Court Report - July 2014 #3

by McDonnell Boehnen Hulbert & Berghoff LLP
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Gavel About Court Report:  Each week we will report briefly on recently filed biotech and pharma cases.

GlaxoSmithKline LLC et al. v. Glenmark Generics Inc. USA
1:14-cv-00877; filed July 3, 2014 in the District Court of Delaware

• Plaintiffs:  GlaxoSmithKline LLC; SmithKline Beecham (Cork) Ltd.
• Defendant:  Glenmark Generics Inc. USA

GlaxoSmithKline LLC et al. v. Teva Pharmaceuticals USA Inc.
1:14-cv-00878; filed July 3, 2014 in the District Court of Delaware

• Plaintiffs:  GlaxoSmithKline LLC; SmithKline Beecham (Cork) Ltd.
• Defendant:  Teva Pharmaceuticals USA Inc.

The complaints in these cases are substantially identical.  Infringement of U.S. Patent No. RE40,000 ("Method of Treatment for Decreasing Mortality Resulting from Congestive Heart Failure," reissued January 8, 2008) based on defendants' manufacture and sale of a generic version of GSK's Coreg® (carvedilol, used to treat congestive heart failure), for some time with label that included a heart failure indication (part of a Section viii carve-out in defendants' ANDA) and based on defendants marketing their product as therapeutically equivalent to and fully substitutable for GSK's COREG® tablets.  View the Glenmark complaint here.

Merck Sharp & Dohme Corp. v. Teva Pharmaceuticals USA Inc.
1:14-cv-00874; filed July 2, 2014 in the District Court of Delaware

Infringement of U.S. Patent No. 6,127,353 ("Mometasone Furoate Monohydrate, Process for Making Same and Pharmaceutical Compositions," issued October 3, 2000) following a Paragraph IV certification as part of Teva's filing of an ANDA to manufacture a generic version of Merck's Nasonex® (mometasone furoate monohydrate metered nasal spray, used to treat diseases of the upper airways, including allergic and nonallergic rhinitis).  View the complaint here.

ViiV Healthcare UK Ltd. et al. v. Aurobindo Pharma Ltd. et al.
1:14-cv-00868; filed July 2, 2014 in the District Court of Delaware

• Plaintiffs:  ViiV Healthcare UK Ltd.; ViiV Healthcare Co.
• Defendants:  Aurobindo Pharma Ltd.; Aurobindo Pharma USA Inc.

Infringement of U.S. Patent No. 6,294,540 ("Carbocyclic Nucleoside Hemisulfate and its Use in Treating Viral Infections," issued September 25, 2001) following a Paragraph IV certification as part of Aurobindo's filing of an ANDA to manufacture a generic version of Viiv's Epzicom® (abacavir sulfate and lamivudine, used to HIV infection in humans).  View the complaint here.

Pfizer Inc. et al. v. Aurobindo Pharma Ltd. et al.
1:14-cv-00872; filed July 2, 2014 in the District Court of Delaware

• Plaintiffs:  Pfizer Inc.; Wyeth LLC; Pfizer Pharmaceuticals LLC; PF Prism C.V.; Pfizer Manufacturing Holdings LLC
• Defendants:  Aurobindo Pharma Ltd.; Aurobindo Pharma USA Inc.

Infringement of U.S. Patent Nos. 7,879,828 ("Tigecycline Compositions and Methods of Preparation," issued February 1, 2011) and 8,372,995 ("Crystalline Solid Forms of Trigecycline and Methods of Preparing Same," issued February 12, 2013), licensed to Pfizer, following a Paragraph IV certification as part of Aurobindo's filing of an ANDA to manufacture a generic version of Pfizer's Tygacil® (tigecycline injectible, used for the treatment of complicated skin and skin structure infections, complicated intra-abdominal infections, and community-acquired bacterial pneumonia).  View the complaint here.

Teijin Ltd. et al. v. Prinston Pharmaceutical Inc.
1:14-cv-00854; filed July 1, 2014 in the District Court of Delaware

• Plaintiffs:  Teijin Limited; Teijin Pharma Ltd.; Takeda Pharmaceuticals USA Inc.
• Defendant:  Prinston Pharmaceutical Inc.; Prinston Pharmaceutical Inc.

