This advisory summarizes new legislation in California, titled, “Preserving Access to Affordable Drugs,” which aims to establish a different standard for determining whether a patent settlement violates antitrust laws. This...more
Key Points
- In February, the U.S. Food and Drug Administration issued a "bright-line rule" redefining "biological products" under the Biologics Price Competition and Innovation Act (BPCIA) to include insulin and other...more
3/2/2020
/ Biologics ,
Biosimilars ,
BPCIA ,
Bright-Line Rule ,
Final Rules ,
Food and Drug Administration (FDA) ,
Health Care Providers ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
PHSA ,
Purple Book
On January 22, the Supreme Court issued a rare 9–0 affirmance of the Federal Circuit in Helsinn Healthcare S.A. v. Teva Pharmaceuticals USA, Inc. (585 U.S. ___ (2018). The issue on appeal was whether the sale of an invention...more
1/25/2019
/ America Invents Act ,
Confidentiality Agreements ,
Helsinn Healthcare SA v Teva Pharmaceuticals USA Inc ,
Inventions ,
On-Sale Bar ,
Patent Applications ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
SCOTUS ,
Third-Party Relationships
On December 9, 2014, the Patent Trial and Appeal Board (PTAB) issued final decisions in three inter partes review (IPR) proceedings filed by Amneal Pharmaceuticals challenging three patents listed in the Orange Book for...more