About Court Report:  Each week we will report briefly on recently filed biotech and pharma cases.

Tris Pharma Inc. v. Par Pharmaceutical Inc. et al.
1:15-cv-00068; filed January 21, 2015 in the District Court of Delaware

• Plaintiff:  Tris Pharma Inc.
• Defendants:  Par Pharmaceutical Inc.; Par Pharmaceutical Companies Inc.

Infringement of U.S. Patent Nos. 8,062,667 ("Modified Release Formulations Containing Drug-Ion Exchange Resin Complexes," issued November 22, 2011), 8,287,903 ("Orally Effective Methylphenidate Extended Release Powder And Aqueous Suspension Product," issued October 16, 2012 to), 8,465,765 (same title, issued June 18, 2013), 8,653,033 (same title, issued October 22, 2013), and 8,778,390 (same title, issued July 15, 2014) following a Paragraph IV certification as part of Par's filing of an ANDA to manufacture a generic version of Tris' Quillivant XR® (methylphenidate hydrochloride oral solution, used to treat attention deficit hyperactivity disorder, distributed by Pfizer).  View the complaint here.

Boehringer Ingelheim Pharma GmbH & Co. KG et al. v. Mylan Pharmaceuticals Inc.
1:15-cv-00010; January 21, 2015 in the Northern District of West Virginia

• Plaintiffs:  Boehringer Ingelheim Pharma GmbH & Co. KG; Boehringer Ingelheim International GmbH; Boehringer Ingelheim Pharmaceuticals, Inc.
• Defendant:  Mylan Pharmaceuticals Inc.

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 Mylan'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.

Teva Pharmaceuticals USA Inc. v. AstraZeneca Pharmaceuticals LP et al.
1:15-cv-00050; filed January 19, 2015 in the District Court of Delaware

• Plaintiff:  Teva Pharmaceuticals USA Inc.
• Defendants:  AstraZeneca Pharmaceuticals LP; Amylin Pharmaceuticals LLC

Declaratory judgment of non-infringement of U.S. Patent Nos. 7,297,761 ("Pharmaceutical Compositions containing Exendins," issued November 20, 2007) and 7,741,269 ("Exendins and Exendin Agonists for Weight Reduction and Obesity," issued June 22, 2010) based on Teva's Paragraph IV certification as part of its filing of an ANDA to manufacture a generic version of AstraZeneca's Byetta® (exenatide injection, used to improve blood sugar control in adults with Type II diabetes, when used with diet and exercise).  View the complaint here.

Laboratoire HRA Pharma v. Teva Pharmaceuticals USA Inc.
1:15-cv-00045; filed January 16, 2015 in the District Court of Delaware

Infringement of U.S. Patent Nos. 8,426,392 ("Method for Providing Emergency Contraception," issued April 23, 2013), 8,512,745 ("Ulipristal Acetate Tablets," issued August 20, 2013), and 8,735,380 (same title, issued May 27, 2014) following a Paragraph IV certification as part of Teva's filing of an ANDA to manufacture a generic version of Laboratoire's Ella® (ulipristal acetate, used for emergency contraception to prevent pregnancy within five days after unprotected intercourse or a known or suspected contraceptive failure).  View the complaint here.

Boehringer Ingelheim Pharma GmbH & Co. KG et al. v. Teva Pharmaceuticals USA Inc. et al.
1:15-cv-00048; filed January 16, 2015 in the District Court of Delaware

• Plaintiffs:  Boehringer Ingelheim Pharma GmbH & Co. KG; Boehringer Ingelheim International GMBH; Boehringer Ingelheim Pharmaceuticals Inc.
• Defendants:  Teva Pharmaceuticals USA Inc.; Teva Pharmaceutical Industries 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 Teva'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.

Shionogi & Co., Ltd. et al. v. Aurobindo Pharma Ltd. et al.
1:15-cv-00478; filed January 16, 2015 in the Northern District of Illinois

• Plaintiffs:  Shionogi & Co., Ltd.; Shionogi Inc.
• Defendants:  Aurobindo Pharma Ltd.; Aurobindo Pharma U.S.A., Inc.

Shionogi & Co., Ltd. et al. v. Aurobindo Pharma Ltd. et al.
3:15-cv-00319; filed January 16, 2015 in the District Court of New Jersey

• Plaintiffs:  Shionogi & Co., Ltd.; Shionogi Inc.
• Defendants:  Aurobindo Pharma Ltd.; Aurobindo Pharma U.S.A., Inc.

