Conditions of Patentability &

Non Patentable Inventions

Khushwant Yadav, Ph.D.

SVKM’s NMIMS
PATENTABILITY REQUIREMENTS
An invention will be eligible for a patent grant in India only if it satisfies the patentability
requirements. To be patentable, the invention must satisfy all of the requirements, which
check worthiness of the invention for patent grant from different perspectives. Some of
the requirements are relatively easy to satisfy when compared to others, but all of them
are equally important for purposes of patentability assessment.
The five (5) requirements for patentability of inventions in India are:
A. Patentable Subject Matter;
B. Industrial Applicability;
C. Novelty;
D. Inventive Step; and
E. Specification.
Patentability requirements may
be viewed as filters arranged in
succession for purposes of
analysing patentability of
inventions.
Only inventions that pass
through all the filters will be
eligible for patent grant, and
those that get filtered out will
be refused. The picture
provides a view of the patent
filter model.
INVENTIONS
Under Section 2(1)(j) of the Patents Act, inventions are defined as
those that are either products or processes, are novel, have an
inventive step, and are industrially applicable. When seen through
the lens of patent law, inventions are only those products and
processes that satisfy patentability requirements. The definition of
invention however includes only three of the patentability
requirements, and inventions must satisfy two additional
requirements to be eligible for patent grant. One of them relates to
the list of subjects that are not patentable even if they are
inventions, and the other reviews the description and workability of
the invention.
 PATENTABLE SUBJECT MATTER

The Patents Act does not use the phrase patentable subject matter anywhere, and
this phrase has been borrowed from the US Patent Code. The TRIPS Agreement
uses the phrase ‘Patentable Subject Matter’ in a context broader than that of this
chapter. For purposes of this chapter, patentable subject matter refers to subjects
that are considered patentable, and those that are excluded from patentability.

Patentable subjects are provided in broad terms in the definition of invention,

which states that an invention under the Act must either be a product or process.
In other words, in order to be considered for patentability an invention must either
be a product or process. Patent eligible subjects are therefore products and
processes without any limitation of field, technology, or any other. At a general
level, every invention is either a product and/or process, and patentability
objections at this level are not very common. However, the Patents Act provides a
long list of inventions not patentable, which form material part of the patentable
subject matter requirement.
Sections 3 and 4 of the Patents Act provide a list of inventions that are not patentable. While Section 3 deals
with a general list of subjects not considered as inventions, Section 4 excludes inventions relating to atomic
energy from the scope of patentability. If the subject matter of an invention falls within the list provided in the
said sections, the invention will not satisfy the patentable subject matter requirement.

The interplay between Section 2(1)(j), which defines ‘invention’ and Section 3, which provides a list of
subjects that are not inventions can sometimes get very complicated. For several subjects not considered as
inventions under Section 3, the analysis of their scope and coverage overlaps with analysis of invention
assessment criteria under Section 2(1)(j). Having said that, the Supreme Court in the Novartis case stated that
determination of Section 2(1)(j) and Section 3 are independent of each other and must be conducted
separately. The demarcation of assessment by the Supreme Court means that the determination of one
should not have a bearing on the other, but that is more theoretical than practical with respect to many
excluded subjects.

Section 3 has sixteen (16) clauses each of which list multiple subjects that are not considered inventions. By
one count, around forty-six (46) subjects form part of the sixteen (16) clauses. On its face, the long listing of
non-patentable inventions restricts the scope of patentable subject matter in India. However, the statutory
language of the subjects leaves scope for interpretation, which has been, and will continue to be employed by
applicants to carve out patentable inventions from the scope of unpatentable ones.
Non patentable inventions
Non patentable inventions are given in Section 3 of the Indian Patent Act:
Section 3 (a): Frivolous inventions
Section 3 (b): Inventions which are contrary to Law or Mortality or injurious to public
health
Section 3 (c): Mere discovery of a scientific principle or formulation of an abstract
theory.
Section 3 (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 is not an invention.
Section 3(d) provides an explanatory clause to In a recent landmark decision (Novartis AG Vs.
make it more clear which reads as follows: Union of India, W.P. No. 24760/06), the Madras High
(Explanation- For the purposes of this clause, salts, Court held that efficacy means therapeutic efficacy.
esters, ethers, polymorphs, metabolites, pure form, It was held that going by the meaning for the word
particle size, isomers, mixtures of isomers, efficacy and therapeutic what the patent applicant is
complexes, combinations and other derivatives of expected to show is, how effective the new discovery
known substance shall be considered to be the made would be in healing a disease or having a
same substance, unless they differ significantly in good effect on the body.
properties with regard to efficacy) In other words, as the Court further clarified, the
The complete specification must clearly and patent applicant is definitely aware as to what is the
categorically bring out in the description, as to how therapeutic effect of the drug for which he had
the subject matter differs significantly in properties already got a patent and what is the difference
with regard to efficacy from the known substance. . between the therapeutic effect of the patented drug
and the drug in respect of which patent is asked for.
Section 3 (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 is not an invention.
A mere aggregation of features must be distinguished from a combination
invention. The existence of a combination invention requires that the
relationship between the features or groups of features be one of functional
reciprocity or that they show a combinative effect beyond the sum of their
individual effects. The features should be functionally linked together which
is the actual characteristic of a combination invention.
An admixture resulting in synergistic properties is not considered as mere
admixture, e.g., a soap, detergent, lubricant and polymer composition etc,
and hence may be considered to be patentable.
Section 3 (f): Mere arrangement or re-arrangement of known devices
The Manual of Patent Practice & Procedure says that in order to be
patentable, an improvement on something known before or a
combination of different matters already known, should be something
more than a mere workshop improvement; and must independently
satisfy the test of invention or an 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 before.
Section 3 (h): Method of agriculture or horticulture

