THE REFILL: Latest Dosage of Rx Patent Abuse


  • During a hearing before the Senate Finance Committee, United States Secretary of Health and Human Services Alex Azar highlighted the need for legislation to address Big Pharma’s use of patent thickets to abuse the American patent system.
  • “Just one drug alone the savings from biosimilar market entry would be billions of dollars of savings but they layer patent on patent on patent, late on patents, manufacturing process patents. Just added, added, extending beyond anything that one would have thought of as the original deal for intellectual property when the original products were approved. It’s what’s stopping us from having a robust biosimilar market here in the United States. We’re approving historic levels of biosimilars, but they have to get to market, they’ve got to be reimbursed, there has to got be financial incentive to use them.” — United States Secretary of Health and Human Services Alex Azar
  • President Trump addressed the need to lower prescription drug prices during the 2020 State of the Union. CAPA commends the administration’s efforts to expand patient access to more affordable life-changing medications and treatments and looks forward to working with the Administration to address Big Pharma’s abuse of the patent system.
  • As the administration focuses on approving more generic drugs to increase competition in the marketplace, any substantive plan to lower prescription drug costs for millions of American patients must address the issue of patent abuse by brand-name companies. It’s through this type of multifaceted approach that we can put an end to abusive practices within our patent system that directly contribute to skyrocketing prescription drug prices. We look forward to seeing what progress the administration makes in these efforts and encourage all lawmakers to come together for practical solutions that benefit American patients.” – Matthew Lane, Executive Director of the Coalition Against Patent Abuse
  • The Food and Drug Administration (FDA) released a proposal to speed up the application review process for biosimilars to get into the marketplace. Reported by Politico Pro, the proposal will also attempt to address the “skinny label” problem, where older drugs are re-patented to treat other diseases, by making it easier for biosimilars come onto the market for off-patent uses.
  • “The guidance document promises to try to shorten its expanded use application reviews from 10 months to six months as part of the Trump administration’s effort to get more generics approved and lower health care prices. The 10-month goal was set in 2018 user fee negotiations.” — Politico Pro


STAT News: U.S. Officials Lash Out At The Dutch Government For Moves That ‘Undermine’ Pharma Patent Rights
Ed Silverman

  • In an unusual move, the U.S. Embassy in the Netherlands is taking the Dutch government to task for policies that would purportedly undermine patent rights held by drug makers, drawing criticism from consumer advocates who argue such declarations place pharmaceutical industry profits over patients. Late last month, the embassy issued a missive criticizing Dutch officials for plans to expand compulsory licensing and pharmaceutical compounding, which would “send a clear message” to companies that patents in the Netherlands “can be undermined or circumvented for short-term financial benefits.”

STAT News: In Their Words: Warren, Buttigieg, Klobuchar, And Other Democrats Explain Exactly How They’d Lower Drug Prices
Andrew Joseph

  • Every single Democratic presidential candidate agrees that the federal government should take a far more aggressive approach to lowering drug prices — including letting Medicare negotiate drug prices. But beyond that plank, there are quite a few differences between the candidates when it comes to taking on the pharmaceutical industry. To suss out exactly where they diverge, STAT questioned seven candidates during their interviews with the editorial board of the Boston Globe, STAT’s sister publication.

Axios: Why Biogen’s Generic Drug Patent Win Matters
Bob Herman

  • Mylan is itching to make a generic version of Biogen’s popular multiple sclerosis drug Tecfidera, but that won’t be happening for a while now that federal patent reviewers turned down Mylan’s patent challenge. The big picture: The victory for Biogen not only secures several more years of monopoly pricing for the company — Biogen has a history of raising Tecfidera’s list price by at least 5% per year — but also likely will create a higher baseline price for when Tecfidera generics finally come out.

Center For Biosimilars: FDA, FTC Pledge Close Cooperation To Create Biosimilar Competition
Allison Inserro

  • The subject of the FTC’s involvement in the biosimilars market came up several times in 2019 in various congressional hearings about drug pricing as well as proposed legislation. A role for the FTC was included in the Affordable Prescriptions for Patients Act of 2019 (S. 1416) but the bipartisan bill was blocked late last year by Senate Majority Leader Chuck Schumer, D-New York. Another bipartisan bill introduced in the House of Representative, HR 2387, Stop the Overuse of Petitions and Get Affordable Medicines to Enter Soon Act of 2019, codified the FDA’s plan to the decide if citizen petitions are abusive and meant to stall a generic drug’s approval, and it directs the HHS secretary to report such petitions to the FTC.