Addressing the epidemic of high drug prices; Harvard Law Today, January 5, 2024

 Jeff Neal, Harvard Law Today; Addressing the epidemic of high drug prices

"The Biden administration is once again targeting high drug prices paid by Americans. This time, officials are focused on prescription medications developed with federal tax dollars. The United States government, through the National Institutes of Health (NIH), awards billions of dollars of research grants to university scientists each year to fund biomedical research, which is often patented. The universities in turn grant exclusive licenses to companies to produce and sell the resulting drugs to patients in need. But what happens if a drug company fails to make a medication available, or sets its price so high that it is out of reach for a significant percentage of patients?

To tackle this problem, the Biden administration recently released a “proposed framework” that specifies when and how the NIH can “march in” and award the rights to produce a patented drug to a third party if the patent licensee does not make it available to the public on “reasonable terms.” The plan is based on a provision included in the Bayh-Dole Act, a 1980 federal law which was designed to stimulate innovation by encouraging universities to obtain and license patents for inventions resulting from federally funded research.

According to Harvard Law School intellectual property expert Ruth Okediji LL.M. ’91, S.J.D. ’96, although the Biden administration’s proposed framework for using government march-in rights to lower drug costs is an important development, whether it will be successfully implemented and result in meaningful drug price reductions remains to be seen. Harvard Law Today recently spoke to Okediji, the Jeremiah Smith, Jr. Professor of Law and faculty director of Global Access in Action(GAiA) at the Berkman Klein Center, about the new proposal and the legal challenges it might face."

The NIH and Moderna Are Fighting Over Who Owns Their Vaccine; Intelligencer, November 10, 2021

Matt Stieb, Intelligencer; The NIH and Moderna Are Fighting Over Who Owns Their Vaccine

"While last year the government was calling the shot the “NIH-Moderna COVID-19 vaccine,” the biotech giant filed a patent made public this week in which it found that “only Moderna’s scientists” designed the vaccine. The patent, filed in July, is specific to the genetic sequence creating spike proteins, which allow vaccine recipients to build antibodies to block the virus when the body is actually exposed. As the New York Times reports, the NIH was surprised by the attempt at a solo effort. If the two parties cannot figure out a way to split the credit, the government will have to determine if it will take the expensive step of going to court. Already, the U.S. has paid $10 billion in taxpayer funds for Moderna to help create the vaccine, test its efficacy, and provide shots for the federal government."

Open-data contest unearths scientific gems — and controversy; Nature, March 8, 2017

Heidi Ledford, Nature; 

Open-data contest unearths scientific gems — and controversy

"Now one-third of the 60 papers that Wright's team had planned to publish are in jeopardy of being scooped. “I think the incentives to do these trials will be dramatically lessened if this is going to be the expectation going forward,” he says. “It's a huge time commitment.”

But others favour making data from trials publicly available as soon as possible. Doing so, they argue, opens up the possibility of a wide range of additional analysis, and speeds up analyses that can yield important clinical insights. “Clinical trial data are quite valuable, but usually they're kept locked away,” says Sandosh Padmanabhan, a participant in the competition who researches cardiovascular genomics at the University of Glasgow, UK. “Everybody who does clinical trials needs to open up their data for everybody to use.”"