Posts Tagged: "National Institutes of Health"

NIH’s Fight for Ownership of Moderna’s COVID-19 Patent Highlights Hazards of Business Collaborations

The National Institutes of Health (NIH) is at legal odds with Moderna, claiming that Moderna neglected to add three NIH scientists to Moderna’s patent application on a principal COVID-19 vaccine. If a court ends up siding with NIH, it would co-own any issued patents on the technology, which could prove to be quite valuable; in 2021, Moderna’s vaccine sales were forecasted to be in the range of $15 billion and $18 billion. With an equal undivided interest in the patent, NIH could do whatever it wishes with it, such as licensing it to others and collecting royalties.

It’s Time for NIH to Uphold the Law, Once Again

As discussed previously, the critics are in full howl now that their attempts to enact legislation controlling drug prices has failed once again. They are applying unprecedented political pressure on Secretary Xavier Becerra at the Department of Health and Human Services (HHS) to misuse the march in provisions of the Bayh-Dole Act to accomplish their goal. Nearly 100 distinguished organizations and individuals endorsed the following letter from the Bayh-Dole Coalition, which I lead, warning HHS not to take this disastrous misstep. Here’s what we said.

Knowledge Ecology International’s New March-In Petition is Déjà vu All Over Again – With One Twist

Some say the definition of insanity is doing the same thing over and over while expecting a different outcome. That would appear to be the case with the recent refiling of a petition by Knowledge Ecology International (KEI) to the National Institutes of Health (NIH) asking it to march in under the Bayh-Dole Act to force licensing to additional parties of the prostate cancer drug Xtandi, because of its cost. The law allows academic institutions, companies and federal laboratories to own and license inventions made with government support. Similar petitions were rejected by NIH and the Department of Defense (which funded the research on the underlying invention) in the Obama/Biden Administration for a simple reason: the law is for the commercialization of federally funded inventions; it does not allow the government to set prices for successful products.

Examining the Moderna-NIH COVID-19 Vaccine Debate in the Context of Bayh-Dole

In the wake of the development of COVID-19 vaccines, the Biden-Harris Administration has suggested major shifts in U.S. policy concerning patent protection. In May of this year, Ambassador Katherine Tai, the U.S. Trade Representative (USTR) announced the Administration’s support for waiving intellectual property protections for COVID-19 vaccines. Most recently, the National Institutes of Health (NIH) Director Dr. Francis Collins accused Moderna of excluding three NIH scientists as co-inventors of a key patent for the COVID-19 vaccine. This article explores an alternative possibility of the Administration exercising certain rights in the COVID-19 vaccine invention under the 1980 Bayh-Dole Act—one day after the bill’s co-sponsor, Senator Bob Dole, passed away—and whether such an exercise of rights is in line with past precedent or would be a violent disruption to the status quo.  

Inventing Chaos with the Moderna/NIH Dispute

Moderna and the National Institutes of Health (NIH) are poised for a legal battle over inventorship of a vaccine for COVID-19. While a court may resolve the dispute over inventorship for the patent application, court review of current inventorship rules could be a slippery slope to chaos. Moderna and NIH collaborated on developing a functional vaccine for COVID-19, which is not in dispute. As a result of the collaboration, a vaccine labeled “mRNA-1273” was created and a U.S. patent application was filed by Moderna, with no NIH scientists listed as inventors. Moderna has commented that, after an internal review, no NIH scientists designed the actual vaccine claimed in the U.S. patent application. NIH has commented that it believes three scientists should be included in the U.S. patent application as co-inventors with the Moderna scientists.