There is no denying the importance of preserving rights for appeal. A recent example of this came about in Novartis Pharmaceuticals Corp. v Accord Healthcare, Inc. et al., Civil Action No. 18-1043 (Memorandum Opinion dated...more
On February 11, 2021, in a unanimous decision, the Federal Circuit affirmed the district court’s holding that Amgen Inc., Amgen Manufacturing, Ltd., and Amgen USA, Inc.’s (collectively, “Amgen’s”) antibody composition claims...more
On November 5, 2020, the Federal Circuit issued a precedential opinion deciding a patent venue question concerning Hatch-Waxman cases left open after the Supreme Court’s decision in TC Heartland LLC v. Kraft Foods Grp. Brands...more
11/10/2020
/ Abbreviated New Drug Application (ANDA) ,
Corporate Counsel ,
Food and Drug Administration (FDA) ,
Hatch-Waxman ,
Intellectual Property Protection ,
Patent Infringement ,
Patent Litigation ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Venue
On May 8, 2019, the Federal Circuit issued a precedential opinion affirming a district court’s finding of noninfringement in an action brought under the Biologics Price Competition and Innovation Act (“BPCIA”). Amgen Inc. et...more
6/13/2019
/ Amgen ,
Biosimilars ,
BPCIA ,
Food and Drug Administration (FDA) ,
Patent Infringement ,
Patent Litigation ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Popular ,
Sandoz ,
Sandoz v Amgen
On April 13, 2018, in a split decision, the Federal Circuit held that Vanda Pharmaceuticals Inc.’s method of treatment claims are directed to patent-eligible subject matter under step one of the Mayo two-step test. Vanda...more
On February 9, 2018, the Federal Circuit affirmed the District of Delaware’s holding that Merck Sharp & Dohme Corp. (“Merck”) failed to meet its burden of proving that Amneal Pharmaceuticals LLC’s (“Amneal”) ANDA product...more
Is post-priority date evidence admissible as relevant to determining whether a patentee has complied with the written description requirement? What about for enablement? Recently, the Federal Circuit answered those...more
In Sandoz Inc. v. Amgen Inc., No. 15-1039 (U.S. June 12, 2017) the Supreme Court held (i) that biosimilar applicants may provide the requisite 180-days’ notice of commercial marketing to the reference product sponsor even...more
Introduction -
In proving a patent invalid (or infringed), all claim limitations must be considered. A recent case illustrates this maxim for both derivation under 35 U.S.C. § 102(f) and obviousness under 35 U.S.C. §...more
On December 28, 2016, Judge Stark of the District of Delaware, despite having previously found infringement, held that plaintiffs Bayer Pharma AG, Bayer Intellectual Property GmbH, and Bayer HealthCare Pharmaceuticals Inc....more
1/12/2017
/ Abbreviated New Drug Application (ANDA) ,
Bayer ,
FDA Approval ,
Food and Drug Administration (FDA) ,
Generic Drugs ,
Patent Infringement ,
Patent Litigation ,
Patents ,
Permanent Injunctions ,
Pharmaceutical Industry ,
Pharmaceutical Patents
On October 6, 2016, nearly thirteen years after passage of the Medicare Modernization Act (MMA), FDA published a final rule in the Federal Register implementing amendments and revisions to title 21 of the Code of Federal...more
On July 11, 2016, the Federal Circuit, en banc, overruled the merits panel and affirmed the District of Delaware’s decision in The Medicines Company v. Hospira, Inc. finding that an assignee’s entry into a manufacturing...more
The on-sale bar defense under 35 U.S.C. § 102(b) remains a topic of interest for the Federal Circuit. For example, the Federal Circuit, en banc, is considering whether a supplier exception should exist to the on-sale bar...more
On December 11, 2015, the United States District Court for the Southern District of Indiana granted a motion to stay a Hatch-Waxman litigation pending the outcome of inter partes reviews (IPRs) on two of the patents-in-suit...more
1/13/2016
/ Abbreviated New Drug Application (ANDA) ,
Eli Lilly ,
Food and Drug Administration (FDA) ,
Generic Drugs ,
Hatch-Waxman ,
Inter Partes Review (IPR) Proceeding ,
Motion To Stay ,
Patent Litigation ,
Patent-in-Suit ,
Patents ,
Pharmaceutical Patents ,
USPTO
The Federal Circuit recently affirmed that a generic pharmaceutical company’s use of post-approval quality control testing was not “making” under 35 U.S.C. § 271(g). See Momenta Pharmaceuticals, Inc. et al. v. Teva...more
On November 10, 2015, the Federal Circuit issued its opinion in Prometheus Laboratories, Inc. v. Roxane Laboratories, Inc. et al., No. 14-1634, -1635, slip op. (Fed. Cir. Nov. 10, 2015) affirming the district court’s decision...more
On October 2, 2015, the Federal Circuit affirmed a district court’s holding (1) that a substantially pure compound would have been obvious when a lesser pure compound (“the 50/50 mixture”) and the pure compound were known in...more
In December of last year, the Federal Circuit vacated and remanded the U.S. District Court for the District of Maryland’s (“the Court”) decision finding U.S. Patent No. 7,101,576 (“the ‘576 patent”) invalid as obvious. See...more
On July 2, 2015, the Federal Circuit issued a decision in The Medicines Company v. Hospira, Inc., --- F.3d ---, 2015 WL 4033143 (Fed. Cir. July 2, 2015) reversing the District of Delaware’s finding that the asserted claims...more