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
This ruling may have eliminated the practice of transferring patents to Native American tribes for immunization from IPR proceedings.
The Federal Circuit, in a matter of first impression, has ruled that tribal sovereign...more
On May 26, 2017, the United States District Court for the District of Delaware announced new procedures for assigning cases and handling case-dispositive issues....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