About Court Report: Each week we will report briefly on recently filed biotech and pharma cases.
Tris Pharma Inc. v. Actavis Elizabeth LLC et al.
1:16-cv-00603l; filed July 12, 2016 in the District Court of Delaware
• Plaintiff: Tris Pharma Inc.
• Defendants: Actavis Elizabeth LLC; Actavis Inc.
Infringement of U.S. Patent Nos. 8,202,537 ("Modified Release Formulations Containing Drug-Ion Exchange Resin Complexes," issued June 19, 2012), 8,287,903 ("Orally Effective Methylphenidate Extended Release Powder and Aqueous Suspension Product," issued October 16, 2012), 8,999,386 ("Methylphenidate Extended Release Chewable Tablet," issued April 7, 2015), and 9,295,642 (same title, issued March 29, 2016) following a Paragraph IV certification as part of Actavis' filing of an ANDA to manufacture a generic version of Tris' QuilliChew ER® (methylphenidate hydrochloride extended-release chewable tablets, used to treat ADHD in children 6 years and above). View the complaint here.
Imprimis Pharmaceuticals, Inc. v. Alcon Pharmaceuticals Ltd. et al.
3:16-cv-01794; filed July 11, 2016 in the Southern District of California
• Plaintiff: Imprimis Pharmaceuticals, Inc.
• Defendants: Alcon Pharmaceuticals Ltd.; Alcon Research, Ltd.
Declaratory judgment of noninfringment of U.S. Patent Nos. 6,716,830 ("Ophthalmic Antibiotic Compositions Containing Moxifloxacin," issued April 6, 2004) and 7,671,070 ("Method of Treating Ophthalmic Infections with Moxifloxacin Compositions," issued March 2, 2010) based on Imprimis' manufacture and sale of certain ophthalmic products. View the complaint here.
Gilead Sciences, Inc. et al. v. Aurobindo Pharma Ltd. et al.
1:16-cv-04178; filed July 8, 2016 in the District Court of New Jersey
• Plaintiffs: Gilead Sciences, Inc.; Emory University
• Defendants: Aurobindo Pharma Ltd.; Aurobindo Pharma USA Inc.
Infringement of U.S. Patent Nos. 6,642,245 ("Antiviral Activity and Resolution of 2-Hydroxymethyl-5-(5-fluorocytosin-1-yl)-l,3-oxathiolane," issued November 4, 2003), 6,703,396 ("Method of Resolution and Antiviral Activity of 1,3-Oxathiolane Nucleoside Enantiomers," issued March 9, 2004), 8,592,397 ("Compositions and Methods for Combination Antiviral Therapy," issued November 26, 2013), and 8,716,264 (same title, issued May 6, 2014) following a Paragraph IV certification as part of Aurobindo's filing of an ANDA to manufacture a generic version of Gilead's Truvada® (emtricitabine and tenofovir disoproxil fumarate, used for the treatment of HIV-1 infection in adults). View the complaint here.
Merck Sharp & Dohme Corp. v. Genentech, Inc. et al.
2:16-cv-04992; filed July 7, 2016 in the Central District of California
• Plaintiff: Merck Sharp & Dohme Corp.
• Defendants: Genentech, Inc.; City of Hope
Declaratory judgment of invalidity and noninfringement of U.S. Patent No. 7,923,221 ("Methods of Making Antibody Heavy and Light Chains Having Specificity for a Desired Antigen," issued April 12, 2011) based on Merck's manufacture and sale of its Keytruda® product (pembrolizumab, used to treat patients with unresectable or metastatic melanoma, and for the treatment of patients with metastatic or PD-L1 positive, non-small cell lung cancer, as determined by an FDA-approved test, with disease progression on or after platinum-containing chemotherapy) and/or Merck's anticipated manufacture and sale of its bezlotoxumab products (to be used for the prevention of Clostridium difficile infection recurrence). View the complaint here.
AstraZeneca AB v. Apotex Corp. et al.
1:16-cv-00583; filed July 7, 2016 in the District Court of Delaware
• Plaintiff: AstraZeneca AB
• Defendants: Apotex Corp.; Apotex Inc.
Infringement of U.S. Patent No. RE44,186 ("Cyclopropyl-Fused Pyrrolidine-Based Inhibitors of Dipeptidyl Peptidase IV and Method," issued April 30, 2013) following a Paragraph IV certification as part of Apotex's filing of an ANDA to manufacture a generic version of AstraZeneca's Onglyza® (saxagliptin hydrochloride, used as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus). View the complaint here.
