This week, we take a closer look at two precedential cases concerning pharmaceutical patent protections as applied to drugs in development.
In Incyte Corp. v. Sun Pharm., Judge Hughes entered a dissent pushing back on the...more
5/13/2025
/ Appeals ,
FDA Approval ,
Food and Drug Administration (FDA) ,
Hatch-Waxman ,
Injunctive Relief ,
Patent Infringement ,
Patent Litigation ,
Patent Trial and Appeal Board ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Remand ,
USPTO
Azurity Pharmaceuticals, Inc. v. Alkem Laboratories Ltd., Appeal No. 2023-1977 (Fed. Cir. Apr. 8, 2025)
In our Case of the Week, the Federal Circuit affirmed that defendant Alkem’s proposed generic antibiotic did not...more
4/15/2025
/ Abbreviated New Drug Application (ANDA) ,
Appeals ,
Claim Construction ,
Generic Drugs ,
Hatch-Waxman ,
Patent Infringement ,
Patent Litigation ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Prior Art ,
Writ of Mandamus
Regeneron Pharmaceuticals, Inc. v. Mylan Pharmaceuticals Inc., Appeal Nos. 2024-1965, -1966, -2082, -2083 (Fed. Cir. Jan. 29, 2025)
Our Case of the Week is a 31-page decision that touches on a variety of issues, including...more
2/4/2025
/ Appeals ,
Biologics ,
Cross-Appeals ,
Food and Drug Administration (FDA) ,
Intellectual Property Litigation ,
Inter Partes Review (IPR) Proceeding ,
Jurisdiction ,
Obviousness ,
Obviousness-Type Double Patenting (ODP) ,
Patent Litigation ,
Patent Trial and Appeal Board ,
Patents ,
Pharmaceutical Patents ,
Preliminary Injunctions ,
Section 112 ,
Written Descriptions
In re Entresto (Sacubitril/Valsartan), Appeal Nos. 2023-2218, -2220, -2221 (Fed. Cir. Jan. 10, 2025)
In our Case of the Week, the Federal Circuit revived Novartis’s US Patent No. 8,101,659 by reversing the district...more
CloudofChange, LLC v. NCR Corp., Appeal No. 2023-1111 (Fed. Cir. Dec. 18, 2024)
In our Case of the Week, the Federal Circuit addressed the question of divided infringement in the context of system claims. In its...more
12/24/2024
/ Abbreviated New Drug Application (ANDA) ,
Appeals ,
Claim Construction ,
Food and Drug Administration (FDA) ,
Hatch-Waxman ,
Inter Partes Review (IPR) Proceeding ,
Motivation to Combine ,
Patent Infringement ,
Patent Litigation ,
Patent Trial and Appeal Board ,
Patents ,
Pharmaceutical Patents ,
Remand ,
Reversal ,
Technology ,
Vacated
Allergan USA, Inc. v. MSN Laboratories Private Ltd., Appeal No. 2024-1061 (Fed. Cir. August 13, 2024)
In this week’s Case of the Week, the Federal Circuit clarifies rules relating to when an applicant’s patent can be...more
8/20/2024
/ Appeals ,
Article III ,
Constitutional Challenges ,
EU ,
Helsinn Healthcare SA v Teva Pharmaceuticals USA Inc ,
Inter Partes Review (IPR) Proceeding ,
International Trade Commission (ITC) ,
Inventions ,
Inventors ,
Patent Infringement ,
Patent Invalidity ,
Patent Litigation ,
Patent Trial and Appeal Board ,
Patents ,
Pharmaceutical Patents ,
SCOTUS
Natera, Inc. v. NeoGenomics Laboratories, Inc., Appeal Nos. 2024-1324, -1409 (Fed. Cir. July 12, 2024)
In its only precedential patent opinion last week, the Federal Circuit affirmed a preliminary injunction that largely...more
Amarin Pharma, Inc. v. Hikma Pharms. USA Inc., Appeal No. 2023-1169 (Fed. Cir. June 25, 2024)
