Court Report – March 2015

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GavelAbout Court Report:  Every week we’ll report briefly on lately filed biotech and pharma cases.

Shire LLC v. Par Pharmaceutical, Inc. et al.
1:15-cv-01454 filed Feb 25, 2015 within the District Court of Massachusetts

  • Complaintant: Shire LLC
  • Defendants: Componen Pharmaceutical, Corporation. Componen Pharmaceutical Companies, Corporation.

Violation of U.S. Patent Nos. RE42,096 (“Dental Pulsed Dose Drug Delivery System,” issued Feb 1, 2011) and RE41,148 (same title, issued Feb 23, 2010) carrying out a Paragraph IV certification included in Par’s filing of the ANDA to fabricate a normal form of Shire’s Adderall XR? (a mix of dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, and amphetamine sulfate, accustomed to treat attention deficit disorder). See the complaint here.

Cephalon Corporation. v. Sandoz Corporation. et al.

1:15-cv-00178 filed Feb 23, 2015 within the District Court of Delaware

  • Complaintant: Cephalon Corporation.
  • Defendants: Sandoz Corporation. Accord Healthcare Corporation. Intas Pharmaceuticals Limited. InnoPharma Corporation. Agila Specialties Corporation. Onco Therapies Limited Glenmark Pharmaceuticals Limited. Glenmark Generics S.A. USA Eurohealth Worldwide SARL West-Ward Pharmaceutical Corp. Glenmark Generics Limited. Glenmark Generics Corporation USA

Cephalon Corporation. v. Dr Reddy’s Laboratories Limited et al.

1:15-cv-00179 filed Feb 23, 2015 within the District Court of Delaware

  • Complaintant: Cephalon Corporation.
  • Defendants: Dr Reddy’s Laboratories Limited Dr Reddy’s Laboratories Corporation. Emcure Pharmaceuticals Limited. Emcure Pharmaceuticals USA Corporation. Pharmascience Corporation. Hospira Corporation. Breckenridge Pharmaceutical Corporation. Natco Pharma Limited. Hetero Labs Limited. Hetero USA Corporation. Sun Pharmaceutical Industries Limited. Actavis LLC Sagent Pharmaceuticals Corporation. Wockhardt Bio AG Wockhardt Limited. Wockhardt USA LLC Sun Pharma Global FZE

The complaints in these instances are substantially identical. Violation of U.S. Patent Nos. 8,669,279 (“Solid Types of Bendamustine Hydrochloride,” issued March 11, 2014), 8,883,836 (same title, issued November 11, 2014), and eight,895,756 (“Bendamustine Pharmaceutical Compositions,” issued November 25, 2014) carrying out a Paragraph IV certification included in defendants’ filing of the ANDA to fabricate a normal form of Cephalon’s Treanda? (bendamustine hydrochloride, accustomed to treat chronic lymphocytic leukemia and non-Hodgkin’s lymphoma). See the Sandoz complaint here.

Ferring Pharmaceuticals Corporation. et al. v. Componen Pharmaceutical Corporation.

1:15-cv-00173 filed Feb 20, 2015 within the District Court of Delaware

  • Plaintiffs: Ferring Pharmaceuticals Corporation. Ferring Worldwide Center SA
  • Defendant: Componen Pharmaceutical Corporation.

Violation of U.S. Patent Nos. 8,450,338 (“Granular Compositions of Sodium Picosulfate and Potassium Bicarbonate and Uses Thereof,” issued May 28, 2013) and eight,481,083 (“Granular Compositions of Magnesium Oxide and Citric Acidity and Uses Thereof,” issued This summer 9, 2013) carrying out a Paragraph IV certification included in Par’s filing of the ANDA to fabricate a normal form of Ferring’s Prepopik? (sodium picosulfate, magnesium oxide and citric acidity, employed for the cleansing from the colon like a preparation for colonoscopy in grown-ups). See the complaint here.

Fresenius Health Care Holdings, Corporation v. Novel Laboratories, Corporation.

1:15-cv-10472 filed Feb 20, 2015 within the District Court of Massachusetts

Fresenius Health Care Holdings, Corporation. v. Novel Laboratories, Corporation.

3:15-cv-01361 filed Feb 20, 2015 within the District Court of Nj

The complaints in these instances are substantially identical. Violation of U.S. Patent No. 6,576,665 (“Encapsulated Calcium Acetate Caplet along with a Way of Inhibiting Gastrointestinal Phosphorous Absorption,” issued June 10, 2003) carrying out a Paragraph IV certification included in Novel’s filing of the ANDA to fabricate a normal form of Fresenius’ PhosLo? GelCaps (calcium acetate, accustomed to treat kidney failure) and violation of U.S. Patent No. 6,875,445 (“Encapsulated Calcium Acetate Caplet along with a Way of Inhibiting Gastrointestinal Phosphorous Absorption,” issued April 5, 2005) according to Novel’s anticipated manufacture and purchase of their generic PhosLo?. See the D. Mass. complaint here.

Jazz Pharmaceuticals, Corporation. et al. v. Roxane Laboratories, Corporation.

2:15-cv-01360 filed Feb 20, 2015 within the District Court of Nj

  • Plaintiffs: Jazz Pharmaceuticals, Corporation. Jazz Pharmaceuticals Ireland Limited.
  • Defendant: Roxane Laboratories, Corporation.

Violation of U.S. Patent Nos. 8,461,203 (“Microbiologically Seem and Stable Solutions of Gamma-Hydroxybutyrate Salt to treat Narcolepsy,” issued June 11, 2013), 8,772,306 (“Approach to Administration of Gamma Hydroxybutyrate with Monocarboxylate Transporters,” issued This summer 8, 2014), and eight,859,619 (“Microbiologically Seem and Stable Solutions of Gamma-Hydroxybutyrate Salt to treat Narcolepsy,” issued October 14, 2014) carrying out a Paragraph IV certification included in Roxane’s filing of the ANDA to fabricate a normal form of Jazz’s Xyrem? (sodium oxybate, accustomed to treat narcolepsy). See the complaint here.

Cosmo Technologies Limited. et al. v. Actavis Laboratories FL, Corporation.

2:15-cv-01312 filed Feb 19, 2015 within the District Court of Nj

  • Plaintiffs: Cosmo Technologies Limited. Santarus, Corporation.
  • Defendant: Actavis Laboratories FL, Corporation.

Violation of U.S. Patent Nos. 7,410,651 (“Controlled Release and Taste Masking Dental Pharmaceutical Composition,” issued August 12, 2008), 7,431,943 (same title, issued October 7, 2008), 8,293,273 (same title, issued October 23, 2012), 8,784,888 (same title, issued This summer 22, 2014), 8,895,064 (same title, issued November 25, 2014), and RE43,799 (same title, issued November 13, 2012) carrying out a Paragraph IV certification included in Actavis’ filing of the ANDA to fabricate a normal form of Santarus’ Uceris? (budesonide, accustomed to treat mildly to moderately active ulcerative colitis). See the complaint here.

 

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