Court Report -- Part III

by McDonnell Boehnen Hulbert & Berghoff LLP
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Gavel About Court Report:  Each week we will report briefly on recently filed biotech and pharma cases.

Cubist Pharmaceuticals Inc. v. Fresenius Kabi USA LLC
1:14-cv-00914; filed July 11, 2014 in the District Court of Delaware

Infringement of U.S. Patent Nos. 6,468,967 ("Methods for Administration of Antibiotics," issued October 22, 2002), 6,852,689 (same title, issued February 8, 2005), 8,058,238 ("High Purity Lipopeptides," issued November 15, 2011), and 8,129,342 (same title, issued March 6, 2012) following a Paragraph IV certification as part of Fresenius' filing of an ANDA to manufacture a generic version of Cubist's Cubicin® (daptomycin for injection, used for the treatment of skin infections caused by certain Gram-positive microorganisms).  View the complaint here.

Merck Sharp & Dohme Corp. v. Hospira Inc.
1:14-cv-00915; filed July 11, 2014 in the District Court of Delaware

Merck Sharp & Dohme Corp. v. Sandoz Inc.
1:14-cv-00916; filed July 11, 2014 in the District Court of Delaware

The complaints in these cases are substantially identical.  Infringement of U.S. Patent No. 5,952,323 ("Carbapenem Antibiotic," issued September 14, 1999) following a Paragraph IV certification as part of defendants' filing of an ANDA to manufacture a generic version of Merck's Invanz® (ertapenem, used for the treatment of complicated intra-abdominal infections, complicated skin and skin structure infections, community acquired pneumonia, complicated urinary tract infections, and acute pelvic infections, and for the prophylaxis ofvsurgical site infection following elective colorectal surgery).  View the Hospira complaint here.

Acorda Therapeutics Inc. et al. v. Alkem Laboratories Ltd. et al.
1:14-cv-00917; filed July 11, 2014 in the District Court of Delaware

• Plaintiffs:  Acorda Therapeutics Inc.; Alkermes Pharma Ireland Ltd.
• Defendants:  Alkem Laboratories Ltd.; Ascend Laboratories LLC

Acorda Therapeutics Inc. et al. v. Aurobindo Pharma Ltd. et al.
1:14-cv-00909; filed July 10, 2014 in the District Court of Delaware

• Plaintiffs:  Acorda Therapeutics Inc.; Alkermes Pharma Ireland Ltd.
• Defendants:  Aurobindo Pharma Ltd.; Aurobindo Pharma USA Inc.

The complaints in these cases are substantially identical.  Infringement of U.S. Patent Nos. 5,540,938 ("Formulations and Their Use in the Treatment of Neurological Diseases," issued July 30, 1996), 8,007,826 ("Sustained Release Aminopyridine Composition," issued August 30, 2011), 8,354,437 ("Method of Using Sustained Release Aminopyridine Compositions," issued January 15, 2013), 8,440,703 (same title, issued May 14, 2013), and 8,663,685 ("Sustained Release Aminopyridine Composition," issued March 4, 2014) following a Paragraph IV certification as part of defendants' filing of an ANDA to manufacture a generic version of Acorda's Ampyra® (dalfampridine extended release, used to improve walking in patients with multiple sclerosis).  View the Aurobindo complaint here.

Luitpold Pharmaceuticals, Inc. v. Apotex Corp. et al.
2:14-cv-04409; filed July 11, 2014 in the District Court of New Jersey

• Plaintiff:  Luitpold Pharmaceuticals, Inc.
• Defendants:  Apotex Corp.; Apotex Inc.; Recordati Ireland Ltd.

Infringement of U.S. Patent No. 6,333,044 ("Therapeutic compositions for intranasal administration which include KETOROLAC®," issued December 25, 2001) following a Paragraph IV certification as part of Apotex's filing of an ANDA to manufacture a generic version of Luitpold's Sprix® (ketorolac tromethamine nasal spray, used for the management of moderate to moderately severe pain that requires analgesia at the opioid level).  View the complaint here.

