In Amgen Inc. v. Hospira, Inc., the Federal Circuit held that Amgen could not obtain discovery related to activities that might infringe a patent that it had not asserted in its biosimilar patent litigation against Hospira....more
8/31/2017
/ Amgen ,
Appeals ,
Biosimilars ,
BPCIA ,
Collateral Order Doctrine ,
FDA Approval ,
Federal Rules of Civil Procedure ,
FRCP 11 ,
Hospira ,
Judicial Review ,
Motion to Compel ,
Patent Dance ,
Patent Infringement ,
Patent Litigation ,
Patents ,
Pharmaceutical Patents ,
Writ of Mandamus
In Sandoz Inc. v. Amgen Inc. (which you can read more about here), the Supreme Court held that 42 USC § 262(l)(9)(C) sets forth the exclusive federal remedy for failing to provide a copy of the biosimilar application to the...more
6/29/2017
/ Amgen ,
Appeals ,
Biosimilars ,
BPCIA ,
Commercial Marketing ,
Disclosure Requirements ,
Exclusive Remedy ,
Patent Dance ,
Patent Infringement ,
Patents ,
Pharmaceutical Patents ,
Preemption ,
Remand ,
Sandoz ,
Sandoz v Amgen ,
SCOTUS ,
State Law Claims ,
Supremacy Clause ,
Unfair Competition
The U.S. Supreme Court rendered its first interpretations of the biosimilar patent dispute resolution procedures of the Biologics Price Competition and Innovation Act (BPCIA), ruling largely in favor of Sandoz on both issues...more
6/13/2017
/ Amgen ,
Biologics ,
Biosimilars ,
BPCIA ,
Content Marketing ,
Dispute Resolution ,
FDA Approval ,
Food and Drug Administration (FDA) ,
IP License ,
Notice Requirements ,
Patent Dance ,
Patent Infringement ,
Patents ,
Pharmaceutical Patents ,
Preemption ,
Preliminary Injunctions ,
Sandoz ,
Sandoz v Amgen ,
SCOTUS ,
State Law Claims ,
Unfair Competition
In Fresenius Kabi USA, LLC v. Fera Pharmaceuticals, LLC, et al., Case No. 15-3654 (D.N.J.) the district court recently denied Fresenius’s motion to dismiss Fera’s antitrust counterclaims, but simultaneously decided to sever...more
In Mylan Institutional LLC, et al. v. Aurobindo Pharma Ltd., et al., Case No. 2017-1645, the Federal Circuit affirmed the district court’s grant of a preliminary injunction as to one of three patents-in-suit, while finding...more
The recent decision from the New Jersey District Court in Par Pharmaceutical, Inc. v. Luitpold Pharmaceuticals, Inc., Civ. No. 16-02290 (WHW)(CLW) (D.N.J. April 24, 2017) provides an interesting look at the boundaries of...more
In VirtualAgility Inc. v. Salesforce.com, Inc., No. 2014-1232 (July 10, 2014), the Federal Circuit issued its first opinion directed to the issue of when it is appropriate to grant a stay of a district court patent...more
A decision issued by the Federal Circuit earlier this year raises a few things to have in mind when considering whether to concede infringement and when planning to design around a patent.
In Proveris Scientific Corp....more
Under the America Invents Act (“AIA”), the Federal Circuit has jurisdiction over appeals based on a civil action “in which a party has asserted a compulsory counterclaim arising under any Act of Congress relating to patents.”...more