Court Report - May 2016

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

Boehringer Ingelheim Pharma GmbH & Co. KG et al. v. Hetero USA, Inc. et al.
3:16-cv-02356; filed April 26, 2016 in the District Court of New Jersey

• Plaintiffs:  Boehringer Ingelheim Pharma GmbH & Co. KG; Boehringer Ingelheim International GmbH; Boehringer Ingelheim Pharmaceuticals, Inc.
• Defendants:  Hetero USA, Inc.; Hetero Labs Ltd. Unit-III; Hetero Labs Ltd.

Infringement of U.S. Patent No. 6,087,380 ("Disubstituted Bicyclic Heterocycles, the Preparations and the Use Thereof as Pharmaceutical Compositions," issued July 11, 2000) following a Paragraph IV certification as part of Hetero's filing of an ANDA to manufacture a generic version of Boehringer's Pradaxa® (dabigatran etexilate mesylate, used to reduce the risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation).  View the complaint here.

Amneal Pharmaceuticals LLC v. GlaxoSmithKline LLC et al.
1:16-cv-00300; filed April 25, 2016 in the District Court of Delaware

• Plaintiff:  Amneal Pharmaceuticals LLC
• Defendants:  GlaxoSmithKline LLC; Glaxo Group Ltd.

Declaratory judgment of non-infringement of U.S. Patent Nos. 8,637,512 ("Formulations and Method of Treatment," issued January 28, 2014) and 9,144,547 ("Oral Dosage Form for Controlled Drug Release," issued September 29, 2015) based on Amneal's filing of an ANDA (and Paragraph IV certification) to manufacture a generic version of GSK's Lamictal XR® (lamotrigine, used as adjunctive therapy for primary generalized tonic-clonic seizures and partial-onset seizures with or without secondary generalization in patients aged 13 years and older and as conversion to monotherapy in patients aged 13 years and older with partial-onset seizures who are receiving treatment with a single AED).  View the complaint here.

Novartis AG et al. v. Mylan Pharmaceuticals Inc. et al.
1:16-cv-00289; filed April 22, 2016 in the District Court of Delaware

• Plaintiffs:  Novartis AG; Novartis Pharmaceuticals Corp.; Mitsubishi Tanabe Pharma Corp.; Mitsui Sugars Co., Ltd.
• Defendants:  Mylan Pharmaceuticals Inc.; Mylan, Inc.

Infringement of U.S. Patent No. 5,604,229 ("2-Amino-1,3-Propanediol Compound and Immunosuppressant," issued February 18, 1997) following a Paragraph IV certification as part of Mylan's filing of an ANDA to manufacture a generic version of Novartis' Gilenya® (fingolimod hydrochloride, used to reduce the frequency of clinical exacerbations and to delay the accumulation of physical disability in patients with relapsing forms of multiple sclerosis).  View the complaint here.

Senju Pharmaceutical Co., Ltd. et al. v. Hi-Tech Pharmacal Co. Inc. et al.
1:16-cv-02270; filed April 22, 2016 in the District Court of New Jersey

• Plaintiffs:  Senju Pharmaceutical Co., Ltd.; Bausch & Lomb Inc.; Bausch & Lomb Pharma Holdings Corp.
• Defendants:  Hi-Tech Pharmacal Co. Inc.; Akorn, Inc.; Akorn Ophthalmics, Inc.

Infringement of U.S. Patent Nos. 8,129,431 ("Aqueous Liquid Preparation Containing 2-amino-3-(4-bromobenzoyl)phenylacetic acid," issued March 6, 2012), 8,669,290 (same title, issued March 1, 2014), 8,754,131 (same title, issued June 17, 2014), 8,871,813 (same title, issued October 28, 2014), 8,927,606 (same title, issued January 6, 2015), and 9,144,609 (same title, issued September 29, 2015) following a Paragraph IV certification as part of Hi-Tech'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.

