An intellectual property generated through publicly funded research and commercially exploited is the cornerstone of innovation-driven economies. The Bayh-Dole Act of 1980 is one of the most effective and widely debated legislations in the world. This U.S. legislation allows universities, small businesses, and non-profits to own and patent inventions resulting from federally funded research. Basically, the Act was targeting the facilitation of innovation by allowing such bodies to license their inventions with the private sector in pursuit of commercialization. Indeed, the Act has contributed enormously to research commercialization that led to the formation of start-ups as well as industrialization in the U.S.
Contrastingly, India has handled intellectual property from publicly funded research very disintegrated. Despite serious attempts through the Public Funded IP Bill of 2008, the Indian government till date hasn't enacted any legislation identical to that of the Bayh-Dole Act. This article would discuss the limitations and challenges the Indian Public Funded IP Bill brings and juxtapose it with the U.S. Bayh-Dole Act to highlight the necessary adjustments India must consider in order to achieve effective IP commercialization.
The Public Funded IP Bill 2008: Missed Opportunities
The Indian Public Funded IP Bill, 2008, followed the structure of the U.S. Bayh-Dole Act pretty closely. Though the Indian act has the same structure as the Bayh-Dole Act of the U.S., the Indian legislation was harshly criticized and could not even pass. The U.S. While Bayh-Dole Act had explicit provisions for public access to innovations and for making benefits available on reasonable terms, the Indian bill had no such equivalent provisions. The result was that its absence raised serious questions as to whether the bill would achieve the intended objectives of fostering innovation and ensuring public access to research outputs.
An important distinction between U.S. Bayh-Dole Act and the Indian Public Funded IP Bill differ on counts of "march-in rights" not being there in the latter. In the United States, march-in rights confer the ability of the government to take steps if an invention resulting from public funding is not being made available to the public on reasonable terms. This would essentially act as a check, in ensuring that the commercial interests of the patent holder do not override public access. It was the Indian bill, on the contrary, that did not provide any such protection raised the doubt of publicly funded innovations being restricted only to the monolization advantage without setting up any mechanism that can be allowed for use towards public benefit.
The Indian bill had nothing concrete on the way the commercialization of the IP from the research institution would be carried out. The licensing and technology transfer strategy had not been defined, which brought some questions on the efficacy of the bill in basically stimulating the commercial market of public research outputs. In this way, without clear terms or guidelines on either licensing or technology transfer, the bill would face a challenge in advancing its own objective of bridging the gap between research and commercialization.
The Response: Recommendation by Parliamentary Standing Committee
On hearing the criticism, a Parliamentary Standing Committee was formed on the issue. Its recommendations led to the success of an amended version of the bill that incorporated several key provisions with a view toward bringing in public benefit. The new bill was remarkable since amendments were made to it. They allowed the government or any other designated person to manufacture and distribute the publicly funded inventions when the primary creators were unable to do so. Additionally, the government was allowed to issue non-exclusive licenses for third parties and ensure the use of the publicly funded inventions even when no commercial value would be derived from the innovations by the primary researchers or the patent holder.
These amendments were a significant step indeed because they provided the mechanism for the benefits of publicly funded research to accrue automatically to the public. However, after making these amendments, this proposed bill was again shunted into cold storage and never became a law. Consequently, India today remains without a full framework to administer the commercialization of its owned intellectual property akin to what is afforded under the Bayh-Dole Act of the U.S.
National IPR Policy 2016: New Strategy
Even though the Public Funded IP Bill was not enacted, India has, on other occasions, sought to encourage the commercialization of intellectual property out of the research institutions. The most significant such development in this respect is the National Intellectual Property Rights Policy that took effect in 2016. The policy has had several key objectives, of which two are specific to encouraging the creation of IP from research institutions and universities and promoting its commercialization.
Under the National IPR Policy, Cell for IPR Promotion and Management was created as a professionally administered body under the Department for Promotion of Industry and Internal Trade. The role of CIPAM would be to implement the objectives of the IPR policy more particularly in respect of facilitating the commercialization of intellectual property from research institutions. One of the big objectives of CIPAM is to form an interface which facilitates connecting creators and innovators with users, buyers, and funding agencies. The same interface is supposed to facilitate license and transfer of technology developed out of public research so that such innovation can be translated into marketable products and services.
Model Guidelines for Academic Institutions: A Step Forward
To make further easy the commercialization of intellectual property emanating from research institutions, CIPAM had published the Draft Model Guidelines on the Implementation of IPR Policy for Academic Institutions in the year 2019. The guidelines, the first of their kinds in India, have been formulated responding to the objectives set within the ambit of National IPR Policy. The guidelines must guide the process of managing, protecting, and commercializing intellectual property generated in the course of doing research activities by the academic institutions.
The Model Guidelines is a major step forward in that it brings much-needed clarity on how research institutions manage intellectual property. Of the IP management aspects, including patent filing, licensing, and technology transfer, the guidelines outline recommendations for each of these aspects. In addition, they provide guidelines on how institutions can better engage with industry partners and funding agencies with regard to the commercialization of research outputs.
Although the Model Guidelines are a step in the right direction, they are not legally binding and adoption is at present voluntary. India currently still does not possess an integrated system for commercializing publicly funded research without having any legislative framework similar to that of the U.S. Bayh-Dole Act. Its success or failure will very largely depend upon the willingness of academic institutions and industry partners to adopt and implement them.
Conclusion: The Way Ahead for India
India has made significant strides in recent years toward helping push the commercialization of intellectual property generated from publicly funded research. Still, in the absence of a similar statutory framework to that of the U.S. Bayh-Dole Act, the country still faces huge hurdles in translating such research into public benefits. The failure of the Public Funded IP Bill of 2008 from becoming a law has pointed out the kind of hardships India has met in trying to balance the interest of the researcher, the government, and the public in the commercialization of intellectual property.
The National IPR Policy along with efforts by CIPAM in promoting technology transfer and commercialization, is one of the most positive steps. However, they need stronger legal frameworks that ensure that public-funded research must reap some kind of benefits to society. Going forward, India needs to come back to the Public Funded IP Bill with what it learns from the U.S. Bayh-Dole Act and create a better system for managing intellectual property and fostering innovation.
The right combination of legislative and policy framework will unlock the entire potential of research institutions in India by ensuring that benefits from publicly funded research for the public is derived in stimulating innovation and consequently economic growth.
REFERENCES
12. United States Code, Title 35, $204
13. Peter S. Arno and Michael H. Davis, "Why Don't We Enforce Existing Drug Price Controls – The Unrecognized and Unenforced Reasonable Pricing Requirements Imposed upon Patents Deriving in Whole or in Part from Federally Funded Research", 75(3) Tulane Law Review 631 (2000).
14. Objective 5, National IPR policy, 2016, available at: https://dpiit.gov.in/policies-rules-and-acts/policies/national-ipr-policy (last visited on November 12, 2023).
16. Indian Patent Act, 1970, s.92
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