THE REFILL: Latest Dosage of Rx Patent Abuse


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

    “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.” 

    Read More From CAPA on the Federal Circuit’s Decision to Throw Generics’ ‘Skinny Label’ Back in Jeopardy Here 
  • CAPA Joined in the Conversation Around the Next U.S. Patent and Trademark Office Director 

    In a Bloomberg Law article, CAPA Executive Director Matthew Lane weighed in on the rumors that President Biden’s pick for USPTO Director could expand efforts to limit the number of patents granted. 

    Read the full article here 
  • CAPA Kept a Close Eye on Big Pharma’s Anti-Competitive Tactics that Keep Drug Prices High, Such as AbbVie’s International Pricing of Humira

    Axios reported that 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.

    CAPA Executive Director Matthew Lane stated: “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.”

    Read more here 
  • CAPA’s Executive Director Matthew Lane penned an op-ed in Morning Consult on the need to address patent abuse and anti-competitive pricing tactics used by some major pharmaceutical companies. 

    In his op-ed, Mr. Lane dives into the current imbalance between rewarding new drug innovations and competition from low-cost alternatives.  The continued manipulation of the U.S. patent system hasn’t helped either, allowing some major drug companies to extend market exclusivity for their drugs, sometimes indefinitely, keeping prices high for millions.

    Click Here to Read the Full Op-ed in Morning Consult 
  • CAPA Concluded “Spot-On Savings” Mini-Series Showing How The IPR Process Can Generate Savings For Millions Of Patients & The U.S. Healthcare System – Calls on Congress to Strengthen IPR.

    It is clear that the IPR process generates savings for patients and the entire U.S. healthcare system as a cost-effective tool for knocking down erroneously issued patents.  IPR should be strengthened, but repeated legal challenges have weakened its ability to correct erroneously issued patents.

    You can find the entire blog series here.


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

… 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. An executive order Biden issued earlier this month calls for measures to bolster competition to lower drug prices… 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.

Inside Health Policy: Generics Ask HHS To Include Rebate, Biosimilar Policies In Plan To Biden
John Wilkerson

Proposals to avoid rebate walls, mandate preferred formulary placement for biosimilars and share savings from biosimilars with doctors are among the many policies that the generic drug industry suggests HHS include in a drug-pricing report due to President Biden Monday (Aug. 23). The Association for Accessible Medicines also would like HHS to clarify rules for so-called skinny labels because the generic drug lobby says a recent court ruling makes the common tactic all but impossible for generic drug makers to use, and without skinny labels generic competition will often be stalled.