The patent process in India for biotechnology and biosciences inventions follows the guidelines of the Indian Patent Act, 1970 (herein referred as “Act”). Applicants file patent applications with the Indian Patent Office, which examines them for novelty, inventive step, industrial applicability, subject-matter eligibility and other requirements of the Act. Upon successful examination, a patent is granted for 20 years from the filing date.

Biotechnology inventions in India must meet the universal criteria like novelty, inventive step, and industrial applicability. In addition to this, the subject-matter (product/process) of the patent applications should not fall under the exclusions under Section 3 of the Act [this is one of the key challenges in biotechnology/biosciences inventions wherein certain types of products/processes are not patent eligible in India, and requires a careful evaluation before applying for a patent]. Also, they must comply with provisions with regard to Biological Diversity Act (BDA), 2002 and biological material depositions under the Budapest Treaty, if applicable.

India permits patenting of genetically modified microbes. GMOs which are plants or animals are not patent eligible in India as per Section 3(j) of the Act. However, the underlying genetic elements such as transgene/gene constructs, vectors, prokaryotic host cells etc. are patent eligible subject to fulfilling other patentability criteria as discussed above.

Yes, biotechnology inventions typically face additional challenges/complexities apart from the requirement of meeting the primary patentability criteria – novelty, inventive step, industrial applicability. Those challenges include overcoming the patentable subject-matter exclusions under Section 3 of the Act, complying with biological sequence disclosures, biological material depositions, Biological Diversity Act (BDA), 2002 etc. Strategic drafting, prosecution and compliance can overcome these challenges effectively.

Strategies such as comprehensive prior art searches to analyse the patentable merits of the invention and developing subsequent strategies to strengthen the invention (if needed); drafting detailed specifications covering different alternatives/possibilities of the invention along with meticulous drafting of claims for better protection/coverage; supporting the specification/claims with reasonable experimental data etc. are some of the approaches which can enhance patent grant in India.

As a signatory to TRIPS, India maintains a patent regime aligned with international standards. In fact, some of the legistations under Indian patent regime are inspired from well-known/patent savvy jurisdictions such as Europe. Patent Offices and the judiciary oversee compliance

Data from WIPO shows a steady annual growth rate of approximately 15% in biotechnology patent filings in India over the past decade, indicating significant growth and innovation in the sector. Post adopting measures such as regular amendments to the Patents Act/Rules benefitting patent applicants, ramping up the Patent Office work force, introducing Start-up India initiative etc. by Government of India, there has been a sharp rise in patent filings in Bio sector. Particularly, initiatives such as reduced official/patent office fees, expedited examination process, reduction in overall patenting timelines due to proactive measures adopted by IPO and the overall improvement in the IP ecosystem have encouraged both Indian and Foreign Entities to protect and enforce their IP in India.

Patents in diverse biotechnology areas have been successfully granted in India which include those for innovative products/processes in the domain of therapeutic protein/antibody/biologics, protein/antibody libraries, gene editing tools (e.g., CRISPR-Cas systems), recombinant microbes, fermentation technology, agritech (eg. biofertilizers), bioscaffolds/tissue engineering, RNAi/siRNA technology, veterinary, nutraceuticals, biopolymers etc.

. Patents in these diverse Bioscience technology areas highlight the diversity and innovation in India’s biotechnology sector.