New Delhi : The Department of Biotechnology (DBT) has come out with the Intellectual Property Guidelines, 2023 to enable seamless transfer of intellectual property (IP) at academic institutes and research laboratories towards commercialisation into technologies and products for larger societal impact.
The guidelines, developed based on the recommendations of an expert committee which delved into various aspects of IP development and technology transfer in government institutions and universities, is envisaged to address the issues related to the current technology transfer modalities.
“IP arising out of public-funded research is a huge asset and must be appropriately harnessed for maximising socio-economic impact and achieving public good. The means and modes of IP transfer should be decided by the scientists based on their Institutional committees with external expert members,” said the guideline issued by the DBT.
A suitable committee comprising external experts, including from the scientific, legal, finance and other relevant fields may advise the director/head of institute. The committee may review IP filing, granted status, as well their transfer or licensing. IP piling up for long periods without transfer or licensing should be avoided, it said.
Under the principles on IP commercialisation modality in the guideline, DBT says that the mechanism of licensing is to be decided on a case-to-case basis by the host institute through the institutional IP committees and informed to the government.
“Transparent mechanisms should be built-in by the institutes to ensure that IP is transferred to the right industry with potential capability and competence to scale-up the innovation especially for exclusive licensing,” it said.
Following licensing, the host institution should report details to DBT. In exclusive licensing, for products/technologies that are intended for large scale public deployment, agreements should include a clause of affordability in Indian markets.
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.
IP Assignment requests, if any, need to be referred to DBT by the host institutions and will be taken up separately on a case to case basis with approval of Secretary, DBT to encourage spin-outs and start-ups formation.
The guideline states that for research leads in higher Technology Readiness Levels (TRLS), non-exclusive licensing may be the preferred modality with licensing fees decided on a case to case basis. Competition should be encouraged so as to bring out high-quality, affordable products in the market. Timelines on commercialisation should be clearly defined in licensing agreements. There should also be preference for biotech SMEs and for manufacturing in India.
For the exclusive licensing route, research leads in lower TRLs may be considered and public interest should be protected with clauses on availability of the final product in Indian markets at affordable rates, especially for products with potential for mass deployment, said the document.
Timelines on commercialization should be clearly defined in licensing agreements. There should also be preference to Biotech SMEs and manufacturing in India. Besides, preferred purchase arrangements should be arranged for start-ups for products developed under government funded programmes.
A standard licensing agreement framework may be developed by the public institution that would ensure a share of the revenue earned by the licensee to be given to the partnering public institutions for a limited timeframe.
The license shall be subject to the irrevocable, royalty-free right of the Government of India to practice or to require the licensee to grant sublicenses to responsible applicants, on reasonable terms, when necessary to fulfill health or safety or security needs of the country.
For IP from academic/public funded research labs to be realized as a product and be deployed for the public good, focused up-scaling and other development is needed and this requires significant investments.
The technologies developed at academia are generally not market-ready and up-scaling with persistent efforts is required to realize their value and potential.
The capacity and ecosystem to convert promising research leads into technology and products for the masses lies in the industrial/start-up ecosystem. Hence transfer of research outcomes from publicly-funded research labs to SMEs/start-ups is important, added the guideline document.
However, at present, as per DBT grant MoA, the IPs developed with DBT grant support can be transferred to industry only on a non-exclusive basis. This means that the government can also provide the same IP to another interested industry.
“This has become a deterrent to technology and product development, as industries are not willing to invest significant time and finances into furthering technologies which may also be taken up by others,” it said.
The same issue arises where IP has been jointly developed by publicly funded academic institutes/research laboratories along with Industry, as this requires substantial commitment of time and finances by Industry. Similar issues arise for IP that arises from research that is jointly funded by multiple agencies both national and international.
The department held discussion meetings with the Prime Minister’s Office, Principal Scientific Advisor and organized inter-ministerial brainstorming meetings regarding this. DBT constituted a committee under the chairmanship of additional secretary & financial advisor, to suitably draft the policy and implementation modalities of the working group recommendations.
The principles are applicable for commercialisation of both IP obtained through DBT intra-mural funding and owned by the DBT institutions and IP obtained through extra-mural competitive grant funding to DBT and other public/private institutions that are owned by the institutions. In case more than two public/private institutions are partnering in the research programme, they may enter into IP sharing agreement mutually amongst them, it said.
Identifying the significance of the Government to know the outcomes of its public-funded research for enhanced participation in public research and also to leverage evidence for future policy initiatives and suitable reforms, the guideline advices that all investigators and host institutions to undertake in grant MoA for reporting the research outcomes from their DBT-funded research.
Both publications and IP granted (if commercialized, the mechanism of tech transfer) should be mandatorily reported to DBT. All investigators and host institutions undertake to grant MoA for acknowledging the support of DBT in their publications and products.