This paper thus seeks to establish the relationship between public funding, financing of R and innovation and IP rights in today’s world economy. This is, therefore, a good way through which publicly funded research, especially in developing nations such as India, can go a long way in solving some of the world’s problems such as lack of access to medicines and other technologies. Although, there is still controversy on the framework that regulates the commercialization and the availability of such innovations.

The principle law in the United States governing the ownership and utilization of inventions developed with the use of federally funded research is the Bayh-Dole Act of 1980. This legislation has been useful in ensuring that the fruits of research carried out in universities and other institutions gets to the people, since this has been sponsored by their taxes. On following this model India put in motion the Public Funded Intellectual Property (IP) Bill in 2008 similar to the Bayh-Dole Act. Nevertheless, the Indian Bill received much scrutiny and was never passed into law, mainly on account of the doubts raised about its capacity to serve the public interest.

The present paper aims to discuss the Indian scenario of the problems and existing deficiencies in managing the IP emerged from the publicly funded research projects. To this regard, it analyses the Public Funded IP Bill of 2008, the contours of the Bayh-Dole Act, and the subsequent developments in the Indian policy framework for IP generation, including the draft Model Guidelines on Implementation of IPR Policy for Academic Institutions promulgated in 2019. From this perspective, the paper recommends that it is high time India adjusted its IP polices to capture the needs of its public research system and make available to the public the gains of its funded research innovations.

INDIAN SCENARIO

Coming to the Indian scenario, we do not have a Bayh-Dole like legislation in India. However, a Public Funded IP Bill was introduced in 2008; however it was not passed into law owing to the large criticisms it received since its introduction. The Indian Public Funded IP Bill had almost similar provisions with that of the US Bayh Dole Act. Even though the Indian Bill resembled the Bayh Dole in its basic structure, a comparative readthrough of the provisions of both instruments reveals some thought-provoking and even appalling deviations. For example, as stated above, the US Act contains various provisions designed to regulate the licensing inventions and to step in if benefits are not made available to the public on reasonable terms. However, the Indian Bill contained no such terms and conditions. Unlike its US counterpart, there were no requirements in the bill as to how the commercialization of research results is to be undertaken. There were no provisions to address the issues of how access and benefit to the public will be ensured. There were also no provisions for intrinsic march in-rights in the bill, which raises the question as to whether the bill will in fact achieve the sought objective of making the research results available to the public. The lawmakers did an important oversight in this process of drafting the bill. The Bayh-Dole Act contained, however, in a more effective way, provisions through which benefits to the public may be envisaged.

A Parliamentary Standing Committee was constituted to submit a report based on the concerns of the stakeholders. The committee submitted a report which included the amended version of the bill. The bill was amended to include some provisions to ensure that the protected IP will reach the public. First, the bill added that the Government and any authorized person authorized can manufacture or make available the public funded invention. The Government also has the power to issue non-exclusive licenses to any person for the utilization of the public funded intellectual property. Such revisions enabled the government or any person to step in when the benefits of public funded research did not reach the public. However, since the bill has been tabled the article does not go further into the details of the bill. Much later in 2019, the Government of India issued a draft of model guidelines on implementation of IPR policy for academic institutions. It is the first of its kind in India and has been delivered based on the National IPR Policy 2016.

The National IPR Policy has several objectives and two of the objectives are to stimulate the creation and growth of Intellectual Property from R&D institutions and universities, through measures that encourage IP generation and to commercialise Intellectual Property. The CIPAM was established under the Department for Promotion of Industry and Internal Trade, to deliver on the objectives of the National IPR Policy. They are tasked with the responsibility to generate and commercialise IPRs from the research institutions and the universities. The CIPAM also has the responsibility to create a platform where the creators and innovators of Intellectual Property Rights could connect with potential users, buyers and funding agencies, so that they could promote the licensing and technology transfers of their IPRs. This commercialization of IPRs, will result in creating IPR based products and services for the society. To facilitate the commercialisation of IPRs from research institutions and universities, the CIPAM published the ‘Draft Model Guidelines on Implementation of IPR Policy for Academic Institutions.’

SUGGESTIONS TO CHANGES IN POLICY AND LEGAL FRAMEWORK TO ENSURE ACCESS

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.

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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.

Author :Vikram Choudhary, in case of any query, contact us at Global Patent Filing or write back us via email at support@globalpatentfiling.com.