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."

MSF Challenges Gilead Hepatitis C Patent In China; Intellectual Property Watch, June 19, 2018

Intellectual Property Watch; MSF Challenges Gilead Hepatitis C Patent In China

"According to the [Médecins Sans Frontières (MSF, Doctors Without Borders) press] release, “Gilead launched the sofosbuvir/velpatasvir combination at a price of US$51,000 for a 12-week treatment course in the United Kingdom, whereas the same treatment course is available for as low as $286 in India from generic manufacturers. In China, this combination was registered in May 2018, but Gilead has not yet announced its price.”

Drug Company ‘Shenanigans’ to Block Generics Come Under Federal Scrutiny; The New York Times, April 14, 2018

Robert Pear, The New York Times; Drug Company ‘Shenanigans’ to Block Generics Come Under Federal Scrutiny

"At a time when researchers are using sophisticated science to develop new treatments and cures, the fight over physical samples — a few thousand pills — sounds mundane. But it has huge implications for consumers’ access to affordable medicines.

The F.D.A. says it has received more than 150 inquiries from generic drug companies unable to obtain the samples needed to show that a generic product works the same as a brand-name medicine. Some of the disputes over samples involve drugs that are costly to patients and to the Medicare program and that have experienced sharp price increases in recent years.

“Without generic competition, there is no pressure to drive down the costs of these medications,” the food and drug agency said. Under current law, it said, it cannot compel a brand-name drug manufacturer to sell samples to a generic company."