News & Analysis as of

Abbreviated New Drug Application (ANDA) Subject Matter Jurisdiction

Akin Gump Strauss Hauer & Feld LLP

Generic’s Conversion from Paragraph IV to Section viii Upends Subject Matter Jurisdiction on Declaratory Judgment Counterclaims

The District Court of Delaware dismissed a generic drug company’s declaratory judgment counterclaims of non-infringement and invalidity, finding that the court no longer had subject matter jurisdiction after the generic...more

Mintz - Intellectual Property Viewpoints

N.D. Ill. Finds that a Foreign Parent Corp. May be Sued Under BPCIA Without the U.S. Subsidiary that Signed and Filed aBLA

In what appears to be a case of first impression, on August 23, 2021 U.S. District Judge John Z. Lee of the United States District Court for the Northern District of Illinois denied a biosimilar applicant’s motion to dismiss...more

Sterne, Kessler, Goldstein & Fox P.L.L.C.

Federal Circuit Appeals from the PTAB and ITC: Summaries of Key 2020 Decisions

[co-author: Kathleen Wills] Last year, the global COVID-19 pandemic created unprecedented challenges for American courts. By making several changes, however, the U.S. Court of Appeals for the Federal Circuit was able to...more

Dechert LLP

District of Delaware Holds that ANDA Filer’s Conversion from a PIV Certification to a PIII Certification Does Not Strip Court of...

Dechert LLP on

Generic manufacturers seeking to put an end to Hatch-Waxman Act patent litigation over a branded company’s Orange Book-listed patents can seek to do so by converting from Paragraph IV (“PIV”) patent certifications to...more

Mintz - Intellectual Property Viewpoints

Celgene v. Sun Pharma Global: Satisfying Subject Matter Jurisdiction Under § 271(e)(2)

On April 6, 2020, the U.S. District Court for the District of New Jersey, in Celgene Corp. v. Sun Pharma Global FZE, No. 19-cv-10099, denied Sun’s motion to dismiss Celgene’s claims that Sun’s generic Revlimid® (lenalidomide)...more

WilmerHale

Federal Circuit Patent Updates - January 2019

WilmerHale on

Barry v. Medtronic, Inc. (No. 2017-2463, 1/24/19) (Prost, Moore, Taranto) - Taranto, J. Affirming judgement of no invalidating public use of patents related to methods for correcting spinal column anomalies. Also...more

Foley & Lardner LLP

Federal Circuit Finds ANDA Jurisdiction Before PIV Certification

Foley & Lardner LLP on

Our first article on Vanda Pharmaceuticals, Inc. v. Aventisub, LLC focused on the subject matter eligibility of the personalized method of treatment claims under 35 USC § 101. Next, we considered how the Fanapt® label was...more

McDermott Will & Emery

Earlier Eye Drop Settlement Agreement Relieves Court of Subject Matter Jurisdiction

McDermott Will & Emery on

Finding no case or controversy, the US District Court for the Southern District of Indiana granted Intervenor-Defendant Barr’s motion to dismiss Apotex’s declaratory judgment action for lack of subject matter jurisdiction....more

Schwabe, Williamson & Wyatt PC

Fresh From the Bench: Precedential Patent Cases From the Federal Circuit

In Mylan v. Aurobindo the Circuit affirms the grant of a preliminary injunction based upon the infringement of one of the three patents in suit. However, the panel reverses the injunction as to the other two patents based on...more

Akin Gump Strauss Hauer & Feld LLP

Subject Matter Jurisdiction Remains in Hatch-Waxman Patent Infringement Action after ANDA Filer Changes from Paragraph IV to...

The District Court of Delaware denied defendant Wockhardt’s motion to dismiss a patent infringement action based on the reasonable inference that plaintiff AstraZeneca may need to assert its patent rights in the future. On...more

McDonnell Boehnen Hulbert & Berghoff LLP

Apotex Inc. v. Daiichi Sankyo, Inc. (Fed. Cir. 2015)

Can a Federal district court ever have subject-matter jurisdiction to hear a declaratory judgment action of non-infringement for a disclaimed patent? Of course, the Federal Circuit explained this week in the Apotex Inc. v....more

Robins Kaplan LLP

GENERICally Speaking - Vol. 4, No. 1

Robins Kaplan LLP on

The Hatch-Waxman Litigation and Life Sciences practice groups at Robins, Kaplan, Miller & Ciresi L.L.P. are pleased to offer the latest edition of their quarterly publication regarding ANDA patent litigation issues and the...more

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