THE REFILL: Latest Dosage of Rx Patent Abuse

WHAT YOU NEED TO KNOW

  • In case you missed it, the Coalition Against Patent Abuse applauded a recent decision by the U.S. House of Representatives’ Committee on Oversight and Reform to subpoena AbbVie, the drug company that makes Humira, as part of its probe into pricing practices by the big drug companies.  
    • “CAPA applauds today’s announcement by the House Committee on Oversight to require AbbVie to produce documents concerning its pricing practices for expensive medicines like Humira.  That AbbVie has refused to be forthcoming with Congress about its pricing practices should speak volumes,” stated Matthew Lane, executive director of the Coalition Against Patent Abuse. “With millions of Americans struggling with high drug prices it’s more important than ever for Congress to address the root causes of this problem which includes systemic abuses of U.S. patent laws.  Our nation’s drug policies and patent system must balance competition and innovation to reward new breakthroughs in medical treatments while ensuring that patients have access to affordable medications.”
  • Big Pharma routinely makes use of underhanded tactics like patent thickets to extend their drug monopolies and prevent American patients from accessing more affordable generic drug and treatment alternatives.  As the House Oversight Committee noted in a memo announcing their decision:
    • “In 2019, AbbVie’s United States net revenues from Humira were nearly $14.9 billion. That same year, AbbVie’s worldwide net revenues from Humira were nearly $19.2 billion.  The Initiative for Medicine, Access, and Knowledge (IMAK) found that AbbVie has filed 247 patent applications on Humira with the intention of delaying competition for 39 years. According to I-MAK, 89% of these patent applications were filed after Humira was brought to market. The company has raised the price of Humira on 18 occasions between January 1, 2009, and January 14, 2019.” 

WHAT YOU SHOULD BE READING:

Lexology: Antitrust Plaintiffs Complain Of Patent “Thickets”
David S. Kleban and Jonathan H. Hatch

  • For years, antitrust commentators have warned of threats to innovation and competition posed by “thickets” of patents—the “dense web[s] of overlapping intellectual property rights that a company must hack its way through in order to actually commercialize new technology.”…Yet an entity’s creation of such a “thicket” has rarely been the basis of antitrust claims—and never, as far as we can tell, successfully.

Health Affairs: Challenging Patents To Promote Timely Generic Drug Entry: The Second Look Act And Other Options
Liam Bendicksen, Jonathan J. Darrow, Aaron S. Kesselheim

  • When the market entry of generic drugs is delayed due to patent fights and other factors, the price tag for lost savings opportunities approaches more than $100 million annually (Health Aff 2020;39[6]:1011-1017). Among 69 brand-name drugs studied that were expected to lose patent exclusivity in 2010 to 2016, generic entry occurred before or within a quarter-year of the expected date for just 38 products (55%), the investigators found. Market entry for generics was delayed by more than a quarter for 20 products (29%) and did not occur for 11 products (16%).

Bloomberg Law: Virus Delays, Few Approvals Dry Up Generic Drug Lawsuits In 2020
Valerie Bauman

  • Drug patent lawsuits took a 21% dive from this time last year, a “perfect storm” that traces back to 2016 when the FDA only approved a handful of new drugs. That means fewer generic drugs are expected to hit the shelves based on lawsuits launched in 2020. However, the dip is expected to be temporary because the number of novel drugs winning Food and Drug Administration approval rebounded in 2017 and in subsequent years. “There’s just far fewer opportunities for generics to take advantage of this year,” said Keri Schaubert, a patent attorney at Cozen O’Connor. “When you combine that with Covid-19, you have the perfect storm.”

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