In the Court’s only precedential patent opinion last week, the Federal Circuit reversed the district court’s dismissal of...more
Copan Italia SPA v. Puritan Med. Prods. Co. LLC, Appeal No. 2022-1943 (Fed. Cir. May 14, 2024)
The Federal Circuit’s only precedential opinion concerning a patent case this week had nothing to do with patent law....more
5/21/2024
/ Appeals ,
Coronavirus/COVID-19 ,
Final Judgment ,
Inter Partes Review (IPR) Proceeding ,
Life Sciences ,
Motion to Dismiss ,
Patent Infringement ,
Patent Litigation ,
Patents ,
Pharmaceutical Patents ,
Precedential Opinion
Janssen Pharms., Inc. et al. v. Teva Pharm. USA, Inc. et al., Appeal Nos. 2022-1258, -1307 (Fed. Cir. April 1, 2024)
In this week’s Case of the Week, the Federal Circuit vacated-in-part a district court’s bench trial...more
4/9/2024
/ Abstract Ideas ,
Appeals ,
Claim Construction ,
Janssen Pharmaceuticals ,
Obviousness ,
Patent Infringement ,
Patent Invalidity ,
Patent Litigation ,
Patent-Eligible Subject Matter ,
Patents ,
Pharmaceutical Patents ,
Prior Art ,
Remand ,
Teva Pharmaceuticals
VLSI Technology LLC v. Intel Corporation, Appeal No. 2022-1906 (Fed. Cir. December 4, 2023)
In this week’s Case of the Week, the Federal Circuit vacated an approximately $2.2 billion damages award against appellant Intel...more
Purdue Pharma L.P. v. Collegium Pharmaceutical, Inc. (United States Patent and Trademark Office intervening), Appeal No. 2022-1482 (Fed. Cir. Nov. 21, 2023)
In the Federal Circuit’s only precedential patent opinion last...more
Baxalta Inc. v. Genentech, Inc., Appeal No. 22-1461 (Fed. Cir. Sept. 20, 2023)
Our Case of the Week focuses on the enablement requirement. It’s the first case to come before the Federal Circuit following the Supreme...more
9/26/2023
/ Amgen ,
Amgen v Sanofi ,
Enablement Inquiries ,
Intellectual Property Protection ,
Inter Partes Review (IPR) Proceeding ,
Inventions ,
Life Sciences ,
Obviousness ,
Patent Litigation ,
Patent Trial and Appeal Board ,
Patents ,
Pharmaceutical Patents ,
SCOTUS
Amgen Inc. et al. v. Sanofi et al, No. 21-757 (S. Ct. May 18, 2023)
The Supreme Court issued a long-awaited decision today concerning the enablement requirement found in Section 112 of the Patent Act. Specifically, the...more
5/19/2023
/ Amgen ,
Biotechnology ,
Enablement Inquiries ,
Healthcare ,
Intellectual Property Litigation ,
Intellectual Property Protection ,
Inventions ,
Judicial Proceedings ,
Life Sciences ,
Patent Invalidity ,
Patent Litigation ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Sanofi ,
SCOTUS ,
Section 112
Jazz Pharmaceuticals, Inc. v. Avadel CNS Pharmaceuticals, LLC, Appeal No. 2023-1186 (Fed. Cir. Feb. 24, 2023)
In this week’s Case of the Week, the Federal Circuit affirmed a permanent injunction requiring appellant Jazz...more
Provisur Technologies, Inc. v. Weber, Inc., Appeal Nos. 2021-1942, -1975 (Fed. Cir. Sept. 27, 2022) -
In this week’s Case of the Week, the Federal Circuit reviewed an IPR decision and addressed the Patent Trial and Appeal...more
10/4/2022
/ Administrative Procedure Act ,
Alice/Mayo ,
Appeals ,
Claim Limitations ,
Federal Rules of Evidence ,
Inter Partes Review (IPR) Proceeding ,
Motion to Exclude ,
Patent Applications ,
Patent Litigation ,
Patent Trial and Appeal Board ,
