Biden wants NIH to have ‘march-in’ power to override patent rights for high-priced drugs

President Joe Biden today stepped into a long-running debate about whether the National Institutes of Health (NIH) has legal authority to override an exclusive patent license granted to drug developers if they charge too much for treatments that relied on agency-funded research. In draft policy guidance, the Biden administration says federal agencies would be able to use so-called “march-in” rights when a company is not charging a “reasonable” price for a product. The “ proposed framework ” was released today as part of other White House actions aimed at the high drug prices that have become a sore point for politicians and the public. It would clarify that a tool for removing patent protection to ensure a government-funded invention is commercialized can be used for an overly pricey drug so that other companies can sell it more cheaply. Although consumer advocates and lawmakers are hailing the proposal, some of them worry it sets an impossibly high bar for determining when a price is reasonable. And drug companies and academic institutions are expected to oppose it, arguing any such actions by NIH will dissuade industry from developing and commercializing treatments based on taxpayer-funded research. The Pharmaceutical Research and Manufacturers of America trade group, noting that companies fund most costs of drug development, called the proposal “a road map for seizing patents” and “another loss for American patients and inv...
Source: Science of Aging Knowledge Environment - Category: Geriatrics Source Type: research