A new chapter on IP litigation in the life sciences was opened in the US with the 2010 enactment of the Biologics Price Competition and Innovation Act, which established a new regulatory approval pathway for biosimilars. Its distinct IP litigation framework – centered on the ill-defined “patent dance” – and the tendency for innovative biologics to be protected by larger patent estates than small molecule drugs have significant strategic implications. With this in mind, IAM spoke to Goodwin partners in the IP Litigation group, Alexandra Valenti and Robert Cerwinski – two of the authors of the recently-released Guide to Biosimilars Litigation and Regulation in the US, 2019-2020 Edition – to identify some key takeaways. Read the article here.
In The Press December 11, 2019