THE REFILL: Latest Dosage of Rx Patent Abuse


  • In case you missed it, Morning Consult published an op-ed by Matthew Lane, executive director of the Coalition Against Patent Abuse, around rising prescription drug prices and the need for reforms that can encourage competition and innovation to drive access and affordability.  In his op-ed, Lane highlights a national survey by the Campaign for Sustainable Rx Pricing, which echoed a separate poll from Gallup and West Health that found American voters have long struggled with affording prescription drugs and shows the great need for leaders and the industry to address this issue. 
    • “Our nation’s drug policy is built on the idea that innovative new medicines are rewarded with a limited monopoly, but then generic competition must enter to bring prices down. Some companies have discovered ways to break that deal and extend their monopolies indefinitely… With real reforms, fairness and competition could be restored. Generic competition has a proven track record of dramatically reducing drug prices. In 2017 alone, savings from generics in the United States totaled $265.1 billion. These savings can be increased if we unlock competition for important older drugs.”
  • Earlier this month, representatives from the Coalition Against Patent Abuse among others attended a meeting at OIRA to raise concerns about amendments proposed by the U.S. Patent and Trademark Office that would apply to proceedings such as the inter partes review process. Because of high drug prices, any changes that make it harder to challenge potentially erroneously granted drug patents and speed up generic competition will have a large impact on the economy and patients’ pocketbooks. Therefore, any proposed changes should examine this potential economic impact. Recent coverage by Bloomberghighlighted this meeting and noted that the White House was eyeing these proposed changes to the rules of practice for patent tribunal trials.  


Bloomberg: Novartis Unit Gets Support For Full Court Review Of Drug Patents
Perry Cooper

  • Novartis AG’s Sandoz Inc. gained outside backing for a full Federal Circuit review of a ruling that blocks the company from selling a version of Amgen Inc.’s rheumatoid arthritis drug Enbrel until 2029. The Association for Accessible Medicines, which represents generic and biosimilar makers, and America’s Health Insurance Plans, which represents insurers, filed an amicus brief in support of Sandoz’s July 31 request for en banc rehearing. Samsung Bioepis Co. filed a separate amicus brief in support. The U.S. Court of Appeals for the Federal Circuit’s July decision upholding Amgen subsidiary Immunex’s two patents on the drug provides a roadmap “to perpetuate patent monopolies well past their lawful expiration,” the health associations’ brief said. The briefs may create momentum for the Novartis unit’s rehearing request. Sandoz had argued that the patents never should have been issued because they were essentially the same as an earlier patent owned by Amgen.

Specialty Pharmacy Continuum: Generics ‘Wall’ Costs Near $1B In Lost Savings
Karen Blum

  • When the market entry of generic drugs is delayed due to patent fights and other factors, the price tag for lost savings opportunities approaches more than $100 million annually (Health Aff 2020;39[6]:1011-1017). Among 69 brand-name drugs studied that were expected to lose patent exclusivity in 2010 to 2016, generic entry occurred before or within a quarter-year of the expected date for just 38 products (55%), the investigators found. Market entry for generics was delayed by more than a quarter for 20 products (29%) and did not occur for 11 products (16%).

Forbes: As COVID Threatens Supply Chains, Lawmakers Move To Stop Patent Abuse In Trade Courts
Roslyn Layton

  • Suzan DelBene (WA-01) and David Schweikert (AZ-06) recently introduced the Advancing America’s Interests Act to stop patent abuse at the ITC and confirm its public interest standard. Whereas some intellectual property (IP) reform efforts have slowed leading up to the election, this bill comes at a critical time to ensure supplies of essential products.  IP and technology expert Michael Rosen calls the bill, “The first serious effort at ITC reform in four years.” He notes that “The ITC has over the last 20 years become an increasingly important venue for patent disputes. Congress hasn’t paid much attention to it during that time, and a review of its practices and rulings is well warranted.”

STAT News: Many Psoriasis Patients Are Paying Higher Prices Than Ever At The Pharmacy Counter
Ed Silverman

  • Over the past decade, wholesale prices for self-administered psoriasis medicines rose substantially, underscoring the ongoing financial burden for many patients, according to a new analysis. Since 2009, the annual mean increase in price ranged from 4% to 12% for nine different psoriasis medicines, although some of the drugs were launched more recently. For instance, the largest rise in wholesale price was for Cimzia, which exceeded $94,000 last year, compared with just under $40,000 when the drug became available 11 years ago. Meanwhile, net prices also rose substantially, and in some cases, more than doubled. Although more recently, these have since declined in some cases, likely due to increased competition.


Alternate text