Court Report -- November 17, 2013

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

Eli Lilly and Company et al. v. Watson Laboratories Inc et al.
3:13-cv-00637; filed November 14, 2013 in the District Court of Nevada

• Plaintiffs:  Eli Lilly and Company; Acrux DDS Pty. Ltd.; Eli Lilly Export S.A.
• Defendants:  Watson Laboratories Inc; Actavis, Inc.; Actavis Pharma, Inc.

Eli Lilly and Company et al. v. Watson Laboratories, Inc. et al.
1:13-cv-01799; filed November 12, 2013 in the Southern District of Indiana

• Plaintiffs:  Eli Lilly and Company; Eli Lilly Export S.A.; Acrux DDS Pty Ltd.
• Defendants:  Watson Laboratories, Inc.; Actavis, Inc.; Actavis Pharma, Inc.

The complaints in these cases are substantially identical.  Infringement of U.S. Patent Nos. 6,299,900 ("Dermal Penetration Enhancers and Drug Delivery Systems Involving Same," issued October 9, 2001), 6,818,226 (same title, issued November 16, 2004), 6,923,983 ("Transdermal Delivery of Hormones," issued August 2, 2005), 8,071,075 (Dermal Penetration Enhancers and Drug Delivery Systems Involving Same," issued December 6, 2011), 8,419,307 ("Spreading Implement," issued April 16, 2013), and 8,435,944 ("Method and Composition for Transdermal Drug Delivery," issued May 7, 2013) following a Paragraph IV certification as part of Watson'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 Nevada complaint here.

Pfizer Inc. et al. v. Fresenius Kabi USA LLC
1:13-cv-01893; filed November 13, 2013 in the District Court of Delaware

• Plaintiffs:  Pfizer Inc.; Wyeth LLC; Pfizer Pharmaceuticals LLC; PF Prism C.V.; Pfizer Manufacturing Holdings LLC; Wyeth Holdings LLC; Wyeth Holdings Corp.
• Defendant:  Fresenius Kabi USA LLC

Infringement of U.S. Patent Nos. RE40,183 ("7-Substituted-9-Substituted Amino-6-Demethyl-6-Deoxytetracyclines," issued March 25, 2008), 7,879,828 ("Tigecycline Compositions and Methods of Preparation," issued February 1, 2011) and 8,372,995 ("Crystalline Solid Forms of Trigecycline and Methods of Preparing Same," issued February 12, 2013), licensed to Pfizer, following a Paragraph IV certification as part of Fesenius' filing of an ANDA to manufacture a generic version of Pfizer's Tygacil® (tigecycline injectible, used for the treatment of complicated skin and skin structure infections, complicated intra-abdominal infections, and community-acquired bacterial pneumonia).  View the complaint here.

Millennium Pharmaceuticals Inc. v. Apotex Corp. et al.
1:13-cv-01874; filed November 8, 2013 in the District Court of Delaware

• Plaintiff:  Millennium Pharmaceuticals Inc.
• Defendants:  Apotex Corp.; Apotex Inc.

Infringement of U.S. Patent Nos. 6,713,446 ("Formulation of Boronic Acid Compounds," issued March 30, 2004) and 6,958,319 (same title, issued October 25, 2005), licensed exclusively to Millennium, following a Paragraph IV certification as part of Fresenius' filing of an NDA (under § 505(b)(2) of the Food, Drug and Cosmetic Act) to manufacture a generic version of Millenium's Velcade® (bortezomib, used to treat multiple myeloma).  View the complaint here.

Genzyme Corp. et al. v. Dr. Reddy's Laboratories, Inc. et al.
1:13-cv-06827; filed November 8, 2013 in the District Court of New Jersey

• Plaintiffs:  Genzyme Corp.; Southern Research Institute
• Defendants:  Dr. Reddy's Laboratories, Inc.; Dr. Reddy's Laboratories, Ltd.

