The 'ultimate objective' of patenting public funding should be to ensure access to the public funded inventions for public good. But, currently in India, we do not have provisions to effectuate the actual social benefits from public funded research by ensuring access to the public. Thus, the policy makers should have brought forward a set of model guidelines that could have addressed all these concerns existing around Intellectual Property Protection and Commercialisation. This is not to suggest that the issue of commercialisation of institutional IP is not pertinent. However, this model for Intellectual Property Protection and Commercialisation is not a fit policy taking into account the current needs of our public funded research system. What is required is the appreciation of underlying structural problems in our public funded research system and then taking policy cues from other developed countries and fine tuning them to our needs.
An IP Policy should relate to, support and operationalize the Institution's mission. Institutions have a range of differing missions ranging from education, research, revenue generation and societal engagement. IP commercialization and transfer of knowledge forms only a part of such missions and not their entire objective. Thus any model guidelines aiming to increase licensing of inventions must identify the problems that are preventing the institutions from entering into licensing agreements with the industries for commercialisation.
Here the model guidelines have not made any such attempt. One may attribute the absence of such provisions as already stated to the difficulties associated with determining beforehand the nature of licensing or commercial activities required for each invention. Licensing approaches can vary considerably from case to case. Several factors like the capacity of the institution, nature of the invention, licensee and industry affects the licensing practices. However, in spite of these differences, institutions can maintain certain core principles in all licensing activities which the guidelines could have identified.
For example, there have been several policy initiatives in the US to ensure access to pharmaceutical inventions. The NIH had issued a notice to the public funded institutions to pursue only non-exclusive licences to genomic inventions and to use exclusive licenses only when necessary "with the goal of promoting federally funded inventions' utilization, commercialization, and public availability." Further, the Association of American Medical Colleges issued a document titled "Nine Points to Consider in Licensing University Technologies", which recognises that the Universities have a "social compact with the society" and they have to share their inventions with "the world's poor". It urged institutions to ensure that the public has access to the pharmaceutical products at low costs or at no costs, if necessary. Additionally both these agencies along with the Centres for Disease Control and Prevention and other institutions also issued the Statement of Principles and Strategies for the Equitable Dissemination of Medical Technologies.
This policy stated that the universities had a pivotal role in improving the health of the public and urged them to include strategies for making such products available to the public especially in the developing countries by nut pursuing patent rights, or abandoning patents and by providing early publication for the wider dissemination of results.
The Indian institutions or policy makers could also take a cue from such initiatives. The model guidelines could have contained provisions that cautioned universities the factors to be considered while negotiating license, like to issue non-exclusive licenses, where greater commercial incentives seem necessary or ask the universities to weigh the benefits of nonexclusive licensing against the social cost of exclusive licenses or reserve the right of universities to use inventions for further research even if they are licensed or provisions or include strategies for fixing license fees etc.
The Guidelines should also have provisions to ensure follow up the status of licensed public funded inventions. The public funded institutions must regularly keep track of the inventions licensed by them. They have the responsibility to ensure that whether the licensing terms of the invention has been adhered to, whether adequate quantities of the product are being manufactured and whether the public has access to it at reasonable prices. If not, the universities must intervene and abandon the patent or give license to some other industry or fix the prices. The government must stress on these provisions either through the guidelines or they must make use of the compulsory licensing provisions in the Patent Act.
Further, there must be some provisions to ensure that universities do not deviate from basic research. The guidelines could have included some provisions for the identification and separation of basic research inventions from applied research inventions. Furthermore, developing countries like ours have a specific public need for access to medicines and other social inventions. University research also often forms the knowledge base for an industry to carry forward further research. Hence it is imperative to ensure that such inventions are not locked in via IP or exclusive rights. The guidelines do not have any provisions that take into consideration the specific needs of India apart from the clause in the revised bill which ensures access to plant varieties.
CONCLUSION
It is an established fact that developing countries are more affected by several life threatening diseases. Hundreds and thousands of people die every year from diseases that could have been treated, but they have no access towards such treatments. The findings in the above sections indicate that a substantial chunk of innovation in such fields are taking place in public funded institutions. Thus, significant changes to government and university policies may be needed to promote access to drugs created using public funds. The institutions must adopt socially responsible patenting and licensing strategies by exerting proprietary rights only to the extent necessary for commercialization. Since it is the public that pays for the development for such products in the first place, they have substantial rights both legally and morally to get them at prices convenient for them.
REFERENCES
- National IPR Policy, 2016
- Nine Points to Consider in Licensing University Technology (Autumn Net) Best Practices for the Licensing of Genomic Inventions: Final Notice, available at: https://www.federalregister.gov/documents/2004/11/19/0425671/bestpractices-for-the-licensing-of- genomic-inventions (last accessed on November30, 2022).
- Naval Satarawala Chopra and Dinoo Muthappa, "The Curious Case of Compulsory Licensing in India", 8 Competition Law International 34 (2012).
- Press Release of Nationwide Children's Hospital, October 18, 2013 Lisa Larrimore Ouellette, "How Many Patents does it take to make a Drug-FollowOn Pharmaceutical Patents and University Licensing.
- Paris convention for the protection of industrial property 1883
- Indian patent act, 1970
- The U.S Patent act (35 USC)
- Naval Satarawala Chopra and Dinoo Muthappa, "The Curious Case of Compulsory Licensing in India", 8 Competition Law International 34 (2012).
- Best Practices for the Licensing of Genomic Inventions: Final Notice, available at: https://www.federalregister.gov/documents/2004/11/19/04-25671/best-practices-for-the-licensing-of- genomic-inventions (last accessed on November 12, 2023).
- 17 "Nine Points to Consider in Licensing University Technology", available at: http://www.autm.net/NinePoints 17 "Nine Points to Consider in Licensing University Technology", available at: http://www.autm.net/NinePoints toConsider.html (last visited on November 12, 2023).
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