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
Key Points
- Federal Circuit issued precedential opinion in Hospira Inc. v. Fresenius Kabi USA, LLC that affirmed obviousness of a liquid drug patent claim, encouraging future patent challengers to raise the issue of...more
1/24/2020
/ Appeals ,
Claim Limitations ,
Extrinsic Evidence ,
Inherency ,
Obviousness ,
Orange Book ,
Patent Infringement ,
Patents ,
Pharmaceutical Patents ,
POSITA ,
Precedential Opinion ,
Prior Art
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
The US Circuit Court for the Federal Circuit issued an important decision last week regarding the interplay of court litigation and inter partes reviews (IPRs) at the US Patent and Trademark Appeals Board (PTAB) on the issue...more
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
This morning, the Food and Drug Administration (FDA) opened a public docket and requested comments on its proposed criteria for expedited review of "first generic" Abbreviated New Drug Applications (ANDAs). The comment period...more