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.
Pfizer Inc. v. Viwit Pharmaceutical Co.
1-20-cv-000160; filed January 31, 2020 in the District Court of Delaware
• Plaintiffs: CP Pharmaceuticals International CV, PF Prism CV, Pfizer Inc., amd Pfizer Products Inc.
• Defendant: Viwit Pharmaceutical Co., Ltd.
Claim: Infringement of U.S. Patent Nos.:
• 6,410,550: Aryl fused azapolycyclic compounds
• 6,890,927: Tartrate salts of 5,8, 14-triazateracyclo[10.3.1.02,11 04.9]-hexadeca-2(11),3,5,7,9-pentaene and pharmaceutical compositions thereof
• 7,265,119 Tartrate salts of 5,8,14-triazatetracyclo[10.3.1.0.sup.2,11.0.sup.4.9]-hexadeca-2(11),3,5,7-,9-pentaene and pharmaceutical compositions thereof
Synoposis: Pfizer asserts infringement of the '550, '927, and '119 patents. PF PRISM is the holder of approved NDA No. 021928 for varenicline tartrate tablets, (Chantix®) a nicotinic receptor partial agonist for use in smoking cessation. Viwit submitted ANDA No. 212879 seeking approval to commercially manufacture, use, and sell generic versions of Chantix®. Pfizer asserts that the method of manufacture, and/or the use of Chantix® are covered by one or more claims of the Patents-in Suit.
View the complaint here.
Silvergate Pharmaceuticals, Inc. v. CMP Development LLC
1-20-cv-000161; filed January 17, 2020 in the District Court of Delaware
• Plaintiff: Silvergate Pharmaceuticals, Inc.
• Defendant: CMP Development LLC
Claim: Infringement of U.S. Patent Nos.:
• 10,039,800: Lisinopril formulations
• 10,265,370: Lisinopril formulations
• 10,406,199: Lisinopril formulations
• 9,463,183: Lisinopril formulations
• 9,616,096: Lisinopril formulations
• 9,814,751: Lisinopril formulations
Synopsis: Silvergate asserts infringement of the '800, '370, '199, '183, '096, and '751 patents. Silvergate is the holder of approved NDA No. 208401 for lisinopril formulations of the angiotensin converting enzyme (ACE) inhibitor QBRELIS® for the treatment of hypertension in adults and pediatric patients. CMP Development submitted ANDA No. 213935, seeking FDA approval to engage in commercial manufacturing, sale, and use of a generic version of Silvergate's QBRELIS® product.
View the complaint here.
Boehringer Ingelheim Pharmaceuticals, Inc. v. Mylan Pharmaceuticals Inc.
1-20-cv-00019; filed February 5, 2020 in the Northern District Court of West Virginia
• Plaintiffs: Boehringer Ingelheim Corp., Boehringer Ingelheim International GmbH, Boehringer Ingelheim Pharma GmbH & Co. KG, Boehringer Ingelheim Pharmaceuticals, Inc.
• Defendants: Mylan Inc., Mylan Laboratories Ltd., Mylan Pharmaceuticals Inc.
Claim: Infringement of U.S. Patent No.:
• 9,286,526: Treatment for diabetes in patients inappropriate for metformin therapy
Synopsis: Boehringer asserts infringement of the '526 patent. Boehringer is the holder of NDA No. 201280 for TRADJENTA® for oral use for the treatment of type 2 diabetes via increasing incretin levels. Mylan submitted ANDA No. 208431 seeking approval to engage in the commercial manufacture and sale of generic copies of TRADJENTA®.
View the complaint here.
Boehringer Ingelheim Pharmaceuticals, Inc. v. Aurobindo Pharma Ltd.
5-20-cv-00023; filed February 5, 2020 in the District Court of Delaware
• Plaintiffs: Boehringer Ingelheim Corp., Boehringer Ingelheim International GmbH, Boehringer Ingelheim Pharma GmbH & Co. KG, Boehringer Ingelheim Pharmaceuticals, Inc.
• Defendant: Aurobindo Pharma Ltd.
Claim: Infringement of U.S. Patent No.:
• 9,286,526: Treatment diabetes in patients inappropriate for metformin therapy rs
Synoposis: Boehringer asserts infringement of the '526 patent. Boehringer is the holder of NDA No. 201280 for TRADJENTA® for oral use for the treatment of type 2 diabetes via increasing incretin levels. Aurobindo submitted ANDA No. 208415 seeking approval to engage in the commercial manufacture and sale of generic copies of TRADJENTA®.
View the complaint here.
Gilead Sciences, Inc. v. Apotex, Inc.
1-20-cv-00189; filed February 7, 2020 in the District Court of New Jersey
• Plaintiff: Gilead Sciences, Inc.
• Defendants: Apotex Inc., Cipla Ltd., Hetero Labs Ltd. Unit-V, Hetero Labs Ltd., Hetero USA Inc., Laurus Labs Ltd., Lupin Ltd., Macleods Pharmaceuticals Ltd., Natco Pharma Ltd., Shilpa Medicare Ltd., and Sunshine Lake Pharma Co., Ltd.