Patents ,
Pharmaceutical Patents ,
Prior Art ,
Reversal ,
Vacated
Novartis Pharms. Corp. v. Accord Healthcare, Inc., Appeal No. 2021-1070 (Fed. Cir. June 21, 2022) -
In this week’s Case of the Week, the Federal Circuit granted panel rehearing of and vacated its prior decision in Novartis...more
Adapt Pharma Operations Limited v. Teva Pharmaceuticals USA, Inc., Appeal No. 2020-2106 (Fed. Cir. Feb. 10, 2022) -
In our Case of the Week, the Court of Appeals for the Federal Circuit, in both the majority opinion and...more
2/15/2022
/ Appeals ,
En Banc Review ,
Inter Partes Review (IPR) Proceeding ,
IP License ,
Motion To Seal ,
Obviousness ,
Patent Infringement ,
Patent Invalidity ,
Patent Litigation ,
Patent-Eligible Subject Matter ,
Patents ,
Pharmaceutical Patents ,
Preliminary Injunctions ,
Prior Art ,
Remand ,
Third-Party ,
Vacated
Novartis Pharmaceuticals Corporation v. Accord Healthcare, Inc., Appeal No. 2021-1070 (Fed. Cir. Jan. 3, 2022) -
In this week’s Case of the Week, the Federal Circuit affirmed a district court’s bench trial finding that...more
University of Strathclyde v. Clear-Vu Lighting LLC, Appeal No. 2021-2243 (Fed. Cir. Nov. 4, 2021) -
In this week’s Case of the Week, the Federal Circuit reversed an inter partes review decision finding claims directed to...more
11/9/2021
/ Abbreviated New Drug Application (ANDA) ,
Appeals ,
Dismissals ,
Improper Venue ,
Inter Partes Review (IPR) Proceeding ,
Obviousness ,
Patent Infringement ,
Patent Litigation ,
Patents ,
Pharmaceutical Patents ,
Prior Art
Teva Pharms. Int’l GmbH v. Eli Lilly and Co., Appeal Nos. 2020-1747, -1748, -1750 (Fed. Cir. Aug. 16, 2021) -
Eli Lilly and Co. v. Teva Pharms. Int’l GmbH, Appeal Nos. 2020-1876, -1877, -1878 (Fed. Cir. Aug. 16, 2021)...more
Amgen Inc. v. Sanofi, Appeal No. 2020-1074 (Fed. Cir. Feb. 11, 2021) -
In this week’s Case of the Week, the Federal Circuit affirmed a district court’s JMOL ruling that asserted claims of two related pharmaceutical patents...more
2/17/2021
/ Appeals ,
Indefiniteness ,
Inter Partes Review (IPR) Proceeding ,
JMOL ,
Patent Infringement ,
Patent Litigation ,
Patent Trial and Appeal Board ,
Patent-Eligible Subject Matter ,
Patents ,
Pharmaceutical Patents ,
Summary Judgment
C.R. Bard Inc. v. AngioDynamics, Inc., Appeal No. 2019-1756, -1934 (Fed. Cir. Nov. 10, 2020) -
Our Case of the Week is one of two cases decided this week in which the Federal Circuit finds that a district court jumped the...more
11/17/2020
/ Appeals ,
Appellate Courts ,
Claim Construction ,
Discovery ,
Dismissals ,
Equitable Estoppel ,
Genuine Issue of Material Fact ,
Inter Partes Review (IPR) Proceeding ,
Inventors ,
Obviousness ,
Patent Infringement ,
Patent Litigation ,
Patents ,
Petition for Writ of Certiorari ,
Pharmaceutical Patents ,
Summary Judgment
PATENT CASE OF THE WEEK -
Dana-Farber Cancer Institute, Inc. v. Ono Pharmaceutical Co., Ltd., Appeal No. 2019-2050 (Fed. Cir. July 14, 2020) -
In this week’s Case of the Week, the Federal Circuit addressed inventorship...more
PATENT CASE OF THE WEEK -
Eagle Pharmaceuticals Inc. v. Slayback Pharma LLC, Appeal No. 2019-1924 (Fed. Cir. May 8, 2020) -
This week’s Case of the Week features an appeal from the United States District Court for the...more