Par Pharmaceutical, Inc. et al. v. Luitpold Pharmaceuticals, Inc. et al.
2:16-cv-02290; filed April 22, 2016 in the District Court of New Jersey

• Plaintiffs:  Par Pharmaceutical, Inc.; Par Sterile Products, LLC
• Defendants:  Luitpold Pharmaceuticals, Inc.; Daiichi Sankyo, Inc.; Daiichi Sankyo Company, Ltd.

Par Pharmaceutical, Inc. et al. v. Luitpold Pharmaceuticals, Inc. et al.
2:16-cv-01999; filed April 22, 2016 in the Eastern District of New York

• Plaintiffs:  Par Pharmaceutical, Inc.; Par Sterile Products, LLC
• Defendants:  Luitpold Pharmaceuticals, Inc.; Daiichi Sankyo, Inc.; Daiichi Sankyo Company, Ltd.

The complaints in these cases are substantially identical.  Infringement of U.S. Patent Nos. 9,119,876 ("Epinephrine Formulations," issued September 1, 2015) and 9,295,657 (same title, issued March 29, 2016) following a Paragraph IV certification as part of Luitpold's filing of an ANDA to manufacture a generic version of Par Sterile's Adrenalin® (epinephrine injection, used to treat anaphylaxis and for induction and maintenance of mydriasis during intraocular surgery).  View the New Jersey complaint here.

Galderma Laboratories LP et al. v. Tolmar Inc
3:16-cv-01099; filed April 22, 2016 in the Northern District of Texas

• Plaintiffs:  Galderma Laboratories LP; Galderma SA; Galderma Research & Development SNC
• Defendant:  Tolmar Inc.

Infringement of U.S. Patent Nos. 8,071,644 ("Combinations of Adapalene and Benzoyl Peroxide for Treating Acne Lesions," issued December 6, 2011), 8,080,537 (same title, issued December 26, 2011), 8,129,362 ("Combination/Association of Adapalene and Benzoyl Peroxide for Treating Acne Lesions," issued March 6, 2012), 8,445,543 ("Combinations of Adapalene and Benzoyl Peroxide for Treating Acne Lesions," issued May 21, 2013), and 8,809,305 ("Administration of Adapalene and Benzoyl Peroxide for the Long-Term Treatment of Acne Vulgaris," issued August 19, 2014) following a Paragraph IV certification as part of Tolmar's filing of an ANDA to manufacture a generic version of Galderma's Epiduo® Gel (adapalene and benzoyl peroxide, used to treat acne vulgaris).  View the complaint here.

Sanofi-Aventis U.S. LLC et al. v. Dr. Reddy's Laboratories, Inc. et al.
3:16-cv-02259; filed April 21, 2016 in the District Court of New Jersey

• Plaintiffs:  Sanofi-Aventis U.S. LLC; Aventis Pharma S.A.; Sanofi
• Defendants:  Dr. Reddy's Laboratories, Inc.; Dr. Reddy's Laboratories, Ltd.

Infringement of U.S. Patent No. 5,847,170 ("Taxoids, Their Preparation and Pharmaceutical Compositions Containing Them" issued December 8, 1998) following a Paragraph IV certification as part of DRL's filing of an ANDA to manufacture a generic version of Sanofi's Jevtana® (cabazitaxel injection, used in combination with prednisone for the treatment of patients with hormonerefractory metastatic prostate cancer previously treated with a docetaxel-containing treatment regimen).  View the complaint here.

AbbVie Inc. et al. v. MedImmune, LLC
8:16-cv-01129; filed April 15, 2016 in the District Court of Maryland

• Plaintiffs:  AbbVie Inc.; AbbVie Biotechnology Ltd.
• Defendant:  MedImmune, LLC

Declaratory judgment of invalidity of U.S. Patent No. 6,248,516 ("Single Domain Ligands, Receptors Comprising Said Ligands Methods for Their Production, and Use of Said Ligands and Receptors," issued June 19, 2001) relating to AbbVie's marketing and sale of its Humira® product (adalimumab, used to treat rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn's disease and plaque psoriasis).  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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