Claim: Infringement of U.S. Patent Nos.:
• 7,390,791: Prodrugs of phosphonate nucleotide analogues
• 7,803,788: Prodrugs of phosphonate nucoleotide analogues
• 8,754,065: Tenofovir alafenamide hemifumarate
• 9,296,769: Tenofovir alafenamide hemifumarate
Synoposis: Gilead asserts infringement of the '791, '788, '065, and '769 patents. Gilead is the holder of NDA No. 208464 for VEMLIDY® (tenofovir alafenamide; 25 mg tablets) for the treatment of chronic hepatitis B virus infection in adults with compensated liver disease. Gilead also holds NDA No. 208215 for DESCOVY® (emtricitabine 200 mg, tenofovir alafenamide 25 mg, and anti-viral agents) for treatment of HIV-1 infection in adults and pediatric patients, and for at-risk adults and adolescents for pre-exposure prophylaxis (PrEP) to reduce the risk of HIV-1 infection. Gilead also holds NDA No. 208351 for ODEFSEY® (200 mg emtricitabine, 25 mg rilpivirine, and 25 mg tenofovir alafenamide) for the treatment of HIV-1 infection in adults and pediatric patients either as an initial therapy in those with no antiretroviral treatment history or to replace a stable antiretroviral regimen in those who are virologically-suppressed. Defendants, each independently, submitted one or more ANDA applications to engage in the commercial manufacture, use, importation, offer for sale, and/or sale of VEMLIDY®, DESCOVY®, and/or ODEFSEY®.
View the complaint here.
Allergan Sales, LLC v. Breckenridge Pharmaceutical, Inc.
1-20-cv-00199; filed February 10, 2020 in the District Court of Delaware
• Plaintiffs: Allergan Sales, LLC, Allergan Pharmaceuticals International Ltd., Allergan USA, Inc.
• Defendant: Breckenridge Pharmaceutical, Inc.
Claim: Infringement of U.S. Patent No.:
• 5,763,476: Sublingual or buccal pharmaceutical composition
Synopsis: Allergen asserts infringement of the '476 patent. Allergen is the holder of NDA No. 22117 for the use of SAPHRIS® (asenapine maleate) for the treatment of schizophrenia and bipolar disorder. The FDA granted pediatric exclusivity on March 3, 2015, thereby awarding an additional 6-months of market exclusivity after expiration of the patents listed in the Orange Book for SAPHRIS®. Breckenridge submitted ANDA No. 205960 seeking to obtain approval for the commercial manufacture, use, and sale of asenapine maleate tablets.
View the complaint here.
American Regent, Inc. f/k/a Luitpold Pharmaceuticals, Inc. v. Pharmacosmos A/S
3-20-cv-01350; filed February 7, 2020 in the District Court of New Jersey
• Plaintiff: American Reagent, Inc.
• Defendants: Pharmacosmos Therapeutics Inc. and Pharmacosmos A/S
Claim: Infringement of U.S. Patent Nos.:
• 10,478,450: Methods and compositions for administration of iron
• 8,431,549: Methods and compositions for administration of iron
Synoposis: American Reagent asserts infringement of the '549 and '450 patents. Pharmacosmos A/S submitted NDA No. 208171 to market Monoferric® for the treatment of iron deficiency. Plaintiff contends that Pharmacosmos A/S is working with Pharmacosmos Therapeutics, the latter founded in 2019 "to commercialize Monoferric® in the rapidly growing US high-dose IV iron market." American Reagent contends that Pharmacosmos A/S, in active concert with Pharmacosmos Therapeutics Inc., will import, manufacture, market, offer for sell, and/or sell Monoferric® immediately and imminently.
Previously, in 2015, Pharmacosmos filed an IPR seeking to invalidate claims 7, 17, and 21 of the '549 patent. Pharmacosmos was denied in its validity challenge as to the non-instituted claims (IPR2015-01493). In 2019, Pharmacosmos filed a second IPR petition against claims 7 and 21 of the '549 patent. The petition was denied in its entirety (IPR2019-01142). In January 2020, Pharmacosmos filed a post-grant review, seeking to invalidate all claims of the '450 patent (PGR2020-00009).
View the complaint here.
Amgen Inc. v. Hospira, Inc.
1-20-cv-00201; filed February 11, 2020 in the District Court of Delaware
• Plaintiffs: Amgen Inc. and Amgen Manufacturing Ltd.
• Defendants: Hospira Inc. and Pfizer Inc.
Claim: Infringement of U.S. Patent No.:
• 8,273,707: Process for purifying proteins
Synopsis: Amgen asserts infringement of the '707 patent. Amgen is the reference product sponsor (RPS), of Neulasta® (human granulocyte-colony stimulating factor conjugated to a monomethoxypolyethylene glycol), which is approved for use to decrease the incidence of infection in patients receiving myelosuppressive anti-cancer drugs, by stimulating neutrophil production. Amgen asserts that Hospira, acting in concert with Pfizer, submitted an abbreviated Biologics License Application for a proposed biosimilar to Amgen's Neulasta® product. In August 2019, Amgen and Hospira began exchanging information as required by the BPCIA. However, Amgen asserts that Hospira failed to provide Amgen with a true copy of the FDA application as required under 42 U.S.C. § 262(l)(2)(A). Amgen also asserts that the submission of the Hospira Biologics License Application constitutes one or more acts of infringement of one or more claims of the '707 patent under 35 U.S.C. § 271(e)(2)(C).
View the complaint here.
