Bayh Dole-esque Guidelines Notified by Dept of Biotechnology

Infogram provided by DBT detailing out the Autonomous Institutes and PSUs, as well as various key statistics generated by DBT funded work
Some interesting information, as taken from the DBT Website

Earlier this month the Dept of Biotechnology notified the “DBT Intellectual Property Guidelines 2023 (PDF) which they say ‘provide for ownership, transfer/commercializing of IP arising from DBT funded research outcomes”. The notification says that the Guidelines shall be applicable to all DBT funded extra-mural and intra-mural research organisations. (It’s unclear where the mandate is coming from, as guidelines generally do not have the power of law behind them but are merely discretionary / advisory). It also provides 2 links where ‘details of publications and patents emanating from DBT-funded research may be reported’. (Please note – the official notification has ‘publications’ at the end, but this does not lead to any page. The URL without the ‘s’ at the end leads to a page which seems the official version).

It is certainly high time that policy around government funded research receives more attention and clarity. A few months ago, Prashant wrote a post titled: Over the Last Decade India has Spent Rs. 1,00,000 crores on Scientific Research with No Transparency: Time to Resuscitate the PUPFIP? And more recently, Lokesh covered the whole rise and fall of the earlier Public Funded Research and Development (Protection, Utilisation and Regulation of Intellectual Property) Bill, 2007 (PUPFIP) – that gives some good background context, including that there’s been nearly no development on this front for a decade. So, that anything at all is finally happening, is certainly noteworthy. However, the current set of Guidelines has only 6 pages of content. The thrust of the Guidelines appear to be coming from the 2022 Report on Commercializing Intellectual Property from Public Funded Research (Attached as Annexure A to the Guidelines) published by the DBT and authored by a 9 member committee chaired by Prof Raghavan Varadarajan, (IISc).

At a quick glance, one notable push by the guidelines is to allow “exclusive” licensing from public funded research, to private bodies. While it does mention that exclusive licensing arrangements for products for large scale public deployment “should” include a clause of affordability in Indian markets, it bears repeating that Guidelines generally have no legal mandate behind them. Provision 5.d also mentions ‘march-in’ rights and compulsory licensing but the language makes it unclear what is meant exactly:

5.d. The public-interest issues in exclusive licensing will be protected appropriately and all Indian patents are secured by the GoI through March-in Rights including the option of compulsory license under our patent law, if there will be any exigency arising for that technology/patent.

All Indian Patents are certainly not secured by the GoI through March-in Rights, and as we saw during Covid, there was little to no inclination to bring the topic up at all. Compulsory licensing too remains a paper tiger, and less said about it, the better. Anyhow, a more detailed examination of the guidelines and the Report will be coming up in the next weeks, and hopefully the rest of the Guidelines provide more positive notes than concerning ones.

As seems to be the pattern these days, there doesn’t seem to have been any public calls for stakeholder consultations. On a more positive note however, there is a clear process listed out in Annexure C, as to how the Guidelines came to light. And Annexure B lists the Committee for Reviewing DPIIT and Dept of Expenditure’s comments on DBT IP Guidelines. Both are reproduced below for convenience.

Annexure B of the Guidelines: Committee for reviewing Department for Promotion of Industry and Internal Trade (DPIIT) and Department of Expenditure (DoE) comments on DBT IP Guidelines

  1. Shri. Vishvajit Sahay, AS & FA, DBT (Chair)
  2. Dr. Alka Sharma, Scientist ‘H’/Senior Advisor, DBT
  3. Dr. Malathi Lakshmikumaran, IP Attorney, Executive Director and Practice Head,
    Lakshmikumaran & Sridharan Attorneys and Former Professor, TERI, New Delhi
  4. Dr. Taslimarif Saiyed, CEO and Director, C-CAMP, Bangalore
  5. Shri. Chaitanya Murti, Joint Secretary (Admin), DBT
  6. Dr. Sundeep Sarin, Scientist ‘G’, DBT
  7. Dr. Anamika Gambhir, Scientist ‘G’, DBT
  8. Dr. Nitin Kumar Jain, Scientist ‘F’, DBT
  9. Dr. Kalaivani Ganesan, Scientist ‘F’, DBT (Member Secretary)

Annexure C of the Guidelines – Series of meetings held for framing DBT IP Guidelines

1. Cabinet Secretary Meeting on “Patent practices and IPR
issues for AYUSH academia and industry” – Presentation by
Secretary, DBT
01st August, 2022
2. Letter sent to Secretary, DPIIT on the existing practice and
suitable reforms required
03rd August, 2022
3. Discussion meeting with PMO16th August, 2022
4. Discussion meeting with PSA23rd August, 2022
5. Inter-ministerial Brainstorming meeting on IP, licensing and
commercialization of public funded research
24th August, 2022
6. Meeting with International Experts29th August, 2022
7. Constitution of Working Group and meetings16th September, 2022;
03rd October, 2022 and
11th October, 2022
8. Report of Working Group27th October, 2022
9. DPIIT Observations01st February, 2023
10. Committee to review DPIIT and DoE comments7th March, 2023;
16th March, 2023;
19th April, 2023;
16th May, 2023;
03rd August, 2023
11. DBT IP guidelines approved by Hon’ble Minister17th Aug, 2023


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