Plan brings Big Pharma to new Harris administration – undoes unpopular decision

The pharmaceutical industry, Trump and Obama administration officials, and others are urging the Biden administration to reconsider a controversial plan for seizing patents on a drug when its cost gets too high, claiming the approach misinterprets decades-old law and threatens the delicate pipeline that produces innovative, life-saving drugs.

Over 500 comments were filed by the Feb. 6 deadline for groups and individuals to weigh in on the Biden administration’s framework for the federal government to use its march-in rights. The proposal lays out the Biden administration’s stance in a longstanding debate over whether price is a justifiable reason for the government to “march in” and take over a patent on technology developed with the help of taxpayer dollars and then license it to an outside manufacturer.

The Biden plan is already drawing blowback from a broad swath of players in the innovation space. A collection of former US Patent and Trademark Office directors and other government officials under the George W. Bush, Obama, and Trump administrations wrote to warn that the proposed framework, if adopted, would prove destabilizing.

The Pharmaceutical Research and Manufacturers of America likewise is urging the administration to pump the breaks, calling the plan a misinterpretation of the Bayh-Dole Act, which established march-in rights.

“The proposed framework sounds politically sexy—grab patents of companies if their drug prices are too high. But the impact will disappoint consumers—even the most aggressive efforts to reinterpret march-in rights would not affect 99 percent of drugs,” the Council for Affordable Health Coverage wrote.

“While the Biden Administration talks tough, its approach will simply chill investment in new treatments and cures because the threat of the government stealing patents hangs over every new idea’s success,” the council said.