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Hatch-Waxman Biologics Price Competition and Innovation Act of 2009

Jones Day

Federal Circuit Clarifies Probative Value of Patent Dance Statements

Jones Day on

The Situation: The Biologics Price Competition and Innovation Act was considered in a November 2017 decision by the United States Court of Appeals for the Federal Circuit. The Result: The court found that the commercial...more

Polsinelli

First Biosimilar Drug Now Available; Ongoing Legal Dispute Remains

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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

Polsinelli

Federal Circuit Delays Sandoz Biosimilar Launch

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In a closely-watched case between Amgen and Sandoz regarding the first biosimilar approved (Zarxio), the Federal Circuit interpreted key Biologics Price Competition and Innovation Act (BPCIA) provisions regarding Sandoz's...more

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