In a recent piece for The Washington Post, author Christopher Rowland inaccurately suggested that the federal government has the power to effectively impose price controls over products that have a link to federally-funded research through its patent “march-in” rights under the Bayh-Dole Act.
As Joseph Allen – a former staff member for the U.S. Senate Judiciary Committee who was instrumental in helping craft and pass this historic legislation nearly 40 years ago – countered: “There’s a reason why this ‘little-known power’ has never been used—it doesn’t exist.”
Despite the fact that many anti-drug industry activists have advocated this theory for decades, a series of Democrat and Republican Administrations have repeatedly rejected it – and for good reason. Even if it were legally permissible, government intervention of this sort can only lead to the devaluation of patents and ultimately less innovation of life-saving drugs and other inventions.
Prior to the Bayh-Dole Act – when the government kept all patent rights in the fruits of federally-funded research – the Comptroller General had found that not a single NIH-funded invention had been developed into a new marketed drug. Since then, there have been hundreds.
The reason for this sea change is simple. The private sector, which spends on average more than $2 billion and 10 years to actually develop a drug, secure its approval, and bring it to market for patients in need, would not take such huge risks if the government could take a company’s rights away, long after the fact, just because it doesn’t like the product’s price.
As we work together to make drugs more affordable for patients, we must ensure that policymakers honor the longstanding bipartisan understanding that march-in rights are not to be used to impose government price controls.