News & Analysis as of

Generic Drugs Appeals Patent Litigation

A&O Shearman

Overlapping Range Presumption Not Applied Given Specified Doses Administered At Specified Times

A&O Shearman on

On July 8, 2025, the U.S. Court of Appeals for the Federal Circuit affirmed the validity of a Janssen patent, finding that Teva did not meet its burden to prove obviousness. In so doing, the Federal Circuit provided...more

Rothwell, Figg, Ernst & Manbeck, P.C.

District Circuit Denies Novartis’s Request for Injunctive Relief Against MSN’s Generic Version of Entresto®

The District Court for the District of Delaware recently rejected Novartis’s effort to block MSN Pharmaceuticals from launching a generic version of Entresto® (sacubitril/valsartan), its top-selling heart failure medication....more

McDermott Will & Emery

Motivation, expectation of success negate obviousness presumption in overlapping range case

McDermott Will & Emery on

The US Court of Appeals for the Federal Circuit affirmed (on its second review) a district court’s ruling upholding the validity of patent claims related to a long-acting injectable dosing regimen, finding that the...more

DLA Piper

Purdue Appeals Federal Circuit Obviousness Decision to the Supreme Court

DLA Piper on

Purdue Pharma (Purdue) has filed a petition for a writ of certiorari challenging a recent Federal Circuit decision upholding the invalidation of several Purdue patents on grounds of obviousness....more

Cooley LLP

Janssen v. Teva: Federal Circuit Upholds Claims to Pharmaceutical Dosing Regimen, Clarifies Presumption of Obviousness for...

Cooley LLP on

On July 8, the US Court of Appeals for the Federal Circuit issued a precedential opinion in Janssen Pharmaceuticals, Inc. et al. v. Teva Pharmaceuticals USA, Inc. affirming the district court’s finding that patent claims to a...more

Schwabe, Williamson & Wyatt PC

Latest Federal Court Cases: Janssen Pharmaceuticals, Inc. v. Teva Pharmaceuticals USA, Inc.

Janssen Pharmaceuticals, Inc. v. Teva Pharmaceuticals USA, Inc., Appeal Nos. 2025-1228, -1252 (Fed. Cir. July 8, 2025) Our Case of the Week focuses on obviousness. More particularly, the decision included a lengthy...more

Haug Partners LLP

Federal Circuit Provides Further Guidance on Obvious Type Double Patenting For Patents Sharing Common Priority

Haug Partners LLP on

On June 9th, 2025, the Federal Circuit issued a decision in Acadia Pharms. Inc. v. Aurobindo Pharma Ltd., affirming the district court’s grant of summary judgment of no invalidity for obviousness-type double patenting (OTDP)...more

Knobbe Martens

A Patent Does Not Guarantee the Patent Owner Will Be First to Market

Knobbe Martens on

INCYTE CORPORATION V. SUN PHARMACEUTICAL INDUSTRIES, LTD. - Before Moore, Prost and Hughes. Appeal from the United States District Court for the District of New Jersey. A district court erred in issuing a preliminary...more

Fish & Richardson

Federal Circuit Reverses Injunction That Barred Clinical Trials in Jazz v. Avadel

Fish & Richardson on

The Federal Circuit recently considered the scope of a permanent injunction that prohibited a drug manufacturer from conducting certain clinical and regulatory activities in Jazz Pharmaceuticals, Inc. v. Avadel CNS...more

McDonnell Boehnen Hulbert & Berghoff LLP

Metacel Pharmaceuticals LLC v. Rubicon Research Private Ltd. (Fed. Cir. 2025)

The Federal Circuit affirmed a District Court decision that the label for a generic drug obtained from an ANDA would not induce infringement by reciting optional drug storage conditions the read on the NDA holder's Orange...more

Knobbe Martens

Hard to Stomach: Things You Say to Prosecute a Patent Can and Will Be Used Against You

Knobbe Martens on

AZURITY PHARMACEUTICALS, INC. v. ALKEM LABORATORIES LTD. Before Murphy, Moore, and Chen. Appeal from the United States District Court for the District of Delaware. Arguments and amendments made during prosecution of a parent...more

Hogan Lovells

Court of Appeal hands down reasons for awarding AZ an interim injunction in the UK against Glenmark’s generic dapagliflozin for...

Hogan Lovells on

Just under two weeks ago, we reported the Court of Appeal had awarded AstraZeneca (AZ) a preliminary injunction in the UK against Glenmark’s generic dapagliflozin (dapa) product for type II diabetes, until the hearing...more

A&O Shearman

Federal Circuit Affirms Findings Of Non-Obviousness And Infringement Of Method Of Treatment Patent Claiming Dosing Regimen For...

