The Federal Circuit recently issued decisions in a pair of appeals that provide guidance about when international filers of abbreviated Biologics License Applications (aBLAs) are subject to jurisdiction in the United States....more
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 Zarxio™ (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 Federal Circuit recently provided additional clarity about the scope of the Hatch-Waxman safe harbor. In Classen Immunotherapies, Inc. v. Elan Pharmaceuticals, Inc., the appellate court sharpened the line between...more
6/10/2015
/ Abbreviated New Drug Application (ANDA) ,
Classen Immunotherapies ,
Clinical Trials ,
Elan Pharmaceuticals ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Food and Drug Administration (FDA) ,
Generic Drugs ,
Hatch-Waxman ,
Labeling ,
Medical Devices ,
Merck ,
Patent Infringement ,
Safe Harbors ,
Vaccinations
Earlier this month the Food and Drug Administration ("FDA") published three industry guidances for the Biologics Price Competition and Innovation Act of 2009 ("BPCIA")....more
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
In This Issue:
- I. Traditional Use of General Jurisdiction in Hatch-Waxman Cases
- II. Amenability to General Jurisdiction May Be Waning
- III. Freedom from Jurisdiction Could Be An Advantage
-...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