Module 10

Pharmaceutical Patents:
Subject Matter Exclusions
Learning outcome
Understand the legislative history of Section 3
of the Patents Act.

Learn the statutory definitions and judicial

interpretations of subject matter exclusions of
pharmaceutical patents.
What is Section 3 of the Patents Act?
To be granted a patent, the invention must satisfy three
requirements: (1) novelty, (2) inventive step and (3) utility.

• But what is an invention?

• Section 3 of the Patents Act thus plays an crucial role in determining the
contours of subject matter exclusions for patents.
Why amend Section 3?
To meet TRIPS obligations.

Article 27.1 of TRIPS required the introduction of product and

process patents in “all fields of technology.”
• But flexibility given to ratifying countries: the term “technology” was not defined.

Article 27.3 of TRIPS also allowed for other optional exclusions.

Thus, Section 3 was amended to satisfy India’s international treaty

obligations but has been “customized” to suit national needs.
Section 3 (b): Public Order, Morality or
Prejudicial Subject Matter Not Patentable
Use of Section 3(b) of the Patents Act appears to be rather limited.
• Must identify whether the intention of the invention is to morally objectionable.

Illustrations:
• Rejected patent application for a medicinal powder prepared from the remains of bodies
a week after they were buried!
• The Manual of Patent Office Practice and Procedure provides other useful illustrations
such as ‘methods of adulteration of food” or “method of counterfeiting notes”.
• However an application for inventions such as “pesticides” whose primary intention is not
to cause “serious prejudice to human, animal or plant life or health or to the
environment” are patentable.
Section 3(c): Naturally Occurring
Subject Matter Not Patentable
Section 3(c) bars the patent eligibility of any living
subject matter that occurs in nature.
• Straightforward.
• Phenomena of nature where no human intervention is required
are not patentable subject matter.

Section 3(c) uses the term “discovery” rather than

“invention” to describe such a patent application.
Section 3(d): New Forms of Known Substances
Require to Show Enhanced Efficacy
Most important amendment to the Patents Act occasioned by the TRIPS
Agreement – introduction of product patents for pharmaceuticals.

Initial Concerns?
• (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.

To allay these fears, India introduced Section 3(d) in the Patents Act, 1970 through
the Patents (Amendment) Act, 2005.
Section 3(d): Important Phrases

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

Sectio 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
n 3(d) least one new reactant.

states: • 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…”
Section 3(d): Novartis v. UoI
Section 3(d)
was • The case arose on account of the pre-grant opposition to
Novartis’ patent application for Imatinib Mesylate which was
interpreted by rejected on account of the application being obvious,
the Supreme anticipated, and unpatentable under Section 3(d).
• The procedural history complex and lower court decisions
Court in lengthy; important that Supreme Court decided all matters
of fact and law de novo.
Novartis AG v.
• So what did the Supreme Court decide?
Union of India
& Ors.
Section 3(d): Interpreting “Mere discovery”

Petitioners argued that “discovery” is distinct from the concept of

“invention” defined in Sections 2(1)(j) and 2(1)(ja).

Discussion • Section 3(d) is unique and must be interpreted using legislative history.
• Read the opening words of Section 3 (“The following are not inventions within the meaning of this Act”).
in SC’s • Section 3(d) was especially meant to be an extension of the definition of “invention” as defined in Section
judgment: 2(1)(j) and Section 2(1)(ja) of the Patents Act.

• Section 3(d) read with Sections 2(1)(j) and 2(1)(ja) of the Patents Act now deemed to be setting a
higher “invention threshold”.
HELD: • 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.
Section 3(d): Interpreting “New Form”
Not heavily debated.

• “[S]alts, esters, ethers, polymorphs, metabolites, pure form, particle size,

Explanation to Section 3(d) very isomers, mixtures of isomers, complexes, combinations and other derivatives”
clear: are new forms of known substances.

New forms may be considered inventions if they satisfy the criterion of enhanced efficacy over the
known substance.

Important: In a challenge on the grounds of Section 3(d), the onus is on the Examiner or person
challenging the patent/application to first show how the claimed invention is a mere new form of a
known substance, after which the burden of proof shifts.
Section 3(d): Interpreting “Known Substance”

The SC has interpreted “known substance” broadly.

• Referred to Monsanto Company v. Coramandal Indag Products where it interpreted the phrase “publicly known” as not necessarily
SC limited to being widely used to the knowledge of the consuming public.
Discussion • 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.” Noting 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. (1986) 1 SCC 642, at para 6.
Section 3(e): Admixtures Not Patentable
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.

In Ajantha Pharma v. Allergan Inc., the Intellectual Property Appellate Board (IPAB) observed that the synergistic
effect “has to be something more surprising than what was known.”

Therefore, authorities such as the IPAB

have consistently held that Section 3(e) • La Renon Health Care Pvt. Ltd. v. Kibow Biotech
will apply where the admixture “has no
enhanced effect or does a new function • Ajantha Pharma Limited v. Allergan Inc.
different from that of its constituents”.
Section 3(j): Most Living Things Not Patentable
All plants, animals and their parts from patentability.

Statutory exception: Micro-organisms and microbiological processes are patentable

Guidelines for Examination of Biotechnology Applications for Patent reconciled Section 3(c) and Section 3(j) of the Patents Act :
Modified micro-organisms are patentable.

Patent Office has also objected to applications which relate to, for example, a “method for expression of apoliprotein in
plants” under Section 3(j) of the Patents Act.

In Speaking Roses International Inc. v. Controller-General of Patents, the Bombay HC held that an invention claiming a system
and method for a photo-etched image on an organic product would not fall within the purview of the Section 3(j) exclusion:

Court distinguished a mere “mechanical process” from a biological one.

Section 3(p): Patentable Subject Matter Cannot
Be Traditional Knowledge
Unlike the rest of Section 3, Section 3(p) distinguishes between patentable subject matter
and publicly-known traditional knowledge.

What is Traditional Knowledge?

• “[K]nowledge, 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.”

Difficulties faced: Traditional knowledge is usually undocumented.

Section 3(p) has been supplemented by the Patent Office’s Guidelines for Processing of
Patent Applications Relating to Traditional Knowledge and Biological Materials.
• Not binding and do not have the force of law.
• But instructive and relied upon by the Patent Office to inform its examination of patent applications.
Section 3(p): Patentable Subject Matter Cannot Be
Traditional Knowledge
Illustration: Application 1576/DEL/2006 claimed a product
whose components included Neem, Rasaut and Chaksu • Examination: Objection that the
extracts and the process for the preparation of such claimed invention was not
extracts. patentable under Section 3(p).

Despite amendments by the applicant to overcome these objections, the Assistant

Controller’s finally rejected the patent application.

Importantly observation: “[a]ny value-addition using Traditional Knowledge 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.“