In the first month of the 116th Congress, three bills have been introduced (or re-introduced) that have potential to impact generic pharmaceutical companies.
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2/13/2019
/ Abbreviated New Drug Application (ANDA) ,
Exclusivity ,
Generic Drugs ,
Hatch-Waxman ,
Intellectual Property Protection ,
Patent Infringement ,
Patent Litigation ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Prescription Drugs ,
Proposed Legislation
The Federal Circuit issued a trio of decisions this month further clarifying the application of the patent venue statute in the post-TC Heartland era.
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The first biosimilar is now available in the United States. Sandoz announced the availability of Zarxioâ„¢ (filgrastim-sndz) earlier today, after the Federal Circuit denied Amgen Inc.'s attempt to stall the launch. The launch...more
9/4/2015
/ Amgen ,
Biologics Price Competition and Innovation Act of 2009 ,
Biosimilars ,
BPCIA ,
Food and Drug Administration (FDA) ,
Hatch-Waxman ,
Injunctions ,
Patent Dance ,
Patent Litigation ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Sandoz
The United States District Court for the Southern District of Indiana joined the District of Delaware and the Eastern District of Texas in finding specific jurisdiction based on receipt of a Paragraph IV Notice Letter. See...more
On February 21, 2014, the Federal Circuit released its widely-anticipated decision in Lighting Ballast Control LLC v. Phillips Electronics North America Corporation. The decision renews the Court's commitment to fifteen years...more