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In Hatch-Waxman litigation, Federal Circuit restricts venue under the TC Heartland to districts relating to ANDA filings

On November 5, 2020, the United States Court of Appeals for the Federal Circuit, in Valeant Pharmaceuticals N. Am. LLC v. Mylan Pharmaceuticals Inc., No. 19-2402, resolved a split among district courts over what constitutes...more

Federal Circuit Upholds Application of Dedication-Disclosure Doctrine at the Pleading Stage

On May 8, 2020, the Court of Appeals for the Federal Circuit affirmed the District of Delaware’s application of the disclosure-dedication doctrine in granting a motion for judgment on the pleadings in Eagle Pharmaceuticals...more

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

District Court denies motion to dismiss despite Federal Circuit’s finding of patent invalidity in appeal of parallel ITC...

On December 5, 2019, Judge David C. Godbey of the Northern District of Texas denied the defendant Diebold Nixdorf, Inc.’s (“Diebold”) motion to dismiss under Rule 12(b)(6), in Nautilus Hyosung Inc. v. Diebold, Inc. et al.,...more

ITC rejects minimum threshold requirement for domestic industry economic prong and emphasizes the importance of contextual...

In a recent decision clarifying the legal standards of the International Trade Commission’s domestic industry requirement, the Commission has upheld, with modified reasoning, Chief Administrative Law Judge Bullock’s initial...more

Collateral estoppel does not attach to PTAB invalidity determination pending appeal

Recently, in Sanofi-Aventis v. Mylan, 2:17-cv-09105-SRC-CLW, Judge Stanley Chesler of the United States District Court, District of New Jersey, denied a motion by defendant Mylan for summary judgment of invalidity of asserted...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

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