THE REFILL: Latest Dosage of Rx Patent Abuse


  • Recent Study Points to Need for Patent Reform to Balance Competition with Innovation 
    Recently, a new study by Nature Biotechnology 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%).

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.

  • ICYMI: Biosimilar Competition in the Pharmaceutical Marketplace Could Lower Drug Prices for Many Brand-Name Drugs
    Recently, a study by the RAND Corporation 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.
  • Matthew Lane, executive director for the Coalition Against Patent Abuse stated: “For too long, the financial burden of overpriced prescriptions has been put on the patient, in part due to anti-competitive tactics used by some pharmaceutical companies to indefinitely extend market exclusivity of brand name drugs. Thankfully, it is not too late for Congress to move legislation in the right direction to improve access to effective, high-quality and affordable generic and biosimilar medicines.”

Read more here.


STAT News: ‘Skinny Label’ For Generic Version Of A Pricey Cancer Drug Cut Costs For Consumers
Ed Silverman

  • After a ‘skinny label’ was used to market a generic version of a pricey brand-name medicine, more consumers gained access to the lower-cost copycat drug and saved on out-of-pockets cost, a new study finds. In this instance, a generic version of the Gleevec cancer drug became available in 2016.

STAT News: Patent Thickets Are Thwarting U.S. Availability Of Lower-Cost Biosimilar Medicines, Study Finds
Ed Silverman                                          

  • Amid debate over competition in the pharmaceutical industry, a new analysis found just 6% of patents covered key ingredients — or innovative new molecules — in pricey biologic medicines, underscoring concerns that drug makers abuse the patent system when they go to court to thwart rivals. The researchers examined 21 patent infringement lawsuits filed by pharmaceutical companies against other drug makers and identified 179 patents that were allegedly infringed. 

Bloomberg Government: Pharma Lobbying Hit Record as Democrats Took on Drug Pricing
Alex Ruoff

  • The main influence firm for drugmakers spent a record amount lobbying last year, as Democrats attempted to pass legislation to allow the government to negotiate for better prices on medicines. The Pharmaceutical Research and Manufacturers of America spent nearly $29.6 million on lobbying in 2021, the most the group has ever spent, according to federal disclosures filed Thursday.