THE REFILL: Latest Dosage of Rx Patent Abuse

WHAT YOU NEED TO KNOW:

  • The Truth Behind Patent Thickets: Why Lawmakers Need to Tackle Big Pharma’s Patent Abuse that Prevents Lower-Cost Medicines from Entering the Marketplace

    Many pharmaceutical companies engage in patent thicketing to bury competition from generic and biosimilar drugs by finding ways to re-patent existing inventions. 

    The process of patent thicketing is increasingly used as a strategy to preserve monopoly pricing of brand name drugs, with the makers of the twelve best selling drugs in the U.S. filing many patent applications to extend their monopolies. 
    • AbbVie has filed over 240 patent applications for a single drug, Humira, and received over 130 granted patents. This patent thicket has allowed Humira to control the marketplace in the U.S., leading to Humira claiming the number one spot as the world’s bestseller since 2012.

Recently, the Nature Biotechnology revealed that many pharmaceutical companies engage in patent thicketing to limit competition from lower-cost alternatives in the marketplace. 

  • This study examined 21 patent lawsuits and found that only 6 percent of patents covered active ingredients. The overwhelming majority of patents asserted were for manufacturing processes (42%) and methods of use (24%).

Another study by the RAND Corporation this year found that biosimilar competition in the pharmaceutical marketplace could lower drug prices for numerous medications and lead to $38.4 billion in savings from 2021 to 2025.

Click here to learn more about strengthening the U.S. patent system.

WHAT YOU SHOULD BE READING:

STAT News: A Federal Appeals Court Once Again Casts Doubt On ‘Skinny Labels’ And Generic Drug Access
Ed Silverman

  • A U.S. appeals court upheld 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. And the generic maker on the losing end of this legal battle, Teva Pharmaceuticals (TEVA), now plans to ask the U.S. Supreme Court to overturn the decision.

Bioengineering Community: The Characteristics of Patents Impacting Availability of Biosimilars
Victor Van de Wiele and others

  • High US expenditures on prescription drugs have been fueled by expensive biologics drugs, including monoclonal antibodies and gene therapies. To address the effect of high prices on payers and patients, Congress enacted the Biologics Price Competition and Innovation Act (BPCIA) as part of the 2010 Patient Protection and Affordable Care Act. The legislation introduced an abbreviated pathway for biosimilars—versions of US Food and Drug Administration (FDA)-approved “originator” biologics made by different manufacturers—and a procedure to resolve patents disputes arising from a new biosimilar approval. 

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