With
Melanie Mayer
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...
With
Ewa Davison
The Supreme Court deferred its decision on the parties' certiorari petitions in order to consider the Solicitor General's views.
With
Ewa Davison
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)
With
Ewa Davison,
David Tellekson
Notably, the Federal Circuit took the opportunity to defend its previous holding in Amgen v. Sandoz that notice of intent to commercially market cannot be provided until the FDA approves the biosimilar product.
With
Ewa Davison,
David Tellekson
Ultimately, while the Amgen v. Apotex decision favors biologic manufacturers, its long-term import depends on the outcome of Sandoz's pending petition for certiorari before the Supreme Court.
With
Ewa Davison,
David Tellekson
On Monday, June 20, 2016, the Supreme Court deferred a decision on the certiorari petitions filed by both parties from the Federal Circuit's decision in Amgen v. Sandoz...
