INTRODUCTION
The concept of patenting pharmaceutical innovations has been always a point of debate in the academic community. There is some consensus of opinion that lifesaving drugs are often not affordable to the public because of the patents on such drugs. The recent Covid-19 pandemic have sparked the debate further especially in reference with vaccine equity and access. Further, studies also showed that 97% of Oxford AstraZeneca Covid vaccination was public funded, yet it was provided to public at huge prices. This along with other empirical studies which provided evidence that majority of the pharmaceutical products are being made in the public funded research institutions first and then commercialised to private industries, also shifted the focus of such debates. This Article tries to gather evidence on to what extent the pharmaceutical products are being made in the public funded institutions. After finding substantial evidence to indicate that the majority of the pharmaceutical products had their origins in pubic funded research, the article attempts to address the issue whether it is equitable for the public to not have access to such products created using public funds. The article examines the role of Government and public funded research institutions in ensuring access to pharmaceutical products created using public funds.
Patenting of pharmaceutical products has always been a point of debate in the academic community. On the one hand there exists the concern that patents deter access to lifesaving medicines and on the other hand patents are seen as an essential incentive for investing in the development of new innovative pharmaceutical products and devices. While the literature on the need and consequences of patenting pharmaceutical products are divided in opinion, there is a common consensus that the laws and policies for patenting pharmaceutical products should always try to achieve a trade-off between the invention and access. However, this intrinsic debate on how to effectively use patents for incentive and how to ensure access have caught new momentum in the wave of the Covid pandemic. This increased attention to the problem of 'access' to patented pharmaceuticals have given rise to a new strand of both academic and legislative initiatives which have emphasized the potential role the public funded research institutions could play in shrinking the gap between the pharmaceutical products and the public. Such initiatives are based on the idea that most of the inventions that are taking place in the pharmaceutical industries all over the world had its origins in public funded university or research institutions patents. There is also evidence to indicate that such universities and research institutions are also the leading patent holders in medicinal drugs and devices in many countries. This article attempts to gather the evidence on these university-owned pharmaceutical patents and determine the role of the public funded institutions to increase access to the pharmaceutical products.
EVOLUTION OF THE CONCEPT OF PATENTING PUBLIC FUNDED PHARMACEUTICAL INVENTIONS
Traditionally, the outputs of academic research have always been placed freely in the public domain, to be picked up either by fellow and future researchers for further pursuit of knowledge or by entrepreneurs for industrial or commercial application of the knowledge created in public institutions. Intellectual Property Rights related concerns did not bother public funded institutions for a long time. Dedicating research outputs to the public domain for free use and follow-on research was the standard practice in public- funded research. However, after World-war II, while countries all over the world were trying to recover from the economic injuries the war left on them, the onus was placed on the public funded research institutions and universities to help them recover faster. This was especially more so in the US, where the research universities and institutions were expected to contribute more directly to the economy. There was growing concern about the apparent decline in the social value of public research in the US as the inventions resulting from public-funded research were not reaching the market place. Lack of IPR policies and legislations were said to be the main reason behind the lack of access to public funded inventions. Most inventions that are taking place in the research institutions may most often be in their 'embryonic' form, requiring additional investments for developing them into usable products, even if the inventions are in their final prototype stage of development, additional investments are needed for mass production, distributions and clinical trials. Most research institutions lack the skills or authority to develop their inventions to the point where they can be commercially made available to the public. Hence, such university inventions must be transferred to industries so that they can take up the further development and commercial development of the product. However, it is believed that the private industries lack incentive to invest huge amounts into the commercial development of university inventions without some proprietary rights. Hence, patents are granted to universities and research institutions which then license or assign their ownership in such inventions to the industries for commercialization of research results.1 This prompted policy-makers to enact new legislations to promote patenting, technology transfer and industrial application of inventions generated from publicly funded research. Two consecutive legislations were passed in the US in the year 1980 with this vision. The first one, the Stevenson-Wydler Technology Innovation Act of 1980, made technology transfer an integral part of the research and development responsibilities of federal laboratories and their employees.2 The second statute was the University and Small Business Patent Procedures Act (1980), commonly known as the Bayh-Dole Act. The Bayh–Dole Act gave the research institutions and universities the right to choose ownership over their inventions and to file for and retain patent rights.3 The Act also gave the right to licence these patented inventions to the industries on an exclusive or non- exclusive basis.3 After the enactment of the Bayh-Dole Act, the patenting and licensing activities of the US research institutions grew dramatically and literature shows that most of this growth was concentrated in the biotechnology and pharmaceutical sectors. However, this growth in patenting and licensing numbers were not received positively by the academicians and in fact literature shows that the negative outcomes of patenting and licensing public funded pharmaceutical inventions far outweighs the positive outcomes. While the positive outcomes of patenting and licensing pharmaceutical inventions were one, it led to a dramatic increase in the private sector investment in R&D of pharmaceutical products. Several medicines, medicinal devices and pharmaceutical industries were made because of this patenting of pharmaceutical products. However, there were several concerns associated with aggressive patenting. One, it shifted the focus of academic research from basic towards more 'applied' research on pharmaceutical inventions that had a market, for example, cure for life style diseases and the research on diseases, especially the ones affecting the developing countries remain neglected. Two, excessive patenting led to include more research tools in the patenting realm and this created hindrance to further research.7 Three, the aggressive patenting also led to a decreased quality in the patents granted, creating patent hold-ups and a patent 'anti- commons.' Four, it led to a decrease in the other modes of technology transfer through which information dissemination took place without proprietary rights, mainly the publications of research results.4
The last and the most important, the main rationale for patenting public funded inventions, i.e. to ensure access by the public, was not happening. Studies actually show that while the patenting of pharmaceutical inventions increased, it did not result in the corresponding increase of licensing of patented products5. Further, even when the patented products were licensed, the cost of such products was so high that the average general public did not have access to it.
Footnotes
1. K A. Lemley, "Are Universities Patent Trolls?" 18 Fordham Intellectual Property, Media & Entertainment Law Journal 615 (2008); Arti Kaur Rai, "Regulating Scientific Research: Intellectual Property Rights and the Norms of Science" 94 Northwestern University Law Review 87 (1999).
2. United States Code, Title 35 – PATENTS.
3. Id.
4. Jerry G. Thursby and Marie C. Thursby, "Has the Bayh-Dole Act compromised Basic Research?" 40 Research Policy 1079 (2011).
5. David C. Mowery and Bhaven N. Sampat, "The Bayh-Dole Act of 1980 And University–Industry Technology Transfer: A Model for Other OECD Governments?" 30 The Journal of Technology Transfer 122 (2004).
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