Despite the president’s rhetoric on costs, the Commerce Department has proposed a curb on federal licensing power.
By Christopher Rowland Christopher Rowland Business reporter focused on the health-care economy's effects on patient health, costs, and privacy Email Bio Follow April 18 at 7:45 AM As drug prices have soared, lawmakers and patient advocates have pushed the federal government to deploy for the first time a powerful deterrent: a legal provision that allows it to suspend a drugmaker’s patent and license someone else to produce the drug.
The Commerce draft plan would prohibit the government from suspending a drugmaker’s exclusive patent over excessive pricing. It targets an obscure provision of a 40-year-old law called Bayh-Dole that is supposed to protect taxpayer interests in government-funded inventions, such as drugs discovered using federal grant money.
But in today’s hyper-charged debates over the costs of U.S. prescription drugs, especially with the advent of biotechnology and gene therapies that cost hundreds of thousands of dollars a year, the government’s powers are getting a closer look. Doggett led 50 Democrats who wrote to Trump in 2017 urging the president to order NIH to create guidelines on when excessive pricing would trigger government action. The letter cited Trump’s own declaration after his 2017 inauguration that drug companies were on the White House target list.
The department’s National Institute of Standards and Technology is scheduled to issue a final draft this month of its proposal, which it is calling a “discussion document.’’ The draft plan would block any government agency from exercising march-in rights based on the price of a product. Exclusivity rights could still be suspended in times of national emergency — such as an epidemic.
Industry and university officials who support NIST’s approach say march-in rights were never intended to be used for pricing. The proposal has also galvanized fervent property rights activists such as Andrew Schlafly, son of the late conservative activist Phyllis Schlafly.
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