News & Analysis as of

Motion to Dismiss aBLA

Akin Gump Strauss Hauer & Feld LLP

Prosecution History Estoppel Bars Amgen’s Infringement Claim Under the Doctrine of Equivalents

The Federal Circuit affirmed a district court decision barring Amgen from asserting an infringement claim under the doctrine of equivalents against Coherus Biosciences because Amgen disclaimed all combinations not identified...more

Patterson Belknap Webb & Tyler LLP

Amgen’s Federal Circuit Appeal to Address Important BPCIA Disclosure Issue

The Federal Circuit has now issued two decisions interpreting the Biologics Price Competition and Innovation Act of 2009 (BPCIA). In Amgen v. Sandoz, the first decision to interpret the BPCIA, the majority held that...more

Fish & Richardson

Federal Circuit Denies Motion to Dismiss Appeal of BPCIA-Related Discovery Order

Fish & Richardson on

The Federal Circuit has denied Hospira’s motion to dismiss Amgen’s appeal of a discovery order in an underlying BPCIA district court litigation (Civil Action No. 15-cv-00839, D. Del.) and has instructed the parties to address...more

Goodwin

Amgen v. Hospira: Court Considers Issues Regarding the Scope of Discovery and the RPS’s Ability to Assert Additional Patents in...

Goodwin on

In a recent hearing held in Amgen v. Hospira, the parties offered arguments on some novel issues relating to litigation under the BPCIA, particularly: - ..Whether a reference product sponsor (“RPS”) can compel a...more

Patterson Belknap Webb & Tyler LLP

Update on Personal Jurisdiction for BPCIA Litigants after the Supreme Court’s decision in Daimler

Under 35 U.S.C. § 271(e), filing an Abbreviated Biologics License Application (aBLA)—like filing an Abbreviated New Drug Application (ANDA)— can be an act of patent infringement resulting in ‘artificial’ injury to a patentee....more

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