Analysing the Department of Biotechnology (DBT) Intellectual Property Guidelines 2023

With increasing awareness of securing intellectual property rights and deriving value from them, the commercialisation of patents is an important aspect. There have been discussions to link academia and industry to liaise the research expertise of academia and the product development expertise of the industry to boost the commercialisation of patents.

The Department of Biotechnology (DBT) recognises the importance of the commercialisation of IP and acknowledges that for IP from academic/public-funded research labs to be realised as a product and be deployed for the public good, focused up-scaling and other development is needed, and this requires significant investments. It was further mentioned that the technologies developed in academia are generally not market-ready, and up-scaling with persistent efforts is necessary in order to realise their value and potential.

It was identified that the capacity and ecosystem to convert promising research leads into technology and products for the masses lies in the industrial/Start-up ecosystem. Hence, transferring research outcomes from publicly funded research labs to SMEs/startups is essential and should be followed for the greater public good.

Hence, DBT issued guidelines on September 06, 2023, outlining the principles and procedures for managing and transferring intellectual property (IP) generated through publicly funded research in India. The guidelines emphasise the importance of disseminating research knowledge for the public good and aim to facilitate the seamless transfer of IP from academic institutions and research laboratories to commercialisation for broader societal impact.

DBT held discussion meetings with the PMO, PSA, and organised inter-ministerial brainstorming meetings, details of which have been provided in Annexure C (page 55) of the guidelines. Many deliberations were held with scientists, IP experts, academicians, policymakers, and Government officials, and it has been recommended that grant Memoranda of Agreement (MoA) be amended to provide options for all forms of licensing (nonexclusive and exclusive). The main deterrent to the successful dissemination of IP from academic institutions and research laboratories to commercialisation for broader societal impact was the “non-exclusive licensing clause” in the previous grant MoA guidelines.

With the amended grant MoA, the licensing mechanism will be decided on a case-to-case basis by the inventor and the host institute through the institutional IP committees and informed to the Government. DBT thereafter constituted a Working Group (WG) to draft a Report and recommendations (the working members of which are listed on page 43 of the document). The recommendations were shared with DPIIT, and their recommendations were obtained. DBT committee, under the Chairmanship of Additional Secretary & Financial Advisor, was constituted to suitably draft the Policy and implementation modalities of the WG recommendations.

The drafted guidelines clarify that IP generated through DBT intra-mural funding may be owned by DBT institutions and commercialised according to the outlined principles as discussed below. IP ownership lies with the institutions for extra-mural competitive grant funding, and IP-sharing agreements may be made among collaborating institutions.

The following are required to be followed by the IP-generating institutions funded by DBT :

1) The guidelines require that means and modes of IP transfer should be decided by the scientists based on their Institutional committees with external expert members. A suitable committee comprising external experts from the scientific, legal, finance and other relevant fields may advise the Director/Head of the institute. The committee may review IP filing, granted status, as well as their transfer or licensing. IP piling up for long periods without transfer or licensing should be avoided. Therefore, all DBT-funded institutes should have an institutional IP committee comprising competent professionals from various relevant sectors.
1) The investigators and host institutions must report the research outcomes, i.e., publications and IP granted (if commercialised, the mechanism of tech transfer). Links on which such reports can be done are https://dashboard.dbtindia.gov.in/sbt/patents and https://dashboard.dbtindia.gov.in/sbt/publication
3) The investigators and host institutions must acknowledge the support of DBT in their publications and products.
4) The investigators and host institutions are required to follow the broad principles for IP commercialisation modality as provided in paragraph 05 of the guidelines:

Licensing Mechanism: Licensing mechanisms are to be determined case-by-case through institutional IP committees with transparency to ensure the right industry partners are selected, especially for exclusive licensing.

Reporting to DBT: Host institutions should report details of licensing agreements to DBT.

Affordability Clause: In exclusive licensing agreements for products intended for large-scale public deployment, the licensor should include clauses for affordability in Indian markets.

Public Interest Protection:
The IP generators/ licensors are required to include an appropriate clause in the exclusive licensing agreement clearly capturing the fact that if there will be any exigency arising for a technology/patent, then the Government of India (GoI) through March-in Rights will exercise its right including the option of compulsory license under our patent law as the GoI secures all Indian patents. This is to protect the public interest appropriately.

IP Assignment Requests: Host institutions must refer any request for IP assignment to DBT, encouraging the formation of spinouts and startups.

4) For research in higher Technology Readiness Levels (TRLs), non-exclusive licensing is preferred, with licensing fees determined case-by-case, encouraging competition, defining timelines, and giving preference to Biotech SMEs and Indian manufacturing.

5) For research in lower TRLs, exclusive licensing may be considered. Still, it must protect the public interest, ensure the availability of the product in Indian markets at affordable rates, define timelines, give preference to Biotech SMEs and Indian manufacturing, and allow preferred purchase arrangements for start-ups. A standard licensing agreement framework may be developed to ensure revenue-sharing with public institutions.

6) The license is subject to the irrevocable, royalty-free right of the Government of India to practice or require sublicense, on reasonable terms, when necessary to fulfil health, safety, or security needs.

These guidelines aim to streamline the transfer of IP from publicly funded research to the commercial sector, promoting innovation, economic growth, and public welfare. The emphasis is on flexible approaches to licensing, transparency, and safeguarding public interests in IP commercialisation.