ICYMI: I-MAK Releases Report on Keytruda’s Patent Wall, Highlighting Continued Need for Patent Reform to Balance Innovation and Competition

This Report Comes as the U.S. House Oversight and Reform Committee is Set to Hold a Hearing to Investigate Abuses by the Pharmaceutical Industry

WASHINGTON D.C. – Recently, the Initiative for Medicines, Access & Knowledge (I-MAK) released a report as part of its “Overpatented, Overpriced” series on the cancer drug Keytruda, highlighting the underhanded tactics used by some pharmaceutical companies to effectively extend their drug monopolies indefinitely, keeping competition out and prices high.  These tactics can range from evergreening, in which manufacturers make small, incremental changes to their products and attempt to extend their patent, as well as thicketing, where companies build a veritable “patent walls” around their products, such as the case with Keytruda. 

Key Excerpt From I-MAK:

  • “Keytruda has 129 patent applications; to date, 53 patents have been granted.”
  • “50% of the patent applications on Keytruda were filed after its first FDA approval. 
  • “74% of patent applications cover the different indications and formulations of the drug and not the key antibody.”
  • “The estimated purchasing cost of branded Keytruda during the eight years of extended exclusivity without competition is at least $137 billion.”

“A significant driver of these high drug costs today is Big Pharma’s continued abuse of the patent system.  Patents are supposed to be a reward for new innovations by granting temporary monopolies that are supposed to expire after a limited period of time, after which competition is free to flourish.  Unfortunately, that is not often the case.  We must continue to work to strengthen the patent system and other components such as the inter partes review process that can thwart anti-competitive behaviors to lower drug prices and increase access to life-saving treatments for millions of American patients,” stated CAPA Executive Director Matthew Lane.

This report comes as the U.S. House Committee on Oversight and Reform is set to question AbbVie’s CEO on anti-competitive pricing tactics.  Last year, another report by I-MAK showed how AbbVie could have its patents on cancer drug Imbruvica extended through 2036, forcing consumers to spend an additional $41 billion for the cancer treatment drug.  This move would prevent cheaper generic alternatives from entering the market for almost another 10 more years.