[Ip-health] Taxpayers are subsidizing 80 percent of Regeneron’s COVID-19 treatment’s R&D costs

kathrynardizzonekei kathrynardizzonekei at gmail.com
Sat Oct 10 16:40:41 PDT 2020

Thank you Paul,Yes, I think you are correct. KEI has a copy of the Regeneron contract, which is an amendment to a preexisting Other Transaction Agreement, and the original agreement. Though parts of the contract are heavily redacted, the IP and data terms are unredacted for the most part, and they are weaker than the IP and data terms in a Bayh-Dole, standard contract. This would seem to indicate that the U.S. government hasn't acted as a reasonable investor or negotiated terms that would give it greater ownership of the IP, which it could have and should have done using a declaration of exceptional circumstances at the outset, in the funding agreement. Rather than speaking to what Regeneron will likely do, I wanted my blog to speak to what Regeneron should do, if it is sincerely interested in helping bring about the quickest end to the pandemic and avoid a pandemic apartheid. Funders of R&D and C-TAP would be much better positioned if the R&D funders had negotiated appropriate terms in the funding agreement. However, I believe we can and should advocate for companies like Regeneron, whose R&D was funded mainly by taxpayers, and others rightsholders, to do the right thing. Perhaps with the reputational benefit and other factors at hand we can convince them that it is in their best long term interest to do so. Sent from my Samsung Galaxy smartphone.
-------- Original message --------From: Paul Fehlner <pfehlner at revisiontx.com> Date: 10/10/20  6:29 PM  (GMT-05:00) To: kathryn ardizzone <kathryn.ardizzone at keionline.org> Cc: Ip-health <ip-health at lists.keionline.org> Subject: Re: [Ip-health] Taxpayers are subsidizing 80 percent of Regeneron’s COVID-19 treatment’s R&D costs Kathryn, I agree, but if the US government did not require anything of Regeneron, the company has no great incentive to contribute technology to C-TAP…unless the C-TAP co-sponsors and funders who have influence on Regeneron push them to do so. Certainly it would be fair for the 80% investor to require something like that in the R&D agreement, I just have not idea whether they did, and generally would doubt it.Paul Fehlner> On Oct 9, 2020, at 9:20 AM, kathryn ardizzone <kathryn.ardizzone at keionline.org> wrote:> > https://www.keionline.org/34126> > *Taxpayers are subsidizing 80 percent of Regeneron’s COVID-19 treatment’s> R&D costs*> > Kathryn Ardizzone> October 8, 2020> > Regeneron Pharmaceutical recently applied for Emergency Use Authorization> of its investigational COVID-19 treatment, REGN-COV2, after Donald Trump> said that it cured him of COVID-19, suggesting that Regeneron expects to> cash in on the treatment. Taxpayers, however, are funding 80 percent of the> costs of developing REGN-COV2.> > Regeneron’s May 5, 2020 SEC filing states as follows (emphasis added):> > > > > *We are using our end-to-end antibody technologies to discover and develop> brand new therapeutic antibodies for COVID-19. The Company is advancing> REGN-COV2, a novel investigational antibody “cocktail” treatment designed> to prevent and treat infection from the SARS-CoV-2 virus. In April, the> Company moved its leading neutralizing antibodies into pre-clinical and> clinical-scale cell production lines and plans to have supply available for> clinical studies, which are expected to begin in June 2020.The Company is> also working to rapidly scale-up manufacturing.The Company also announced> an expansion of its Other Transaction Agreement (“OTA”) with BARDA,> pursuant to which HHS is obligated to fund 80% of our costs incurred for> certain research and development activities related to COVID-19 treatments.*> Regeneron should open license the IP rights, data, know-how, and cell lines> necessary to manufacture the COVID-19 treatment to the World Health> Organization COVID-19 Technology Access Pool (C-TAP), a global framework> for the voluntary licensing of rights in COVID-19 medical technologies. A> deep technology transfer to C-TAP, i.e., one that enables other qualified> companies to manufacture the licensed technologies, is the best way to> ensure that any treatment or vaccine deemed safe and effective is> distributed as widely and quickly as possible.> > > -- > Kathryn Ardizzone, Esq.> Counsel> Knowledge Ecology International> 1621 Connecticut Avenue NW, Suite 500> Washington, DC 20009> kathryn.ardizzone at keionline.org> (202) 332-2670> _______________________________________________> Ip-health mailing list> Ip-health at lists.keionline.org> http://lists.keionline.org/mailman/listinfo/ip-health_lists.keionline.org

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