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: 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
On October 17, 2020, the Standing Committee of the National People’s Congress in China promulgated the fourth amended Patent Law of the People’s Republic of China, which came into force in its original form in 1985, with...more
11/19/2020
/ China ,
CNIPA ,
Design Patent ,
Generic Drugs ,
Intellectual Property Protection ,
Patent Infringement ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Prescription Drugs ,
Punitive Damages ,
Statutory Damages
Similar to the laws in the United States and Europe, Chinese law allows those accused of patent infringement to commence actions for declaring non-infringement of patents to clear away the uncertainties. A key precondition...more
Section 271(f)(1) of the Patent Act provides that a party infringes a patent claim when it "supplies or causes to be supplied in or from the United States all or a substantial portion of the components of a patented invention...more
2/27/2017
/ Appeals ,
Component Parts Doctrine ,
Cross-Border Transactions ,
Exports ,
Extraterritoriality Rules ,
Life Technologies Corp v Promega Corp ,
Manufacturer Liability ,
Motion to Set Aside the Verdict ,
Patent Act ,
Patent Infringement ,
Patents ,
Reversal ,
SCOTUS