properties of traditionally known components”, and “[t]herefore, the said claims fall

u/s 3(p) of the Patents Act, 1970.”31 Thus, while any invention which is traditional

knowledge cannot be patented, “[a]ny value-addition using Traditional Knowledge

29 In the matter of Patent Application No. 3098/DELNP/2006(May 13, 2013), available at

http://ipindiaonline.gov.in/decision/3098-DELNP-2006-2650/3098DELNP2006GRANT.pdf. 30 2007 (109) Bom L.R. 630. 31 In the matter of Patent Application No.1576/DEL/2006 (Dec. 27, 2013), available at

http://ipindiaonline.gov.in/decision/1576-DEL-2006-2080/1576%20del%202006.pdf.

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leading to a new process or product,which is novel with inventive step and industrial

applicability” will be considered an invention under the Patents Act.32

The significance of Section 3(p) in protecting traditional knowledge cannot be

fully understood without a brief explanation of traditional knowledge. Traditional

knowledge has been defined by the World Intellectual Property Organisation

(hereinafter WIPO) as “knowledge, know-how, skills and practices … developed,

sustained and passed on from generation to generation within a community, often

forming part of its cultural or spiritual identity.”33 India’s extensive repository of

traditional knowledge is globally renowned and specifically in the context of

medicine, has given rise to various streams of science such as Ayurveda and Unani.34

Some part of this traditional knowledge is codified, but a large portion of this

information remains undocumented and only known passed on each generation

through word of mouth.

The undocumented traditional knowledge creates a unique problem in the patent

regime. Because the information is passed on to each generation, it is possible that

this information is not widely known to the public and some persons have tried to

opportunistically patent this information. Thus any person wishing to challenge the

patenting of such information can challenged under Section 3(p) of the Patents Act.

Section 3(p) of the Patents Act has been supplemented by the Patent Office’s

Guidelines for Processing of Patent Applications Relating to Traditional Knowledge

and Biological Materials.35The Guidelines are not binding and do not have the force

of law. However, as illustrated by the order discussed above, these Guidelines are

instructive and are relied upon by the Patent Office to inform its examination of

patent applications.

Thus, Section 3(p) of the Patents Act removes any subject matter that “in effect, is

traditional knowledge or which is an aggregation or duplication of known properties

of traditionally known … components.”

Conclusion: Understanding Section 3

Section 3 has been amended on several occasions by the legislature to ensure that

the list of exclusions to patentable subject matter is exhaustive. The provision also has

acted to allay concerns that these amendments to the Indian patent regime will

circumvent the interests of the Indian public (and, to some extent, industry

participants). However, the urgency in meeting the deadline for complying with

TRIPS while balancing these varied interests has resulted in some provisions being

32 See, DPS Parmar, “Legislative Framework of IP Administration”, available at

http://www.wipo.int/edocs/mdocs/sme/en/wipo_smes_del_08/wipo_smes_del_08_www_116733-

part2.ppt (using the extraction of Azadirachtin from Neem as an example of patentable subject matter,

which has been patented in India as IN226204.). 33Traditional Knowledge, WIPO, available at http://www.wipo.int/tk/en/tk/. 34 V.K. Gupta, “Protecting India’s Traditional Knowledge”, WIPO Magazine(June 2011), available

athttp://www.wipo.int/wipo_magazine/en/2011/03/article_0002.html. 35 See, “Guidelines for Processing Patent Applications Relating to Traditional Knowledge and

Biological Material”,available at

http://www.ipindia.nic.in/iponew/TK_Guidelines_18December2012.pdf.

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rather complex and ill-defined. Interestingly, some of the amended provisions no

longer strictly relate to subject matter eligibility; instead, some provisions have been

interpreted to be an additional limitation to the concepts of inventive step and novelty.

Thus, policy considerations have dictated the introduction of subsections in

Section 3. And the effect of these policy considerations is perhaps felt most strongly

in the pharmaceutical sector. Thus, carefully evaluating existing statutory and

precedential standards to determine what constitutes an invention under the Patents

Act will enable patent applicants, challengers and courts to more precisely define the

contours of subject matter exclusions for pharmaceutical patents.

Points to Remember

1. For any invention to be granted a patent, the invention must satisfy three

requirements of novelty, inventive step and utility.

2. Article 27 of TRIPs outlines the Patentable Subject Matter which has been

included in sec 3 of Indian Patents Act.

3. Diagnostic, therapeutic and surgical methods for the treatment of

humans or animals are non patentable subject matters.

4. 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 are not prohibited from

patentability.

5. According to TRIPs, members may exclude from patentability

inventions, which are necessary to protect order public or morality,

including to protect human, animal or plant life or health or to avoid

serious prejudice to the environment, provided that such exclusion is not

made merely because the exploitation is prohibited by their law.

6. The mere discovery of a scientific principle or the formulation of an abstract

theory or discovery of any living thing or non-living substance occurring in

nature.

7. 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.

8. Traditional knowledge means know-how , skills and practices developed,

sustained and passed on from generation to generation within a community,

often forming part of its cultural or spiritual identity.

9. Section 3(p) draws the important distinction between what can be protected

under the patents regime and what is already known and entitled to protection

under other realms of intellectual property law with respect to pharmaceutical

inventions.

14

Self-check Exercises

What are patentable and non-patentable subject matter? Contextualize in terms of TRIPs

Agreement.

What is Traditional Knowledge? Why is it important to safeguard it with respect to

pharmaceutical patenting?

A new form of a known substance should exhibit enhanced efficacy. Why?

Utility is one of the most important features of a patent.Elucidate.

Section 3 is an exclusionary provision. Elaborate.