Introduction

Patents can be considered as a crucial aspect for protecting the commercial interests and biotechnology IPR.

Only after complying with the eligibility criteria of novelty, inventive step, and Industrial application, Patent can be granted for biotechnology. India is among the top 12 biotechnology destinations in the world and has the third-biggest biotechnology industry in Asia-Pacific. India’s biotechnology industry is evolving rapidly and growing at a compound annual growth rate of 20%.

This rapid growth is attributed to a range of factors, including heightened demand for healthcare services, intensive R&D activities, and strong government initiatives. India is a huge market for biotechnology products and services due to its billion-plus population and increasing economic prosperity.

Under the Patent Act 1970, every invention must pass a two-step test in order to be patentable – namely, it must:

• not fall in any of the categories specifically excluded under Section 3 of the Patent Act; and
• pass the well-known three-pronged test of novelty, inventive step, and industrial applicability.

Criteria of Patentability to qualify as Invention:

Invention is a new product or process with a combination of an inventive step and capability of industrial application.  The basic requirements for any invention to be patentable are as follows:

• New invention: The term “New invention” has a very vast meaning stating any technology or any invention which has not been anticipated with publication in any documents and is not used in the country or elsewhere in the world. The most important factor involves that it should be before the filling of patent application stating the subject matter does not fall in public domain or forms any part of state of art.

The term “new invention” gives a flavor of the intention of the Legislature as it has not been used anywhere in the Act The section 2 (l) (l) specifies that the invention or the technology must not have been previously used or made in India. It specifies two categories stating a document/ practice and concludes that invention will not stay novel or new if it is anticipated in these two categories. Such invention should not fall in the ambit of Public domain and become a part of “state of the art”.

• New or Novel: “The fundamental principle of Patent law is to grant patent for only new and useful invention. It must have novelty and utility. It is a very valid essential for a patent to be inventor’s own discovery and is opposed to the verification of what was already discovered before the date of patent.  It pragmatically depends on the circumstance of the case to declare whether an invention includes novelty or an inventive step. But there is no specific uniformly applicable rule or circumstance to describe the indication of an invention.  The prior knowledge of the alleged invention would directly disqualify the invention from getting patent. It could be by the publication via books or other media or by word of mouth.

The question arises whether a patented “manner of manufacturing” was used, practiced or publically known in the country before or at the date of patent? If the answer to the question is in affirmation then the manner of invention would be called as negative invention or “subject matter”. A new manufacture means a new method of manufacturing to produce something new along with new article of manufacturing. In short, it highlights a new application of principle in producing a new method or new manufacture The new application of principle is not enough but the involvement of novelty is must in the mode of application.The novelty or the invention should be clearly and briefly mentioned in the claim. If the inventor uses the invention secretly till the time it becomes successful, the novelty will be lost and it will not be considered as new invention if applied for patent at most advantageous moment.

Inventive step:  An inventive step means involvement of any technical advances in comparison to existing knowledge and economic significance,  that may not be obvious to a person skilled in art. The requirement of technical advancement factor is compromised when the patent can be simply granted by the involvement of only economic significance. By the amendment of 2005 , Inventive step has been defined as a feature of invention involving technical advances in comparison to the economic significance and existing knowledge ; not making it obvious to a person skilled in art. It should not be perceptible to any unimaginative person skilled in art or something not published in prior art. Other opinion of court also says that Slight changes or improvement can form very significant results and may lead to great ingenuity.

• Industrial Application Capability: It means that the invention is made capable to be used in an industry. Even if the invention is incomplete, some work can get patent when it has a commercial values or viabilities. The important factor is to focus on physical substance created having potential of commercial manifestation.

Exclusion in Biotechnology related inventions

Section 3(b) – inventions contrary to public morality

Inventions for which the primary or intended use or commercial exploitation is contrary to public order or morality or which cause serious prejudice to human, animal or plant life or health or to the environment are unpatentable.

Examples include genetic modification of animals which results in suffering of the modified animal without any substantial medical or other benefit, and inventions causing adverse environmental impact.

Section 3(c) – discoveries, things isolated from nature, plants and animals

Discoveries of living things or non-living substances occurring in nature are not patentable subject matter. Thus, micro-organisms isolated from nature and DNA, RNA or proteins isolated from living organisms are unpatentable.

Plants and animals or their parts including seeds, varieties and species are unpatentable. Further, essentially biological processes for the production of plants or animals (eg, conventional methods of plant breeding and tissue culture techniques) are also unpatentable.

