Some lawmakers and activists are trying to use the Bayh-Dole Act of 1980 and its “march-in” authority to seize the patent rights for a prostate cancer drug, due to the high price of the drug, but this a misuse of the authority, says Lou Berneman in an editorial for PennLive.
Berneman is the former head of the University of Pennsylvania’s Center for Technology Transfer and a founder of Osage University Partners, which invests in startups based on university inventions.
After the failure of proposed drug price control legislation, “as an end-run, some lawmakers and activists have asked the Department of Health and Human Services (HHS) to misuse a provision in the Bayh-Dole Act of 1980 to seize patent rights to a prostate cancer drug,” Berneman writes in his opinion piece.
The Bayh-Dole Act of 1980 was intended to allow universities to use patents on their inventions, even if the research that led to them was funded by the federal government, Berneman explains. He notes that the act provides a “march-in” authority which, in a limited number of cases, gives the federal government a right to reclaim these patents from the universities, but he adds that the price of a drug is not a legitimate reason for the government to exercise its march-in rights under Bayh-Dole.
“The lawmakers’ and activists’ current end-run petitions HHS to ‘march in’ on the drug company that licensed a discovery from UCLA, which had received $500,000 in research funding. The company then invested $1.4 billion to develop the prostate cancer treatment Xtandi. The $500,000 in government funding, in the activists’ view, entitles HHS to ‘march in’ and grab rights to the patent,” Berman writes.