Duchesnay Inc. et al. v. Actavis Laboratories FL, Inc. et al.
2:14-cv-04384; filed July 11, 2014 in the District Court of New Jersey

• Plaintiffs:  Duchesnay Inc.; Duchesnay USA Inc.
• Defendants:  Actavis Laboratories FL, Inc.; Actavis, Inc.; Actavis Pharma, Inc.

Infringement of U.S. Patent No. 6,340,695 ("Rapid Onset Formulation," issued January 22, 2002) following a Paragraph IV certification as part of Actavis' filing of an ANDA to manufacture a generic version of Duchesnay's Diclegis® (doxylamine succinate and pyridoxine hydrochloride delayed-release tablets, used for the treatment of nausea and vomiting of pregnancy in women who do not respond to conservative management).  View the complaint here.

Otsuka Pharmaceutical Co., Ltd. v. Mylan Inc. et al.
1:14-cv-04508; filed July 11, 2014 in the District Court of New Jersey

• Plaintiff:  Otsuka Pharmaceutical Co., Ltd.
• Defendants:  Mylan Inc.; Mylan Pharmaceuticals Inc.; Mylan Laboratories Ltd.

Infringement of U.S. Patent Nos. 8,017,615 ("Low Hygroscopic Aripiprazole Drug Substance and Process for the Preparation Thereof," issued September 13, 2011), 8,580,796 (same title, issued November 12, 2013), 8,642,760 (same title, issued February 4, 2014), 7,053,092 ("5-HT1A Receptor Subtype Agonist," issued May 30, 2006), and 8,642,600 ("Method of Treating Autism," issued February 4, 2014) following a Paragraph IV certification as part of Mylan's filing of an ANDA to manufacture a generic version of Otsuka's Abilify® (aripiprazole, used to treat bipolar disorder and schizophrenia).  View the complaint here.

Merck Sharp & Dohme Corp. v. Fresenius Kabi USA LLC
1:14-cv-00905; filed July 9, 2014 in the District Court of Delaware

Infringement of U.S. Patent No. 5,691,336 ("Morpholine Compounds Are Prodrugs Useful As Tachykinin Receptor Antagonists," issued November 25, 1997) following a Paragraph IV certification as part of Fresenius' filing of an ANDA to manufacture a generic version of Merck's Emend® (fosaprepitant dimeglumine for injection, used in the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy including high-dose cisplatin, and to prevent nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy).  View the complaint here.

Alza Corp. v. Pack Pharmaceuticals, LLC
2:14-cv-04327; filed July 9, 2014 in the District Court of New Jersey

Infringement of U.S. Patent No. RE44,459 ("Method For Lowering Blood Glucose," reissued August 27, 2013), licensed to Pfizer, following a Paragraph IV certification as part of Pack's filing of an ANDA to manufacture a generic version of Pfizer's Glucotrol XL® (glipizide extended release tablets, used to improve glycemic control in adults with type 2 diabetes mellitus).  View the complaint here.

Takeda Pharmaceutical Co. Ltd. et al. v. Sun Pharma Global FZE et al.
3:14-cv-04616; filed July 9, 2014 in the District Court of New Jersey

• Plaintiffs:  Takeda Pharmaceutical Co. Ltd.; Takeda Pharmaceuticals U.S.A., Inc.; Takeda Pharmaceuticals America, Inc.
• Defendants:  Sun Pharma Global FZE; Sun Pharmaceutical Industries, Ltd.; Caraco Pharmaceutical Laboratories, Ltd.

Infringement of U.S. Patent Nos. 6,328,994 ("Orally Disintegrable Tablets," issued December 11, 2001), 7,431,942 ("Orally Disintegrable Tablets," issued October 7, 2008), 7,399,485 ("Rapidly Disintegrable Solid Preparation," issued July 15, 2008), and 7,875,292 ("Orally Disintegrable Tablets," issued January 25, 2011) following a Paragraph IV certification as part of Sun's filing of an ANDA to manufacture a generic version of plaintiffs' Prevacid® SoluTab (lansoprazole delayed release orally disintegrating tablets, used to treat ulcers, gastroesophageal reflux disease, erosive esophagitis, and pathological hypersecretory conditions, including Zollinger-Ellison syndrome).  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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