Section 3(e) – mere admixture

The mere admixture of two or more previously known substances is unpatentable, unless it is shown that the combinative effect of such substances is more than the sum of their individual effects. In other words, such a combination should result in a synergistic effect. The synergism must be properly demonstrated in the complete specification by providing appropriate experimental data.

Section 3(i) – methods of treatment and diagnosis  

The act does not prevent patenting of pharmaceuticals and medical devices. Thus, medicinal compounds, drugs, formulations, stents, surgical sutures and staplers are patentable. However, Section 3(i) precludes from patentability:

• any process for the medicinal, surgical, curative, prophylactic, diagnostic, therapeutic or other treatment of human beings; or
• any treatment of animals which renders them free of disease or increases their economic value (or that of their products).

Section 3(h) – agricultural or horticultural methods

Methods of agriculture or horticulture are unpatentable. Agriculture and horticulture are processes involving multiple steps, such as preparation of soil, sowing, applying manure and fertilisers, irrigation, protection from pests and weeds, harvesting and storage. The application claimed:

Section 3(p) – traditional knowledge

An invention which is essentially traditional knowledge or which is an aggregation or duplication of the known properties of a traditionally known component or components is specifically excluded from patentability.

Obligations for Patent Application

Under Section 10(4) of the Patent Act, an applicant must deposit the biological material mentioned in the specification if it is unavailable to the public and cannot be described adequately as per the provisions of the act. The material must be deposited with an international depository authority under the Budapest Treaty. The international depository authorities in India are the Microbial Type Culture Collection and Gene Bank, Chandigarh and the Microbial Culture Collection, Pune.

(A) the deposit of the material shall be made not later than the date of filing the patent application in India and a reference thereof shall be made in the specification within the prescribed period;

(B) all the available characteristics of the material required for it to be correctly identified or indicated are included in the specification including the name, address of the depository institution and the date and number of the deposit of the material at the institution;

(C) access to the material is available in the depository institution only after the date of the application of patent in India or if a priority is claimed after the date of the priority;

 (D) disclose the source and geographical origin of the biological material in the specification, when used in an invention.

Biotech Patent Granting in India

India enjoys a large asset of R & D personnel and infrastructure facilities. To bridge the gap between the research outcome and its use for the benefit of the stakeholders, scientists and policymakers need information and facilities for protecting their research. As a step in this direction, Department of Biotechnology established a “Biotechnology Patent Facilitation Cell (BPFC)” in July 1999.

The cell provides a single window awareness-cum-facilitation mechanism to create awareness and understanding about Intellectual Property Rights among the scientists and researchers.

India enjoys a large asset of R & D personnel and infrastructure facilities. To bridge the gap between the research outcome and its use for the benefit of the stakeholders, scientists and policymakers need information and facilities for protecting their research. As a step in this direction, Department of Biotechnology established a “Biotechnology Patent Facilitation Cell (BPFC)” in July 1999.

The cell provides a single window awareness-cum-facilitation mechanism to create awareness and understanding about Intellectual Property Rights among the scientists and researchers.

Its objectives are:

• Creating awareness and understanding among the biologists and biotechnologists relating to patents and the challenges and opportunities in this area. Arranging workshops, seminars, conferences and so on at all levels.
• Introducing patent information as a vital input in the process of promotion of R & D programmes in biotechnology and biology.
• Providing patenting facilities to the Biologists and Biotechnologists in the country for filing Indian and foreign patent applications on a sustained basis
• Keeping a watch on development in the area of IPRs and bring important issues to the attention of policy makers, scientists, biotech industries etc.

The Ministry of Science and Technology has also issued the guidelines called “Instructions for Technology Transfer and Intellectual Property Rights” with a view to encourage intellectual property protection of inventions done by  scientists, research institutions and universities in projects which are funded by the Department of Science and Technology, Department of Biotechnology, Department of Scientific and Industrial Research and Department of Ocean Development.One of the interesting features of this guideline is that the owner institution(s) has been directed to set aside at least 25% of the revenue generated from IPR, to create a Patent Facilitating Fund. The fund shall be utilized by the owner for updating inventions, filing new patent applications and protecting the IP rights against infringement and for building competency in the area of IPR and related issues.

The 2019-20 interim budget saw an allocation of INR 5,321 crore to the Department of Science and Technology (of which, the Department of Biotechnology is a part). This allocation is INR 207 crore more than the allocation made in the 2018-19 Budget.

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Contributed by Shreya Marwah (A Member of the Legal Experts Team at Let’s Learn Law)