Infringement of U.S. Patent No. 5,661,136 ("2-Halo-2'-Fluoro ARA Adenosines as Antinoplastic Agents," issued August 26, 1997) following a Paragraph IV certification as part of Dr. Reddy's filing of an ANDA to manufacture a generic version of Genzyme's Clolar® (clofarabine injection, used to treat acute lymphoblastic leukemia).  View the complaint here.

Novartis Pharmaceuticals Corp. v. Akorn, Inc.
2:13-cv-06835; filed November 8, 2013 in the District Court of New Jersey

Infringement of U.S. Patent Nos. 7,932,241 ("Pharmaceutical Products Comprising Bisphosphonates," issued April 26, 2011) and 8,324,189 ("Use of Zolendronate for the Manufacture of a Medicament for the Treatment of Bone Metabolism Diseases," issued December 4, 2012) following a Paragraph IV certification as part of Akorn's filing of an ANDA to manufacture a generic version of Novartis' Zometa® (zoledronic acid, used for the prevention of skeletal-related complications associated with cancer).  View the complaint here.

Teijin Ltd. et al. v. Apotex Inc. et al.
1:13-cv-01851; filed November 6, 2013 in the District Court of Delaware

• Plaintiffs:  Teijin Ltd.; Teijin Pharma Ltd.; Takeda Pharmaceuticals USA Inc.
• Defendants:  Apotex Inc.; Apotex Corp.

Teijin Ltd. et al. v. Sun Pharma Global FZE et al.
1:13-cv-01852; filed November 6, 2013 in the District Court of Delaware

• Plaintiffs:  Teijin Ltd.; Teijin Pharma Ltd.; Takeda Pharmaceuticals USA Inc.
• Defendants:  Sun Pharma Global FZE; Caraco Pharmaceutical Laboratories Ltd.

The complaints in these cases are substantially identical.  Infringement of U.S. Patent No. 6,225,474 ("Polymorphs of 2-(3-cyano-4-isobutyloxyphenyl)-4-methyl-5-thiazolecarboxylic acid and Method of Producing the Same," issued May 1, 2001) following a Paragraph IV certification as part of defendants' filing of an ANDA to manufacture a generic version of Takeda's Uloric® (febuxostat, used for the chronic management of hyperuricemia in patients with gout).  View the Apotex complaint here.

Johns Hopkins University v. 454 Life Sciences Corp.
1:13-cv-01853; filed November 6, 2013 in the District Court of Delaware

Review of the decision of the Board of Patent Appeals and Interferences awarding priority of invention to 454 Life Sciences in the interference between U.S. Patent Application No. 12/361,690 ("Method and Compositions for Detection and Enumeration of Genetic Variations," filed January 29, 2009), assigned to Johns Hopkins and U.S. Patent Application No. 13/033,240 ("Bead Emulsion Nucleic Acid Amplification," filed February 23, 2011), assigned to 454 Life Sciences.  View the complaint here.

Forest Laboratories Inc. et al. v. Sandoz Inc.
1:13-cv-01830; filed November 4, 2013 in the District Court of Delaware

• Plaintiffs:  Forest Laboratories Inc.; Forest Laboratories Holdings Ltd.; Royalty Pharma Collection Trust
• Defendant:  Sandoz Inc.

Infringement of U.S. Patent Nos. 6,602,911 ("Methods of Treating Fibromyalgia," issued August 5, 2003), 7,888,342 ("Methods of Treating Fibromyalgia Syndrome, Chronic Fatigue Syndrome and Pain," issued February 15, 2011), and 7,994,220 ("Milnacipran for the Long-Term Treatment of Fibromyalgia Syndrome," issued August 9, 2011), all licensed to Forest, following a Paragraph IV certification as part of Sandoz's filing of an ANDA to manufacture a generic version of Forest's Savella® (milnacipran hydrochloride, used in the management of fibromyalgia).  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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