The term Patent[1] means an exclusive right granted by the government to the person who made an invention, to use that invention as well as sell it for a fixed period of time.
For an invention to be patentable, certain legal conditions should be followed in order to pose grant of a patent. As per the Indian Patents Act, 1970, for any invention to fall under the category of patentable subject matter, the following conditions should be satisfied:
- Novelty[2] : an invention is novel if it is new and not disclosed to the public anywhere in the world, in any form or through any medium.
- Inventive step: as per sec 2(1)(ja) of the Indian Patents Act 1970, an inventive step refers to a feature of an invention that involves technical advance as compared to the existing knowledge or having economic significance or both that makes the invention not obvious to a person skilled in the art.
- Industrial Applicability: the term industrial applicability as mentioned in sec 2(1) (ac) of the Indian Patents Act 1970, in relation to an invention, means that the invention is capable of being made or used in an industry.
Patentability criteria based on Novelty
[3]
An invention will not be novel if it has been disclosed to the public in India or anywhere else in the world by a written or oral description or by use or in any other way before filing of the patent application in India or elsewhere. The criterion of knowledge being in public domain is not satisfied on the basis of the inventor’s knowledge alone. The information appearing in magazines, technical journals, books etc., will constitute the prior knowledge. If the invention is already a part of the state of the art or falls under public domain, a patent cannot be granted for such an invention. The material already published in patent documents and also the material of the patent applications having an earlier filing date, but not yet published at the time of filing the new invention, also constitute the state of the art.
An instance of the above can be evaluated while considering one of the cases “Soft Gel Technologies, Inc. v. Jarrow Formulas, Inc[4] .” where the patentability of the respective patent has been questioned. Soft Gels proposed a sequence of a parent patent, a continuation, and a continuation-in-part patent for a soft gel capsule, a solubilized coenzyme Q-10, and a method for preparing a soft gel capsule. After it was established that the Q-10 coenzyme was beneficial to the human body, Soft Gels saw “a need in the art for an improved methodology to deliver increased amount[s] of bioavailable CoQ-10 to an individual in need thereof.” Therefore, Soft Gels created an oil mixture solvent containing d-limonene and gel capsule for the coenzyme. In 2012, Jarrow Formulas, Inc. requested an inter partes reexamination of all three patents. Reexaminations of all three were ordered, and the assigned examiner issued rejections for each set of claims based on grounds of obviousness. Soft Gel claimed that the compound used is d- limonene instead of limonene but the board ignored the fact as it does not have any material effect on its obviousness decision. Thus, the approach was considered novel but not patentable.
Patentability criteria based on Inventive step
A patent application involves an inventive step if the proposed invention is not obvious to a person skilled in the art, i.e. skilled in the subject matter of the patent application. It measures the technical achievement of an invention and serves to fulfil the objective of advancement in science and technology through the patent system. Sec 2(1)(ja) of the Act defines an inventive step as an invention that involves technical advance as compared to the existing knowledge or having economic significance or both that makes the invention not obvious to a person skilled in the art. Thus, in case either of the two conditions is satisfied, the subject matter is patentable. However, in case of Sugen Vs Cipla, hearing held on 18-21st December, Cipla filed a Pre- grant opposition stating patent lacks inventive step under section 2(1)(j). In response thereof, the Board stated that the instant claims are clearly obvious to a skilled person, so the commercial success of the product Sunitinib submitted by the patent cannot be considered as an evidence of a patentable invention.
Patentability criteria based on Industrial Applicability
The invention must be industrially applicable. As per section 2(1)(ac) of the Indian Patents Act, 1970, the term ‘capable of Industrial Application’ can be understood as he invention which can be made or used in the industry. The subject matter related to a presentation of information, a method of performing the mental act, etc., is not patentable as it cannot be used in the industry and is thus not capable of industrial application. An invention should be such that it could be reduced to practice as many numbers of times and has utility in some industry sector. A simple hypothetical case where the invention related to fire- proof cloth, then it should be able to get reproduced exactly in a similar way, each time it is manufactured.
Patentability of Computer Related Inventions[5]
As per the Indian Patents Act, 1970, Section 3(k) discloses the patentability of a computer program per se. As per the recent CRI guidelines the software related inventions may be patentable if:
- there exist any technical advancement in the invention compared to the existing prior arts; and
- the invention discloses a technical solution to any technical problem by providing a practical application or an improved technical effect of the underlying software.
As per one of the famous judgements “Accenture Global Service Gmbh (Appellants) V Assistant Controller of Patents & Design and the Examiner of Patents (Respondents)[6]” where the Board agreed to the respondents stated that a hardware implementation performing a novel function is not patentable if that particular hardware is known or is obvious irrespective of the function performed and if the novel features of the invention resides in a set of instructions (programme) designed to cause the hardware to perform the desired operations without special adoption of the hardware or modification of the hardware, then the matter claimed either alone or in combination is not patentable. However the application was granted based on the observations stating that “the invention as claimed is not software per se but, a system is claimed which is having the improvement in web services and software. the invention since not falling in the category of section 3(K), viz software per se , objection is waived and patent is granted”
As per one of the famous judgements “Accenture Global Service Gmbh (Appellants) V Assistant Controller of Patents & Design and the Examiner of Patents (Respondents)[7]” where the Board agreed to the respondents stated that a hardware implementation performing a novel function is not patentable if that particular hardware is known or is obvious irrespective of the function performed and if the novel features of the invention resides in a set of instructions (programme) designed to cause the hardware to perform the desired operations without special adoption of the hardware or modification of the hardware, then the matter claimed either alone or in combination is not patentable. However the application was granted based on the observations stating that “the invention as claimed is not software per se but, a system is claimed which is having the improvement in web services and software. the invention since not falling in the category of section 3(K), viz software per se , objection is waived and patent is granted”
As per Section 3(j) of the Indian Patents Act 1970, Stem cells fall under the phrase “any part thereof” and hence are not considered patentable subject matter. However, in vitro methods of differentiating, isolating/purifying and culturing of stem cells may qualify as patentable subject matter, provided that the method is novel, involves an inventive step and has industrial applicability.
In addition, inventions pertaining to stem cells may also be opposed under Section 3(b) of the Act, which prohibits the grant of patent to:
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]http://www.legalserviceindia.com/article/l300-Patentability-Criteria.html
[2]https://www.lexology.com/library/detail.aspx?g=db69a258-5bdf-4d8b-97f4-0a0d22cefff4
[3]http://pfc.org.in/ach/novel.htm
[4]https://patentattorneycionca.com/BlogComments?BlogId=190
[5]https://www.lexology.com/library/detail.aspx?g=db69a258-5bdf-4d8b-97f4-0a0d22cefff4
[6]http://www.iiprd.com/section-3-k-indian-patent-act-case-studies/
[7]https://www.lexology.com/library/detail.aspx?g=db69a258-5bdf-4d8b-97f4-0a0d22cefff4