The recent announcement by US Trade Representative Katherine Tai that the “US supports the waiver of IP protections on COVID-19 vaccines to help end the pandemic” has led to concern over the potential scope and effect of such waivers. Forced disclosure of trade secrets related to vaccine manufacturing processes has generated the most concern since such IP rights are forever lost once disclosed. Since the COVID-19 genome was only released in January of 2020 and most patent applications publish a year and a half after filing, it is not surprising that recent surveys of the U.S. patent literature find few patents which are specifically directed to COVID-19 vaccines which are approved or pending approval. Nonetheless, patent filings limited to specific approved COVID19 vaccines and methods of use will likely surface quite soon and would be subject to the IP waivers. Furthermore, the effect of such waivers on established “platform patent” rights which could potentially cover COVID19 and a wide range of other vaccines and vaccine manufacturing processes must also be considered.

Innovator biotech companies and universities pioneering a new field such as mRNA-based vaccines and therapeutics (i.e., treatments) typically seek platform patents which protect new technology applicable to many different types of vaccines and therapeutics. Platform patents covering key design features of new classes of vaccines and therapeutics are key IP assets as their value does not hinge on the success of a single vaccine or therapeutic candidate.  Not surprisingly, innovators in the field of mRNA-based vaccines and therapeutics have sought platform patent rights well prior to the COVID19 pandemic. A recent network analysis [1] of the mRNA vaccine and therapeutics patent landscape reveals over 40 granted patents owned by biotech companies and universities with filings dating back to 2009 and with many more applications pending. Granted platform patents in the mRNA vaccine and therapeutics field are drawn to fatty formulations which effectively deliver mRNAs to patients, mRNAs with improved stability, mRNAs with reduced immunogenicity, and stabilized recombinant DNA vectors for mRNA production.  Since materials and methods covered by such platform patents are potentially applicable to many mRNA-based vaccines or therapeutics, a web of licensing agreements between the universities, biotech companies, and pharmaceutical companies is in place.[2]

Application of the proposed IP waivers to platform patent rights will raise a variety of issues for immediate IP stakeholders such as patent holders as well as their licensees and investors.  Such immediate IP stakeholders have understandably resisted such waivers altogether as they would significantly devalue patents they own or license. While waivers of applicable platform patent rights would presumably be specifically limited to COVID19 vaccine-related activities, infringers may nonetheless use the patented technology to make other unrelated vaccines or therapeutics that fall outside the waiver. Such limited IP waivers may thus make the typically difficult task of enforcing platform patent rights against infringers operating outside of the COVID19 vaccine IP waiver space even more difficult.

It has been argued that IP rights including platform patents restrict COVID19 vaccine distribution and should be waived. However, the mRNA vaccine patent landscape shows that over a decade of investment in what was previously unproven technology placed companies in a position to launch successful mRNA-based COVID19 vaccines in 2020. But for investors seeking platform patent and other IP rights over the course of the past decade, basic enabling technology for the mRNA-based COVID 19 vaccines would not have been in place and the vaccines would not now be available.

[1] Gaviria, M., Kilic, B. A network analysis of COVID-19 mRNA vaccine patents. Nat Biotechnol 39, 546–548 (2021).

[2] Id.

Charles P. Romano, Ph.D. is a Senior Patent Agent in the MVS Biotechnology & Chemical Practice Group. To learn more, visit our MVS website, or contact Charley directly via email.

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