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PATENTABLE SUBJECT MATTER AND PATENTABILITY CRITERIA
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PATENTABLE SUBJECT MATTER AND
PATENTABILITY CRITERIA
AUTHORED BY - ABHISHEK NEMA
ABSTRACT
“The necessity is
the mother of all Inventions”
With the rapidly growing economies
and increase in the demands of people to continuously have an ease in the
standard of living, inventions are the foremost factor of human existence. When
there are inventions there is infringement and it is not necessary to have a
substantial damage instead legal injury is bound to happen. Hence, law is
required to safeguard the rights of people inventing something. With this
vision, this paper focuses on the provisions of The patent act, 1970 relating
to the invention, patents etc.
‘
The legislation focus on picturising
the rights and liabilities but the judiciary paves the way for that picture to
come into existence. Therefore, the judgments of courts across nation have
their own interpretation over the unending debate on the criteria of patents
which is the prime focus of this paper and concluding by imposing remarks
keeping in mind the will power of judiciary to make the laws enforceable!
Keywords: invention,
patentability, novel, industrial application,
INTRODUCTION
With progress in science and technology, the
range of IP continues to broaden. All intellectual property rights, including
patents, copyrights, trademarks, industrial designs, etc., fall under its
remit. When someone comes up with a novel concept, piece of technology, or
innovation, they often go to intellectual property law to secure their rights
to the creation. There are three main tenets of patent law: innovation,
uniqueness, and practicality. The Patents Act of 1970, as revised by the
Patents (Amendment) Act of 2002 and the Patents (Amendment) Act of 2005, is the
primary piece of legislation in this area in India.
An invention patent is an example of
industrial property that falls under the purview of intellectual property
today. If you come up with a new and valuable product, or if you improve an
existing product, or if you come up with a new way to make those items, you may
be eligible for a patent, which gives you the exclusive right to sell those
products and make money off of them. Obtaining a patent for an innovation
requires, it has to pass the test of:
·
Foremost
important Novelty,
·
Distinguishing
factor is Non-obviousness and
·
Utility
of the said invention.
The Paper intents to explain the
meaning, objectives, terms, and advantages of a patent and the test imposed by statutes and judiciary that an
invention has to undergo in India to get a patent.
RESEARCH
QUESTIONS:
·
What
are the provisions of patentable criteria under The Patents Act, 1970?
·
Whether
the Patents Act, 1970 describes what are not inventions?
·
Whether
the judiciary has paved the way for multiple interpretations to provisions?
Discuss with the help of landmark judgments.
WHAT
ARE THE PATENTABILITY CRITERIA?
An invention is a qualified patentable subject matter if it
complies with the following criteria–
It should be novel.
Innovation is an important criterion in determining
the patent potential of an invention. Under the Patent
Act,[1]
a novelty or new Invention is defined as
“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”.
The definition of invention provides a wide scope
of patentable subject matter, stating that an invention under the Act must be
either a product or a process. To rephrase, an innovation must be either a
product or a process to qualify for patent protection. There are no
restrictions on the type of technology, industry, or other context in which a
product or procedure can be patented. General patentability challenges are
uncommon because every innovation is either a product or a process. However,
the Patents Act includes a comprehensive list of non-patentable ideas that
significantly contribute to the scope of what can be granted a patent.
The novelty criterion states, in essence, that a
previously unpublished invention must be kept secret. It needs to be the most
recent advancement in the field, with no analogues in the prior art.
It should have inventive step or it
must be non-obvious.
“"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”[2]
In other words, the idea must not be
obvious to someone with expertise in the same field. It shouldn't require too
much creativity or seem too obvious to someone with similar expertise.
Section 2(1)(j), which defines
"invention," and Section 3, which provides a list of subject areas
that are not innovations, can interact in ways that can be somewhat confusing.
