Illustration: Annelise Capossela/Axios
A bipartisan group of senators has been pushing a bill for years to crack down on what they say is patent abuse by drug companies. Now, they hope one more shove can get it over the finish line.
Driving the news: The bill, led by Sens. John Cornyn and Richard Blumenthal, is set to be marked up by the Senate Judiciary Committee on Thursday. Action this early in the new Congress is a promising sign for their efforts.
Why it matters: Backers say the bill would help prevent patent games like with AbbVie's blockbuster drug Humira, which faced no competition for years.
What they're saying: "We've come close to passing it now a couple of times; I think now's the time," Blumenthal told Axios. "I think there's a good chance."
What the bill does:
- Seeks to prohibit "product hopping," where a drug company makes small changes to a drug in a bid to extend its period of exclusivity.
- Places a limit on the number of patents a company can contest, helping crack down on "patent thickets" that delay competition.
Between the lines: Backers say they are discussing changes to the bill to help overcome any remaining opposition, including from the pharmaceutical industry, which objects to the product hopping provisions in particular.
- PhRMA argues those provisions would hinder research that happens after a drug's initial approval.
- "This legislation as introduced would upend the biopharmaceutical innovation ecosystem, creating an FTC enforcement cloud over almost any post-approval innovation," said PhRMA spokesperson Megan Van Etten. PhRMA has not taken a position on the patent thicket portion of the bill.
The other side: "They don't like it very much, but we are talking to them," Cornyn told Axios, referencing the pharmaceutical industry.
- "Hopefully, they understand that opposition puts them in a very bad light. And I'm not an enemy of pharma. I think obviously they do amazing things, and I'm a strong believer in patent protection and intellectual property protection, but this is very obviously gaming the system, and that needs to stop," he said.
- In response, Van Etten said, "We don’t condone bad behavior — PhRMA publicly condemns anti-competitive product hopping, which is already addressed under current law. Our worry is around the lack of clarity in this legislation and how it could discourage important medical innovations. We hope to work with the committee to address their concerns."
The big picture: In 2019, Sen. Chuck Schumer blocked Cornyn's unanimous consent request on the floor to pass this bill, arguing that larger action on drug pricing was needed.
- Now that Medicare drug price negotiation has passed in the Inflation Reduction Act, it's possible there is a clearer path for this measure.
- Cornyn said he had "no idea" what Schumer plans to do on the bill now, but added, "If we can get it through the Judiciary Committee again with a strong bipartisan vote, then I think that bodes well."
- Judiciary is also marking up other drug pricing bills, including one aimed at preventing "pay for delay" deals that hold off generic competition.
- "We believe they all have a good chance of moving through the full Senate," a Judiciary Committee Democratic aide said of the drug pricing bills, noting they are bipartisan.
The bottom line: The patent thicket portion of the bill may have a better chance of passage than the product hopping section, given less opposition on that front from the pharmaceutical industry and from the House GOP.
- Any action on the bill is a test of Congress' appetite for continuing to take on the pharmaceutical industry in the wake of the IRA — and whether it can do so in a bipartisan manner this time.