Section 3 (i): Any process for the medicinal, surgical, curative, prophylactic
diagnostic therapeutic or othertreatment of human being 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 is not patentable
a) Medicinal methods: As for example a process of administering medicines
orally, or through injectables, or topically or through a dermal patch.
(b) Surgical methods: As for example a stitch-free incision for cataract
removal.
(c) Curative methods: As for example a method of cleaning plaque from teeth.
(d) Prophylactic methods: As for example a method of vaccination.
(e) Diagnostic methods: Diagnosis is the identification of the nature of a
medical illness, usually by investigating its history and symptoms and by
applying tests.
Therapeutic methods: The term ―therapy includes prevention as well as
treatment or cure of disease. Therefore, the process relating to therapy may
be considered as a method of treatment and as such not patentable.
Section 3 (j): Plants and animals in whole or any part thereof other than micro-organisms but
including seeds, varieties and species and essentially biological processes for production or
propagation of plants and animals are not inventions.
The subject matters excluded under this provision are:
(a) plants in whole or in part
(b) animals in whole or in part
(c) seeds
(d) varieties and species of plants and animals
(e) essentially biological process(es) for production or propagation of plants and animals.
Microorganisms, other than the ones discovered from the nature, may be patentable. For
instance, genetically modified microorganisms may be patentable subject to other requirements
of Patentability.
Plant varieties are provided protection inIndiaunder the provisions of the Protection of Plant
Varieties and FarmersRights Act, 2002.
Section 3 (k): A mathematical or business method or a computer programme per se or
algorithms are not inventions and hence not patentable.
Software per se not patentable. Technical applicability of the software claimed as a process
or method claim, is required to be defined in relation with the particular hardware
components.
Computer Implemented Inventions can be patented if:
They have technical character and solve a technical problem.
They are new.
They involve an inventive technical contribution to the prior art.
The method claims should clearly define the steps involved in carrying out the invention. It
should have a technical character.
The claims should incorporate the details regarding the mode of the implementation of the
invention via. hardware or software, for better clarity.
Section 3 (l): A literary, dramatic, musical or artistic work or any other aesthetic creation
whatsoever including cinematographic works and television productions is not
patentable.

Section 3 (m): A mere scheme or rule or method of performing mental act or method of
playing game is not patentable.

Section 3 (n): A presentation of information is not patentable.

Section 3 (o) Topography of integrated circuits is not patentable.

Section 3 (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 is not patentable.
Case Study
Section 3(d) has been a hotly contested clause, and has by far been the most reported and publicized provision
of the Indian Patents Act. This clause was the subject of discussions and debates, many of them led by
Shamnad Basheer, a distinguished IP professor, who made significant contributions with respect to the
provision’s scope, and its role in enabling access to medicines. Analysis of whether a new form is patentable
involves the following steps:

Identifying the known substance;

Identifying the known substance’s purpose and efficacy;
Checking if the invention being claimed is a new form of the known substance;
Identifying the efficacy of the new form; and
Comparing the efficacy of the new form with the efficacy of the known substance with respect to the purpose.
If the efficacy of the new form for the purpose for which the patent is claimed is higher than the efficacy of the
known substance for the same purpose, than the new form is considered to have enhanced efficacy, which
makes it patentable subject matter. Advantages provided by the new form, which are unrelated to the purpose
of the substance in question will have no value in proving enhancement of efficacy. In the Novartis case, the
Supreme Court held that attributes of a new form such as enhanced bio-availability and stability, and reduced
hygroscopicity are not sufficient to prove enhanced efficacy because the said advantages are not related to the
purpose of the invention.
NOVARTIS CASE
The Appellant in the case, Novartis AG, filed an application for patent in 1998 for a crystalline salt form of
Imatinib and its use in cancer treatment. It specifically claimed the methanesulfonic acid addition salt form of
the compound, Imatinib, called as Imatinib Mesylate (commonly referred to as Glivac or Glivec), in its beta
crystalline form, which is non-needle shaped, having better flow properties, thus better processible, less
hygroscopic and more thermodynamically stable, thus better storable than its needle shaped, alpha crystalline
form, characterized by the differences in the melting points and the X-ray diffraction diagrams. It also claimed
that the Beta crystalline form of Imatinib Mesylate has higher bio-availability when compared to the free base
form of Imatinib by thirty percent.

