THE REFILL: Latest Dosage of Rx Patent Abuse


  • CAPA: The USPTO must prioritize patent quality and restore the IPR system to its proper focus. UPDATE – As part of its ongoing campaign to safeguard the U.S. patent system and stop Big Pharma from gaming the system, CAPA filed comments this week with the United States Patent and Trademark Office (USPTO).  The filing outlined serious concerns regarding the increased use of discretionary denials by the Patent Trial and Appeal Board (PTAB).  Proposed modifications by the USPTO would continue the disturbing trend of using discretionary denials to block efforts aimed at reviewing potentially bad patents.
    • CAPA Executive Director Matthew Lane stated, “The proposed changes being made by the USPTO regarding its approach to discretionary denials are unraveling Congress’s express will in creating mechanisms to stop bad patents at the USPTO. If enacted, these changes would open the flood gates for significantly more discretionary denial decisions down the road. This practice will result in the delayed entry of generic competition and increase the cost of prescription drugs for Americans. Rather than codifying current misguided policies and practices around the use of discretionary denials, the USPTO should re-prioritize patent quality and restore the inter partes review (IPR) system to its original intent – resolving the problems of erroneously-granted patents quickly and at a lower cost than litigation.”
  • The Following Key Points Were Made In CAPA’s Filing With The USPTO:
    • Invalid Patents Interfere With Price-Lowering Generic And Biosimilar Competition 
    • Inter Partes Review Eliminates Invalid Drug Patents, Lowering Prices 
    • Discretionary Denials Allow Erroneous Patents to Stand, Harming Patient Consumers 
    • Multiple IPR Petitions On Drug Patents Are Often Justified 
    • Parallel Litigation Should Not Be A Cause to Discretionarily Deny IPR

The USPTO can reduce drug costs and encourage generic competition by focusing on improving patent quality through the IPR process rather than looking for reasons to avoid examining valid concerns over a patent’s validity.

Read CAPA’s comments filed with the USPTO here


Bloomberg Law: Pharma Group, Academics Weigh In On PTAB Judge High Court Fight
Ian Lopez

  • Law professors and a membership group focused on drug pricing are weighing in on a Supreme Court case where the future of Patent Trial and Appeal Board judges hangs in the balance. The U.S. Court of Appeals for the Federal Circuit’s Arthrex Inc. v. Smith & Nephew Inc. decision has cast more than 100 Patent and Trademark Office tribunal fights into doubt … The Coalition Against Patent Abuse, which is comprised of patient advocacy organizations, health-care providers, and others, said it’s up to the Supreme Court to preserve the PTAB’s “objectivity and independence from executive branch political influence.”

Law.Com: Supreme Court To Decide If Patent Office Trials Pass Constitutional Muster
Karen Riesenburger Poppel

  • In 2012, Congress established certain processes in the Patent Office under which a third party could challenge the validity of issued patents. One of these processes, known as inter partes review (IPR), has been widely used. IPRs are typically filed by the defendant/accused infringer in a concurrently pending federal patent infringement case. Because the IPR can result in the targeted patent claims being cancelled, there is the possibility that the concurrently pending federal litigation will be resolved (either through judgment or settlement). According to the USPTO’s statistics, over 11,000 petitions for IPR have been filed since enactment in 2012.

Law 360: Biosimilars Group Pushes For Medicine Access Measures
Steven Edelstone

  • In Monday letters to all members of the U.S. House of Representatives and U.S. Senate, the Association for Accessible Medicines President and CEO Dan Leonard laid out what it wants Congress to focus on and support moving forward, emphasizing the importance of expanding the ability of patients to get access to biosimilars, “Ensuring the generics and biosimilars industry remains vibrant is essential to preserving patient savings and the value provided to the U.S. health care system,” he wrote.