The complaints in these cases are substantially identical.  Infringement of U.S. Patent No. 8,247,402 ("Crystal Form of Pyrrolidylthiocarbapenem Derivative," issued August 21, 2012) following a Paragraph IV certification as part of Aurobindo's filing of an ANDA to manufacture a generic version of Shionogi's Doribax® (doripenem injection, used to treat complicated intra-abdominal infections and complicated urinary tract infections, including pyelonephritis).  View the NDIL complaint here.

Senju Pharmaceutical Co., Ltd. et al. v. Apotex Inc. et al.
1:15-cv-00336; filed January 16, 2015 in the District Court of New Jersey

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

Senju Pharmaceutical Co., Ltd. et al. v. Paddock Laboratories, LLC et al.
1:15-cv-00337; filed January 16, 2015 in the District Court of New Jersey

• Plaintiffs:  Senju Pharmaceutical Co., Ltd.; Bausch & Lomb Inc.; Bausch & Lomb Pharma Holdings Corp.
• Defendants:  Paddock Laboratories, LLC; L. Perrigo Co.; Perrigo Co.

The complaints in these cases are identical.  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), and 8,927,606 (same title, issued January 6, 2015) following a Paragraph IV certification as part of defendants' 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 Apotex complaint here.

Senju Pharmaceutical Co., Ltd. et al. v. Lupin, Ltd. et al.
1:15-cv-00335; filed January 16, 2015 in the District Court of New Jersey

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

Infringement of U.S. Patent Nos. 8,871,813 ("Aqueous Liquid Preparation Containing 2-amino-3-(4-bromobenzoyl)phenylacetic acid," issued October 28, 2014) and 8,927,606 (same title, issued January 6, 2015) 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.

Supernus Pharmaceuticals, Inc. v. Par Pharmaceutical Companies, Inc. et al.
2:15-cv-00326; filed January 16, 2015 in the District Court of New Jersey

• Plaintiff:  Supernus Pharmaceuticals, Inc.
• Defendants:  Par Pharmaceutical Companies, Inc.; Par Pharmaceutical, Inc.

Infringement of U.S. Patent Nos. 8,298,576 ("Sustained-Release Formulations of Topiramate," issued October 30, 2012,), 8,298,580 (same title, issued October 30, 2012), 8,663,683 (same title, issued March 4, 2014), and 8,877,248 (same title, issued November 4, 2014 following a Paragraph IV certification as part of Par's filing of an ANDA to manufacture a generic version of Supernus' Trokendi XR® (topiramate extended-release, used to treat certain types of seizures).  View the complaint here.

Supernus Pharmaceuticals, Inc. v. TWI Pharmaceuticals, Inc. et al.
1:15-cv-00369; filed January 16, 2015 in the District Court of New Jersey

• Plaintiff:  Supernus Pharmaceuticals, Inc.
• Defendants:  TWI Pharmaceuticals, Inc.; TWI International LLC

Infringement of U.S. Patent Nos. 7,722,898 ("Modified-Release Preparations Containing Oxcarbazepine and Derivatives Thereof," issued May 25, 2010), 7,910,131 ("Method of Treating Seizures Using Modified Release Formulations of Oxcarbazepine," issued March 22, 2011), 8,617,600 ("Modified Release Preparations Containing Oxcarbazepine and Derivatives Thereof," issued December 31, 2013), and 8,821,930 (same title, issued September 2, 2014) following a Paragraph IV certification as part of TWI's filing of an ANDA to manufacture a generic version of Supernus'Oxtellar XR (oxcarbazepine extended-release tablets, used for adjunctive therapy in the treatment of partial seizures in adults and in children 6 to 17 years of age).  View the complaint here.

Sanofi-Aventis U.S. LLC et al. v. Apotex Corp. et al.
1:15-cv-00044; filed January 15, 2015 in the District Court of Delaware

• Plaintiffs:  Sanofi-Aventis U.S. LLC; Aventis Pharma S.A.; Sanofi
• Defendants:  Apotex Corp.; Apotex Inc.

Infringement of U.S. Patent Nos. 5,847,170 ("Taxoids, Their Preparation and Pharmaceutical Compositions Containing Them" issued December 8, 1998) and 7,241,907 ("Acetone Solvate of Dimethoxy Docetaxel and its Process of Preparation" issued July 10, 2007) following a Paragraph IV certification as part of Apotex'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.

