Infringement litigation over biosimilars and pharmaceuticals poses its own knotty jurisdictional and venue issues due to the unique frameworks of the BPCIA and Hatch-Waxman.
These issues are particularly hot right now, with several disputes pending that could have a wide impact going forward, such as Momenta Pharmaceuticals v. Bristol-Myers Squibb. Further, after the Supreme Court’s TC Heartland decision, judges must decide where the artificial act of infringement occurs —and district courts are already split.
To help you navigate these complex issues, our panel includes the head of U.S. patent litigation for a major international pharma and biologic company that is active both as an innovator and in biosimilars, as well as two veteran litigators (one who typically represents innovators and the other who represents biosimilar applicants and generic drug companies). They will discuss what you need to know, and will make predictions, regarding:
- Whether a biosimilar applicant will be able to bring BPCIA litigation before the brand sponsor brings its own suit.
- Will a biosimilar maker who has not yet filed its marketing application with the FDA be able to appeal an unsuccessful inter partes review? Or does it need Article III standing to seek an appeal?
- The complicated calculus regarding venue in both Hatch-Waxman litigation and BPCIA litigation.
- Issues when there are multiple defendants in different jurisdictions.
- How to deal with foreign defendants.
- Cynthia Lamber Hardman, Procter Goodwin
- Christopher Loh, Fitzpatrick, Cella, Harper & Scinto
- Peter Waibel, Novartis