The Situation: The Hatch-Waxman Act allows generic drug manufacturers to "carve out" a brand's patented indications from their proposed labeling. Generic manufacturers often rely on these so-called "skinny labels" to try to...more
7/9/2024
/ Abbreviated New Drug Application (ANDA) ,
Food and Drug Administration (FDA) ,
Generic Drugs ,
Hatch-Waxman ,
Intellectual Property Protection ,
Life Sciences ,
Patent Infringement ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Prescription Drugs
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
Citing its priority to facilitate the timely development and approval of generic drugs, the U.S. Food and Drug Administration ("FDA") solicits stakeholder input on the types of patents that should be listed in the Orange...more
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 Situation: In a Hatch-Waxman litigation, a district court determined that the claims covering a method of using the drug everolimus to treat kidney cancers were not obvious. The court found a motivation to "pursue"...more
When exercising its broad discretion on whether to institute review, the PTAB is not limited to consideration of factors associated with the type of denial it ultimately issues. In a recent decision that the PTAB designated...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
Rumors of the PTAB’s demise were greatly exaggerated, it turns out. In a 7-2 decision, the Supreme Court held on Tuesday that Inter Partes Reviews (IPRs) violate neither Article III nor the Seventh Amendment of the...more
4/26/2018
/ Administrative Proceedings ,
America Invents Act ,
Article III ,
Constitutional Challenges ,
Inter Partes Review (IPR) Proceeding ,
Oil States Energy Services v Greene's Energy Group ,
Patent Trial and Appeal Board ,
Patents ,
Public Rights Doctrine ,
SCOTUS ,
Seventh Amendment ,
USPTO
The Situation: Following the U.S. withdrawal from the original Trans-Pacific Partnership ("TPP") agreement last year, the 11 remaining TPP countries agreed to implement the original text in a new "TPP-11" agreement. However,...more
4/17/2018
/ Data Protection ,
Exports ,
Free Trade Agreements ,
Intellectual Property Protection ,
Patents ,
Pharmaceutical Patents ,
Safe Harbors ,
Trade Agreements ,
Trade Policy ,
Trans-Pacific Partnership ,
TRIPS Agreement
On December 14, 2017, the U.S. Court of Appeals for the Federal Circuit again interpreted the Biologics Price Competition and Innovation Act ("BPCIA"). In Amgen Inc. et al. v. Sandoz Inc., 15-cv-1499 (Fed. Cir. 2017), the...more
12/27/2017
/ aBLA ,
Amgen ,
Biosimilars ,
BPCIA ,
Food and Drug Administration (FDA) ,
Patent Dance ,
Patent Infringement ,
Patents ,
Pharmaceutical Patents ,
Popular ,
Preemption ,
Sandoz ,
Sandoz v Amgen ,
SCOTUS ,
State Law Claims ,
Unfair Competition
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 June 12, 2017, the U.S. Supreme Court decided two important questions under the Biologics Price Competition and Innovation Act ("BPCIA"), which provides an abbreviated pathway for the approval of generic biologics: (i) the...more
6/26/2017
/ Amgen ,
Biologics ,
Biosimilars ,
BPCIA ,
Commercial Marketing ,
Declaratory Judgments ,
FDA Approval ,
IP License ,
Notice Requirements ,
Patent Dance ,
Patent Infringement ,
Patents ,
Pharmaceutical Patents ,
Preliminary Injunctions ,
Sandoz ,
Sandoz v Amgen ,
SCOTUS ,
State Law Claims
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