The Federal Circuit has issued a landmark venue decision setting forth the standard for determining what constitutes a “regular and established place of business” under 28 U.S.C. § 1400(b). Section 1400(b) limits venue in...more
Last week in Amgen Inc. v. Apotex Inc., No. 2016-1308 (Fed. Cir. July 5, 2016), a unanimous Federal Circuit panel ruled that under the Biologics Price Competition and Innovation Act of 2009 (“BPCIA”), a biosimilar applicant...more
7/13/2016
/ aBLA ,
Amgen ,
Apotex ,
Biosimilars ,
BPCIA ,
Commercial Marketing ,
Declaratory Judgments ,
Food and Drug Administration (FDA) ,
Generic Drugs ,
Notice of Intent ,
Patent Dance ,
Patent Infringement ,
Patent Litigation ,
Pharmaceutical Patents ,
Sandoz v Amgen
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, 794 F.3d 1347 (2015), and instead called for the views...more
6/24/2016
/ Amgen ,
Biologics ,
Biosimilars ,
BPCIA ,
Certiorari ,
Food and Drug Administration (FDA) ,
Life Sciences ,
Patent Infringement ,
Patent Litigation ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Sandoz ,
Sandoz v Amgen ,
SCOTUS
According to ten judges of the Federal Circuit, a patent owner’s right to sue for infringement in the United States is not exhausted by sales of products abroad or by sales subject to valid post-sale contractual restrictions...more
In June of this year, the Federal Circuit panel in Ariosa Diagnostics, Inc. v. Sequenom, Inc. invalidated a patent on the grounds of patent-ineligible subject matter. 788 F.3d 1371 (Fed. Cir. 2015). While the case is one of...more
11/5/2015
/ Declaratory Rulings ,
DNA ,
En Banc Review ,
Life Sciences ,
Mootness ,
Myriad-Mayo ,
Patent Infringement ,
Patent Invalidity ,
Patent-Eligible Subject Matter ,
Patents ,
Petition For Rehearing ,
Preemption ,
Product of Nature Doctrine ,
Section 101
Fifty years ago, in Brulotte v. Thys Co., the U.S. Supreme Court held that “a patentee’s use of a royalty agreement that projects beyond the expiration date of the patent is unlawful per se.” 379 U.S. 29, 32 (1964). On June...more
10/2/2015
/ Breach of Contract ,
Brulotte ,
IP License ,
Kimble v Marvel Enterprises ,
License Agreements ,
Licensing Rights ,
Patent Expiration ,
Patent Infringement ,
Patent Royalties ,
Patents ,
Public Domain ,
SCOTUS ,
Stare Decisis
On August 13, 2015, the Federal Circuit in Akamai Technologies, Inc. v. Limelight Networks, Inc. changed the law regarding liability for direct infringement of a method patent involving more than one actor (divided...more
In Amgen Inc. v. Sandoz Inc. (No. 2015-1499), a fractured panel of the Federal Circuit Court of Appeals recently decided two issues of first impression relating to the Biologics Price Competition and Innovation Act of 2009...more
8/13/2015
/ aBLA ,
Amgen ,
Biosimilars ,
BPCIA ,
Commercial Marketing ,
Food and Drug Administration (FDA) ,
Generic Drugs ,
Hatch-Waxman ,
License Agreements ,
Patent Dance ,
Patent Infringement ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Preliminary Injunctions ,
Sandoz ,
Sandoz v Amgen
Six justices of the Supreme Court agree that an accused indirect infringer’s good faith belief in invalidity of a patent “will not negate the scienter required under §271(b).” Commil USA, LLC v. Cisco Sys., Inc., No. 13-896,...more