Court Report - May 2016 #4

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

Allergan, Inc. et al. v. Somerset Therapeutics, LLC
1:16-cv-00392; filed May 26, 2016 in the District Court of Delaware

• Plaintiffs:  Allergan, Inc.; Vistakon Pharmaceuticals, LLC
• Defendant:  Somerset Therapeutics, LLC

Infringement of U.S. Patent No. 8,664,215 ("Ocular Allergy Treatments with Alcaftadine," issued March 4, 2014), licensed to Allergan, following a Paragraph IV certification as part of Somerset's filing of an ANDA to manufacture a generic version of Allergan's Lastacaft® (alcaftadine ophthalmic solution 0.25%, used for the prevention of itching associated with allergic conjunctivitis).  View the complaint here.

Forest Laboratories, LLC et al. v. Accord Healthcare, Inc. et al.
1:16-cv-00375; filed May 20, 2016 in the District Court of Delaware

• Plaintiffs:  Forest Laboratories, LLC; Forest Laboratories Holdings, Ltd.; Allergan USA, Inc.; Adamas Pharmaceuticals, Inc.
• Defendants:  Accord Healthcare, Inc.; Intas Pharmaceuticals Ltd.

Infringement of U.S. Patent Nos. 8,039,009 ("Modified Release Formulations of Memantine Oral dosage Forms," issued October 18, 2011), 8,058,291 ("Methods and Compositions For the Treatment of CNS-Related Conditions," issued November 15, 2011), 8,168,209 ("Method and Composition for Administering an NMDA Receptor Antagonist to a Subject," issued May 1, 2012), 8,173,708 (same title, issued May 8, 2012), 8,283,379 ("Method and Compositions for the Treatment of CNS-Related Conditions," issued October 9, 2012), 8,293,794 (same title, issued October 23, 2012), 8,329,752 ("Composition for Administering an NMDA Receptor Antagonist to a Subject," issued December 11, 2012), 8,338,485 ("Compositions for the Treatment of CNS-Related Conditions," issued December 25, 2012), 8,338,486 ("Methods for the Treatment of CNS-Related Conditions," issued December 25, 2012), 8,362,085 ("Method for Administering an NMDA Receptor Antagonist to a Subject," issued January 29, 2013), 8,580,858 ("Compositions For the Treatment of CNS-Related Conditions," issued November 12, 2013), and 8,598,233 ("Method for Administering an NMDA Receptor Antagonist To A Subject," issued December 3, 2013) following a Paragraph IV certification as part of Accord's filing of an ANDA to manufacture a generic version of Forest's Namzaric ® (memantine hydrochloride extended-release and donepezil hydrochloride, used for the treatment of moderate to severe dementia of the Alzheimer's type).  View the complaint here.

Lotus Pharmaceutical Co. Ltd v. GlaxoSmithKline LLC et al.
1:16-cv-00377; filed May 20, 2016 in the District Court of Delaware

• Plaintiff:  Lotus Pharmaceutical Co. Ltd
• 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 Lotus' 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.

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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