Robert Cerwinski, JD, Partner at Goodwin, discusses the impact of the recent Supreme Court ruling in TC Heartland v Kraft on biosimilar litigation.
Could the SCOTUS ruling in TC Heartland v Kraft have an impact on litigation for biosimilars?
I think it can. The TC Heartland decision applies to patent infringement litigation, generally, and it concerns the patent venue statute. The issue in TC Heartland is: where can a patent infringement suit be brought against particular defendants? Before TC Heartland was decided, the Federal Circuit had taken the position that anywhere that a defendant was subject to personal jurisdiction, either personal jurisdiction because it was the place where the defendant was incorporated, or had his principal place of business, or because there was specific personal jurisdiction, i.e. where the acts of jurisdiction occurred. The Supreme Court took a narrow view of the venue statute, or the venue provision in the patent statute, and said really a suit can only be brought where the patent defendant resides or where the acts of infringement have occurred and the defendant has a regular established place of business. The dispute in TC Heartland was really: what does “reside” mean? The Federal Circuit had taken the position that it’s anywhere the personal jurisdiction lay, and the Supreme Court said it’s just where the defendant is incorporated. So, the upshot of all of this is where particular defendants can be sued is now more limited in the context of patent infringement litigation. Interestingly, the Supreme Court did not weigh in on where foreign defendants can be sued. So, foreign defendants that aren’t really incorporated anywhere in the US—that question remains unanswered. As the reference product sponsors and biosimilar manufacturers jockey over where suits under the BPCIA should be adjudicated, which venues may be more favorable to the biosimilar applicant versus the reference product sponsor, now TC Heartland is going to limit some of those choices.