Elaine Blais, JD: Helsinn v Teva and Its Implications for Biosimilar Developers

Transcript:

The Supreme Court’s January 2019 decision in Helsinn v Teva is an important decision for biologics manufacturers and biosimilar companies. In that case, which was argued by our partner [William Jay, JD], the Supreme Court held that an inventor's sale of an invention to a third party could trigger the statutory on-sale bar even where the third party was obligated to keep the invention confidential.

This case has important implications for biosimilar manufacturers in that it is a warning that they need to be very careful about the types of contracts they enter into prior to applying for a patent. And it is an opportunity for biosimilar manufacturers in that it opens the door for potential on-sale defense invalidity argument, and biosimilar manufacturers should be careful to investigate and take appropriate discovery to determine whether such a defense is viable in any given case.