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Federal Circuit affirms Safe Harbor ruling and $70 million award in Amgen Inc. v. Hospira, Inc.

On December 16, 2019, the Court of Appeals for the Federal Circuit issued an opinion that fully upheld the District of Delaware’s denial of Hospira, Inc.’s motion for judgment as a matter of law (JMOL), or alternative motion...more

Means-Plus-Function Structure – Can be it Incorporated by Reference?

In its recent decision, Fiber, LLC. v. Ciena Corp., No. 2019-1005 (Fed. Cir. Nov. 21, 2019), the Court of Appeals for the Federal Circuit (Federal Circuit) issued a reminder that the structure necessary to satisfy the...more

ANDA Applicant Dismissed for Lack of Venue Under § 1400(b) as District of New Jersey Departs from its own and the District of...

On August 13, 2019, the United States District Court for the District of New Jersey, in Valeant Pharmaceuticals N. Am. LLC v. Mylan Pharmaceuticals Inc., No. 18-cv-14305, held that venue was not proper in New Jersey over...more

Federal Circuit Cautions Against Rigid Approach to Prosecution History Estoppel in Fourth Appeal from ALIMTA® Litigations

On August 9, 2019, the United States Court of Appeals for the Federal Circuit, in Eli Lilly & Co. v. Hospira, Inc., Nos. 2018-2126, 2127, 2128, reversed in-part and affirmed in-part a district court’s determination of...more

District of Delaware Dismisses ANDA Applicant for Lack of Venue under TC Heartland

On October 18, 2018, the United States District Court for the District of Delaware, in Bristol-Myers Squibb v. Mylan Pharmaceuticals Inc., No. 17-00379, held that venue was not proper in Delaware over Mylan Pharmaceuticals...more

Federal Circuit Holds Federal Circuit Law Applies to Patent Venue Challenges and Places Burden on Plaintiffs to Establish Venue

On May 14, 2018, the United States Court of Appeals for the Federal Circuit, In re: ZTE (USA) Inc., No. 2018-113, held that Federal circuit law governs the burden of proof for venue challenges under 28 U.S.C. § 1400(b) and...more

Federal Circuit Puts the Brakes on PTAB Final Written Decision For Procedural APA Violation

In EmeraChem Holdings LLC v. Volkswagen Group of Am. Inc., the Federal Circuit reminded the PTAB that it must abide by the APA’s requirements of adequate notice and an opportunity to respond when conducting a post-grant...more

Losing IPR Petitioners May Lack Standing To Appeal

When the Patent Trial and Appeal Board issues a final written decision finding against an IPR Petitioner, can that Petitioner necessarily appeal that adverse decision? In a case of first impression, the Federal Circuit...more

Pleading Standard Defined– CAFC Holds that Joint Infringement Complaint Requires Identification of All Required Claim Steps

Plaintiffs bringing patent infringement complaints under the Iqbal/Twombly pleading standard should take notice. On September 30, 2016, a panel of the Federal Circuit affirmed a district court’s dismissal of a deficient...more

Fed. Cir. Defers to PTAB Finding of Obviousness in First Pharma IPR Reviews (Merck v. Gnosis)

On December 17, 2015, the Federal Circuit issued a precedential decision affirming a determination by the Patent Trial and Appeal Board (“PTAB”) that patent claims related to methods of treating elevated homocysteine levels...more

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