News & Analysis as of

Pharmaceutical Patents Patent Litigation

A&O Shearman

Federal Circuit clarifies presumption of obviousness for overlapping ranges

A&O Shearman on

After the Federal Circuit vacated and remanded the district court’s non-obviousness determination, the district court again found that Teva failed to show, by clear and convincing evidence, that the claims of Janssen’s patent...more

A&O Shearman

Court of Appeal upholds invalidity of AstraZeneca's compound patent and clarifies the standard of plausibility

A&O Shearman on

On July 16 2025, the Court of Appeal dismissed AstraZeneca’s appeal and upheld the first instance decision, finding that AstraZeneca’s compound patent for dapagliflozin, an SGLT2 inhibitor used to treat diabetes, was invalid...more

Knobbe Martens

Federal Circuit Review | July 2025

Knobbe Martens on

In Janssen Pharmaceuticals, Inc. v. Teva Pharmaceuticals USA, Inc., Appeal No. 25-1228, The Federal Circuit found that claims reciting a dosing regimen with unequal loading doses were not obvious and that a presumption of...more

Robins Kaplan LLP

Ingenus Pharms., LLC v. Nexus Pharms., Inc.

Robins Kaplan LLP on

Nature of the Case and Issue(s) Presented: Cyclophosphamide is an antineoplastic agent used to treat various cancers, including lymphomas, myeloma, leukemia, and breast carcinoma. The ’952 patent, issued to Plaintiffs in May...more

Hudnell Law Group

Federal Circuit Rejects Formalistic Shield to Prosecution History Estoppel

Hudnell Law Group on

On July 18, 2025, the U.S. Court of Appeals for the Federal Circuit reversed a $106 million jury verdict in Colibri Heart Valve LLC v. Medtronic CoreValve, LLC, No. 2023-2153, finding that Colibri’s infringement claim under...more

Robins Kaplan LLP

United Therapeutics Corp. v. Liquidia Techs., Inc.

Robins Kaplan LLP on

Nature of the Case and Issue(s) Presented: UTC’s ’782 patent claims a method for treating pulmonary hypertension (“PH”). PH manifests in different varieties, including pulmonary arterial hypertension (“PAH”) and pulmonary...more

Goodwin

Final Judgment of Non-Infringement Entered in Alnylam v. Pfizer Vaccine Patent Dispute

Goodwin on

​​​​​​​On July 30, 2025, the U.S. District Court for the District of Delaware entered a Final Judgment in the dispute between Alnylam Pharmaceuticals, Inc. (“Alnylam”) and Pfizer, Inc. (“Pfizer”)—concluding that Pfizer’s...more

Womble Bond Dickinson

Reminder: “Consisting essentially of” Is U.S. Patent Claim Language Needing Interpretation

Womble Bond Dickinson on

On June 30, 2025, the Federal Circuit issued a precedential opinion in Eye Therapies v. Slayback Pharma in which the court interpreted the transition phrase “consisting essentially of” to be a closed term excluding other...more

Venable LLP

Fresenius Kabi Files Two EYLEA® IPRs Prior to aBLA Filing Announcement

Venable LLP on

On July 14, 2025, Fresenius Kabi filed IPR2025-01268 against Regeneron’s U.S. Patent No. 11,084,865 (“the ’865 patent”) and IPR2025-01269 against U.S. Patent No. 10,828,345 (“the ’345 patent”), both relating to EYLEA®...more

Venable LLP

Jury Finds Botox® Patent Claims Nonobvious and Awards Damages from Daxxify® Sales

Venable LLP on

On July 18, 2025, after a five-day trial, the jury in Allergan v. Revance Case No. 1:21-cv-01411 (D. Del.) entered a verdict finding claim 8 of Allergan’s U.S. Patent No. 7,354,740 (“the ’740 patent”), claim 6 of U.S. Patent...more

Robins Kaplan LLP

Astellas Pharma Inc. v. Zydus, Inc. II

Robins Kaplan LLP on

Nature of the Case and Issue(s) Presented: Astellas sued Lupin and Zydus based on the generics manufacturers’ ANDA filing and their efforts to make and sell generic mirabegron. In the leadup to the 2023 bench trial, the...more

Robins Kaplan LLP

Azurity Pharms., Inc. v. Alkem Labs. Ltd.

