News & Analysis as of

Patent Litigation Generic Drugs

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

Robins Kaplan LLP

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

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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

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

Jenner & Block

A Secured Reversal of Preliminary Injunction in High-Stakes Pharmaceutical Battle

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In a significant victory for pharmaceutical competition and access to generic drugs, Jenner & Block secured a key litigation win on behalf of client MSN Pharmaceuticals. A federal judge denied a pharmaceutical company’s...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

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

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

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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

DLA Piper

Purdue Appeals Federal Circuit Obviousness Decision to the Supreme Court

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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

Venable LLP

Spotlight On: Neulasta® (pegfilgrastim) / Fulphila® (pegfilgrastim-jmdb) / Udenyca® (pegfilgrastim-cbqv) / Ziextenzo®...

Venable LLP on

Pegfilgrastim Challenged Claim Types in IPR and Litigation: Claims include those challenged in litigations and IPRs. Claims are counted in each litigation and IPR, so claims from the same patent challenged in multiple...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

Venable LLP

Spotlight On: Biosimilar Litigations - July 2025

Venable LLP on

Biosimilar Litigations include litigations relating to biosimilar/follow-on products of CDER-listed reference products. Litigations between biosimilar applicants/manufacturers and reference product sponsors as well as...more

Goodwin

DOJ and FTC Host ‘Listening Sessions’ on Competition Issues in the Pharmaceutical Industry

Goodwin on

In two recent public panels, the Department of Justice (DOJ) and the Federal Trade Commission (FTC) hosted the first of three joint listening sessions mandated by Executive Order No. 14273, Lowering Drug Prices by Once Again...more

Venable LLP

Spotlight On: Humira® (adalimumab) / Amjevita™ (adalimumab-atto) / Cyltezo® (adalimumab-adbm) / Hyrimoz™ (adalimumab-adaz) /...

Venable LLP on

Adalimumab Challenged Claim Types in IPR and Litigation: Claims include those challenged in litigations and IPRs. Claims are counted in each litigation and IPR, so claims from the same patent challenged in multiple...more

Venable LLP

Spotlight On: Rituxan® (rituximab) / Truxima® (rituximab-abbs) / Ruxience® (rituximab-pvvr) / Riabni™ (rituximab-arrx) - July 2025

Venable LLP on

Rituximab Challenged Claim Types in IPR and Litigation: Claims include those challenged in litigations and IPRs. Claims are counted in each litigation and IPR, so claims from the same patent challenged in multiple...more

Venable LLP

Spotlight On: Lantus® / Lantus® SoloSTAR® (insulin glargine recombinant) / Basaglar® (insulin glargine) / Semglee® (insulin...

Venable LLP on

Insulin Glargine Challenged Claim Types in IPR and Litigation: Claims include those challenged in litigations and IPRs. Claims are counted in each litigation and IPR, so claims from the same patent challenged in multiple...more

Goodwin

Denosumab Updates: Wyost and Jubbonti Launch as First Denosumab Biosimilars in the U.S.

Goodwin on

On June 2, 2025, Sandoz announced that WYOST® (denosumab-bbdz) and Jubbonti® (denosumab-bbdz) are now available to patients in the United States. ...more

Haug Partners LLP

FTC Issues a Third Round of Warning Letters Over Improper Orange Book Listings

Haug Partners LLP on

On May 21, 2025, the Federal Trade Commission (FTC) renewed its efforts to challenge pharmaceutical manufacturers that have allegedly listed patents improperly in the Food and Drug Administration’s (FDA) publication of...more

Haug Partners LLP

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

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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

Proskauer - The Patent Playbook

Eyes Open to the Past: Federal Circuit Holds Prosecution History Is Claim Construction Evidence

The Federal Circuit’s decision in Eye Therapies, LLC v. Slayback Pharma, LLC provides further insight into the tools available for patent claim construction. The Federal Circuit had previously held that a patent’s...more

Knobbe Martens

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

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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

Venable LLP

Sandoz Launches Jubbonti® / Wyost® (denosumab-bbdz) as First Prolia® / Xgeva® Interchangeable Biosimilars

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On June 2, 2025, Sandoz announced the launch of Jubbonti® / Wyost® (denosumab-bbdz), the first Prolia® / Xgeva® (denosumab) interchangeable biosimilars to launch in the U.S....more

DLA Piper

The Federal Circuit Upholds Drug Dosing Regimen as Valid and Nonobvious

DLA Piper on

In Janssen Pharmaceuticals, Inc. v. Mylan Laboratories., the United States Court of Appeals for the Federal Circuit affirmed a district court ruling that a pharmaceutical dosing claim limitation was nonobvious despite prior...more

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