THE REFILL: Latest Dosage of Rx Patent Abuse


  • CAPA Applauds Introduction of the “Restoring the America Invents Act” Targeting Patent Abuse

    CAPA released a statement commending Senator Patrick Leahy (D-VT) and Senator John Cornyn (R-TX) on the introduction of the “Restoring the America Invents Act” to reform the U.S. patent system and strengthen tools within the U.S. Patent and Trademark Office, such as the inter partes review process, that helps eliminate low-quality patents.   “CAPA welcomes the introduction of the Restoring the America Invents Act as a practical solution to reducing patent system abuse that denies access to safe, lower-cost medicines for millions of patients.” Lane goes on to add that, “It’s been ten years since the America Invents Act was passed with the goal to balance the value of innovation with price-reducing competition.  Unfortunately, continued patent abuse by many major pharmaceutical companies has tilted this balance away from pro-patient, pro-consumer competition and drug pricing.  Now, it is up to Congress to enact meaningful legislation to lower drug costs and make true innovation sustainable for generations to come, and this is a strong step towards that goal.” 

Read the full statement here.

  • CAPA Calls On Congress to Prevent Anti-Competitive Tactics, Increase Avenues for Generic Competition

    Recently, the House Judiciary Committee passed three bills regarding patent reform and drug pricing.  Notably, the bills targeted anti-competitive practices like product-hopping and patent thickets. CAPA Executive Director Matthew Lane applauded the initiatives and added, “Congress must continue to make progress on ensuring more competition in the marketplace so millions of American patients can access more affordable generic alternative medications and treatments.  It is also imperative that Congress and the Administration keep working to strengthen the inter partes review process, which has proven to be an effective tool used by the U.S. Patent and Trademark Office to identify anti-competitive patent practices and invalidate low-quality patents.” 

Read the full statement here.

  • ICYMI: Big Pharma Abuses Drug Patents To Prop Up Prices 

    In case you missed it, an op-ed by Sandra Newell, a Denver community leader, titled “Big Pharma abuses drug patents to prop up prices” was placed in Colorado Politics on October 6 calling on Congress to end patent abuse to help lower prescription drug prices. “Big Pharma has ways to keep these prices rising year after year. By stockpiling patents, manufacturers of brand name prescription drugs can extend their monopolies and keep cheaper generic and biosimilar drugs out of the market — thus ensuring that Coloradans struggling to afford their prescriptions must continue to pay these high prices by limiting competition,” Newell writes. Newell points to the patent abuse by Abbvie’s Humira and points out that, “90 percent of the patents were applied for after the U.S. Food and Drug Administration (FDA) initially approved the drug, or after the drug was already on the market.  This egregious number of patents has kept all generic, cheaper competition to Humira out of the U.S. market for 39 years.” “Sens. Bennet and Hickenlooper must work across the aisle to end the abuse of the patent system to increase competition in the pharmaceutical marketplace and increase transparency so Big Pharma can no longer skate by after raising their prices without justification or public scrutiny,” Newell concludes. 

Read the full piece here.


Bloomberg Law: Biden Drug Price Pressure On Patent Office Draws Skeptics
Ian Lopez

  • The Biden administration’s approach to bring down drug costs by challenging aspects of the U.S. patent system lines up with a push from Democrats and Republicans in Congress, but skeptics say it’s looking in the wrong direction. President Joe Biden, working through the Food and Drug Administration, has asked the Patent and Trademark Office to reconsider practices often criticized as vehicles for pharmaceutical companies to block generic competition, effectively extending their drug monopolies.

Financial Times: Merck On Deals Hunt As Patent Cliff Looms For Top Cancer Drug
Jamie Smyth & James Fontanella-Khan

  • Merck’s cancer immunotherapy Keytruda is a wonder drug that has transformed not just the survival odds of thousands of patients but also the pharmaceutical company’s fortunes. However, with the drug poised to lose patent protection in 2028, recently-appointed chief executive Rob Davis must find new treatments to plug an eventual decline in sales when rivals launch cheaper versions.

Inside Health Policy: House Judiciary Advances DrugPatentBills After Two-Day Deliberation
Gabrielle Wanneh

  • The House Judiciary Committee this week passed four drugpatent bills aimed at enhancing competition of generic drugs and biosimilars after a two-day markup that began Wednesday (Sept. 29). The markup comes amid a debate among Democrats in both chambers over how to write Medicare drug price negotiation legislation.

Bloomberg Government: Small Biotechs Waived From Drug Pricing Bill, Finance Chair Vows
Alex Ruoff

  • A Senate leader crafting a drug pricing proposal is trying to win the support of centrist Democrats by promising to carve out exceptions for small biotech companies. Those moderate senators are warning they won’t commit until they see all the details. Ron Wyden (D-Ore.), chairman of the Senate Finance Committee, said he’s promised that pharmaceutical companies with limited access to capital or that invest heavily in research could be exempt from central parts of his drug pricing bill, which he has yet to unveil completely.