Court Report – September 2014 #5

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

Reckitt Benckiser LLC v. Aurobindo Pharma Ltd. et al.
1:14-cv-01203; filed September 17, 2014 in the District Court of Delaware

• Plaintiff:  Reckitt Benckiser LLC
• Defendants:  Aurobindo Pharma Ltd.; Aurobindo Pharma USA Inc.

Infringement of U.S. Patent Nos. 6,372,252 (“Guaifenesin Sustained Release Formulation and Tablets,” issued April 16, 2002), 6,955,821 (“Sustained Release Formulations of Guaifenesin and Additional Drug Ingredients,” issued October 18, 2005), and 7,838,032 (“Sustained Release of Guaifenesin,” issued November 23, 2010 following a Paragraph IV certification as part of Aurobindo’s filing of an ANDA to manufacture a generic version of plaintiff’s Mucinex® and Mucinex® DM (guaifenesin, and guaifenesin/dextromethorphan, respectively, used to treat chest congestion).  View the complaint here.

Novartis Pharmaceuticals Corp. et al. v. Roxane Laboratories, Inc. et al.
2:14-cv-01602; filed September 17, 2014 in the Southern District of Ohio

• Plaintiffs:  Novartis Pharmaceuticals Corp.; Novartis AG
• Defendants:  Roxane Laboratories Inc.; Boehringer Ingelheim Roxane Inc.

Novartis Pharmaceuticals Corp. et al. v. Roxane Laboratories Inc. et al.
1:14-cv-01196; filed September 16, 2014 in the District Court of Delaware

• Plaintiffs:  Novartis Pharmaceuticals Corp.; Novartis AG
• Defendants:  Roxane Laboratories Inc.; Boehringer Ingelheim Roxane Inc.

The complaints in these cases are substantially identical.  Infringement of U.S. Patent Nos. 5,665,772 (“O-alkylated Rapamycin Derivatives and Their Use, Particularly as Immunosuppressants,” issued September 9, 1997), 6,004,973 (“Pharmaceutical Compositions Comprising Rafamycin Coprecipitates,” issued December 21, 1999), 6,239,124 (“Pharmaceutical Compositions for the Treatment of Transplant Rejection or Autoimmune or Inflammatory Conditions Comprising Cyclosporin A and 40-0-(2-hydroxyethyl)-rapamycin,” issued May 29, 2001), and 6,455,518 (“Pharmaceutical Compositions for the Treatment of Transplant Rejection, Autoimmune or Inflammatory Conditions Comprising Cyclosporin A and 40-O-(2-hydroxyethyl)-rapamycin,” issued September 24, 2002) following a Paragraph IV certification as part of Roxane’s filing of an ANDA to manufacture a generic version of Novartis’ Zortress® (everolimus, used for the prophylaxis of organ rejection in adult patients at low-moderate immunologic risk receiving a kidney transplant, and for the prophylaxis of allograft rejection in adult patients receiving a liver transplant).  View the Delaware complaint here.

Genetic Technologies Ltd. v. Ambry Genetics Corp. et al.
8:14-cv-01475; filed September 12, 2014 in the Central District of California

• Plaintiff:  Genetic Technologies Ltd.
• Defendants:  Ambry Genetics Corp.; DOES

Infringement of U.S. Patent No. 5,612,179 (“Intron Sequence Analysis Method for Detection of Adjacent Locus Alleles as Haplotypes,” issued March 18, 1997) based on Ambry’s provision of genetic disorder testing, including for cystic fibrosis.  View the complaint here.

Celgene Corp. et al. v. InnoPharma Inc.
1:14-cv-01188; filed September 12, 2014 in the District Court of Delaware

• Plaintiffs:  Celgene Corp.; Astellas Pharma Inc.
• Defendant:  InnoPharma Inc.

Infringement of U.S. Patent Nos. 7,608,280 (“Method of Producing FR901228,” issued October 27, 2009) and 7,611,724 (same title, issued November 3, 2009) following a Paragraph IV certification as part of InnoPharma’s filing of an ANDA to manufacture a generic version of Celgene’s Istodax® (romidepsin for injection, used to treatment of peripheral and cutaneous T-cell lymphoma).  View the complaint here.

Shire LLC v. Corepharma, LLC
2:14-cv-05694; filed September 12, 2014 in the District Court of New Jersey

Infringement of U.S. Patent Nos. RE42,096 (“Oral Pulsed Dose Drug Delivery System,” issued February 1, 2011) and RE41,148 (same title, issued February 23, 2010) following a Paragraph IV certification as part of Corepharma’s filing of an ANDA to manufacture a generic version of Shire’s Adderall XR® (a combination of dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, and amphetamine sulfate, used to treat attention deficit hyperactivity disorder).  View the complaint here.

Teva Pharmaceuticals USA, Inc. et al. v. Doctor Reddy’s Laboratories, Ltd. et al.
3:14-cv-05672; filed September 11, 2014 in the District Court of New Jersey

• Plaintiffs:  Teva Pharmaceuticals USA, Inc.; Teva Pharmaceutical Industries Ltd.; Teva Neuroscience, Inc.; Yeda Research and Development Co., Ltd.
• Defendants:  Doctor Reddy’s Laboratories, Ltd.; Doctor Reddy’s Laboratories, Inc.; Sandoz, Inc.; Momenta Pharmaceuticals, Inc.

Infringement of U.S. Patent Nos. 8,232,250 (“Low Frequency Glatiramer AcetateTherapy,” issued July 31, 2012) and 8,399,413 (same title, issued March 19, 2013) following a Paragraph IV certification as part of defendants’ filing of an ANDA to manufacture a generic version of Teva’s Copaxone® (glatiramer acetate injection, used for the reduction or frequency of relapses in patients with relapsing-remitting multiple sclerosis).  View the complaint here.