About Life Sciences Court Report: We will periodically report on recently filed biotech and pharma litigation.
Allergan USA, Inc. v. Prollenium US Inc.
1-20-cv-00104; filed January 23, 2020 in the District Court of Delaware
• Plaintiffs: Allergan USA, Inc. and Allergan Industrie SAS
• Defendants: Prollenium Medical Technologies Inc. and Prollenium US Inc.
Claim: Infringement of U.S. Patent Nos.:
• 10,391,202: Hyaluronic acid-based gels including lidocaine
• 10,485,896: Hyaluronic acid-based gels including lidocaine
Synopsis: Allergan asserts infringement of the '202 and '896 patents. Allergen develops, manufacturers, and distributes dermal filler products including JUVEDÉRM® Ultra XC, JUVEDÉRM® Ultra Plus XC, and JUVEDÉRM® VOLUMA® XC. Prollenium makes, uses, sells, offers to sell, and/or imports into the United States Revanesse® Versa+TM, a dermal filler. Allergen asserts that Revanesse® Versa+TM infringes one of more claims of the '202 and '896 patents.
View the complaint here.
Relypsa, Inc. v. Alkem Laboratories Ltd.
1-20-cv-00106; filed January 23, 2020 in the District Court of Delaware
• Plaintiffs: Relypsa, Inc. and Vifor (International) Ltd.
• Defendant(s): Alkem Laboratories, Ltd. And Ascent Pharmaceuticals, Inc.
Claim: Infringement of U.S. Patent Nos.:
• 8,147,873 Methods and compositions for treatment of ion imbalances
• 8,337,824 Linear polyol stabilized polyfluoroacrylate compositions
• 9,492,476 Potassium-binding agents for treating hypertension and hyperkalemia
• 9,925,212 Potassium-binding agents for treating hypertension and hyperkalemia
Synopsis: Relypsa asserts infringement of the '873, '824, '476, and '212 patents. Relypsa is the holder of approved NDA No. 205739 for patiromer sorbitex calcium powder for oral suspension sold under the trade name VELTASSA®, a potassium binder indicated for the treatment of hyperkalemia. Relypsa submitted ANDA No. 214075 seeking approval to engage in commercial manufacture, use, offer for sale, sale, and/or importation of patiromer sorbitex as generic versions of VELTASSA®.
View the complaint here.
Amgen Inc. v. Bionpharma Inc.
1-20-cv-00105; filed January 23, 2020 in the District Court of Delaware
• Plaintiffs: Amgen Inc. and Les Laboratoires Servier
• Defendant: Bionpharma, Inc.
Claim: Infringement of U.S. Patent Nos.:
• 7,361,649: -crystalline form of ivabradine hydrochloride, a process for its preparation and pharmaceutical compositions containing it
• 7,361,650 -crystalline form of ivabradine hydrochloride, a process for its preparation and pharmaceutical compositions containing it
• 7,867,996 -crystalline form of ivabradine hydrochloride, a process for its preparation and pharmaceutical compositions containing it
• 7,879,842 Beta-crystalline form of ivabradine hydrochloride, a process for its preparation and pharmaceutical compositions containing it
Synoposis: Amgen asserts infringement of the '649, '650, '996, and '842 patents. Amgen is the holder of approved NDA 20-6143 for Corlanor® (ivabradine) for the treatment of certain cases of chronic heart failure. Amgen asserts that the method of manufacture, and/or their use of Corlanor® are covered by one or more claims of the Patents-in Suit. Cadila submitted ANDA No. 213276 seeking approval to market generic Corlanor®.
View the complaint here.
Janssen Products, LP v. Zydus Pharmaceuticals (USA) Inc.
3-20-cv-00787; filed January 23, 2020 in the District Court of New Jersey
• Plaintiffs: Janssen Products, LP and Janssen Sciences Ireland UC
• Defendants: Cadila Healthcare Limited d/b/a Zydus Cadila and Zydus Pharmaceuticals (USA) Inc.
Claim: Infringement of U.S. Patent Nos.:
• 7,126,015 Method for the preparation of hexahydro-furo-[2,3-b]furan-3-ol
• 7,595,408 Methods for the preparation of (3R,3aS,6aR) hexahydro-furo[2,3-b]furan-3-ol
• 7,700,645 Pseudopolymorphic forms of a HIV protease inhibitor
• 8,518,987 Pseudopolymorphic forms of a HIV protease inhibitor
Synoposis: Jassen Products asserts infringement of the '015, '408, '645, and '987 patents. Jassen is the holder of approved NDA 21-976 for PREZISTA® for the treatment of HIV. Zydus submitted ANDA No. 214085 seeking approval to make substantial and meaningful preparations to import into the United States and/or offer to sell, and/or use generic versions of PREZISTA®.
View the complaint here.
Amgen Inc. v. Multiple Defendants (separate cases)
Several cases filed on January 24, 2020 in the District Court of Delaware
• Plaintiffs: Amgen Inc. and Les Laboratoires Servier
• Defendants: Annora Pharma Private Ltd., Hetero Labs Ltd., Hetero USA, Inc., and Centaur Pharmaceuticals Private Ltd.
