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

Tris Pharma Inc. v. Actavis Laboratories FL Inc. et al.
1:15-cv-00393; filed May 15, 2015 in the District Court of Delaware

• Plaintiff:  Tris Pharma Inc.
• Defendants:  Actavis Laboratories FL Inc.; Andrx Corp.; Actavis Inc.; Actavis Pharma Inc.

Tris Pharma, Inc. v. Actavis Laboratories FL, Inc. et al.
2:15-cv-03399; filed May 15, 2015 in the District Court of New Jersey

• Plaintiff:  Tris Pharma, Inc.
• Defendants:  Actavis Laboratories FL Inc.; Andrx Corp.; Actavis, Inc.; Actavis Pharma Inc.

The complaints in these cases are substantially identical.  Infringement of U.S. Patent No. 8,956,649 ("Orally Effective Methylphenidate Extended Release Powder And Aqueous Suspension Product," issued February 17, 2015) following a Paragraph IV certification as part of Actavis' filing of an ANDA to manufacture a generic version of Tris' Quillivant XR® (methylphenidate hydrochloride oral suspension, used to treat attention deficit hyperactivity disorder, distributed by Pfizer).  View the Delaware complaint here.

Acorda Therapeutics Inc. v. Sun Pharmaceutical Industries Limited et al.
1:15-cv-00391; filed May 15, 2015 in the District Court of Delaware

• Plaintiff:  Acorda Therapeutics Inc.
• Defendants:  Sun Pharmaceutical Industries Ltd.; Sun Pharmaceutical Industries Inc.

Infringement of U.S. Patent Nos. 8,007,826 ("Sustained Release Aminopyridine Composition," issued August 30, 2011), 8,354,437 ("Method of Using Sustained Release Aminopyridine Compositions," issued January 15, 2013), 8,440,703 (same title, issued May 14, 2013), and 8,663,685 ("Sustained Release Aminopyridine Composition," issued March 4, 2014) following a Paragraph IV certification as part of Sun's filing of an ANDA to manufacture a generic version of Acorda's Ampyra® (dalfampridine extended release, used to improve walking in patients with multiple sclerosis).  View the complaint here.

Horizon Pharma Ireland Ltd. et al. v. Amneal Pharmaceuticals LLC
1:15-cv-03367; filed May 15, 2015 in the District Court of New Jersey

• Plaintiffs:  Horizon Pharma Ireland Ltd.; HZNP Ltd.; Horizon Pharma USA, Inc.
• Defendant:  Amneal Pharmaceuticals LLC

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 Amneal'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.

Takeda GmbH et al. v. Torrent Pharma Inc. et al.
3:15-cv-03375; filed May 15, 2015 in the District Court of New Jersey

• Plaintiffs:  Takeda GmbH; AstraZeneca Pharmaceuticals LP; AstraZeneca UK Ltd.
• Defendants:  Torrent Pharma Inc.; Torrent Pharmaceuticals Ltd.

Takeda GmbH et al. v. Micro Labs USA, Inc. et al.
3:15-cv-03376; filed May 15, 2015 in the District Court of New Jersey

• Plaintiffs: Takeda GmbH; AstraZeneca Pharmaceuticals LP; AstraZeneca UK Ltd.
• Defendants: Micro Labs USA, Inc.; Micro Labs Ltd.

Takeda GmbH et al. v. Zydus Pharmaceuticals (USA) Inc.
3:15-cv-03377; filed May 15, 2015 in the District Court of New Jersey

• Plaintiffs: Takeda GmbH; AstraZeneca Pharmaceuticals LP; AstraZeneca UK Ltd.
• Defendant: Zydus Pharmaceuticals (USA) Inc.

Takeda GmbH et al. v. Strides Pharma, Inc. et al.
3:15-cv-03378; filed May 15, 2015 in the District Court of New Jersey

• Plaintiffs: Takeda GmbH; AstraZeneca Pharmaceuticals LP; AstraZeneca UK Ltd.
• Defendants: Strides Pharma, Inc.; Strides Pharma, Inc.

Takeda GmbH et al. v. Apotex Corp. et al.
3:15-cv-03379; filed May 15, 2015 in the District Court of New Jersey

• Plaintiffs: Takeda GmbH; AstraZeneca Pharmaceuticals LP; AstraZeneca UK Ltd.
• Defendants: Apotex Corp.; Apotex Inc.

Takeda GmbH et al. v. Citron Pharma LLC et al.
3:15-cv-03383; filed May 15, 2015 in the District Court of New Jersey

• Plaintiffs: Takeda GmbH; AstraZeneca Pharmaceuticals LP; AstraZeneca UK Ltd.
• Defendants: Citron Pharma LLC; MSN Laboratories Private Ltd.