Infringement of U.S. Patent No. 6,225,474 ("Polymorphs of 2-(3-cyano-4-isobutyloxyphenyl)-4-methyl-5-thiazolecarboxylic acid and Method of Producing the Same," issued May 1, 2001) following a Paragraph IV certification as part of Prinston's filing of an ANDA to manufacture a generic version of Takeda's Uloric® (febuxostat, used for the chronic management of hyperuricemia in patients with gout).  View the complaint here.

AstraZeneca AB v. Par Pharmaceutical Inc.
1:14-cv-00845; filed June 30, 2014 in the District Court of Delaware

Infringement of U.S. Patent No. 7,951,400 ("Coated Tablet Formulation and Method," issued May 31, 2011) following a Paragraph IV certification as part of Par's filing of an ANDA to manufacture a generic version of AstraZeneca's Onglyza® (saxagliptin hydrochloride, used as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus).  View the complaint here.

Forest Laboratories Inc. et al. v. Aurobindo Pharma USA Inc. et al.
1:14-cv-00833; filed June 27, 2014 in the District Court of Delaware

• Plaintiffs:  Forest Laboratories Inc.; Forest Laboratories Holdings Ltd.; Merz Pharmaceuticals GmbH; Merz Pharma GmbH & Co. KGaA
• Defendants:  Aurobindo Pharma USA Inc.; Aurobindo Pharma Ltd.

Infringement of U.S. Patent No. 5,061,703 ("Adamantane Derivatives in the Prevention and Treatment of Cerebral Ischemia," issued on October 29, 1991), following a paragraph IV certification as part of Aurobindo's filing of an ANDA to manufacture a generic version of Forest's Namenda® (memantine hydrochloride, used for the treatment of moderate to severe dementia of the Alzheimer's type).  View the complaint here.

UCB Inc. et al. v. Apotex Corp. et al.
1:14-cv-00834; filed June 27, 2014 in the District Court of Delaware

• Plaintiffs:  UCB Inc.; UCB Pharma GmbH; Research Corporation Technologies Inc.; Harris FRC Corp.
• Defendants:  Apotex Corp.; Apotex Inc.

Infringement of U.S. Patent No. RE38,551 ("Anticonvulsant Enantiomeric Amino Acid Derivatives," issued July 6, 2004) following a Paragraph IV certification as part of Apotex's filing of an ANDA to manufacture a generic version of UCB's Vimpat® (lacosamide, used as adjunctive therapy in the treatment of partial-onset seizures in people with epilepsy aged 17 years and older).  View the complaint here.

Par Pharmaceutical Inc. v. Novartis Pharmaceuticals Corp. et al.
1:14-cv-00843; filed June 27, 2014 in the District Court of Delaware

• Plaintiff:  Par Pharmaceutical Inc.
• Defendants:  Novartis Pharmaceuticals Corp.; Novartis AG; Novartis Pharma AG; Novartis International Pharmaceutical Ltd.; LTS Lohmann Therapie-Systeme AG

Declaratory judgment of non-infringement and invalidity of U.S Patent No. 6,316,023 ("TTS Containing an Antioxidant," issued November 13, 2001) in conjunction with Par's Paragraph IV certification as part of its filing of an ANDA to manufacture a generic version of Novartis' Exelon® Patch (rivastigmine tartrate, used to treat mild to moderate dementia of the Alzheimer's type, and mild to moderate dementia associated with Parkinson's disease).  View the complaint here.

Senju Pharmaceutical Co., Ltd. et al. v. Lupin, Ltd. et al.
1:14-cv-04149; filed June 26, 2014 in the District Court of New Jersey

• Plaintiffs:  Senju Pharmaceutical Co., Ltd.; Senju Pharmaceutical Co., Ltd.; Bausch & Lomb Pharma Holdings Corp.
• Defendants:  Lupin, Ltd.; Lupin Pharmaceuticals, Inc.

Infringement of U.S. Patent No. 8,669,290 ("Aqueous Liquid Preparation Containing 2-amino-3-(4-bromobenzoyl)phenylacetic acid," issued March 11, 2014) following a Paragraph IV certification as part of Lupin's filing of an ANDA to manufacture a generic version of B&L's Prolensa® (bromfenac ophthalmic solution, used to treat postoperative inflammation and reduction of ocular pain in patients who have undergone cataract surgery).  View the complaint here.

 

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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