Robins Kaplan LLP on

Nature of the Case and Issue(s) Presented: The ’948 patent claims non-sterile drinkable liquid formulations of vancomycin, an antibiotic used to treat Clostridium difficile infection. These formulations are particularly...more

Goodwin

Fresenius Files Two IPRs Against Regeneron Aflibercept Patents

Goodwin on

On July 14, 2025 Fresenius filed two IPR petitions challenging Regeneron’s patents related to aflibercept. Regeneron has not asserted that Fresenius infringes either of these patents in district court litigation; however,...more

Robins Kaplan LLP

Metacel Pharms. LLC v. Rubicon Rsch. Priv. Ltd.

Robins Kaplan LLP on

Nature of the Case and Issue(s) Presented: Ozobax is indicated for treatment of spasticity resulting from multiple sclerosis, and particularly flexor spasms and concomitant pain, clonus, and muscular rigidity. While the use...more

Venable LLP

Amgen and Accord Settle Prolia® / Xgeva® BPCIA Litigation over INTP23

Venable LLP on

On July 16, 2025, Amgen and Accord settled Case No. 1:25-cv-01305 (D.N.J.) / MDL 1:25-md-03138 (D.N.J.) alleging infringement of 34 of Amgen’s patents by Accord’s proposed Prolia® / Xgeva® (denosumab) biosimilar INTP23...more

Knobbe Martens

Combination Dosing Regimen Not Obvious Despite Overlapping Prior-Art Ranges

Knobbe Martens on

JANSSEN PHARMACEUTICALS, INC. v. TEVA PHARMACEUTICALS USA, INC. Before Prost, Reyna, and Taranto. Appeal from the United States District Court for the District of New Jersey. The Federal Circuit found that claims reciting a...more

Alston & Bird

Patent Case Summaries | Week Ending July 18, 2025

Alston & Bird on

Shockwave Medical, Inc. v. Cardiovascular Systems, Inc., et al., Nos. 2023-1864, -1940 (Fed. Cir. (PTAB) July 14, 2025). Opinion by Dyk, joined by Lourie and Cunningham....more

Goodwin

Amgen and Accord BioPharma Settle Denosumab BPCIA Case

Goodwin on

​​​​​​​On July 16, 2025, the District Court for the District of New Jersey entered a Consent Judgment and Injunction in view of a settlement agreement between Amgen, Inc. (“Amgen”) and Accord BioPharma, Inc. (“Accord”)...more

Herbert Smith Freehills Kramer

The UPC – Two Years On

The Unified Patent Court – a one-stop-shop for European patent litigation – is now two years old. As it enters its third year of operation, we look at the approach that is becoming established in the new system, drawing out...more

Sheppard Mullin Richter & Hampton LLP

Lexicography: Clear And Unequivocal

This Federal Circuit opinion analyzes lexicography in the context of claim construction. Alnylam Pharmaceuticals owns U.S. Patent Nos. 11,246,933 (parent) and 11,382,979 (child). These patents relate to biodegradable...more

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

McDermott Will & Schulte

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

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

Carlton Fields

Court Finds MSN Does Not Infringe Novartis’s Patent and Clears the Way for Generic Entresto

Carlton Fields on

In In re Entresto (Sacubitril/Valsartan) Patent Litigation, Judge Richard G. Andrews of the U.S. District Court for the District of Delaware granted MSN Pharmaceuticals Inc. a victory on noninfringement of U.S. Patent No....more

Jones Day

Discretionary Denial of IPR Institution Due to Advanced Hatch-Waxman Litigation

Jones Day on

In a recent decision, the Patent Trial and Appeals Board (“PTAB”) exercised its discretion under 35 U.S.C. § 314(a) to deny institution of an inter partes review (“IPR”) after applying the Fintiv factors, despite Petitioner’s...more

Venable LLP

Fresenius Kabi and Celltrion Launch Prolia® / Xgeva® (denosumab) Biosimilars Conexxence™ / Bomyntra™ and Stoboclo® / Osenvelt®

Venable LLP on

On July 1, 2025, Fresenius Kabi announced the U.S. launch of Conexxence™ / Bomyntra™ (denosumab-bnht), biosimilars of Amgen’s Prolia® / Xgeva® (denosumab), pursuant to a settlement agreement between the parties ending BPCIA...more

2,658 Results
 / 
View per page
Page: of 107

"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