It’s a big week for drug pricing on Capitol Hill — and we’ve got the latest intel
Two major pieces of legislation are expected to move forward in Congress this week.
First up: The Senate Judiciary Committee is planning to hold a markup on a package of patent bills this Thursday. The drug industry successfully watered down the most consequential bill in that package, a measure from Sen. John Cornyn (R-Texas) that took aim at so-called patent thickets. (You can read plenty more about the twists and turns that process has taken, here.)
Now, it’s looking increasingly like the committee’s chairman, Sen. Lindsey Graham, may leave his own mark on the bill. (Though even Monday afternoon, rumors were flying that he may have gotten gun shy and stood down.)
Nonetheless, drug makers are on high alert over a new potential amendment from Graham that would take on so-called patent evergreening by making it harder for drug makers to use patents on new drug formulations or delivery mechanisms to block lower cost drugs from coming to market. The bill “would effectively require separate patent applications for compounds, delivery methods, [and] dosing,” a summary of that draft amendment obtained by STAT states. If enacted, this would mean a generic or biosimilar maker could copy a branded drug whose main patent has expired without having to also challenge all the secondary patents protecting the drug.
It’s also still unclear what will happen to a separate Cornyn proposal to limit the number of patent lawsuits a biologic maker can bring under federal law. Lobbyists expected Cornyn to offer that instead of his patent thicketing measure, but that language may still be in flux after objections from the generic drug industry, according to lobbyists on both sides of that fight.
Keep the popcorn handy, folks — I’d guess there’ll be plenty more drama before the markup on Thursday.
Not to be outdone, the Senate HELP Committee will mark up the “Lower Health Costs Act,” which, as of Monday, contains the long-awaited CREATES Act plus a priority of Senate Majority Leader Mitch McConnell’s: banning tobacco sales to people under age 21.
That package also contains the BLOCKING Act, a bill that would start the 180-day clock on exclusivity for first generics when they’re accused of blocking other generics from coming to market. Jeff Francer, the general counsel for the Association for Accessible Medicines — the generic drug industry’s D.C. lobby — told reporters Monday the bill would “gut 180-day exclusivity period” generic companies rely on for revenue and result in less competition overall.
That markup is Wednesday.
First up: The Senate Judiciary Committee is planning to hold a markup on a package of patent bills this Thursday. The drug industry successfully watered down the most consequential bill in that package, a measure from Sen. John Cornyn (R-Texas) that took aim at so-called patent thickets. (You can read plenty more about the twists and turns that process has taken, here.)
Now, it’s looking increasingly like the committee’s chairman, Sen. Lindsey Graham, may leave his own mark on the bill. (Though even Monday afternoon, rumors were flying that he may have gotten gun shy and stood down.)
Nonetheless, drug makers are on high alert over a new potential amendment from Graham that would take on so-called patent evergreening by making it harder for drug makers to use patents on new drug formulations or delivery mechanisms to block lower cost drugs from coming to market. The bill “would effectively require separate patent applications for compounds, delivery methods, [and] dosing,” a summary of that draft amendment obtained by STAT states. If enacted, this would mean a generic or biosimilar maker could copy a branded drug whose main patent has expired without having to also challenge all the secondary patents protecting the drug.
It’s also still unclear what will happen to a separate Cornyn proposal to limit the number of patent lawsuits a biologic maker can bring under federal law. Lobbyists expected Cornyn to offer that instead of his patent thicketing measure, but that language may still be in flux after objections from the generic drug industry, according to lobbyists on both sides of that fight.
Keep the popcorn handy, folks — I’d guess there’ll be plenty more drama before the markup on Thursday.
Not to be outdone, the Senate HELP Committee will mark up the “Lower Health Costs Act,” which, as of Monday, contains the long-awaited CREATES Act plus a priority of Senate Majority Leader Mitch McConnell’s: banning tobacco sales to people under age 21.
That package also contains the BLOCKING Act, a bill that would start the 180-day clock on exclusivity for first generics when they’re accused of blocking other generics from coming to market. Jeff Francer, the general counsel for the Association for Accessible Medicines — the generic drug industry’s D.C. lobby — told reporters Monday the bill would “gut 180-day exclusivity period” generic companies rely on for revenue and result in less competition overall.
That markup is Wednesday.
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