On November 15, 2019, FDA approved Pfizer’s adalimumab product, a biosimilar to AbbVie’s Humira, marking the 25th approval of a biosimilar under the Biologics Price Competition and Innovation Act (BPCIA). A biosimilar is a...more
FDA (Finally!) Issues New Regulations to Clarify Pharmaceutical Patent Litigation: How to Use Patent “Use Codes” -
October 6, 2016, the FDA issued a final rule implementing certain provisions of the Medicare...more
11/29/2016
/ Copyright ,
De Minimis Claims ,
Enforcement ,
Food and Drug Administration (FDA) ,
New Regulations ,
Patent Litigation ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Popular ,
Trademarks ,
UK ,
UK Brexit
On October 6, 2016, the FDA issued a final rule implementing certain provisions of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA) governing the approval of generic drugs, including...more
In This Issue:
- Supreme Court Hears Six Patent Cases This Term
- Is Implied License the New Fair Use?
- Navigating the Murky Waters of the Domestic Industry Requirements in the International Trade...more
7/11/2014
/ CLS Bank v Alice Corp ,
Fair Use ,
Highmark v. Allcare ,
International Trade Commission (ITC) ,
License Agreements ,
Limelight v Akamai ,
Nautilus Inc. v. Biosig Instruments ,
Octane Fitness v. ICON ,
Patent Litigation ,
Patents ,
SCOTUS