Biden Administration Moves to Invalidate Medical Innovators’ Patent Rights

President Biden is moving to impose “march-in” rights on prescription drugs with the stated goal of lowering prices. The idea sounds good at first blush, but it actually will be devastating to patients across the country and to America’s global preeminence in medical innovation.

Background

The Bayh-Dole Act includes the right for the feds to march in on inventions, including pharmaceuticals, created with federal funds—under a narrow set of circumstances—and force patent holders to grant a license to a “responsible applicant,” effectively negating patent protections. The two most common circumstances: 1) where effective steps have not been taken, or are not expected to be taken, within a reasonable period to commercialize the invention, or 2) the action is necessary to alleviate “health or safety needs not reasonably satisfied” by the patent holder or licensee.”

In other words, the march-in provision contained in the Bayh-Dole Act would allow the federal government to take the intellectual property rights from the companies and institutions that invented the products being patented. 

Price has never been and should never be a trigger for march-in. This was made clear by the authors of the law themselves.

Biden Overreach

Yet in his statement on why his administration is asserting march-in authority, Biden talks only about price and makes no claim that pharmaceutical companies have failed to commercialize their medicines adequately or that drug patent holders are failing to satisfy health or safety needs. Moreover, the administration is making this move in spite of the fact that the National Institutes of Health has expressly stated and confirmed that the “extraordinary remedy of march-in is not an appropriate means of controlling prices.”

Implications

The Biden administration’s egregious misapplication of the Bayh-Dole Act’s provisions will have a serious chilling effect on public-private partnerships and could create a disincentive for scientists and drug companies to make the large and long-term investments required to find miracle cures and therapies for diseases like cancer or to respond quickly to global health emergencies.

It will also disrupt the innovative environment, ultimately to the detriment of Americans’ health.

The Trade Alliance to Promote Prosperity supports strong intellectual property protections for the scientists who routinely produce the miracle cures and therapies that American patients have come to enjoy and expect. That is why we, therefore, denounce President Biden’s move to assert march-in authority.