Patents for biotechnology inventions are granted in India after complying with the patent eligibility criteria of novelty, inventive step and industrial application. Biotechnology industry in India is currently burgeoning as the statistics speak for themselves. Ranked in the top 12 destinations for biotechnology worldwide, India also prides itself on being number 3 in Asia Pacific.1 It is estimated that the biotech industry in India will be worth USD 100 billion by 2025.2
As the biotechnology industry is heavily dependent on a vast amount of research and development activities, it is crucial for biotech companies to understand the legal protections available to protect the innovations by way of patent rights. This article presents a brief overview of the current regime of rights available for safeguarding the biotech sector.
Before we delve deep into the legal framework, it would be helpful to understand what exactly does biotechnology comprise of. The World Health Organization defines biotechnology to mean “biological processes that have been engineered”3. One can say without a doubt that biotechnology is the building block of the healthcare and pharmaceutical sciences. It is also important to note that there are three broad sectors of biotechnology4:
Healthcare Biotechnology – also known as red biotechnology and refers to the technology employed for drug discovery etc.
Agricultural Biotechnology – also known as green biotechnology and refers to the technology employed for enhancing plants to make them more resilient to environmental conditions etc. or achieve better yields.
Industrial Biotechnology – also known as white technology. This sector involves bioprocessing (i.e. application of biotech based tools to traditional methods) and manufacturing bio-based products such as bio-fuels and bio-plastics. The main aim of industrial biotechnology is to discover products and process which are more environment friendly.
The key segments of the biotech industry comprise of bio pharma, bio agriculture, bio services, bio industrial and bio-informatics.5
Market share: As per the data published by the National Investment Promotion and Facilitation Agency, the biopharmaceutical sector accounts for the largest share of the biotech industry with a share of 64% of total revenues, followed by bio-services with 18% market share. India is becoming a leading destination for clinical trials, contract research, and manufacturing activities, which is further fuelling the growth of the bio-services sector. Bio-agri segments accounted for 14% of the biotech industry in 2015-16, while the remaining market is catered by bio-industrial (3%) and bio-informatics (1%).6
The most common form of protection popular in the sector is through patents. The table below sets out an overview of the other forms of IP protection which are available7:
Type of IP Protection | Type of innovation |
Patents | · isolated polynucleic acids, peptides and polypeptides, enzymes, microorganisms, viruses, vectors, antibodies, probes, vaccines, compositions, expression systems, cell lines, plants, seeds, transgenic organisms, methods for preparation or use of the above; · medical devices |
Trademarks | · Words/name, computer icons, graphical designs, multimedia elements or use of the above; · medical devices |
Registered designs | Medical devices, biochemical, biophysical or bio-electrochemical apparatus |
Trade secrets / know-how | Laboratory notebooks, design workbooks, customer information, documented internal processes, “data exclusivity” on clinical data generated for therapeutic approval |
Plant breeders’ or plant variety rights | Plant varieties, propagating and harvesting material from plant varieties |
Domain names | Web addresses |
Protection by way of patents is governed by the Indian Patent Act, 1970 (Act). The key criteria for an invention to qualify for patent protection are :
Section 3 of the Act provides several exclusions to what is patentable. In case of biotech patents, the following inventions are excluded from patent protection:8
Legal Issues in Biotech Patents
One of the most controversial features the patents laws is the exclusion of an invention on the grounds of ‘mere discovery of new forms or uses of known substances’ which do not demonstrate enhanced efficacy.9 While the purpose of the law is to prevent evergreening of patents, a lot of applications filed for biotech patents are dismissed on this ground alone without the recordal of detailed explanation of the grounds of rejection. This has been despite several rulings from the IPAB which state that any objection should be specific and definite.10
Scholars have noted that the absence of a clear distinction between what is a patentable invention and what is an un-patentable discovery gives rise to great confusion.11 The Manual of Patent Office Practice and Procedure which intends to serve as a practical guide for patent prosecutions in India also lacks guidance on what kind of inventions pass the muster of Section 3(d). Additionally, the requirement of satisfying the presence of an inventive step and novelty also means that the invention has to take a “substantial intellectual leap” to be considered worthy of patent protection.12 So the correct interpretation of Section 3 (d) continues to remain a gray area.
A landmark SC judgment on the interpretation of Section 3(d) was the Novartis case where Novartis was denied a patent over its anti-cancer drug Glivec on the grounds that the drug did not demonstrate ‘therapeutic efficacy’. The judgement did not lay down any guidelines to determine what would qualify to be efficacious leaving the fate of similar patent applications in lurch.13
The latest report available on the website of the Office of the Controller General of Patents, Designs and Trademarks pertains to 2016-17.14 As of March 31, 2017, 876 patent applications in relation to biotechnology were filed out of which 333 patents were granted.
To promote research and development in the field of biotechnology, the government of India set up a dedicated Department of Biotechnology within the Ministry of Science and Technology. The DBT has established a “Biotechnology Patent Facilitation Cell (BPFC)” which is a single window awareness-cum-facilitation mechanism aiming at creating awareness and understanding about IPRs (especially patents) among the scientists and researchers15.
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.16 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.17 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.18
Our team of advanced patent attorneys assists clients with patent searches, drafting patent applications, and patent (intellectual property) agreements, including licensing and non-disclosure agreements.
Advocate Rahul Dev is a Patent Attorney & International Business Lawyer practicing Technology, Intellectual Property & Corporate Laws. He is reachable at rd (at) patentbusinesslawyer (dot) com & @rdpatentlawyer on Twitter.
Quoted in and contributed to 50+ national & international publications (Bloomberg, FirstPost, SwissInfo, Outlook Money, Yahoo News, Times of India, Economic Times, Business Standard, Quartz, Global Legal Post, International Bar Association, LawAsia, BioSpectrum Asia, Digital News Asia, e27, Leaders Speak, Entrepreneur India, VCCircle, AutoTech).
Regularly invited to speak at international & national platforms (conferences, TV channels, seminars, corporate trainings, government workshops) on technology, patents, business strategy, legal developments, leadership & management.
Working closely with patent attorneys along with international law firms with significant experience with lawyers in Asia Pacific providing services to clients in US and Europe. Flagship services include international patent and trademark filings, patent services in India and global patent consulting services.
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