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
Click here for PDF On May 10, 2019, the United States Food and Drug Administration (FDA) issued a new draft Guidance entitled Considerations in Demonstrating Interchangeability With a Reference Product....more
On May 9, 2019, the United States Food and Drug Administration (FDA) released a final guidance entitled Determining Whether to Submit an ANDA or 505(b)(2) Application to guide an applicant’s decision on which abbreviated...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On January 16, 2019, the United States Food and Drug Administration issued a new draft Guidance entitled “ANDA Submissions –Amendments and Requests for Final Approval to Tentatively Approved ANDAs”.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 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
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 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 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