Takeda GmbH et al. v. Hetero USA Inc. et al.
3:15-cv-03385; filed May 15, 2015 in the District Court of New Jersey

• Plaintiffs: Takeda GmbH; AstraZeneca Pharmaceuticals LP; AstraZeneca UK Ltd.
• Defendants: Hetero USA Inc.; Hetero Labs Ltd. Unit-III; Hetero Labs Ltd.

The complaints in these cases are substantially identical.  Infringement of U.S. Patent Nos. 8,536,206 ("Process for the Preparation of Roflumilast," issued September 17, 2013), 8,604,064 (same title, issued December 10, 2013), and 8,618,142 (same title, issued December 31, 2013) following a Paragraph IV certification as part of defendants' filing of an ANDA to manufacture a generic version of AstraZeneca's Daliresp® (roflumilast, used to reduce the risk of COPD exacerbation in patients with severe COPD associated with chronic bronchitis and a history of exacerbation).  View the Torrent complaint here.

Takeda GmbH et al. v. Prinston Pharmaceutical Inc.
3:15-cv-03380; filed May 15, 2015 in the District Court of New Jersey

• Plaintiffs:  Takeda GmbH; AstraZeneca Pharmaceuticals LP; AstraZeneca UK Ltd.
• Defendant:  Prinston Pharmaceutical Inc.

Takeda GmbH et al. v. Breckenridge Pharmaceutical Inc.
3:15-cv-03382; filed May 15, 2015 in the District Court of New Jersey

• Plaintiffs: Takeda GmbH; AstraZeneca Pharmaceuticals LP; AstraZeneca UK Ltd.
• Defendant: Breckenridge Pharmaceutical Inc.

Takeda GmbH et al. v. Mylan Pharmaceuticals Inc.
3:15-cv-03384; filed May 15, 2015 in the District Court of New Jersey

• Plaintiffs: Takeda GmbH; AstraZeneca Pharmaceuticals LP; AstraZeneca UK Ltd.
• Defendant: Mylan Pharmaceuticals Inc.

The complaints in these cases are substantially identical.  Infringement of U.S. Patent Nos. 5,712,298 ("Fluoroalkoxy-Substituted Benzamides And Their Use As Cyclic Nucleotide Phosphodiestrerase Inhibitors," issued January 27, 1998), 8,536,206 ("Process for the Preparation of Roflumilast," issued September 17, 2013), 8,604,064 (same title, issued December 10, 2013), and 8,618,142 (same title, issued December 31, 2013) following a Paragraph IV certification as part of defendants' filing of an ANDA to manufacture a generic version of AstraZeneca's Daliresp® (roflumilast, used to reduce the risk of COPD exacerbation in patients with severe COPD associated with chronic bronchitis and a history of exacerbation).  View the Prinston complaint here.

Sanofi-Aventis U.S. LLC et al. v. Onco Therapies Ltd.
3:15-cv-03392; filed May 15, 2015 in the District Court of New Jersey

• Plaintiffs:  Sanofi-Aventis U.S. LLC; Aventis Pharma S.A.; Sanofi
• Defendant:  Onco Therapies Ltd.

Infringement of U.S. Patent No. 8,927,592 ("Antitumoral Use Of Cabazitaxel," issued January 6, 2015) following a Paragraph IV certification as part of Onco'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.

Vanda Pharmaceuticals Inc. v. Inventia Healthcare Pvt. Ltd.
3:15-cv-00059; filed May 15, 2015 in the Northern District of West Virginia

Infringement of U.S. Patent No. 8,586,610 ("Methods for the Administration of Iloperidone," issued November 19, 2013) following a Paragraph IV certification as part of  Inventia's filing of an ANDA to manufacture a generic version of Vanda's Fanapt® (iloperidone, used for the acute treatment of adults with schizophrenia).  View the complaint here.

Merz Pharmaceuticals, LLC et al. v. Taro Pharmaceuticals U.S.A., Inc. et al.
1:15-cv-03720; filed May 14, 2015 in the Southern District of New York

• Plaintiffs:  Merz Pharmaceuticals, LLC; Merz North America, Inc.
• Defendants:  Taro Pharmaceuticals U.S.A., Inc.; Taro Pharmaceutical Industries Ltd.

Infringement of U.S. Patent No. 8,778,365 ("Topical Compositions and Methods for Making and Using Same," issued July 15, 2014) following a Paragraph IV certification as part of Taro's filing of an ANDA to manufacture a generic version of Merz's Naftin® (naftifine hydrochloride gel 2%, used for the treatment of interdigital tinea pedis caused by certain fungi).  View the complaint here.