C4IP and IP Celebrities Tell Biden to Pass on Extension of TRIPS Waiver

Nearly 50 former government officials and other well-known figures in the IP space signed onto a letter today penned by the Council for Innovation Promotion (C4IP) urging President Biden to oppose the World Trade Organization’s (WTO’s) proposed extension of the COVID-19 IP waiver to therapeutics and diagnostics.

The WTO announced a deal on waiver of IP rights for COVID-19 vaccine technologies under the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) in June 2022. The final text made almost no one happy and was much narrower than the original proposal by South Africa and India. The waiver is limited to “patented subject matter required for the production and supply of COVID-19 vaccines” only.

In October, the International Trade Commission  (ITC) released a report it was asked to produce by the U.S. Trade Representative (USTR) in December 2022. The report analyzed market dynamics surrounding the question of whether to extend the waiver to diagnostics and therapeutics. The report stopped short of making any recommendations, but ultimately did not find any definitive evidence that IP rights present a barrier to access in the context of COVID diagnostics and therapeutics.

To that end, the C4IP letter argues that extending the waiver of TRIPS protections would do little to solve the real problems. “The ITC report concludes that there are indeed disparities among countries regarding access to Covid-19 treatments and diagnostics, but underscores that these disparities stem from non-IP barriers,” says the letter.

“Rather, to effectively address this genuine global problem, we must tackle its root causes, which encompass — among other non-IP factors — last-mile administration and distribution challenges.”

In fact, argues C4IP, such an expansion of the waiver may in fact undermine public health by stifling new medical research. “American pharmaceutical companies have entered into more than 400 voluntary licensing agreements with partners on every continent” and Pfizer and Merck have licensed their patents to the Medicines Patent Pool (MPP), “enabling generic producers across the globe to manufacture their antivirals.” But obstacles such as lack of cold storage for treatments and understaffed healthcare workforces remain and waiving IP rights won’t solve those challenges, the letter adds.

Signatories to the letter include former U.S. Patent and Trademark Office (USPTO) Directors Andrei Iancu, David Kappos and Michelle Lee; Retired U.S. Court of Appeals for the Federal Circuit Chief Judge Paul Michel and Judge Kathleen O’Malley; Bayh-Dole Coalition Executive Director Joseph Allen; Retired United States Court of Federal Claims Judge Susan Braden; former USPTO Commissioner for Patents Drew Hirshfeld; former Secretary of Commerce Gary Locke; former World Intellectual Property Organization (WIPO) Deputy Director James Pooley; Former U.S. Representative Lamar Smith (R-TX); and many more.

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