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
The long-awaited decision in United States v. Arthrex held that the Patent Trial and Appeal Board (PTAB) is inconsistent with the Constitution’s Appointments Clause because the administrative patent judges (APJs) that...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
To treat? Or not to treat? – that was the question in the Federal Circuit decision in the case of INO Therapeutics LLC v. Praxair Distribution Inc.1 (2018-1019). INO provides an interesting development in the patent...more
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
As the path to legality of cannabis and cannabis-related products progresses, the formerly illegal world of marijuana now confronts legal principles beyond law enforcement. And the patent laws are no exception. On April 17,...more
On January 22, 2019, the Supreme Court unanimously ruled that the provision of the America Invents Act (“AIA”) barring an inventor from obtaining a patent for an invention that was “in public use, on sale, or otherwise...more
On January 16, 2019, the United States Food and Drug Administration issued a new draft Guidance entitled “ANDA Submissions –Amendments and Requests for Final Approval to Tentatively Approved ANDAs”.
This new FDA Guidance...more
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
The Patent Trial and Appeal Board (“PTAB”) recently issued guidance on the effects the Supreme Court of the United States’ decision in SAS Institute Inc. v. Iancu, No. 16-969 (U.S. Apr. 24, 2018) will have on the inter partes...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 October 26, 2017, the Federal Circuit, in a split decision, upheld the invalidity of the asserted claims of U.S. Patent No. 6,486,150 (“the ’150 patent”) as obvious under 35 U.S.C. § 103. See Merck Sharp & Dohme Corp. v....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
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
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 January 12, 2017, the Federal Circuit affirmed the district court’s holding that, under Akamai Technologies, Inc. v. Limelight Networks, Inc., 797 F.3d 1020, 1022 (Fed. Cir. 2015) (en banc), the acts of patients may be...more
1/26/2017
/ Abbreviated New Drug Application (ANDA) ,
Direct Infringement ,
Induced Infringement ,
Limelight v Akamai ,
Method Claims ,
Patent Litigation ,
Patents ,
Patients ,
Pharmaceutical Industry ,
Physicians ,
Product Labels
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 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
On November 16, 2015, the Federal Circuit vacated and remanded a Patent Trial and Appeal Board (PTAB, also the “Board”) inter partes review (“IPR”) decision holding that a prior art reference, though not identified as an...more