Summary -
Last year the World Intellectual Property Organization (WIPO), under a threat of a vote, accelerated negotiations on an international legal instrument related to intellectual property (IP) and genetic resources...more
10/31/2023
/ Biotechnology ,
Comment Period ,
Deadlines ,
Genetic Materials ,
Intellectual Property Protection ,
International Harmonization ,
Life Sciences ,
Patent Law Treaty ,
Patents ,
Pharmaceutical Industry ,
USPTO ,
WIPO
The District Court of Delaware dismissed a generic drug company’s declaratory judgment counterclaims of non-infringement and invalidity, finding that the court no longer had subject matter jurisdiction after the generic...more
The Federal Circuit held that supplemental applications submitted to the Food and Drug Administration (FDA) to further support approval of a biosimilar product under Section 262(k) of the Biologics Price Competition and...more
The District Court for the Northern District of West Virginia recently found method of treatment claims directed to treating a specific disease at a specific dose invalid for lack of written description based on the context...more
7/6/2020
/ Evidence ,
Hatch-Waxman ,
Patent Infringement ,
Patent Invalidity ,
Patent Litigation ,
Patent Prosecution History ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Treatment Method Patents ,
Written Descriptions
Hear from the FDA and the leaders of the biosimilars and innovator biologics industries about the impact of the pandemic on the global IP market and gain practical guidance for what is coming down the pipeline.
The novel...more
6/5/2020
/ Best Practices ,
Biologics ,
Biosimilars ,
Continuing Legal Education ,
Coronavirus/COVID-19 ,
Diagnostic Tests ,
Food and Drug Administration (FDA) ,
Infectious Diseases ,
Intellectual Property Litigation ,
Intellectual Property Protection ,
IP License ,
Patent Litigation ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Webinars
On January 15, 2020, the United States and China signed a Phase 1 trade agreement (the “Agreement”). The Agreement addresses a broad range of economic issues including intellectual property, agriculture, financial markets,...more
In Amerigen Pharmaceuticals Limited v. UCB Pharma GmbH, generic drug manufacturer Amerigen appealed a decision of the Patent Trial & Appeal Board finding UCB’s patent to certain chemical derivatives of diphenylpropylamines...more
1/28/2019
/ Abbreviated New Drug Application (ANDA) ,
Appeals ,
Article III ,
Generic Drugs ,
Intellectual Property Protection ,
Inter Partes Review (IPR) Proceeding ,
Obviousness ,
Patent Infringement ,
Patent Litigation ,
Patent Trial and Appeal Board ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Prescription Drugs ,
Standing
On January 13, 2017, the Supreme Court granted certiorari to two related petitions brought by Amgen, Inc. and Sandoz, Inc. to resolve disputes regarding the interpretation of the Biologics Price Competition and Innovation Act...more