THE REFILL: Latest Dosage of Rx Patent Abuse


  • CAPA Calls on Congress to Intervene as Courts Undermine the ‘Skinny Label’ Framework, Preventing Generic Competition While Drug Companies Profit

    Recently, the U.S. Court of Appeals for the Federal Circuit upheld the verdict in GlaxoSmithKline LLC v. Teva Pharmaceuticals USA, Inc., subjecting Teva to a $234 million judgment that includes damages for the period of time that it used a template skinny label provided by the Food and Drug Administration (FDA). 

    CAPA Executive Director Matthew Lane released the following statement in response: 

    “Today, millions of patients and families are increasingly impacted by high drug prices while some Big Pharma companies continue abusing the U.S. patent system through anti-competitive tactics that hurt American patients.  By allowing the original verdict to stand, the Federal Circuit has undermined the ‘skinny label’ framework used by generic drug companies to compete against brand-name drugs in the marketplace… Now, we’re calling on Congress to restore the proper functioning of the skinny label process to support innovation while encouraging generic competition.” CAPA previously warned that the recent Federal Circuit Court decision could erode Hatch-Waxman, leading to even higher drug prices.  As it stands, companies can continue their anti-generic patent thicketing strategies to establish a cluster of blocking patents around a blockbuster drug to completely bar generic entry and increase profits. 

    Read More From CAPA on the Federal Circuit’s Decision to Throw Generics’ ‘Skinny Label’ Back in Jeopardy Here  
  • Axios has the Scoop: “AbbVie’s Blockade Of Cheaper Humira Options” This week, Axios reported on international sales of Humira, a medicine that treats a number of chronic conditions and is widely prescribed and used by millions of people around the world, are declining due to the introduction of biosimilar competition in the marketplace.  Prices in the U.S. for Humira, meanwhile, continue to rise as Humira’s manufacturer AbbVie has gamed the U.S. patent system to keep out competition until 2023. 

    “It’s no secret, competition works when allowed.  Unfortunately in the U.S., loopholes within our patent system enable some major pharmaceutical companies to extend monopolies, sometimes indefinitely, on their blockbuster drugs without any regard to the costs for patients.  AbbVie’s patent blockade with Humira is the poster child for why Congress must act to reform the system,” said CAPA Executive Director Matthew Lane. 

    Key Excerpts: 
    • “Humira biosimilars entered the European market in October 2018.”  
    • “AbbVie raised Humira’s price by 7.4%at the start of this year.” Read more here  
  • ICYMI: Senate Judiciary Committee Takes Another Step Towards Ending Big Pharma’s Patent Abuse, Passes the Affordable Prescriptions for Patients Act of 2021 Out Committee 

    This bill by Senator John Cornyn (R-TX) and Senator Richard Blumenthal (D-CT) aims to reduce anti-competitive practices like product-hopping and limits the number of patents that can be asserted in patent litigation. CAPA Executive Director Matthew Lane released the following statement: 

    “CAPA applauds Senators on both sides of the aisle today for passing this legislation out of Committee as a much-needed first step towards preventing major drug companies from gaming the U.S. patent system in pursuit of higher profits.  The Affordable Prescriptions for Patients Act of 2021 is a necessary step towards tackling Big Pharma’s patent abuses that protect their monopolies at the expense of patients and the entire healthcare system.  There is certainly more work to be done, and our Coalition looks forward to working with all stakeholders on this and other proposals to rein in Big Pharma’s rampant patent abuse.”

Watch the Recent Markup Here


Washington Post: Perspective: Our Patent System Is Broken. And It Could Be Stifling Innovation

Robin Feldman

  • Patents are supposed to incentivize success. Across more than 200 years, they have emerged as an important tool for advancing society by encouraging inventors to create and share successful innovations, in exchange for the right to exclude others from the market for a limited period of time. And yet that’s not how patent law works today. Rather, we are at risk of incentivizing failure. The courts, Congress and boardrooms are advancing a simple logic that turns the patent system on its head.

Bloomberg: Biden Patent Office Pick Will Shape Fight Over High Drug Prices

Ian Lopez

  • The path toward lower drug prices could hinge on who President Joe Biden picks as the next director of the U.S. Patent and Trademark Office… Biden has yet to announce a nomination. But the debate comes amid renewed government efforts to boost access to treatments for Covid-19 and other potentially life-threatening conditions… The choice of a PTO director is “pretty important in this particular moment” for the pharma industry, said Matthew Lane, executive director of the Coalition Against Patent Abuse.

Fierce Pharma: Senate Takes Aim At Pharma’s Patent schemes, Pay-For-Delay Deals In Renewed Drug Pricing Crackdown

Kevin Dunleavy

  • Earlier this month, groups lobbying for lower prescription drug prices called on Congress to enact long-awaited reforms and stressed the urgency of the movement. Given the change of the guard in Washington, D.C. and the fresh momentum to address anti-competitive practices, the groups told Congress that it “has a unique and time-limited window for crafting meaningful drug pricing reform this year.” Answering the call on Thursday was the Senate Judiciary Committee, which voted unanimously to advance four pieces of legislation which would help rein in the cost of prescription drugs.

STAT News: A Federal Appeals Court Throws Into Question The Fate Of ‘Skinny Labels’ — And Access To Generic Drugs

Ed Silverman

  • In a decision with enormous implications for the U.S. health care system, a federal appeals court panel issued a ruling that throws into question the ability of generic companies to “carve out” uses for their medicines and supply Americans with lower-cost alternatives to pricey brand-name drugs. At issue is skinny labeling, which refers to an effort by a generic company to seek regulatory approval to market its medicine a specific use, but not other patented uses for which a brand-name drug is prescribed.