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

Elaine Blais, JD, partner at Goodwin and head of the litigation department in Goodwin’s Boston office, discusses the Supreme Court’s January 2019 decision in Helsinn v Teva.


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.

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