A Senate Hearing Reveals an Overwhelming Consensus on Patent Abuse

7 Jun 2024

Awareness of the drug patent problem has been growing steadily in D.C. over the last five years, but the recent Senate Judiciary Committee’s hearing scrutinising drugmakers’ patenting and pricing tactics delivered something new: a broad, actionable consensus. Save for a few predictable holdouts, Senator after Senator pointed to patent abuse as a root cause of the drug pricing crisis and said something must be done. 

This is a big deal. But, while consensus is important, agreement alone won’t stop drugmakers from abusing our patent system and price gouging Americans. For that, we need action. Here’s what that should look like.

In the near-term, Congress must move on options that are currently on the table, including: 

  • Passing two bipartisan bills: Sen. Welch, Braun and Klobuchar’s A Bill to Address Patent Thickets and Sen. Cornyn and Blumenthal’s Affordable Prescriptions for Patients Act. Neither of these bills are the be-all, end-all solution to patent abuse, but both bills are helpful in tackling specific competition-blocking tactics drugmakers rely on.
  • Shutting down the deceptively-named PREVAIL Act, which is no more than a brazen effort by Sen. Tillis and Coons to hand even more power to brand-name drugmakers and to keep drug prices high.
  • Using their authority to compel the PTO and the FDA to get on the right side of this fight. Both agencies need to start collaborating and exchanging information, the PTO needs to increase public participation in the patent system, and the FDA must rein in the rampant abuse of its Orange Book. 

These steps will go a long way towards addressing some of the impacts of patent abuse, but even taken all together they aren’t a comprehensive enough solution to end it once and for all.

To actually solve the drug patent problem, which is now something Washington agrees must be done to address devastatingly high drug prices, our legislators have to go upstream to address the source of the problem. 

How? By raising the bar for what should be considered an invention that is deserving of being granted a patent in the first place. Here are key solutions for doing just that.


What We’re Doing

As the spotlight on drug patent abuse continues to get brighter, legislators are increasingly scrutinising one part of the problem: the FDA’s role in regulating improper listings on its Orange Book. I spoke to STAT about the need for the FDA to step up, show leadership, and provide some clarity. Right now, they are a regulatory agency that is refusing to regulate. 

We just released a new resource, Biologics, Biosimilars and Patents: A Beginner’s Guide. Given the recent history of the Biologics Price Competition and Innovation Act (BPCIA) and the complexity surrounding regulating biologics, we created this as an entry point for those who want to learn more about how the biologics regulatory system works for biosimilar drugs and how it intersects with the patent system.

Regardless of whatever next steps legislators take to address the drug patent problem, transparent and accurate data is essential. A recent peer-reviewed JAMA Internal Medicine study on the “Patent Portfolios Protecting 10 Top-Selling Prescription Drugs” relies on data listed in our Drug Patent Book, a searchable and comprehensive list of patents filed on each of the 10 top-selling drugs in the U.S. We will continue to dig into the patent data and make our findings transparent because we believe that sunlight is the best disinfectant. 

Relevant News Rundown

Anthony Barrueta, Government Relations Executive at Kaiser Permanente, just released a LinkedIn article on why we need to take drug patent reform seriously. It’s a thorough rundown of both the problem and potential solutions, and I particularly loved this line: “Patent laws have a long history, but they aren’t inscribed on stone tablets. They have always been a work in progress. When they aren’t serving their purpose, it is time to revisit them.”

Wayne Brough of the R Street Institute published an excellent assessment of recent patent legislation, providing a great analysis of the dangers posed by the PREVAIL Act. I couldn’t agree more with his statement that PREVAIL threatens to “revert to a more litigious patent system that is easier to exploit and less conducive to innovation.”

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