Year Of IP: From The TRIPS Waiver Proposal To The Moderna-NIH Patent Tussle
Intellectual property became front page news in 2021 as the pandemic ignited a debate on the role of patents in accessing COVID-19 vaccines and therapeutics. 2022 will see a decision on the TRIPS waiver, a new USPTO director, and action on a pending march-in petition.
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Oncology sponsors would handle ex-US trial enrollment, but Pazdur feels tapping into the NCI network would improve trial speed and diversity. Biggest challenge will likely be generating sponsor enthusiasm for move that would involve giving up some control of development.
Proposed agreement limits waiver of certain patent rights to COVID-19 vaccines with potential to extend to COVID-19 diagnostics and therapeutics. India, South Africa, US and EU have agreed to the compromise but whether it becomes final depends on other WTO member countries.
The World Health Organization’s BioHub project is gathering momentum, with the spotlight on the equitable and timely sharing of viruses and other biological materials to develop medical products for use in future health emergencies such as a pandemic. But while its objectives are lauded by many, concerns have been raised about the intellectual property implications of the project.