THE REFILL: Latest Dosage of Rx Patent Abuse


  • ICYMI: Kathi Vidal Confirmed as Director of U.S. Patent and Trademark Office
    In case you missed it, the U.S. Senate confirmed Katherine Vidal as Under Secretary of Commerce for Intellectual Property and Director of the United States Patent and Trademark Office (USPTO).

To read the full statement, click here. 

  • The Evidence Exists: Discover the Truth Behind Out-of-Control Drug Prices
    The lack of affordability for prescription drugs is reaching a fever pitch nationwide.  While some attempt to evade the truth, ample evidence points to continued abuses of the U.S. patent system as a large driver in today’s skyrocketing drug costs.  It is time our lawmakers in Washington recognize and address the anti-competitive methods drug makers use to extend market exclusivity of brand-name drugs and prevent low-cost alternatives from entering the marketplace.  Patents aren’t the problem – abuse of the U.S. patent system is.

    But don’t take our word for it. Check out reports below to learn more:
    • In January, Nature Biotechnology released a study that revealed the extent to which drug makers were gaming the patent system by way of stockpiling patents to keep generic and biosimilar competition from entering the market, a process known as “patent thicketing.”
    • Of the 21 patent lawsuits examined, just six percent covered active ingredients within the drugs. Meanwhile, most patents were for manufacturing processes, 42 percent, or methods of use, 24 percent.
    • Another report titled, “Estimating The Cost Of Delayed Generic Drug Entry To Medicaid” found that Medicare spent an average of $109 million a year from 2010-16 due to delayed generic entry. The most common cause of generic delay was patent litigation.

Read more on drug makers’ patent abuses here.


Modern Healthcare: Biosimilars, Generics To Slow Drug Cost Increases In 2022
Alex Kacik                                             

  • Biosimilars and generic drugs are poised to slow drug cost growth this year, a new report indicates. Total drug spending increased 7.7% from 2020 to 2021 to $576.9 billion, driven by an uptick in the utilization of COVID-19 therapies, according to an American Society of Health-System Pharmacists analysis. Drug prices only increased 1.9% in 2021, in part thanks to new biosimilars and generics that came to market. Drug spending rose 4.9% to $535.3 billion from 2019 to 2020 while prices ticked up 0.3%.

STAT News: Incentives To Spur Repurposing Of Existing Generics For Novel Uses Would Open A New Paradigm In Drug R&D
Marc Herant and Jason Brauner              

  • The Drug Price Competition and Patent Term Restoration Act of 1984, better known as the Hatch-Waxman Act, which enabled the regulatory process for generic drugs, has been remarkably successful. Generic drugs now represent about 90% of prescriptions, bringing substantial cost savings to the health care system.

Bloomberg Law: High Drug Prices Spur New Call To Probe Impact Of IP Rights
Ian Lopez

  • Republican Sen. Thom Tillis is upping a call for the Food and Drug Administration to investigate claims that pharmaceutical companies’ intellectual property rights are a culprit behind the high costs for blockbuster drugs. The Biden administration,  Democratic lawmakers and activists have all taken shots at the American IP system for fueling those costs. But many stakeholders are doubtful that patents are to blame, with some taking issue with data used to bolster such claims.