About Life Sciences Court Report: We will periodically report on recently filed biotech and pharma litigation.
Amgen Inc. v. Zydus Pharmaceuticals (USA) Inc.
1-20-cv-00075; filed January 17, 2020 in the District Court of Delaware
• Plaintiffs: Amgen Inc. and Les Laboratoires Servier
• Defendants: Cadila Healthcare Ltd. d/b/a Zydus Cadila and Zydus Pharmaceuticals (USA) Inc.
Claim: Infringement of U.S. Patent Nos.:
• 7,361,649: "β-crystalline form of ivabradine hydrochloride, a process for its preparation and pharmaceutical compositions containing it"
• 7,361,650: "γ-crystalline form of ivabradine hydrochloride, a process for its preparation and pharmaceutical compositions containing it"
• 7,867,996: "γ-crystalline form of ivabradine hydrochloride, a process for its preparation and pharmaceutical compositions containing it"
• 7,879,842: "β-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. 213442 seeking approval to market generic Corlanor®.
View the complaint here.
Novartis Pharmaceuticals Corp. v. Alembic Pharmaceuticals, Ltd.
1-20-cv-00074; filed January 17, 2020 in the District Court of Delaware
• Plaintiff: Novartis Pharmaceuticals Corp.
• Defendants: Alembic Global Holdings SA, Alembic Pharmaceuticals, Inc., and Alembic Pharmaceuticals, Ltd.
Claim: Infringement of U.S. Patent Nos.:
• 8,101,659: "Methods of treatment and pharmaceutical composition"
• 8,796,331: "Methods of treatment and pharmaceutical composition"
• 8,877,938: "Compounds containing S-N-valeryl-N-{[2'-(1H-tetrazole-5-yl)-biphenyl-4-yl]-methyl}-valine and (2R,4S)-5-biphenyl-4-yl-4-(3-carboxy-propionylamino)-2-methyl-pentanoic acid ethyl ester moieties and cations"
• 9,388,134: "Compounds containing S-N-valeryl-N-{[2'-(1H-tetrazole-5-yl)-biphenyl-4-yl]-methyl)-valine and (2R,4S)-5-biphenyl-4-yl-4-(3-carboxy-propionylamino)-2-methyl-pentanoic acid ethyl ester moieties and cations"
Synopsis: Novartis asserts infringement of the '659, '331, '938, and '134 patents. Novartis is the holder of New Drug Application No. 207620 for the commercial manufacturing, marketing, sale, and use of ENTRESTO® (sacubitril and valsartan) tablets, to reduce the risk of cardiovascular death and hospitalization for heart failure in patients with chronic heart failure (NYHA Class II-IV) and reduced ejection fraction, and for the treatment of symptomatic heart failure with systemic left ventricular systolic dysfunction in pediatric patients aged one year and older. Actavis submitted ANDA No. 213682, seeking FDA approval to engage in the commercial manufacture, use, sale, offer for sale, and/or importation of sacubitril/valsartan tablets, generic versions of Novartis’s ENTRESTO® tablets.
View the complaint here.
Merck Sharp and Dohme Corp. v. Actavis Laboratories FL, Inc. f/k/a Watson Laboratories, Inc.
1-20-cv-20217; filed January 17, 2020 in the Southern District Court of Florida
• Plaintiffs: Cubist Pharmaceuticals LLC f/k/a Cubist Pharmaceuticals, Inc.; MSD International GmbH; MSD Investment Holdings (Ireland); Merck Sharp & Dohme Corp.; Optimer Pharmaceuticals LLC f/k/a Optimer Pharmaceuticals, Inc.
• Defendants: Actavis Laboratories FL, Inc. f/k/a Watson Laboratories, Inc. – Florida; Actavis Pharma, Inc. f/k/a Watson Pharma, Inc.; Teva Pharmaceuticals USA, Inc.