The application was rejected by the patent office and later by the Intellectual Property Appellate Board on the
ground that the compound did not meet the requirements of Section 3(d), which excludes new forms of a known
substance with known efficacy from the scope of patentability unless enhanced efficacy is shown. The Appellate
Board relied on the decision of the Madras High court, which held that enhanced efficacy means enhanced
therapeutic effect and stated that the compound in question lacked efficacy and therefore fell within the scope
of Section 3(d). It however agreed that the compound satisfied the other patentability requirements such as
industrial applicability, novelty and inventive step. Novartis challenged the decision of the Appellate Board
before the Supreme Court of India, which led to this decision.
ANALYSIS
Reiterating its prior decisions stating that the text of a statute must be seen in the light of its context,
which is understood from internal and external sources, the Supreme Court reviewed the history of the
patent law in India from 1911 to 2005, with specific emphasis on Agreement on TRIPs and changes
brought about for its compliance. Stating that patent systems are not created for inventors but in the
interests of national economy, the Court pointed out how the patent law in India impacted the
pharmaceutical industry. Noting that the growth of Indian pharmaceutical and chemical industry was
propelled by the 1970 Patents Act, which enabled effective health care in India and many other countries,
the Supreme Court observed that the changes in patent provisions to comply with TRIPs agreement were
brought about bearing in mind the context of health care as served by the Indian pharmaceutical
companies. Though the Court cited discussions about Section 3(d) in the parliament and its perceived role
in safeguarding access to health, it did not delve into the role of public health and public interest in
interpreting Section 3(d).
Talking about patentability, the Court pointed out that an invention would be patentable
only if it satisfies the twin tests of invention, which tests novelty, industrial applicability and
inventive step, and patentability, which is provided under sections 3 and 4.
Though certain products or processes are inventions in the general sense, the Court
observed that they may not be eligible inventions under the patent law. Discussing the
backdrop of Section 3(d), the Court pointed out that the section primarily deals with
pharmaceutical and chemical inventions and that its objective was to prevent abuse of
product patents in medicines.
According to the Court, 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, checks any attempt at
repetitive patenting or extension of the patent term on spurious grounds.
With respect to Imatinib Mesylate, pre-cursor of the invention
Having established that Imatinib Mesylate
in question, the Supreme Court after analyzing the scope of a
formed part of prior disclosure, the Supreme
prior patent filed by the Appellant on Imatinib, infringement
Court compared its efficacy with that of Beta
action initiated by the Appellant against NATCO, an Indian
Crystalline form of Imatinib Mesylate, which was
pharma company, and articles published by the inventor, came
its polymorph, for purposes of Section 3(d).
to the conclusion that Imatinib Mesylate was not new and
Stating that efficacy under Section 3(d) for
lacked inventive step. It pointed out that the salt form was
pharmaceutical substances, meant therapeutic
covered in the US Patent, which claimed Imatinib and all its
efficacy, the Court reviewed the data with
pharmaceutically acceptable salt forms. While coming to the
respect to enhanced flow properties, increased
said conclusion, the Court pointed out that the scope of claims
thermodynamic stability, reduced hygroscopicity
in a patent cannot go beyond the disclosure and teaching in the
and enhanced bioavailability, submitted by the
patent. It stressed that it did not want the law of patents to
Appellant, and concluded that the Beta
develop on lines where there may be a vast gap between the
Crystalline form of Imatinib Mesylate did not
coverage and the disclosure under the patent; where the scope
have enhanced efficacy. The said properties,
of the patent is determined not on the intrinsic worth of the
according to the court, did not contribute
invention but by the artful drafting of its claims by skillful
towards enhancing the efficacy in treatment of
lawyers, and where patents are traded as a commodity not for
cancer when compared to the free base
production and marketing of the patented products but to
Imatinib or its Mesylate salt.
search for someone who may be sued for infringement of the
patent.
Discussing the meaning of efficacy, the Court stated that therapeutic efficacy of a medicine must be
judged strictly and narrowly.
It came to this conclusion based on the fact that the text added to section 3(d) by the 2005 amendment,
which laid down the condition of “enhancement of the known efficacy” and the fact that the explanation
required the derivative to “differ significantly in properties with regard to efficacy”.
According to the Court, not all advantageous or beneficial properties are relevant, but only such properties
that directly relate to efficacy, which in case of a medicine, is its therapeutic efficacy. The mere change of
form with properties inherent to that form would, as per the Court, not qualify as “enhancement of
efficacy” of a known substance. As a precautionary measure with respect to interpretation of the
judgment, the Court stated at the end that Section 3(d) does not bar patent protection for all incremental
inventions of chemical and pharmaceutical substances.
Following the Supreme Court’s judgment, several patents have been
granted with respect to new forms as applicants were able to show
enhancement of efficacy related to the purpose of the invention.
Section 3(d) sets higher standards for new forms based on showing of
enhanced efficacy by way of enabling data and information, which calls for
a change in strategy with respect to disclosures made in patent
documents as well as timing of filings. It places higher standards for
patentability of new forms, which are to be tested by the extent of their
efficacy, and does not completely bar their patentability.