In December 2020, the U.S. District Court for the District of Columbia issued a decision in Teva v. FDA, reviewing FDA’s definition of “protein” in connection with the agency’s determination that Teva’s Copaxone®, a...more
Amgen Inc. and Alexion Pharmaceuticals Inc. settled three Inter Partes Review (IPR) proceedings concerning patents covering Alexion’s blockbuster humanized monoclonal antibody drug Soliris®, with Amgen obtaining a...more
6/23/2020
/ Alexion ,
Amgen ,
Biologics ,
Biosimilars ,
Life Sciences ,
Patent Infringement ,
Patent Litigation ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Popular
On June 12, the Supreme Court decided Sandoz Inc. v. Amgen Inc., the first case under the Biologics Price Competition and Innovation Act of 2009 (BPCIA) to reach the high court. The BPCIA establishes a regulatory pathway for...more
6/16/2017
/ Amgen ,
Biologics ,
Biosimilars ,
BPCIA ,
Commercial Marketing ,
Food and Drug Administration (FDA) ,
Patent Dance ,
Patent Infringement ,
Patent Litigation ,
Patents ,
Petition for Writ of Certiorari ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Sandoz ,
Sandoz v Amgen
In a case with potential wide-ranging ramifications for patent validity challenges, on May 22, 2017, the Supreme Court granted a writ of certiorari in an appeal from an inter partes review (“IPR”) decision, SAS Institute v....more
6/1/2017
/ America Invents Act ,
Final Written Decisions ,
Intellectual Property Protection ,
Inter Partes Review (IPR) Proceeding ,
Life Sciences ,
Patent Trial and Appeal Board ,
Patent Validity ,
Patents ,
Petition for Writ of Certiorari ,
Post-Grant Review ,
SAS Institute Inc. v Lee ,
SCOTUS
On Friday, Jan. 13, the Supreme Court granted the appellant’s petition and the respondent’s cross-petition for a writ of certiorari in Sandoz Inc. v. Amgen Inc. This is the first time the Court will construe the Biologics...more
1/18/2017
/ Biologics ,
Biosimilars ,
BPCIA ,
Commercial Marketing ,
Declaratory Judgments ,
License Applications ,
Notice Requirements ,
Patent Dance ,
Patent Infringement ,
Patents ,
Petition for Writ of Certiorari ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Remedies ,
Sandoz v Amgen ,
SCOTUS ,
Solicitor General