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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The contentious issue of data exclusivity came to the fore during the European Free Trade Association's negotiations with India for a Free Trade Agreement. What are the arguments in support and against, including impact on compulsory and voluntary licensing?
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.