Alcon Laboratories, Inc. et al. v. Akorn, Inc.
2:15-cv-00285; filed January 14, 2015 in the District Court of New Jersey

• Plaintiffs:  Alcon Laboratories, Inc.; Alcon Pharmaceuticals Ltd; Senju Pharmaceutical Co., Ltd; Mitsubishi Chemical Corp.
• Defendant:  Akorn, Inc.

Infringement of U.S. Patent No. 6,114,319 ("Compositions Containing Difluprednate," issued September 5, 2000) following a Paragraph IV certification as part of Akorn's filing of an ANDA to manufacture a generic version of Alcon's Durezol® (difluprednate ophthalmic emulsion, used to treat pain and swelling following eye surgery).  View the complaint here.

Sumitomo Dainippon Pharma Co., Ltd. et al. v. Emcure Pharmaceuticals Ltd. et al.
2:15-cv-00280; filed January 14, 2015 in the District Court of New Jersey

• Plaintiffs:  Sumitomo Dainippon Pharma Co., Ltd.; Sunovion Pharmaceuticals Inc.
• Defendants:  Emcure Pharmaceuticals Ltd.; Emcure Pharmaceuticals USA, Inc.

Sumitomo Dainippon Pharma Co., Ltd. et al. v. InvaGen Pharmaceuticals, Inc.
2:15-cv-00281; filed January 14, 2015 in the District Court of New Jersey

• Plaintiffs:  Sumitomo Dainippon Pharma Co., Ltd.; Sunovion Pharmaceuticals Inc.
• Defendants:  InvaGen Pharmaceuticals, Inc.

The complaints in these cases are substantially identical.  Infringement of U.S. Patent No. 5,532,372 ("Imide Derivatives, and Their Production and Use," issued July 2, 1996) following a Paragraph IV certification as part of defendants' filing of an ANDA to manufacture a generic version of Sumitomo's Latuda® (lurasidone hydrochloride, used to treat depressive episodes associated with Bipolar I Disorder (bipolar depression) as monotherapy and as adjunctive therapy with lithium or valproate and used for the treatment of schizophrenia).  View the Emcure complaint here.

Horizon Pharma Ireland Ltd. et al. v. Paddock Laboratories, LLC et al.
1:15-cv-00368; filed January 13, 2015 in the District Court of New Jersey

• Plaintiffs:  Horizon Pharma Ireland Ltd.; HZNP Ltd.; Horizon Pharma USA, Inc.
• Defendants:  Paddock Laboratories, LLC; Perrigo Co.

Infringement of U.S. Patent Nos. 8,217,078 ("Treatment of Pain with Topical Diclofenac," issued July 10, 2012), 8,252,838 ("Diclofenac Topical Formulation," issued August 28, 2012), 8,546,450 ("Treatment of Pain with Topical Diclofenac," issued October 1, 2013), 8,563,613 ("Diclofenac Topical Formulation," issued October 22, 2013), 8,618,164 ("Treatment of Pain with Topical Diclofenac," issued December 31, 2013), and 8,871,809 ("Diclofenac Topical Formulation," issued October 28, 2014) following a Paragraph IV certification as part of Paddock's filing of an ANDA to manufacture a generic version of Horizon's Pennsaid® (diclofenac sodium topical solution, used for the treatment of signs and symptoms of osteoarthritis of the knee(s)).  View the complaint here.

Johnson Matthey Inc. et al. v. Pfizer, Inc. et al.
2:15-cv-00014; filed January 13, 2015 in the Eastern District of Virginia

• Plaintiffs:  Johnson Matthey Inc.; Johnson Matthey Pharmaceutical Materials, Inc.
• Defendants:  Pfizer, Inc.; Pfizer Ireland Pharmaceuticals; Pfizer Ltd.

Declaratory judgment of noninfringement and invalidity of U.S. Patent No. 6,124,363 ("Dofetilide Polymorphs," issued September 26, 2000) based on plaintiffs' filing of a DMF (drug master file) with the FDA for the manufacture of a generic version of Pfizer's Tikosyn® (dofetilide, used for the maintenance of normal sinus rhythm in patients with atrial fibrillation/atrial flutter of greater than one week duration who have been converted to normal sinus rhythm and for the conversion of atrial fibrillation and atrial flutter to normal sinus rhythm).  View the complaint here.