Claim: Infringement of U.S. Patent Nos.:
• 7,361,649: -crystalline form of ivabradine hydrochloride, a process for its preparation and pharmaceutical compositions containing it
• 7,361,650 -crystalline form of ivabradine hydrochloride, a process for its preparation and pharmaceutical compositions containing it
• 7,867,996 -crystalline form of ivabradine hydrochloride, a process for its preparation and pharmaceutical compositions containing it
• 7,879,842 Beta-crystalline form of ivabradine hydrochloride, a process for its preparation and pharmaceutical compositions containing it
Synoposis: Amgen asserts infringement of the '649, '650, '996, and '842 patents. Amgen is the holder of approved NDA 20-6143 for Corlanor® (ivabradine) for the treatment of certain cases of chronic heart failure. Amgen asserts that the method of manufacture, and/or their use of Corlanor® are covered by one or more claims of the Patents-in Suit. Defendants submitted ANDAs seeking approval to manufacture, import into the United States, market, and sell generic Corlanor®.
Novartis Pharmaceuticals Corp. v. Apotex Inc.
1-20-cv-000133; filed January 28, 2020 in the District Court of Delaware
• Plaintiff: Novartis Pharmaceuticals Corp.
• Defendants: Apotex Inc., Bionpharma Inc., Cadila Healthcare Ltd. d/b/a Zydus Cadila, Emcure Pharmaceuticals Ltd., Ezra Ventures, LLC, Glenmark Pharmaceuticals Inc. USA f/k/a Glenmark Generics Inc. USA, Glenmark Pharmaceuticals Ltd. f/k/a Glenmark Generics Ltd., HEC Pharm Co., Ltd., HEC Pharm USA Inc., Heritage Pharmaceuticals Inc., Hetero Labs Ltd. Unit-V, Hetero Labs Ltd., Hetero USA, Inc., Prinston Pharmaceutical Inc., Strides Global Pharma Private Ltd., Strides Pharma Inc., Zydus Pharmaceuticals (USA) Inc.
Claim: Infringement of U.S. Patent No.:
• 10,543,179 Dosage regimen of an S1P receptor modulator
Synopsis: Novartis asserts infringement of the '179 patent. Novartis is the holder of approved NDA No. 022257 for GILENYA® (fingolimod) Capsules, a sphingosine 1-phosphate receptor (S1PR) modulator for the treatment of relapsing forms of multiple sclerosis (MS). Novartis has pending litigation against the parties for infringement of U.S. Patent No. 9,187,405. Novartis alleges that the the defendants continues to make, substantial preparation to engage in the commercial manufacture, use, offer to sell, or sale generic versions of Novartis’s GILENYA® Capsules.
View the complaint here.
Sucampo GmbH f/k/a Sucampo AG v. Zydus Pharmaceuticals (USA) Inc.
1-20-cv-00936; filed January 28, 2020 in the District Court of New Jersey
• Plaintiffs: Sucampo GmbH f/k/a Sucampo AG, Sucampo Pharma Americas LLC, Sucampo Pharma, LLC, Sucampo Pharmaceuticals, Inc., Takeda Pharmaceutical Co. Ltd., Takeda Pharmaceuticals America, Inc., Takeda Pharmaceuticals USA, Inc.
• Defendant: Zydus Pharmaceuticals (USA) Inc.
Claim: Infringement of U.S. Patent Nos.:
• 7,795,312 Method for treating abdominal discomfort
• 8,026,393 Soft-gelatin capsule formulation
• 8,338,639 Soft-gelatin capsule formulation
• 8,748,481 Method for treating gastrointestinal disorder
• 8,779,187 Soft-gelatin capsule formulationMethods of treatment and pharmaceutical composition
Synopsis: Sucampo asserts infringement of the '312, '393, '639, '481, and '187 patents. Sucampo is the holder of NDA No. 021908, lubiprostone capsules, both marketed in the United States under the trade name AMITIZA® for the treatment of chronic idiopathic constipation in adults and the treatment of opioid-induced constipation in adult patients with chronic, non-cancer pain. Zydus submitted ANDA No. 2141313 seeking approval to commercially manufacture, use, market, or sell generic lubiprostone capsules.
View the complaint here.
Amgen Inc. v. MSN Pharmaceuticals, Inc.
1-20-cv-00137; filed January 29, 2020 in the District Court of Delaware
• Plaintiffs: Amgen Inc. and Les Laboratoires Servier
• Defendants: MSN PPharmaceuticals, Inc. and MSN Laboratories Private Ltd.
Claim: Infringement of U.S. Patent Nos.:
• 7,361,649: -crystalline form of ivabradine hydrochloride, a process for its preparation and pharmaceutical compositions containing it
• 7,361,650 -crystalline form of ivabradine hydrochloride, a process for its preparation and pharmaceutical compositions containing it
• 7,867,996 -crystalline form of ivabradine hydrochloride, a process for its preparation and pharmaceutical compositions containing it
• 7,879,842 Beta-crystalline form of ivabradine hydrochloride, a process for its preparation and pharmaceutical compositions containing it
Synopsis: Amgen asserts infringement of the '649, '650, '996, and '842 patents. Amgen is the holder of approved NDA 20-6143 for Corlanor® (ivabradine) for the treatment of certain cases of chronic heart failure. Amgen asserts that the method of manufacture, and/or their use of Corlanor® are covered by one or more claims of the Patents-in Suit. Defendants submitted ANDA 213483 seeking approval to manufacture, import into the United States, market, and sell generic Corlanor®.
View the complaint here.
