How could waiving COVID-19-related intellectual property rights affect biopharma?

In the first instalment of this series I explored the remit of the proposed Agreement of Trade-Related Intellectual Property Rights (TRIPS) waiver for COVID-19 vaccines, medicines, diagnostics and technologies and why certain countries are supporting it. Here, I examine the possible implications for biopharma, biotech and other stakeholders, should the intellectual property (IP) rights waiver be approved, with comment from Ash Ramzan, founder and principal consultant at regulatory consultancy Woodley BioReg.

“In my opinion, for pharma, waiving IP rights for COVID-19 treatments and therapies would have less of an impact, but certainly, biopharma and biotech could potentially be significantly affected,” stated Ramzan. “That impact will be commercial for several reasons, depending on the extent of the waiver in biotech and biopharma, because the IP rights do not just cover one product or process, they cover multiple processes across a whole range of products.” He continued that these technologies are developed as a platform upon which numerous therapies, vaccines and diagnostics are potentially based, so the “know-how” behind them is critical to a business’ bottom line, not just in the immediate term but also in future.

Ramzan added: “We all acknowledge that something needs to happen, but I do not think [the IP rights waiver] is the right way forward because it will stifle a lot of commercial development, since lots of small university spin-out groups rely on IP for market capitalisation and their business valuation is really driven by the type of IP they hold. Additionally, setting a precedent where you can open these technologies up to anybody through a route other than licensing means they almost become valueless because there is no way to ever get that knowledge back.”

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