Patent Thicket Remedies

Alex Brill and Christy Robinson

Yesterday, the Initiative for Medicines, Access, and Knowledge (I-MAK) took an important step by proposing six policy solutions to address patent thickets that block generic and biosimilar drug competition. I-MAK’s blueprint, available here, is easy to digest and worth a read. As we have written, patent thickets—a strategy brand drugmakers use whereby they obtain many overlapping patents on a product, often after it is on the market—unduly limit competition and harm consumers by delaying savings and access.

I-MAK has for years raised the alarm about patent thickets. Their new blueprint is a practical step toward ending this anticompetitive tactic. Unfortunately, five of the six solutions have a legislative component. We say unfortunate because patent reform proposals before Congress have already stalled.

Some lawmakers are aware that drugmakers have taken advantage of the patent system to extend monopolies on their products. But thus far, Congress has lacked the willpower to enact patent reform proposals. While I-MAK’s blueprint risks the same near-term fate as proposals already approved by the Senate Judiciary Committee but not voted on by the full Senate, we must not give up the fight.

And maybe the glass isn’t half empty. There has been progress on several fronts. Executive Order 14036, signed by President Biden in July 2021, kicked off a new cooperative exchange between the Patent and Trademark Office (PTO) and the Food and Drug Administration (FDA). Since then, the PTO and FDA have requested public comments, held a stakeholder listening session, and organized multiple cross-training sessions. As the FDA describes, the two agencies “are engaged in a robust set of initiatives aimed at protecting and promoting U.S. innovation while advancing marketplace competition that can lower drug prices for all Americans.”

More information about these collaborative efforts is available here and here. Public comments, over 200 in total, can be found here. In 2024, the PTO and FDA will likely announce additional steps toward improving the patent system with respect to pharmaceuticals. While regulatory reforms and staff training can’t solve the patent-related challenges inhibiting timely drug competition, they can certainly help. And when it comes to the healthcare savings that patent thickets are delaying, we need all the help we can get.