New Study Finds Further Evidence of Big Pharma’s Patent Abuse That Thwarts Lower-Cost Alternatives From Entering the Marketplace

Study Finds Pharmaceutical Companies Largely Rely on Low-Quality Patents to Shield Brand-Name Drugs From Biosimilar Competition

WASHINGTON, D.C. – This week, Nature Biotechnology released a new study titled, “The Characteristics of Patents Impacting Availability of Biosimilars,” that revealed many pharmaceutical companies engage in patent thicketing to limit competition from lower-cost alternatives in the marketplace.  Out of the 21 patent lawsuits examined, only 6 percent of patents covered active ingredients. The overwhelming majority of patents asserted were for manufacturing processes (42%) and methods of use (24%).

“This study is another reminder of just how big the drug pricing issue is today, and a key driver of rising costs is the continued abuse by drug makers who block competition on older, brand-name drugs.  Meanwhile, American patients are saddled with high costs and little choice at the pharmacy counter,” stated Matthew Lane, executive director of the Coalition Against Patent Abuse.  “This continued use of anticompetitive tactics by Big Pharma underscores the urgency for Congress to pass critical reforms to balance competition with innovation.”

Recently, a study by the RAND Corporation, “Projected US Savings From Biosimilars, 2021-2025,” 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.

As the Coalition Against Patent Abuse previously determined in a White Paper, 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 hundreds of patent applications to extend their monopolies.  As often pointed out, Drug manufacturer 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 1 spot as the world’s bestseller since 2012.

Other takeaways from Nature Biotechnology’s study include: 

  • “Biologics accounted for 48% of net manufacturer revenue and 43% of total medicine spending in the United States in 2019… Biologics are also more expensive. Many of the most widely used biologics have annual net prices of more than US$30,000 per year…”
  • “As of June 2020, only 24 of 177 (14%) approved biologics had approved biosimilars or biosimilars in development.”
  • “A total of 179 patents were allegedly infringed in 21 cases involving 9 originator biologics… Of these patents, 76 (42%) covered manufacturing processes, 63 (35%) covered methods of use, 43 (24%) covered formulations, 11 (6%) covered active ingredients, and 3 (1%) covered devices (Fig. 1). Fourteen (8%) patents met more than one category.”
  • “Among patents asserted in US biosimilar litigation, only 6% covered the active ingredient in the biologic drug, while the vast majority covered uses or peripheral features of the drug, such as its manufacturing processes or delivery devices. The median time of patent filing was more than a decade after approval of the originator biologic, and one-fifth of the patents had no equivalents — either patents or patent applications — in the European Union, Canada or Japan.”

Read the full Nature Biotechnology study here.  

Learn more about CAPA’s mission to fight abuses of the patent system here.

Executive Director Matthew Lane also authored an op-ed recently in TechDirt outlining the ways in which the pharmaceutical marketplace is impacted by Big Pharma’s manipulation and abuse of the U.S. patent system.