Court Report - September 2014 #6

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

Cadence Pharmaceuticals Inc. et al. v. InnoPharma Licensing LLC et al.
1:14-cv-01225; filed September 24, 2014 in the District Court of Delaware

• Plaintiffs:  Cadence Pharmaceuticals Inc.; SCR Pharmatop; Mallinckrodt IP
• Defendants:  InnoPharma Licensing LLC; InnoPharma Inc.

Infringement of U.S. Patent Nos. 6,028,222 ("Stable Liquid Paracetamol Compositions, and Method for Preparing the Same," issued February 22, 2000) and 6,992,218 ("Method for Obtaining Aqueous Formulations of Oxidation-Sensitive Active Principles," issued January 31, 2006), both licensed to Cadence, following a Paragraph IV certification as part of InnoPharma's filing of an NDA (under § 505(b)(2) of the Food, Drug and Cosmetic Act) to manufacture a generic version of Cadence's Ofirmev® (acetaminophen injection, used for the management of mild to moderate pain, the management of moderate to severe pain with adjunctive opioid analgesics, and the reduction of fevers).  View the complaint here.

Purdue Pharma L.P. v. Watson Laboratories Inc. et al.
1:14-cv-01227; filed September 24, 2014 in the District Court of Delaware

• Plaintiff:  Purdue Pharma L.P.
• Defendants:  Watson Laboratories Inc.; Actavis Laboratories UT Inc.; Actavis plc

Infringement of U.S. Patent Nos. RE41,408 ("Method of Providing Sustained Analgesia with Buprenorphine," issued June 29, 2010), RE41,489 (same title, issued August 10, 2010), and RE41,571 (same title, issued August 24, 2010) following a Paragraph IV certification as part of Watson's filing of an ANDA to manufacture a generic version of Purdue Pharma's Butrans® (buprenorphine transdermal, used for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate).  View the complaint here.

Genzyme Corp. et al. v. Emcure Pharmaceuticals USA, Inc. et al.
1:14-cv-05975; filed September 24, 2014 in the District Court of New Jersey

• Plaintiffs:  Genzyme Corp.; Southern Research Institute; Sanofi-Aventis U.S. LLC
• Defendants:  Emcure Pharmaceuticals USA, Inc.; Emcure Pharmaceuticals 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 Emcure'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.

AstraZeneca Pharmaceuticals LP et al. v. Sagent Pharmaceuticals, Inc.
1:14-cv-07358; filed September 22, 2014 in the Northern District of Illinois

• Plaintiffs:  AstraZeneca Pharmaceuticals LP; AstraZeneca UK Ltd.; AstraZeneca AB
• Defendant:  Sagent Pharmaceuticals, Inc.

Infringement of U.S. Patent Nos. 6,774,122 ("Formulation," issued August 10, 2004), 7,456,160 (same title, issued November 25, 2008), 8,329,680 (same title, issued December 11, 2012), and 8,466,139 (same title, issued June 18, 2013) following a Paragraph IV certification as part of Sagent's filing of an ANDA to manufacture a generic version of AstraZeneca's Faslodex® (fulvestrant injection, used to treat hormone receptor positive metastatic breast cancer in postmenopausal women with disease progression following antiestrogen therapy).  View the complaint here.

Reckitt Benckiser Pharmaceuticals, Inc. et al. v. BioDelivery Sciences International, Inc. et al.
3:14-cv-05892; filed September 22, 2014 in the District Court of New Jersey

• Plaintiffs:  Reckitt Benckiser Pharmaceuticals, Inc.; Monosol Rx, LLC
• Defendants:  Biodelivery Sciences International, Inc.; Quintiles Commercial US, Inc.

Infringement of U.S. Patent No. 8,765,167 ("Uniform Films for Rapid-dissolve Dosage Form Incorporating Anti-tacking Compositions," issued July 1, 2014), licensed to Reckitt Benckiser, based on BDSI's manufacture, use, sale, and offer for sale of its Bunavail® product (buprenorphine hydrochloride and naloxone hydrochloride dehydrate mucoadhesive buccal film).  View the complaint here.

BioDelivery Sciences International, Inc. v. Reckitt Benckiser Pharmaceuticals, Inc. et al.
5:14-cv-00529; filed September 20, 2014 in the Eastern District of North Carolina

• Plaintiff:  BioDelivery Sciences International, Inc.
• Defendants:  Reckitt Benckiser Pharmaceuticals, Inc.; RB Pharmaceuticals Ltd.; MonoSol Rx, LLC

Declaratory judgment of non-infringement and invalidity of U.S. Patent Nos. 8,475,832 ("Sublingual and Buccal Film Compositions," issued July 2, 2013), 7,897,080 ("Polyethylene-Oxide Based Films and Drug Delivery Systems Made Therefrom," issued March 1, 2011), and 8,652,378 ("Uniform Films for Rapid Dissolve Dosage Form Incorporating Taste-Masking Compositions," issued February 18, 2014) based on BDSI's anticipated launch of its Bunavail® product (buprenorphine hydrochloride and naloxone hydrochloride dehydrate mucoadhesive buccal film).  View the complaint here.

Otsuka Pharmaceutical Co., Ltd. v. Ajanta Pharma Ltd. et al.
1:14-cv-05876; filed September 19, 2014 in the District Court of New Jersey

• Plaintiff:  Otsuka Pharmaceutical Co., Ltd.
• Defendants:  Ajanta Pharma Ltd.; Ajanta Pharma USA Inc.

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), and 8,642,760 (same title, issued February 4, 2014) following a Paragraph IV certification as part of Ajanta'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.

Otsuka Pharmaceutical Co., Ltd. v. Teva Pharmaceuticals USA, Inc. et al.
1:14-cv-05878; filed September 19, 2014 in the District Court of New Jersey

• Plaintiff:  Otsuka Pharmaceutical Co., Ltd.
• Defendants:  Teva Pharmaceuticals USA, Inc.; Teva Pharmaceutical Industries Ltd.

Infringement of U.S. Patent Nos. 8,580,796 (same title, issued November 12, 2013) and 8,642,760 (same title, issued February 4, 2014) following a Paragraph IV certification as part of Teva'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.

Jazz Pharmaceuticals, Inc. v. Par Pharmaceutical, Inc.
2:14-cv-05824; filed September 18, 2014 in the District Court of New Jersey

Infringement of U.S. Patent No. 8,772,306 ("Method of Administration of Gamma Hydroxybutyrate with Monocarboxylate Transporters," issued July 8, 2014) following a Paragraph IV certification as part of Par's filing of an ANDA to manufacture a generic version of Jazz's Xyrem® (sodium oxybate, used to treat narcolepsy).  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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