Pharma’s ready to rumble ... over patents
There’s a fight brewing over legislation meant to rein in the over-patenting of drugs. Drug makers are trying to gut a bill from Sens. John Cornyn (R-Texas) and Richard Blumenthal (D-Conn.) that would open up drug makers to Federal Trade Commission lawsuits when they’re suspected of product hopping (where drug makers introduce a new, slightly tweaked version of a drug to thwart competition) and patent thicketing (where drug makers file dozens or even hundreds of patents on a single drug to keep competitors off the market well beyond the exclusivity period awarded by the FDA).
This is a big deal for the drug industry: If Cornyn and Blumenthal’s bill passes, some of the nation’s top drug makers like AbbVie would suddenly be vulnerable to new lawsuits. And industry is running out of time to stop it. The Senate Judiciary Committee announced Monday night that it'll begin considering the bill during a Thursday hearing, though the bill likely won't be formally acted upon until the following week. The committee will also consider three other drug pricing bills.
Multiple drug industry lobbyists told me pharma is pushing lawmakers to strike the thicketing section of the bill altogether. One lobbyist tells me the trade group PhRMA has had multiple strategy calls to discuss the patent legislation. And multiple lobbyists said the broader industry is also enlisting the help of Sen. Thom Tillis (R-N.C.), who has been a stalwart defender of the patent system and a friend of the drug industry. Exactly how he’ll intervene isn’t quite clear, but lobbyists suggested he could negotiate with Cornyn on new language or even introduce his own legislation on the issue.
PhRMA did not comment on questions about its lobbying strategy, but in a statement a spokesperson said the bill: “would fundamentally upend the biopharmaceutical innovation ecosystem, creating a presumption of violation for almost any post-approval innovation.”
The aggressive stance from pharma has advocates for the bill worried. “It would be extremely disappointing to see Sen. Cornyn’s bill gutted due to pressure from the pharma lobby. Sen. Cornyn and his colleagues need to decide who they’re with — prescription drug corporations or patients who need lower drug prices now,” Public Citizen’s Steve Knievel told STAT.
It doesn’t appear the drug industry has won just yet: The latest version of the bill, obtained Monday by STAT, still includes the patent thicketing language.
That isn’t the only patent reform bill that stands a chance of being taken up this month. Cornyn also has introduced legislation with Sen. Patty Murray (D-Wash.) that also takes aim at the thicketing issue — albeit in a more industry friendly way. While the bill isn’t currently included in a separate draft proposal being mulled by the Senate HELP Committee, Murray’s role as ranking member of the committee makes her as well suited to get the bill in the package as anyone.
While you’re at it, my colleague Ed Silverman has a new story out this morning about Sen. Debbie Stabnow (D-Mich.) and Rep. Elijah Cummings (D-Md.) writing to the Government Accountability Office about how it manages patents that were discovered through tax-payer funded research. That story is just up this morning, here.
This is a big deal for the drug industry: If Cornyn and Blumenthal’s bill passes, some of the nation’s top drug makers like AbbVie would suddenly be vulnerable to new lawsuits. And industry is running out of time to stop it. The Senate Judiciary Committee announced Monday night that it'll begin considering the bill during a Thursday hearing, though the bill likely won't be formally acted upon until the following week. The committee will also consider three other drug pricing bills.
Multiple drug industry lobbyists told me pharma is pushing lawmakers to strike the thicketing section of the bill altogether. One lobbyist tells me the trade group PhRMA has had multiple strategy calls to discuss the patent legislation. And multiple lobbyists said the broader industry is also enlisting the help of Sen. Thom Tillis (R-N.C.), who has been a stalwart defender of the patent system and a friend of the drug industry. Exactly how he’ll intervene isn’t quite clear, but lobbyists suggested he could negotiate with Cornyn on new language or even introduce his own legislation on the issue.
PhRMA did not comment on questions about its lobbying strategy, but in a statement a spokesperson said the bill: “would fundamentally upend the biopharmaceutical innovation ecosystem, creating a presumption of violation for almost any post-approval innovation.”
The aggressive stance from pharma has advocates for the bill worried. “It would be extremely disappointing to see Sen. Cornyn’s bill gutted due to pressure from the pharma lobby. Sen. Cornyn and his colleagues need to decide who they’re with — prescription drug corporations or patients who need lower drug prices now,” Public Citizen’s Steve Knievel told STAT.
It doesn’t appear the drug industry has won just yet: The latest version of the bill, obtained Monday by STAT, still includes the patent thicketing language.
That isn’t the only patent reform bill that stands a chance of being taken up this month. Cornyn also has introduced legislation with Sen. Patty Murray (D-Wash.) that also takes aim at the thicketing issue — albeit in a more industry friendly way. While the bill isn’t currently included in a separate draft proposal being mulled by the Senate HELP Committee, Murray’s role as ranking member of the committee makes her as well suited to get the bill in the package as anyone.
While you’re at it, my colleague Ed Silverman has a new story out this morning about Sen. Debbie Stabnow (D-Mich.) and Rep. Elijah Cummings (D-Md.) writing to the Government Accountability Office about how it manages patents that were discovered through tax-payer funded research. That story is just up this morning, here.
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