Court Report

        By Sherri Oslick --

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

Pfizer Inc. et al. v. Apotex Inc. et al.
1:13-cv-01613; filed September 25, 2013 in the District Court of Delaware

• Plaintiffs:  Pfizer Inc.; Wyeth LLC; Pfizer Pharmaceuticals LLC; PF Prism C.V.; Pfizer Manufacturing Holdings LLC
• Defendants:  Apotex Inc.; Apotex Corp.

Infringement of U.S. Patent No. 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 Apotex's 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.

Merck Sharp & Dohme Corp. et al. v. Ben Venue Laboratories Inc.
1:13-cv-01611; filed September 25, 2013 in the District Court of Delaware

• Plaintiffs:  Merck Sharp & Dohme Corp.; Millennium Pharmaceuticals Inc.
• Defendant:  Ben Venue Laboratories Inc.

Infringement of U.S. Patent Nos. 5,807,825 ("Platelet Aggregation Inhibitors," issued September 15, 1998), 5,747,447 ("Stable Polypeptide Composition," issued May 5, 1998) and 5,968,902 ("Platelet Aggregation Inhibitors," issued October 19, 1999), licensed to Merck, following a Paragraph IV certification as part of Ben Venue's filing of an ANDA to manufacture a generic version of Merck's Integrilin® (eptifibatide injection, used to treat acute coronary syndrome).  View the complaint here.

Helsinn Healthcare SA et al. v. Ben Venue Laboratories Inc.
1:13-cv-01612; filed September 25, 2013 in the District Court of Delaware

• Plaintiffs:  Helsinn Healthcare SA; Roche Palo Alto LLC
• Defendant:  Ben Venue Laboratories Inc.

Infringement of U.S. Patent Nos. 7,947,724 ("Liquid Pharmaceutical Formulations of Palonosetron," issued May 24, 2011), 7,947,725 (same title, issued May 24, 2011), and 7,960,424 (same title, issued June 14, 2011) following a Paragraph IV certification as part of Ben Venue's filing of an ANDA to manufacture a generic version of Helsinn's Aloxi® (palonosetron hydrochloride intravenous solution, used to prevent chemotherapy induced nausea and vomiting).  View the complaint here.

Cornerstone Therapeutics, Inc. et al. v. Sandoz Inc.
1:13-cv-05723; filed September 25, 2013 in the District Court of New Jersey

• Plaintiffs:  Cornerstone Therapeutics, Inc.; Cornerstone Biopharma, Inc.; EKR Therapeutics, LLC
• Defendant:  Sandoz Inc.

Infringement of U.S. Patent Nos. 7,612,102 ("Pre-mixed, Ready-to-Use Pharmaceutical Compositions," issued November 3, 2009), 7,659,291 ("Methods of Treatment with Pre-Mixed, Ready-to-Use Pharmaceutical Compositions," issued February 9, 2010), 8,455,524 (same title, issued June 4, 2013), and 7,659,290 ("Methods of Preparing Pre-Mixed, Ready-to-Use Pharmaceutical Compositions," issued February 9, 2010) following a Paragraph IV certification as part of Sandoz's filing of an ANDA to manufacture a generic version of EKR's Cardene® I.V. Premixed Injection (nicardipine hydrochloride premixed injection for intravenous administration, used for the short-term treatment of hypertension when oral therapy is not feasible or not desirable).  View the complaint here.

Forest Laboratories Inc. et al. v. Apotex Corp. et al.
1:13-cv-01602; filed September 23, 2013 in the District Court of Delaware

• Plaintiffs:  Forest Laboratories Inc.; Forest Laboratories Holdings Ltd.; Royalty Pharma Collection Trust
• Defendants:  Apotex Corp.; Apotex Inc.

Forest Laboratories Inc. et al. v. Hetero USA Inc. et al.
1:13-cv-01603; filed September 23, 2013 in the District Court of Delaware

• Plaintiffs:  Forest Laboratories Inc.; Forest Laboratories Holdings Ltd.; Royalty Pharma Collection Trust
• Defendants:  Hetero USA Inc.; Hetero Labs Ltd. Unit V; Hetero Labs Ltd.

Forest Laboratories Inc. et al. v. Lupin Limited et al.
1:13-cv-01604; filed September 23, 2013 in the District Court of Delaware

• Plaintiffs:  Forest Laboratories Inc.; Forest Laboratories Holdings Ltd.; Royalty Pharma Collection Trust
• Defendants:  Lupin Ltd.; Lupin Pharmaceuticals Inc.

Forest Laboratories Inc. et al. v. Mylan Inc. et al.
1:13-cv-01605; filed September 23, 2013 in the District Court of Delaware

• Plaintiffs:  Forest Laboratories Inc.; Forest Laboratories Holdings Ltd.; Royalty Pharma Collection Trust
• Defendants:  Mylan Inc.; Mylan Pharmaceuticals Inc.

Forest Laboratories Inc. et al. v. Par Pharmaceutical Inc.
1:13-cv-01606; filed September 23, 2013 in the District Court of Delaware

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

Forest Laboratories Inc. et al. v Ranbaxy Inc. et al.
1:13-cv-01607; filed September 23, 2013 in the District Court of Delaware

• Plaintiffs:  Forest Laboratories Inc.; Forest Laboratories Holdings Ltd.; Royalty Pharma Collection Trust
• Defendants:  Ranbaxy Inc.; Ranbaxy Laboratories Ltd.

