On Friday, January 13, the Supreme Court granted certiorari in Amgen v. Sandoz (Nos. 15-1039 & 15-1195). The Supreme Court originally deferred its decision on the parties’ certiorari petitions in order to consider the Solicitor General’s views. See prior post. On December 7, the Solicitor General filed a briefing recommending that certiorari be granted.

The Supreme Court has been asked to review whether the safe harbor established by 35 U.S.C. § 271(e)(1) encompasses a generic drug manufacturer’s bioequivalence testing performed only as a condition of maintaining FDA approval. Section 271(e)(1) exempts certain pharmaceutical-related activities from patent infringement, stating that “[i]t shall not be an act of infringement to make, use,

“People’s fates are simplified by their names” goes the quote from the Bulgarian novelist and playwright Elias Canetti. Whether this is indeed true for people is debatable but for biological drugs names are apparently critical, or so we can gather from recent warring between branded and generic industry organizations. Last week industry organizations BIO and