A&O Shearman on

On March 28, 2025, the United States Court of Appeals for the Federal Circuit issued an opinion affirming the United States District Court for the District of New Jersey decision that Mylan Laboratories Ltd. (“Mylan”) induced...more

Robins Kaplan LLP

Merck Sharp & Dohme B.V. v. Aurobindo Pharma USA, Inc

Robins Kaplan LLP on

Bridion® (sugammadex) - Case Name: Merck Sharp & Dohme B.V. v. Aurobindo Pharma USA, Inc., No. 2023-2254, 2025 WL 795317 (Fed. Cir. Mar. 13, 2025) (Circuit Judges Dyk, Mayer, and Reyna presiding; Opinion by Dyk, C.J.) (Appeal...more

Robins Kaplan LLP

Janssen Pharms., Inc. v. Mylan Labs. Ltd.

Robins Kaplan LLP on

Invega Trinza® (paliperidone palmitate) - Case Name: Janssen Pharms., Inc. v. Mylan Labs. Ltd., No. 2023-2042, 2025 WL 946390 (Fed. Cir. Mar. 28, 2025) (Circuit Judges Dyk, Prost, and District Judge Goldberg presiding;...more

MoFo Life Sciences

In Patent Prosecution, You Have the Right to Remain Silent. Anything You Say Can and Will Be Used Against You in the Court of Law

MoFo Life Sciences on

While a Miranda warning isn’t given prior to starting substantive examination, perhaps it should be. In Azurity Pharmaceuticals, Inc. v. Alkem Laboratories, Ltd., a precedential decision issued on April 8, 2025, the Federal...more

Alston & Bird

Patent Case Summaries | Week Ending April 11, 2025

Alston & Bird on

Azurity Pharmaceuticals, Inc. v. Alkem Laboratories Ltd., No. 2023-1977 (Fed. Cir. (D. Del.) Apr. 8, 2025). Opinion by Murphy (sitting by designation), joined by Moore and Chen. Azurity owns a patent directed to non-sterile...more

McDermott Will & Emery

Prosecution Disclaimer Alive and Well, Especially in Closed Claim

McDermott Will & Emery on

The US Court of Appeals for the Federal Circuit affirmed a district court’s noninfringement determination, finding that the presence of a disclaimed compound in the accused product precluded infringement. Azurity Pharm., Inc....more

Irwin IP LLP

“Consisting of” Consequences: Prosecution Disclaimers Outweigh Pretrial Stipulations 

Irwin IP LLP on

The Federal Circuit recently opined on whether a stipulation in litigation can overcome a disclaimer made during the prosecution history of a patent. The Hatch-Waxman Act allows generic drug companies to use clinical results...more

Schwabe, Williamson & Wyatt PC

Latest Federal Court Cases: Azurity Pharmaceuticals, Inc. v. Alkem Laboratories Ltd.

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

Hogan Lovells

UK Court of Appeal grants AstraZeneca an interim injunction against Glenmark’s generic dapagliflozin for type II diabetes

Hogan Lovells on

In a reversal of fortune, yesterday (9 April) the UK Court of Appeal awarded AstraZeneca (AZ) an interim injunction keeping Glenmark’s dapagliflozin (dapa) off the UK market until the form of order hearing in the parallel...more

Irwin IP LLP

Federal Circuit Finds Loophole Allowing Patents To Cover Later Developed Technologies

Irwin IP LLP on

In re Entresto, 125 F.4th 1090 (Fed. Cir. 2025) - After Novartis’ patent on the blockbuster blood pressure medication Entresto was found invalid at the district court for covering technology that was developed after the...more

A&O Shearman

AstraZeneca refused interim injunction on SPC for blockbuster diabetes treatment against Glenmark but swiftly obtains permission...

A&O Shearman on

On March 28, 2025, Michael Tappin KC, sitting as a deputy judge of the High Court, refused to grant AstraZeneca (“AZ”) an interim injunction to restrain Glenmark from launching in the U.K. a generic version of its type 2...more

McDermott Will & Emery

Hatch-Waxman Litigation Expenses Are Deductible Under Internal Revenue Code § 162(a)

The US Court of Appeals for the Federal Circuit upheld a US Court of Federal Claims ruling that Hatch-Waxman Act litigation expenses are ordinary and necessary business expenses under § 162(a) of the Internal Revenue Code,...more

Irwin IP LLP

Federal Circuit Finds Against Generics Where Hatch-Waxman's Full Five-Year Extension Fixes Delay For Pharmaceutical FDA-Review  

Irwin IP LLP on

Merck Sharp & Dohm B.V. v. Aurobindo Pharma USA, Inc. et al (Fed. Cir. March 13, 2025) - The Hatch-Waxman Act seeks to strike a balance in the pharmaceutical industry by incentivizing drugs makers to develop innovative...more

73 Results
 / 
View per page
Page: of 3

"My best business intelligence, in one easy email…"

Your first step to building a free, personalized, morning email brief covering pertinent authors and topics on JD Supra:
*By using the service, you signify your acceptance of JD Supra's Privacy Policy.
- hide
- hide