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
In almost every claim construction, the courts make their claim construction ruling largely based on the intrinsic evidence – the claims, specification and prosecution history. However, the Federal Circuit (CAFC) bucked this...more
Bayer v. Baxalta is a patent case dealing with several issues of claim scope, infringement, validity, and damages. Bayer Healthcare LLC v. Baxalta Inc., No. 2019-2418 (Fed. Cir. Mar. 1, 2021). Here, as a follow up to our...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 23, 2018, the Patent Trial and Appeal Board of United State Patent and Trademark Office (“the Board”) denied Saint Regis Mohawk Tribe’s (“the Tribe”) motion to terminate inter partes review (“IPR”) proceedings...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
On August 4, 2017, a pair of decisions reaffirmed that claimed methods which apply routine and conventional techniques to a law of nature are invalid and do not satisfy the “inventive concept” step of the patent eligibility...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
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
The doctrine of claim vitiation prevents application of the doctrine of equivalents in a way that would completely eliminate a claim element – i.e., renders the claim limitation inconsequential or ineffective. This doctrine...more
On May 28, 2015, we reported on the Supreme Court’s decision in Commil USA, LLC v. Cisco Systems, Inc., 135 S. Ct. 1920 (2015) which reversed the Federal Circuit’s earlier decision and held that, inter alia, a reasonable...more
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
Following last year’s decision in Limelight Networks, Inc. v. Akamai Technologies, Inc. et al., 572 U.S. ____ (2014) (holding that a finding of induced infringement requires that all infringing acts be performed by a single...more
5/29/2015
/ Cisco ,
Cisco v CommilUSA ,
Good Faith ,
Honest Belief Defense ,
Induced Infringement ,
Limelight v Akamai ,
Patent Infringement ,
Patent Invalidity ,
Patents ,
Presumption of Validity ,
Scienter ,
SCOTUS