If you think the renegade dance challenge taking over TikTok at the moment is tough, you haven’t tried ‘the patent dance’. In the United States, the Biologics Price Competition and Innovation Act (BPCIA) created an abbreviated approval pathway for biosimilar products.
Like the Hatch-Waxman Act, the BPCIA encourages generic competition by allowing biosimilar manufacturers to piggyback off the clinical data of the reference biologic. The BPCIA also established a framework for patent litigation addressing alleged infringement by biosimilars for patents that may be infringed by generic drugs, dubbed “The Patent Dance” for its complex exchange of information relating to the products and patents at issue to the parties.
Like the renegade dance, it involves fast paced dance moves that require you to watch tutorials (several times if you have two left feet) before attempting. This webinar is your first tutorial – for the patent dance that is.
The duration of this webinar will be approximately one hour.