On Tuesday, January 22, 2019, the U.S. Supreme Court held in a unanimous decision that, even where the details of the invention are kept confidential, a commercial sale may place the invention “on sale” under the Leahy-Smith...more
1/24/2019
/ America Invents Act ,
Appeals ,
Assignment of Inventions ,
Confidentiality Agreements ,
Helsinn Healthcare SA v Teva Pharmaceuticals USA Inc ,
Inventions ,
On-Sale Bar ,
Patent Applications ,
Patent Infringement ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Public Use ,
Reaffirmation ,
Reversal ,
SCOTUS ,
Section 102 ,
Teva Pharmaceuticals ,
Third-Party Relationships
In an en banc decision on July 12, 2016 in The Medicines Co. v. Hospira, Inc., the Federal Circuit established the circumstances under which a product manufactured according to product-by-process claims is invalid under the...more
Biosimilar Applicants Must Provide Notice of Commercial Launch:
What You Need To Know -
Case Background -
In an opinion released today in Amgen v. Apotex, the Federal Circuit held biosimilar applicants who...more
7/7/2016
/ Amgen ,
Apotex ,
Appeals ,
Biologics ,
Biosimilars ,
BPCIA ,
Commercial Marketing ,
Food and Drug Administration (FDA) ,
Generic Drugs ,
Hatch-Waxman ,
Licensing Rules ,
Notice Requirements ,
Patent Dance ,
Patent Infringement ,
Patents ,
Pharmaceutical Patents ,
Preliminary Injunctions
In the first instance of a district court interpreting the patent litigation provisions of the Biologics Price Competition and Innovation Act (“Biosimilars Act”), Judge Maxine E. Chesney (N.D. Cal.) dismissed a declaratory...more
On Tuesday, July 23, Knobbe Martens hosted a live webinar event covering "Preparing for Biosimilars: Key Points for Participating in the U.S. Regulatory Framework." Partners Eli Loots, Carol Pitzel Cruz, and Sheila Swaroop...more