Comparing the scope and coverage of various topics that aren't deemed
innovations under Section 3 with the criteria for evaluating inventions under
Section 2(1) is redundant (j). However, the Supreme Court ruled in Novartis
that deciding whether or not a patent infringes Section 2(1)(j) and whether or
not it infringes Section 3 are two different and distinct inquiries. The
Supreme Court's demarcation of assessment suggests that the outcome of one form
of evaluation should not affect the other, although in many cases, this is
easier said than done.
It should be capable of Industrial
application.
The industrial application requirement of Section
2(1) determines whether or not an innovation may be manufactured or put to industrial
use (ac). A product is regarded industrially relevant if it has at least one
use in a certain sector and can be mass-produced. To qualify, a procedure needs
to be applicable to a given industrial setting. Use that is ambiguous,
hypothetical, or otherwise not grounded in the present will not be accepted.
The same holds true for applications that lack credibility or are otherwise
insufficient.
The Delhi High Court noted that an innovation needs
to be commercially viable in a case between Cipla and Roche[3],
after reviewing several Indian and foreign cases relating to the utility or
industrial applicability criteria. Must have commercial value; proven success
in the marketplace is not required. The invention must be useful in some way
and accomplish what is claimed for it in the patent. There will be no more
proof of utility needed to secure a patent.
The Delhi High Court found that the pharmaceutical
compound Sitagliptin is industrially applicable in another case between MSD and
Glenmark[4]
by applying the principles for industrial applicability set forth by the UK
Court of Appeals. The principles cited by the Court are as follows:
“i) The patent has to disclose “a practical
application” and “some profitable use” for the substance that is to be claimed,
for the ensuing of monopoly “can be
expected [to lead to] some … commercial benefit”;
ii) A “concrete benefit”, by the name of invention
“use … in industrial practice” must be “derivable directly from the
description”, need to be in connection to common general knowledge;
iii) the mere fact “speculative” use will not
suffice, so “a vague and speculative indication of possible objectives that
might or might not be achievable” will not do;
iv) The general common knowledge and patent need to
enable the skilled person “to reproduce” or “exploit” the claimed invention
without “undue burden”, or having to carry out “a research programme”; …”
The Court applied the aforementioned principles and
determined that Sitagliptin is industrially applicable even though it cannot be
used in practise due to an ineffective carrier.
It should not fall within the preview
of section 3 and 4 of the Patents Act 1970.
The Indian Patents Act of 1970, Sections 3 and 4,
list the items that cannot be patented in India. In order to be granted a
patent in India, one must first meet a number of requirements. They are:
·
Whether or not the
Invention is about something that can be patented is the primary concern. In
the Patents Act, forbidden topics are outlined in Sections 3 and 4. Unless the
Invention falls under one of the exceptions listed in Sections 3 or 4, it is
patentable subject matter.
·
It would appear
that the range of patentable subject matter in India is narrowed by the
extensive listing of non-patentable inventions. However, applicants have used,
and will continue to use, interpretations of the statutory language of the
subjects to separate patentable inventions from the scope of unpatentable ones.
WHAT
SHALL NOT BE CONSIDERED AS INVENTIONS?
The following shall not be considered as inventions
within the meaning of section 3(d) 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. 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”[5]
Monsanto Case[6]
Gene sequences and methods for inserting such gene
sequences into plant cells to express Bacillus thuringiensis (BT)
Delta-endotoxin to provide Bollworm resistance in plants are covered by an
Indian patent owned by Monsanto (Patent No. 214436, referred to as the "BT
Patent") (Monsanto Technology LLC.). One set of claims in the granted
patent is for the isolated, purified, and modified gene sequences themselves,
while the other set of claims is for the methods used to insert the sequences
into plant cells. The Indian Patent Office rejected the claims made in the
patent application concerning transgenic plants, hybrid varieties, and seeds
during prosecution.
Nuziveedu (Nuziveedu Seeds Ltd.) disputed the
"trait fee" that Monsanto was charging as a licensee of the BT Patent
owned by Monsanto, and subsequently contested the validity of the licence on
the grounds that the BT Patent was invalid. According to Nuziveedu, Section
3(j) of the Patents Act prohibits patents for inventions relating to subject
matter that is already known or obvious to the public, implying that Monsanto's
BT Patent is invalid.