The complaints in these cases are substantially identical.  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 defendants' filing of an ANDA to manufacture a generic version of Forest's Savella® (milnacipran hydrochloride, used in the management of fibromyalgia).  View the Apotex complaint here.

Counsyl, Inc v. Myriad Genetics, Inc.
3:13-cv-04391; filed September 20, 2013 in the Northern District of California

Declaratory judgment of noninfringement and invalidity of U.S. Patent Nos. 5,709,999 ("Linked Breast and Ovarian Cancer Susceptibility Gene," issued January 20, 1998), 5,747,282 ("17-Q-Linked Breast and Ovarian Cancer Susceptibility Gene," issued May 5, 1998), 5,753,441 (same title, issued May 19, 1998), 6,951,721 ("Method for Determining the Haplotype of a Human BRCA1 Gene," issued October 4, 2005), 7,250,497 ("Large Deletions in Human BRCA1 Gene and Use Thereof," issued July 31, 2007), 5,837,492 ("Chromosome 13-Linked Breast Cancer Susceptibility Gene," issued November 17, 1998), 6,033,857 (same title, issued March 7, 2000), and 6,051,379 ("Cancer Susceptibility Mutations of BRCA2," issued April 18, 2000) based on Counsyl's development and anticipated launch of genetic tests and related services related to sequencing and analysis of BRCAI and BRCA2 genes.  View the complaint here.

Senju Pharmaceutical Co. et al. v. Sandoz Inc.
1:13-cv-06608; filed September 18, 2013 in the Southern District of New York

• Plaintiffs:  Senju Pharmaceutical Co.; Bausch & Lomb, Inc.; Bausch & Lomb Pharma Holdings Corp.
• Defendant:  Sandoz Inc.

Infringement of U.S. Patent Nos. 6,335,335 ("Prolonged-Action Eye Drop," issued January 1, 2002) and 6,645,963 (same title, issued November 11, 2003) following a Paragraph IV certification as part of Sandoz's filing of an ANDA to manufacture a generic version of Senju's Istalol® (timolol maleate ophthalmic solution, 0.5%, used treat elevated intraocular pressure in patients with ocular hypertension or open-angle glaucoma).  View the complaint here.

AbbVie Inc. et al. v. Hikma Pharmaceutical Co Ltd. et al.
1:13-cv-01557; filed September 13, 2013 in the District Court of Delaware

• Plaintiffs:  AbbVie Inc.; Wisconsin Alumni Research Foundation
• Defendants:  Hikma Pharmaceutical Co Ltd.; West-Ward Pharmaceuticals Corp.; Exela Pharma Sciences LLC

Infringement of U.S. Patent No. 5,597,815 ("Prevention of Hyperphosphatemia in Kidney Disorder Patients," issued January 28, 1997) following a Paragraph IV certification as part of defendants' filing of an NDA (under § 505(b)(2) of the Food, Drug and Cosmetic Act) to manufacture a generic version of AbbVie's Zemplar® (paricalcitol, used to treat secondary hyperparathyroidism in patients with kidney failure).  View the complaint here.

Eli Lilly and Co. v. Sun Pharmaceutical Industries Ltd. et al.
1:13-cv-01469; filed September 13, 2013 in the Southern District of Indiana

• Plaintiff:  Eli Lilly and Co.
• Defendants:  Sun Pharmaceutical Industries Ltd.; Sun Pharma Global FZE

Infringement of U.S. Patent No. 7,772,209 ("Novel Antifolate Combination Therapies," issued August 10, 2010) following a Paragraph IV certification as part of Sun's filing of an ANDA to manufacture a generic version of Lilly's Alimta® (pemetrexed for injection, used to treat malignant pleural mesothelioma and locally advanced or metastatic non-small cell lung cancer).  View the complaint here.

Jazz Pharmaceuticals, Inc. v. Amneal Pharmaceuticals, LLC
2:13-cv-05450; filed September 12, 2013 in the District Court of New Jersey

Infringement of U.S. Patent Nos. 8,457,988 ("Sensitive Drug Distribution System and and Method," issued June 4, 0213) and 8,461,203 ("Microbiologically Sound and Stable Solutions of Gamma-Hydroxybutyrate Salt for the Treatment of Narcolepsy," issued June 11, 2013) following a Paragraph IV certification as part of Amneal's filing of an ANDA to manufacture a generic version of Jazz's Xyrem® (sodium oxybate, used to treat narcolepsy).  View the complaint here.

Merck, Sharp & Dohme Corp. et al. v. Aurobindo Pharma Ltd. et al.
1:13-cv-05442; filed September 11, 2013 in the District Court of New Jersey

• Plaintiffs:  Merck, Sharp & Dohme Corp.; Bristol-Myers Squibb Co.; Bristol-Myers Squibb Pharma Co.
• Defendants:  Aurobindo Pharma Ltd.; Aurobindo Pharma USA, Inc.

Infringement of U.S. Patent Nos. 6,639,071 ("Crystal Forms of (-)-6-chloro-4-cyclopropylethynyl-4-trifluoromethyl-1,4-dihydro-2H-3,1-benzoxazin-2-one," issued October 28, 2003), 6,939,964 (same title, issued September 6, 2005), and 6,673,372 ("Crystalline Efavirenz," issued January 6, 2004) following a Paragraph IV certification as part of Aurobindo's filing of an ANDA to manufacture a generic version of BMS' Sustiva® (efavirenz, used to treat HIV infection).  View the complaint here.