What Others Say: Proposed drug patent reforms would do more harm than good

Congress is considering a bill that could exacerbate government waste and give American companies’ most valuable trade secrets to China.

That’s obviously not lawmakers’ goal. But it’s likely to happen — if the Medication Affordability and Patent Integrity Act, introduced by Senators Maggie Hassan (D-NH) and Mike Braun (R-IN), becomes law.

The bill’s supporters claim that insufficient coordination between the Food and Drug Administration (FDA) and the U.S. Patent and Trademark Office (USPTO) is inflating drug prices. They believe pharmaceutical companies “unfairly extend the exclusivity period for a drug by submitting partial information for their initial patent” and then later submitting new information.

These claims are unfounded. Under current law, a patent will not be granted or subsequently upheld if the patent holder is shown to have withheld relevant information during the application process.

Given that a full deterrent is already in place, the bill’s primary effect — introducing redundant patent disclosure requirements — would merely cause government waste. As former directors of USPTO — one of us under President Obama, the other under President Trump — we know that these requirements would force the agency to squander thousands of hours on work that provides no public benefit.

Under the provisions of the bill, a patent applicant must forward any and all information provided to the FDA, and any related communications with the FDA, to USPTO as well.

The proposed legislation specifically mandates double disclosure of “any statement or characterization of analytical or clinical data” — including confidential proprietary data. While the FDA regards such information as essential to its review process, and maintains that information in strict confidence, the USPTO, by its nature and mandate, typically operates in full public view. The word “patent” comes from the Latin word for “lay open.” Communications between drug manufacturers and the FDA that contain trade secrets and are not publicly disclosed for drug approval purposes, will be put into the public domain once disclosed to the USPTO for patentability purposes, and their disclosure could result in substantial damage.

This fact is especially relevant in the context of global competition. International rivals, China above all, have proven more than willing to take advantage of American intellectual property whenever they can get their hands on it. The strict confidentiality of sensitive information is absolutely essential to preserving American competitiveness. But this will be impossible if the proposed legislation becomes law.

The bill would also aid intellectual property thieves both at home and abroad. A small inventor’s accidental failure to comply with the legislation’s onerous requirements could be weaponized by patent infringers — including those abroad — seeking to skirt otherwise strong patents.

America already prohibits the sort of patent gaming that lawmakers are concerned about, and the United States has the highest rate of generic drug usage in the developed world. There’s simply no evidence that the patent process is unduly delaying the introduction of generic medicines.

Blurring the lines of authority around the comprehensive processes already in place at USPTO and the FDA won’t make patients better off. It’ll only jeopardize American companies’ competitive edge, squander government resources, and help foreign competitors and copycats.

Andrei Iancu served as the undersecretary of commerce for intellectual property and director of the U.S. Patent and Trademark Office from 2018 to 2021. David Kappos served in the same offices from 2009 to 2013. Both serve as board co-chairs of the Council for Innovation Promotion. This piece originally ran in RealClearHealth.