Court Report - January 2016 #4

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

Purdue Pharma L.P. et al. v. Amneal Pharmaceuticals LLC
1:15-cv-00831; filed September 17, 2015 in the District Court of Delaware

• Plaintiffs:  Purdue Pharma L.P.; P.F. Laboratories Inc.; Purdue Pharmaceuticals L.P.
• Defendant:  Amneal Pharmaceuticals LLC

Infringement of U.S. Patent Nos. 9,060,976 ("Pharmaceutical Formulation Containing Gelling Agent" issued June 23, 2015) and 9,034,376 (same title, issued May 19, 2015) following a Paragraph IV certification as part of Amneal's filing of an ANDA to manufacture a generic version of Purdue Pharma's OxyContin® (controlled release oxycodone hydrochloride, used to treat pain).  View the complaint here.

Horizon Pharma Ireland Ltd. et al. v. Lupin Ltd. et al.
1:15-cv-06935; filed September 17, 2015 in the District Court of New Jersey

• Plaintiffs: Horizon Pharma Ireland Ltd.; HZNP Limited; Horizon Pharma USA, Inc.
• Defendants: Lupin Ltd.; Lupin Pharmaceuticals, Inc.

Horizon Pharma Ireland Ltd. et al. v. Actavis Laboratories UT, Inc. et al.
1:15-cv-06989; filed September 17, 2015 in the District Court of New Jersey

• Plaintiffs: Horizon Pharma Ireland Ltd.; HZNP Limited; Horizon Pharma USA, Inc.
• Defendants: Actavis Laboratories UT, Inc.; Actavis, Inc.; Allergan PLC

Horizon Pharma Ireland Ltd. et al. v. IGI Laboratories, Inc.
1:15-cv-06991; filed September 17, 2015 in the District Court of New Jersey

• Plaintiffs: Horizon Pharma Ireland Ltd.; HZNP Limited; Horizon Pharma USA, Inc.
• Defendant: IGI Laboratories, Inc.

Horizon Pharma Ireland Ltd. et al. v. Amneal Pharmaceuticals LLC
1:15-cv-06990; filed September 17, 2015 in the District Court of New Jersey

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

The complaints in these cases are substantially identical.  Infringement of U.S. Patent No. 9,132,110 ("Treatment of Pain with Topical Diclofenac," issued September 15, 2015) in conjunction with defendants' 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 Lupin complaint here.

Impax Laboratories, Inc. v. Actavis Laboratories FL, Inc. et al.
2:15-cv-06934; filed September 17, 2015 in the District Court of New Jersey

• Plaintiff:  Impax Laboratories, Inc.
• Defendants:  Actavis Laboratories FL, Inc.; Actavis Pharma Inc.

Infringement of U.S. Patent Nos. 7,094,427 ("Combination Immediate Release Controlled Release Levodopa/Carbidopa Dosage Forms," issued August 22, 2006), 8,377,474 ("Controlled Release Formulations of Levodopa and Uses Thereof," issued February 19, 2013), 8,454,998 (same title, issued June 4, 2013), 8,557,283 (same title, issued October 15, 2013), 9,089,607 (same title, issued July 28, 2015), and 9,089,608 (same title, issued July 28, 2015) following a Paragraph IV certification as part of Actavis' filing of an ANDA to manufacture a generic version of Impax's Rytary® (levodopa and carbidopa, used to treat Parkinson's disease).  View the complaint here.

Gilead Sciences, Inc. et al. v. Lupin Pharmaceuticals, Inc. et al.
1:15-cv-02793; filed September 16, 2016 in the District Court of Maryland

• Plaintiffs:  Gilead Sciences, Inc.; Hoffmann-LaRoche Inc.; F. Hoffmann-LaRoche LTD; Genentech, Inc.
• Defendants:  Lupin Pharmaceuticals, Inc.; Lupin Atlantis Holdings S.A.; Lupin Ltd.

Infringement of U.S. Patent No. 5,763,483 ("Carbocyclic Compounds," issued June 9, 1998) following a Paragraph IV certification as part of Lupin's filing of an ANDA to manufacture a generic version of Genentech's Tamiflu® (oseltamivir phosphate, used to treat uncomplicated acute illness due to influenza infection in patients one year or older who have been symptomatic for no more than two days and for the prophylaxis of influenza in patients one year or older).  View the complaint here.

Otsuka Pharmaceutical Co. Ltd. v. Hetero USA Inc. et al.
1:15-cv-00822; filed September 15, 2015 in the District Court of Delaware

• Plaintiff:  Otsuka Pharmaceutical Co. Ltd.
• Defendants:  Hetero USA Inc.; Hetero Labs Ltd.; Hetero Labs Ltd. Unit V

Infringement of U.S. Patent No. 5,753,677 ("Benzoheterocyclic Compounds," issued May 19, 1998) following a Paragraph IV certification as part of Hetero's filing of an ANDA to manufacture a generic version of Otsuka's Samsca® (tolvaptan, used to treat hyponatremia).  View the complaint here.  [NB: This case has been dismissed.]

Acorda Therapeutics Inc. v. Par Pharmaceutical Inc.
1:15-cv-00824; filed September 15, 2015 in the District Court of Delaware

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 Par'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.

Allergan, Inc. v. InnoPharma, Inc. et al.
1:15-cv-00815; filed September 14, 2015 in the District Court of Delaware

• Plaintiff:  Allergan, Inc.
• Defendants:  InnoPharma, Inc.; Pfizer Inc.

Infringement of U.S Patent Nos. 8,629,111 ("Methods of Providing Therapeutic Effects Using Cyclosporine Components," issued January 14, 2014), 8,633,162 (same title, issued January 21, 2014), 8,642,556 (same title, issued February 4, 2014), 8,648,048 (same title, issued February 11, 2014), and 8,685,930 (same title, issued April 1, 2014) following a Paragraph IV certification as part of InnoPharma's filing of an ANDA to manufacture a generic version of Allergan's Restasis® (cyclosporine ophthalmic emulsion, 0.05%, used to treat dry eye).  View the complaint here.  [NB: This case has been dismissed.]

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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