Allergan v Sandoz

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Federal Circuit Finds No Biosimilars Application Means No Case or Controversy for Sandoz

In Sandoz Inc. v. Amgen Inc., the Federal Circuit upheld the district court decision dismissing Sandoz’s declaratory judgment action for lack of jurisdiction. Although this may be the first Federal Circuit decision relating...more

Declaratory Judgment Action Premature: Decision Suggests “Patent Dance” Mandatory for Biosimilar Applicants

Biosimilar applicants and branded biologics have been wondering how the procedures set forth in the Biologics Price Competition and Innovation Act (“BPCIA”) will be implemented since its enactment in 2010. The lack of...more

BPCIA

BPCIA = Biologics Price Competition & Innovation Act Before Plaintiffs Can Invoke (jurisdiction they must ?le an) Application. No standing for declaratory judgment before biosimilar application - With the FDA’s...more

Allergan, Inc. v. Sandoz Inc.

Case Name: Allergan, Inc. v. Sandoz Inc., Case No. 11-cv-441, Dkt. No. 136 (E.D. Tex. Jan. 13, 2014) (Schneider, J.) - Drug Product and Patent(s)-in-Suit: Lumigan® (bimatoprost); U.S. Patents Nos. 7,851,504 (“the ’504...more

Recent Ruling Clarifies Patent Litigation Timing Under Biosimilars Act

The first court decision interpreting the Biosimilars Act has arrived, with a federal district court in California finding that a biosimilar application must be filed with the FDA before patent litigation can be initiated....more

Federal Circuit Review - Volume 3 | Issue 5 - May 2013

In This Issue: • Patent Office Must Prove Prior Art Reference Is Enabling • Complaint Was Adequate Despite Non-Infringing Possibilities • FDA Approval Not Relevant to Obviousness Analysis - Excerpt from...more

Patent Watch: Allergan, Inc. v. Sandoz Inc.

On May 1, 2013, in Allergan, Inc. v. Sandoz Inc., the U.S. Court of Appeals for the Federal Circuit (Dyk, Prost,* O'Malley) affirmed-in-part and reversed-in-part the district court's judgment that U.S. Patents No. 7,642,258,...more

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