Under a new U.S. Patent and Trademark Office (“USPTO”) policy issued in March 2025, pre-institution inter partes review (“IPR”) proceedings are now bifurcated, consisting of a first phase in which the director considers...more
7/8/2025
/ Hatch-Waxman ,
Intellectual Property Litigation ,
Inter Partes Review (IPR) Proceeding ,
National Security ,
Orange Book ,
Patent Applications ,
Patent Litigation ,
Patent Trial and Appeal Board ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Post-Grant Review ,
USPTO
On June 23, 2025, the Supreme Court invited the Solicitor General to submit a brief expressing the views of the United States—dramatically increasing the likelihood that the Court will eventually grant review—in Hikma...more
7/1/2025
/ Appeals ,
Food and Drug Administration (FDA) ,
Induced Infringement ,
Patent Infringement ,
Patent Litigation ,
Petition for Writ of Certiorari ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
SCOTUS ,
Solicitor General ,
Statutory Interpretation
Under a new U.S. Patent and Trademark Office ("USPTO") policy issued in March 2025, pre-institution inter partes review ("IPR") proceedings are now bifurcated, consisting of a first phase in which the director considers...more
6/25/2025
/ Hatch-Waxman ,
Intellectual Property Litigation ,
Intellectual Property Protection ,
Inter Partes Review (IPR) Proceeding ,
Orange Book ,
Patent Infringement ,
Patent Litigation ,
Patent Trial and Appeal Board ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
USPTO
The case relates to so-called "skinny labels," in which the filer of an Abbreviated New Drug Application ("ANDA") seeks FDA approval to market a generic version of a branded drug, but "carves out" from its label certain...more
1/21/2022
/ Abbreviated New Drug Application (ANDA) ,
Generic Drugs ,
Inducement ,
Intellectual Property Protection ,
Life Sciences ,
Motion to Dismiss ,
Patent Infringement ,
Patent Litigation ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Prescription Drugs
Background -
On August 5, 2021, the Federal Circuit issued an opinion in GlaxoSmithKline v. Teva Pharmaceuticals, Case No. 18-1976, in favor of GSK, finding that Teva was liable for inducing infringement of GSK's patent....more
9/21/2021
/ Generic Drugs ,
GlaxoSmithKline ,
Hatch-Waxman ,
Induced Infringement ,
JMOL ,
Patent Infringement ,
Patent Litigation ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Prescription Drugs ,
Product Labels ,
Teva Pharmaceuticals
In November, the PTAB Bar Association held its annual Thought Leader Summit. The Summit highlighted recent changes to PTAB practice, with a keynote address from USPTO Director Andrei Iancu.
In the opening remarks, Director...more
12/19/2019
/ § 315(b) ,
Administrative Patent Judges ,
America Invents Act ,
Covered Business Method Proceedings ,
Inter Partes Review (IPR) Proceeding ,
Motion to Amend ,
Patent Infringement ,
Patent Litigation ,
Patent Trial and Appeal Board ,
Patent-Eligible Subject Matter ,
Patents ,
Phillips Standard ,
Precedential Opinion ,
Section 101
What happens when patent claims are found unpatentable in inter partes review (“IPR”) and new claims are subsequently added to that patent through ex parte reexamination? The District Court for the Northern District of...more
The PTAB recently granted a rare motion for additional discovery into the question of whether an unnamed party, Amneal Pharmaceuticals, LLC (“Amneal”), should have been named as a real-party-in-interest. In Kashiv LLC v....more
In a recent decision involving the Biologics Price Competition and Innovation Act ("BPCIA") (Genentech, Inc. and City of Hope v. Amgen Inc.) the Delaware District Court dismissed a claim seeking to enforce a statement of...more
5/14/2018
/ Amgen ,
Biosimilars ,
BPCIA ,
Failure To State A Claim ,
Genentech ,
Motion to Dismiss ,
Patent Dance ,
Patent Litigation ,
Patents ,
Private Right of Action ,
Subject Matter Jurisdiction
The Situation: The Biologics Price Competition and Innovation Act was considered in a November 2017 decision by the United States Court of Appeals for the Federal Circuit.
The Result: The court found that the commercial...more
11/29/2017
/ aBLA ,
Amgen ,
Amgen v Apotex ,
Appeals ,
Biologics ,
Biologics Price Competition and Innovation Act of 2009 ,
Biosimilars ,
Claim Construction ,
Hatch-Waxman ,
Patent Dance ,
Patent Infringement ,
Patent Litigation ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
SCOTUS ,
Witness Statements
On April 26, 2017, the U.S. Supreme Court heard oral argument in Sandoz Inc. v. Amgen Inc. (Nos. 15-1039, 15-1195), on appeal from the Federal Circuit's July 21, 2015, opinion interpreting various provisions of the Biologics...more
5/15/2017
/ Amgen ,
Appeals ,
Biologics ,
Biosimilars ,
BPCIA ,
Certiorari ,
Commercial Marketing ,
Declaratory Judgments ,
Food and Drug Administration (FDA) ,
Notice and Comment ,
Notice Requirements ,
Patent Dance ,
Patent Infringement ,
Patent Litigation ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Sandoz ,
Sandoz v Amgen ,
SCOTUS