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 Situation: Senate Bill 150 ("S.B. 150")—the Affordable Prescriptions for Patients Act of 2023—unanimously passed the Senate and would amend 35 U.S.C. § 272(e) to limit, under certain circumstances, the number of patents...more
7/30/2024
/ Biosimilars ,
Intellectual Property Protection ,
Life Sciences ,
Patent Applications ,
Patent Litigation ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Prescription Drugs ,
Proposed Legislation ,
Regulatory Agenda ,
Regulatory Reform
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
The Federal Circuit upholds the validity of a patent covering a polymorphic form of a chemical compound.
The United States Court of Appeals for the Federal Circuit recently held in Grünenthal Gmbh v. Alkem Labs. Ltd. that...more