Court Report - July 2016

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

Eli Lilly and Company et al. v. Apotex Inc. et al.
1:16-cv-00475; filed June 22, 2016 in the District Court of Delaware

• Plaintiffs:  Eli Lilly and Company; Eli Lilly Export S.A.; Acrux DDS Pty Ltd.
• Defendants:  Apotex Inc.; Apotex Corp.

Eli Lilly and Company et al. v. Apotex Inc. et al.
1:16-cv-01512; filed June 20, 2016 in the Southern District of Indiana

• Plaintiffs:  Eli Lilly and Company; Eli Lilly Export S.A.; Acrux DDS Pty Ltd.
• Defendants:  Apotex Inc.; Apotex Corp.

The complaints in these cases are substantially identical.  Infringement of U.S. Patent Nos. 8,419,307 ("Spreading Implement," issued April 16, 2013), 8,177,449 (same title, issued May 15, 2012), 8,435,944 ("Method and Composition for Transdermal Drug Delivery," issued May 7, 2013), 8,807,861 (same title, issued August 19, 2014), 8,993,520 (same title, issued March 31, 2015), 9,180,194 (same title, issued November 10, 2015), and 9,289,586 ("Spreading Implement," issued March 22, 2016) following a Paragraph IV certification as part of Apotex's filing of an ANDA to manufacture a generic version of Eli Lilly's Axiron® (testosterone metered transdermal solution, used to treat males for conditions associated with a deficiency or absence of endogenous testosterone). View the S.D. Indiana complaint here.

Noven Pharmaceuticals, Inc. v. Actavis Laboratories UT, Inc.
1:16-cv-00465; filed June 20, 2016 in the District Court of Delaware

Infringement of U.S. Patent No. 8,231,906 ("Transdermal Estrogen Device and Delivery," issued July 31, 2012) following a Paragraph IV certification as part of Actavis' filing of an ANDA to manufacture a generic version of Noven's Minivelle® (estradiol transdermal system, used for the treatment of moderate to severe vasomotor symptoms due to menopause and for the prevention of postmenopausal osteoporosis). View the complaint here.

UCB, Inc. et al. v. Aurobindo Pharma Ltd. et al.
1:16-cv-00451; filed June 17, 2016 in the District Court of Delaware

• Plaintiffs:  UCB, Inc.; UCB Biopharma SPRL; Research Corporation Technologies, Inc.; Harris FRC Corp.
• Defendants:  Aurobindo Pharma Ltd.; Aurobindo Pharma USA, Inc.; Aurobindo Pharma USA, Inc.; Aurobindo Pharma Ltd.

UCB, Inc. et al. v. Hetero USA Inc. et al.
1:16-cv-00452; filed June 17, 2016 in the District Court of Delaware

• Plaintiffs:  UCB, Inc.; UCB Biopharma SPRL; Research Corporation Technologies, Inc.; Harris FRC Corp.
• Defendants:  Hetero USA Inc.; Hetero Labs Ltd.

The complaints in these cases are substantially identical. 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 defendants' 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 Aurobindo complaint here.

Shire Orphan Therapies LLC et al. v. InnoPharma Inc.
1:16-cv-00456; filed June 17, 2016 in the District Court of Delaware

• Plaintiffs:  Shire Orphan Therapies LLC; Sanofi-Aventis Deutschland GmbH
• Defendant:  InnoPharma Inc.

Infringement of U.S. Patent No. 5,648,333 ("Peptides Having Bradykinin Antagonist Action," issued July 15, 1997) following a Paragraph IV certification as part of InnoPharma's filing of an ANDA to manufacture a generic version of Shire's Firazyr® (icatibant, used to treat acute attacks of hereditary angioedema in adults 18 years of age and older). View the complaint here.

United Therapeutics Corp. et al. v. Actavis Laboratories FL, Inc.
3:16-cv-03642; filed June 17, 2016 in the District Court of New Jersey

• Plaintiffs:  United Therapeutics Corp.; Supernus Pharmaceuticals, Inc.
• Defendant:  Actavis Laboratories FL, Inc.

Infringement of U.S. Patent Nos. 7,417,070 ("Compounds and Methods for Delivery of Prostacyclin Analogs," issued August 26, 2008), 7,544,713 (same title, issued June 9, 2009), 8,252,839 (same title, issued August 28, 2012), 8,349,892 ("Solid Formulations of Prostacyclin Analogs issued January 8, 2013), 8,410,169 ("Compounds and Methods for Delivery of Prostacyclin Analogs," issued April 2, 2013), 8,497,393 ("Process to Prepare Treprostinil, the Active Ingredient in Remodulin®," issued July 30, 2013), 9,050,311 ("Compounds and Methods for Delivery of Prostacyclin Analogs," issued June 9, 2015), 8,747,897 ("Osmotic Drug Delivery System," issued June 10, 2014), and 9,278,901 ("Compounds and Methods for Delivery of Prostacyclin Analogs," issued March 8, 2016) following a Paragraph IV certification as part of Actavis' filing of an ANDA to manufacture a generic version of UTC's Orenitram® (treprostinil, used to treat pulmonary arterial hypertension). 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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