THE REFILL: Latest Dosage of Rx Patent Abuse


  • CAPA Points To Patent Quality As Key To Ultimately Lowering Prescription Drug Prices 
    In a recent op-ed as part of Patent Quality Week, CAPA Executive Director Matthew Lane outlined the ways in which the pharmaceutical marketplace is impacted by Big Pharma’s manipulation and abuse of the U.S. patent system. Particularly, Lane dives into the effects of patent thickets, which can block competition for an extended period of time while saddling the high cost of news drugs on the backs of hardworking taxpayers.
    Key Excerpts:
    • “Prescription drug spending remains a critical issue in the United States… In 2020, the total US drug spending was estimated at $358.7 billion… One of the key drivers of these rising costs are the habit of drug makers of blocking competition on older drugs that have proven themselves to be blockbusters. And the best modern strategy for doing that is creating a patent thicket.” 
    • “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…” 
    • “The 2020 US revenues of just three drugs – Humira, Enbrel and Revlimid – represent 8.2% of total drug spending in that year. All three of these drugs should be facing competition now or be close to the end of their monopoly terms… Humira has a deal with biosimilar manufacturers that allows them to come to market in 2023, but Enbrel and Revlimid’s final patents don’t expire until 2029 and 2036. Add Imbruvica, a drug we could have seen competition this decade but won’t, and just those four drugs represent almost 10% of all US drug spending.” 
    • “Competition, on the other hand, works when allowed to… As competition from biosimilars and generics hits the marketplace, sales of the industry’s top performing drugs correspondingly drop.” 
    • “Drug patent thickets are largely made up of low quality patents… the USPTO’s inter partes review process (IPR) has been instrumental in cancelling low-quality patents and allowing new drug competition. This is one of the best tools created by the America Invents Act to cut through these dense patent thickets. IPRs were substantially weakened under the last administration, but a Congress that cares about drug pricing could restore and strengthen this tool to great effect.” Read the full op-ed here.


Inside Health Policy: Senate Judiciary Panel Eyes Patent, Antitrust Bills To Spur Competition

Gabrielle Wanneh

  • Right off the heels of President Joe Biden’s executive order to boost competition across multiple business sectors, a Senate Judiciary subcommittee held a hearing Tuesday (July 13) on ways to boost pharmaceutical competition through reforms to antitrust and patent laws and allowing Medicare to negotiate drug prices.

STAT News: Advocates Urge Biden To Name Patent Office Director That Could Transform Drug Pricing

Ed Silverman

  • As the White House gets set to name a new head of the U.S. Patent & Trademark Office, a coalition of advocacy and nonprofit groups see an opportunity to overhaul the approach to issuing patents that may sometimes prevent Americans from accessing needed medicines. For the past several years, patent protection has become a flashpoint in the wider debate over the rising cost of prescription medicines in the U.S.

Washington Examiner: Prescription Drug ‘Sticker Prices’ May Rise In 2021 After Years Of Decline

David Hogberg

  • The number of list price increases of prescription drugs is expected to rise in 2021, reversing a trend of the past five years. A study from 46brooklyn Research, an organization tracking drug prices, found the number of list price increases of brand-name drugs in 2021 has already exceeded the number in 2020, and it is likely to exceed 2018 and 2019. Through July 2021, list price increases are already at 1,156. In 2020, there were 1,064.

STAT News: Biden Wants To Bolster The Pharma Supply Chain. A Major Generic Plant Closing May Make That Harder

Ed Silverman

  • If you think bolstering the pharmaceutical supply chain in the U.S. is a national priority, you could be wrong. Just take a look at the sorry situation in Morgantown, W. Va. A decades-old generic-drug manufacturing plant run by Viatris — which was created last fall through a merger of Mylan and Pfizer’s Upjohn unit — will close this week, eliminating more than 1,200 jobs. Another 200 or so will go next year. The production work is being sent overseas, mostly to India, where Mylan already operates several facilities.