Claim: Infringement of U.S. Patent Nos.:
• 7,378,508: "Polymorphic crystalline forms of tiacumicin B"
• 7,863,249: "Macrolide polymorphs, compositions comprising such polymorphs, and methods of use and manufacture thereof"
• 7,906,489: "18-membered macrocycles and analogs thereof"
• 8,586,551: "18-membered macrocycles and analogs thereof"
• 8,859,510: "Macrocyclic polymorphs, compositions comprising such polymorphs, and methods of use and manufacture thereof"
Synopsis: Cubist asserts infringement of the '508, '249, '489, '551, and '510 patents. Cubist is the holder of NDA No. 201699 for DIFICID® (fidaxomicin) tablets for oral use for the treatment of Clostridium difficile associated diarrhea in adults. Actavis submitted ANDA No. 208443 seeking approval to engage in the commercial manufacture, use, sale, offer for sale, and/or importation of generic copies of DIFICID® (fidaxomicin) tablets.
View the complaint here.
Vanda Pharmaceuticals Inc. v. Apotex Inc.
1-20-cv-00083; filed January 21, 2020 in the District Court of Delaware
• Plaintiff: Vanda Pharmaceuticals Inc.
• Defendants: Apotex Corp. and Apotex Inc.
Claim: Infringement of U.S. Patent Nos.:
• 10,449,176: "Treatment of circadian rhythm disorder"
Synoposis: Vanda asserts infringement of the '176 patent. Vanda is the holder of NDA 205,677 for Hetlioz® (tasimelteon) for the treatment of Non-24, a circadian rhythm sleep disorder. Apotex submitted ANDA No. 211607 seeking approval to to commercially manufacture and sell generic tasimelteon capsules for the treatment of Non-24.
View the complaint here.
Amgen Inc. v. Zydus Pharmaceuticals (USA) Inc.
3-20-cv-00678; filed January 21, 2020 in the District Court of New Jersey
• Plaintiffs: Amgen Inc. and Les Laboratoires Servier
• Defendants: Cadila Healthcare Ltd. d/b/a Zydus Cadila and Zydus Pharmaceuticals (USA) Inc.
Claim: Infringement of U.S. Patent Nos.:
• 7,361,649: "β-crystalline form of ivabradine hydrochloride, a process for its preparation and pharmaceutical compositions containing it"
• 7,361,650: "γ-crystalline form of ivabradine hydrochloride, a process for its preparation and pharmaceutical compositions containing it"
• 7,867,996: "γ-crystalline form of ivabradine hydrochloride, a process for its preparation and pharmaceutical compositions containing it"
• 7,879,842: "β-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. 213442 seeking approval to market generic Corlanor®.
View the complaint here.
Vanda Pharmaceuticals Inc. v. Teva Pharmaceuticals USA, Inc.
1-20-cv-00093; filed January 22, 2020 in the District Court of Delaware
• Plaintiff(s): Vanda Pharmaceuticals Inc
• Defendant(s): Teva Pharmaceuticals USA, Inc.
Claim: Infringement of U.S. Patent No.:
• 10,449,176: "Treatment of circadian rhythm disorders"
Synopsis: Vanda asserts infringement of the '176 patent. Vanda is the holder of NDA 205,677 for Hetlioz® (tasimelteon) for the treatment of Non-24, a circadian rhythm sleep disorder. Teva submitted ANDA No. 211601 seeking approval to to commercially manufacture and sell generic tasimelteon capsules for the treatment of Non-24.
View the complaint here.
Washington State University v. Pro Orchard Management LLC
2-20-cv-00038; filed January 22, 2020 in the District Court of Washington
• Plaintiff: Washington State University
• Defendants: Apple King LLC and Pro Orchard Management LLC
Claim: Infringement of U.S. Patent No.:
• PP21710: "Apple tree named 'WA-2'"
Synopsis: Washington State University (WSU) claims infringement of the '710 patent for an apple cultivar developed by WSU known as WA-2. WSU alleges that Pro Orchard Management infringed Patent No. 21,710 by asexually reproducing and growing WA 2 apple trees and by harvesting WA 2 apples and consigning them to Apple King, LLC for sale. WSU further alleges that Apple King, LLC has infringed the '710 patent by selling WA 2 apples that unlicensed growers such as Pro Orchard Management, LLC have consigned to it for sale. In addition, the WSU alleges that Pro Orchard Management, LLC and,Apple King, LLC have induced infringement of Plant Patent No. 21,710 by providing WA 2 budwood to unlicensed persons who have used the budwood to asexually reproduce WA 2 apple trees.
View the complaint here.
