Fire on the patent dance floor

By William Chin, PhD, Scientific Coordinator, EUCRAF

Cassandra Willyard published an article entitled "Biosimilar makers flout forced patent negotiations in US" on the 5 February 2015 issue of the Nature Medicine. The article reported the ongoing patent dispute between Amgen (producer of the reference product Neupogen, filgrastim) and Sandoz (producer of the biosimilar version of Neupogen). The curent patent litigation could discourage future development of biosimilars in the US.  

The Biosimilars Price Competition and Innovation Act (BPCIA) is a part of the 2010 US Patient Protection and Affordable Care Act that has a designated expedited approval pathway for biosimilars. In this law, there is a multi-steps procedure for resolving potential patent disputes by encouraging biosimilar manufacturer and innovator to share information and clarify any contravention at a defined time schedule. This procedure is now known as the "patent dance".

It seems at the moment, there are mix views regarding the current BPCIA. One observation was that biosimilar manufacturers as well as innovator companies haven't seemed willing to participate in the BPCIA's patent dispute resolution process, mainly for unwillingness to share propriety information to the other parties. Another opinion was that the patent dance is not really a deterrent to future development of biosimilar in the US considering that by 2022 the US biosimilars market will reach an enticing value of $11 billion. In yet another opinion, the patent dance involves a lot of legal work that could add to the cost of biosimilar development and an alternative simpler process to resolve patent disputes could encourage the further development of biosimilar.

The highlights of the dispute between Amgen and Sandoz are as the following: 

  • Amgen's key patents expired in 2013.
  • Amgen wants assurance that Sandoz's biosimilar doesn't infringe on any of the other active patents of its drug.
  • Amgen filed a lawsuit against Sandoz in October 2014 because Amgen claimed that Sandoz refused to hand over the application documents after 20 day from when it filed its application with the FDA (as stated in BPCIA). 
  • Sandoz claims it offered Amgen access to its application under certain conditions, and that Amgen refused.
  • Sandoz argues that the BPCIA does not compel biosimilar applicants to provide their applications to the innovator companies.


1. Biosimilar makers flout forced patent negotiations in US. Cassandra Willyard. Nat Med. 2015 Feb 5;21(2):100-1. doi: 10.1038/nm0215-100.