Specification
·
Before receiving a
patent, the inventor must file a patent application that includes a full
description of their invention (Section 10). The specification's objective is
to specify the scope of the invention and to provide the public with detailed
information about the innovation and its implementation. A full explanation of
the innovation, as well as its construction and usage, must be included in the specification.
Drawings may be included in the written description to aid understanding of the
invention. When filing for a patent, you may be required to submit a model or
sample to the patent office to help show your idea.
• Furthermore, the specification must end with a
claim or claims that define the scope of the invention for which protection is
sought. The purpose of the claims is to define the boundaries of the invention
that is the subject of the patent application. Specification claims should be brief,
to the point, and focused on a single original concept. The claims must clearly
define the territory for which the invention is claimed. The claims must
explicitly explain the core idea of the invention, rather than relying on the
specification as a whole. The claims of the patent must be compatible with the
information in the specification.
PATENTABLE
SUBJECT MATTER
The phrase “patentable subject matter” is taken
from the US Patent Code and is not used anywhere in the Patents Act. The term
"Patentable Subject Matter" has a broader meaning in the TRIPS
Agreement than it does in this section. Topics that can and cannot be patented
are both considered patentable subject matter for the purposes of this chapter.[7]
This provision limits patentability to previously
known configurations, applications, and properties. Regarding novel forms, the
explanation provides an illustrative list of forms that are regarded as the
same substance as the well-established one. To ensure that a new form is patentable,
there is an efficacy-based exception clause. You can get a patent on a new
formulation if it's more effective than the existing one. Although this is a
small window of opportunity to meet the patentable subject matter requirement,
it is nonetheless valuable. The Analysis of whether or not a new form of
invention is patentable involves the following steps:
·
Confirming the
known substance;
·
Confirming the
known substance’s purpose and efficacy;
·
Identifying if the
invention being claimed is a new form of the known substance;
·
Confirming the
efficacy of the new form; and
·
Analysing and
Comparing the efficacy of the new form with the efficacy of the known substance
with respect to the purpose.
The new form has enhanced efficacy and is therefore
patentable if its effectiveness in the context of the purpose for which the
patent is claimed exceeds that of the known substance for the same purpose.
Evidence of improved efficacy will not be strengthened by benefits provided by
the new form that are unrelated to the substance's intended use.
According to the Supreme Court's decision in
Novartis, the benefits of a new form, such as increased bioavailability and
stability and decreased hygroscopicity, are insufficient to prove increased
efficacy.
Novartis Case Brief[8]
Novartis AG, the Appellant here, submitted a patent
application in 1998 for a crystalline salt form of Imatinib and its use in
treating cancer. Imatinib mesylate, also known as Glivac or Glivec, was claimed
in its beta crystalline form, which is non-needle shaped and has better flow
properties, making it more amenable to processing and manufacturing, and less
hygroscopic and thermodynamically stable, making it more amenable to storage.
The beta crystalline form is distinguished from the needle shaped, alpha
crystalline form by its lower melting point and higher X-ray diffractivity The
beta crystalline form of Imatinib mesylate was also reported to have 30%
greater bio-availability than the free base form of the drug.
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, which is why
the patent office and the Intellectual Property Appellate Board both rejected
the application. The Appellate Board reasoned that because the compound in
question was ineffective, it fell under the purview of Section 3(d) of the Act,
citing the Madras High Court's decision that "enhanced efficacy"
means "enhanced therapeutic effect". However, it did find that the
compound did meet the other criteria for patentability, including industrial
applicability, novelty, and inventive step. In this case, the Supreme Court of
India ruled in favour of Novartis after the company appealed the Appellate Board's
ruling.
PROMINENT
JUDGMENTS ON PATENTABILITY CRITERIA
Bajaj Auto Ltd. v. TVS
Motors Comp. Ltd (2010)[9]
Facts of the case
Bajaj auto claimed in
this case that TVS Motors had violated their patents by using their patented
technology without permission, prompting them to sue for an injunction. For
this case, the court looked to the doctrine of pith and marrow to determine
whether or not there was a true infringement of the patented technology at
issue.
