THE REFILL: Latest Dosage of Rx Patent Abuse


  • CAPA Continues “Spot-On Savings” Mini-Series To Show How The IPR Process Can Generate Savings For Millions Of Patients & The U.S. Healthcare System. Part II: IPR & Zytiga – Competition Matters – Here, CAPA looks at how the IPR proceeding for the prostate cancer medicine Zytiga accelerated patient access to generic medicine.  The PTAB Board concluded that Janssen Biotech’s patent on Zytiga, which is made from combining steroids with other anti-cancer treatments, was not a unique or innovative combination.  The Federal Circuit agreed that combining these drugs was a well-known method to make treatments more effective.  Thanks to IPR, generic competitors were able to enter the marketplace and offer $2-$9 per dose, compared to $88 for the brand name. Read the full blog post here. recent report by Patients for Affordable Drugs titled, “Big Pharma’s Big Lie: The Truth About Innovation and Drug Prices” shows how major pharmaceutical companies’ high drug prices – fueled in large part by gaming of the U.S. patent system – do little to fund innovation. Some pharmaceutical companies argue that high drug prices are necessary for the invention of new treatments, but that it simply false.  True innovation comes from competition, not using patent abuse to maintain monopolies and high drug prices.  
  • CAPA IN THE NEWS: Teva Patent Case Redo Spotlights Use of Generic ‘Skinny Labels’ by Ian Lopez – Key Excerpts:
    • “A Federal Circuit rehearing in a patent case against Teva Pharmaceutical Industries Ltd. could offer clarity over the extent to which generic drugmakers can rely on a once surefire practice for quick market entry.”  
    • “The initial decision was bad for drug pricing and raised ‘a lot of red flags’ from health-care industry officials, said Matthew Lane, executive director of the Coalition Against Patent Abuse. A new Federal Circuit decision along the same lines may prove problematic as well.”  
    • “Such a decision could make it harder for generics to get around “patent thicketing,” or overlapping intellectual property rights on a product and its uses—a practice that can be applied for blocking generics from entering the market.”


STAT News: To The Delight Of Generic Drug Makers, Federal Appeals Court Tosses Controversial ‘Skinny Labeling’ Decision
Ed Silverman

  • In a surprising move, a federal appeals court panel may revisit a controversial decision that has raised concerns about the ability of generic drug makers to supply Americans with lower-cost alternatives to pricey brand-name medicines. At issue is an odd term with important implications: skinny labeling. The phrase refers to an effort by a generic company to seek regulatory approval to market its medicine for a specific use, but not other patented uses for which a brand-name drug is prescribed… By doing so, the generic company seeks to avoid lawsuits claiming patent infringement.

Inside Health Policy: Report: Approving 7 Complex Generics Would Save US $1.3B Annually
John Wilkerson

  • The United States would save $1.3 billion annually if FDA were to approve seven complex generics already available in Canada or Europe, according to report by US Matrix Global Advisors. Congress must renew FDA’s generic user fee program next year, and that is viewed as the vehicle for speeding complex generic drug approvals. Complex generics copy brand drugs with complex molecular bases, routes of delivery, formulations or dosage forms.

Becker’s Hospital Review: More Than 800 Drug Prices Increased In January By An Average Of Nearly 5%
Katie Adams

  • In January, 832 drugs’ list prices increased by an average of 4.6 percent, the largest increase the pharmaceutical industry has experienced in years, according to a Feb. 2 report from prescription discount company GoodRx. Below are the 15 drugs whose prices increased the most from January 2019 to January 2021, along with their total price increase percentage during that time period.

Inside Health Policy: Senate Bill Would Make It Harder To Keep Orphan Drug Exclusivity
John Wilkerson

  • A bipartisan group of senators on Thursday (Feb. 4) introduced legislation to let FDA remove orphan drug exclusivity when drug companies cannot prove that drugs would be economically unviable if they were to face competition. Orphan drug exclusivity is an incentive to invent drugs for rare diseases and conditions that affect fewer than 200,000 people. Drug makers also may get orphan exclusivity when they do not expect to recoup the cost of developing drugs.