Feb 2024: The Senate HELP Committee Takes Aim at Drug Patent Abuse

8 Mar 2024

In the decade that we’ve been working on patent reform in the U.S., we’ve been told time and time again that the issue is just too confusing, too wonky, for legislators to take up and run with.

We’ve always known that’s not the case, so the recent HELPCommittee hearing was a welcome reminder that patent reform is firmly established on the political agenda.

Over the course of the hearing – which set out to answer why the U.S. pays the highest prices in the world by interrogating the CEOs of Johnson & Johnson, Merck, and Bristol Myers Squibb (BMS) – patent abuse took center stage. I was honoured to testify and provide my expertise, but it was clear a number of Senators had already done their homework and possessed an in-depth understanding of the drug patent problem.

I will do my best to keep this brief, but here are six important highlights:

  • Sen. Maggie Hassan (D-NH) called out drugmakers for filing “dozens, even hundreds of frivolous patents” and “play[ing] games with the patent system”.
  • Sen. Ben Ray Luján (D-NM) made a critical intervention when he asked Robert Davis, the CEO of Merck, if he would commit to not blocking other drugmakers from entering the market when the primary patent on Keytruda expires. Mr. Davis went on record saying that when the main composition of matter patents (the primary patents) expire on Keytruda, Merck will not stop an IV (intravenous) version of the drug from coming onto the market. It’s worth noting Mr. Davis’s sleight of hand in singling out the IV version. This is because Merck hopes to switch to a subcutaneous version of the drug for which they have additional patent protection that will help them maintain their monopoly in the market. I challenged Mr. Davis’s response, highlighting how Merck has patent protection on Keytruda until at least 2039 and why we’re not likely to see competition due to litigation until 2034.
  • Sen. Luján also asked the same question of BMS’s CEO, Chris Boerner, with respect to its product Eliquis. Much like Merck’s CEO, Mr. Boerner eluded the question by saying BMS would allow competition on Eliquis when the “most relevant” patents expire. Fortunately, Sen. Luján recognised Mr. Boerner’s slippery word games by trying to conflate primary patents with relevant patents, which would include other secondary patents that extend BMS’s protection on the drug.
  • My fellow panelist Peter Maybarduk of Public Citizen made sure that the hearing’s scrutiny focused on drugmakers’ ability to set high prices, telling Senators that “the fish rots from the head.”
  • Sen. Ed Markey (D-MA) evoked his father, who passed away due to lung cancer, in pointing out the many consequences of overpatenting. Massive patent estates, he said, don’t just block competition and delay lower-cost medicines, they also ‘thwart smaller companies from making the breakthroughs that drive new inventions forward”.
  • Finally, the Committee’s official report cited I-MAK’s database, The Drug Patent Book, in its detailing of how drug companies game the patent system to extend their monopolies.

Critics often claim that hearings like this are political theater, but I disagree. This hearing brought much-needed accountability to the industry and its canned talking points while social media and traditional press coverage by outlets including CNNThe New York Times, and CNBC informed the public of the true forces driving America’s drug pricing crisis. As Justice Louis Brandeis once said, “sunlight is said to be the best of disinfectants”.


Relevant News Rundown

The focus on patent abuse wasn’t limited to the HELP Committee. Sen. Peter Welch (D-VT) hosted a panel discussing his newly introduced bill and what must be done to address patent thickets. Sen. Welch was joined by Sen. Amy Klobuchar (D-MN), advocates, and patients who testified to the devastating impact of patent abuse.

We also saw increased scrutiny on sham Orange Book listings manifest as drugmakers continued to delist illegitimate patents thanks to ongoing pressure from the FTC, Sen. Elizabeth Warren (D-MA), Sen. Tammy Baldwin (D-WI), and Rep. Pramila Jayapal (D-WA).

AbbVie CEO Richard Gonzalez announced he’ll soon be stepping down from his position, retiring as one of the most prolific abusers of the U.S. patent system ever. While that must be an immutable part of his legacy, we know that overpatenting is not a bad actor problem but a systemic one.

Useful Reading

This useful report from the Economic Security Project provides both a detailed landscape of modern monopolies and a 4-pillar strategy for building a future beyond them. From drug pricing to groceries, it starts with breaking monopolies’ stranglehold over our economy.

We recently partnered with Politico to release a brief highlighting our new blueprint for reform. The brief clearly explains how reforming the U.S. patent system gets to the root of reducing prescription drug costs and improving competition.

For a sense of patent reform’s bipartisan appeal, you can read the America First Policy Institute’s brief on why patent abuse keeps prescription drugs unaffordable as well as this Washington Examiner Op-Ed from former Louisiana governor Bobby Jindal and Charlie Katebi, both of which cite data from our Top Selling Drugs research.

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