Issue involved in
the case
Whether the defendants
have infringed the technology that was already patented?
Judgment of the
court
The Supreme Court, in
this particular case provide some guidelines that shall be followed in each and
every IPR case. The following were the guidelines:
·
Trial courts must hear IPR cases on a daily basis and render
decisions in no more than 4 months from the date they were filed.
·
Finally, the Madras High
Court ruled that Bajaj Auto has a valid patent on the DTS-i technology and that
the defendants, TVS Motors, are prohibited from using it. If they do, they will
be held accountable for patent infringement.
Koninklijke Philips
Electronics N.V. v. Rajesh Bansal and ors. (2016)[10]
Facts of the case
The plaintiff sued the
defendants, claiming that they had copied and illegally used the patented
technology found in the plaintiffs' DVDs. However, the defendants denied the
claims, maintaining that they had not committed any violations.
Issue raised in
the case
Whether there has been
any infringement of patents on the part of defendants?
Judgment of the
court
In this case, the court
noted that the defendants' products made use of patented technology used by the
plaintiffs in their DVDs, specifically enhanced forward-motion (EFM) and
demodulation. The DVD technology patent held by the plaintiff was effectively
infringed upon. The court found the defendants responsible, and they were
ordered to pay the plaintiffs Rs 5 lakhs in damages.
CONCLUSION AND ANAYLSIS
Intellectual
property includes any intellectual product, such as an idea, invention, or
piece of art, and the rights granted to the creator of such a thing are
referred to as intellectual property rights.As a
form of intellectual property, patents are protected ideas that can be copied
and sold. If it does not fall under the category of non-patentable inventions,
any invention that leads to the creation of a new product or service, or the
production of an existing product using new means and technology, can be patented.
The Indian Patents Act, 1970, as amended in 2002 and 2005, is the law that
applies to patents in India. For an invention to be granted a patent, it must
adhere to a number of patenting requirements. Three primary criteria must be
met: originality (or newness), practicality (or the ability to be applied in
industry), and lack of obviousness. But the patent application can be rejected
for a variety of reasons. The article has already presented these arguments.
BIBLOGRAPHY
BOOKS
I.
Dr. Sheetal
Thakur, Patenting in India, Pg. 77
ARTICLES
I.
Linda L.Lee, Trials and TRIPS-ulations: Indian
Patent Law and Novartis AG v. Union of India, Vol.23, BTLJ, 281-313 (2008).
II.
Jagjit kaur plahe,
The Implications of India's
Amended Patent Regime: sTRIPping Away Food Security and Farmers' Rights?, Vol.
30, TWQ.
III.
Amiya Kumar Bagchi, Indian Patents Act and Its Relation to
Technological Development in India: A Preliminary Investigation.
CASES
I.
Cipla Ltd. vs F.Hoffmann-La Roche Ltd. & Anr. (2008) 37 PTC 71 (Del)
II.
Merck Sharp And Dohme Corporation vs Glenmark
Pharmaceuticals, 2015 SCC OnLine Del 8227.
III.
The Patents Act. 1970, section 3, No.
29, Acts of Parliament, 1970 (India)
IV.
Monsanto
Technology LLC v. Nuziveedu & Ors AIR 2019 SC 559
V.
Novartis A.G v. Union
of India AIR 2013 SC 1311
VI.
Bajaj
Auto Limited v. TVS Motor Company Limited (2009) 9 SCC 797
VII.
Koninklijke Philips
Electronics N.V. v. Rajesh Bansal and ors. (2016) CS (COMM.) 24/2016.
Article Information
PATENTABLE SUBJECT MATTER AND PATENTABILITY CRITERIA
Authors: ABHISHEK NEMA
- Journal IJLRA
- ISSN 2582-6433
- Published 2023/06/08
- Volume 2
- Issue 7
About Journal
International Journal for Legal Research and Analysis
- Abbreviation IJLRA
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