Court Report - May 2016 #2 (Part II)

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

Amgen Inc. et al. v. Sandoz Inc. et al.
3:16-cv-02581; filed May 12, 2016 in the Northern District of California

• Plaintiffs:  Amgen Inc.; Amgen Manufacturing, Ltd.
• Defendants:  Sandoz Inc.; Sandoz International GmbH; Sandoz GmbH; Lek Pharmaceuticals, d.d.

Infringement of U.S. Patent Nos. 8,940,878 ("Capture Purification Processes for Proteins Expressed in a Non-Mammalian System" issued January 27, 2015) and 5,824,784 ("N-Terminally Chemically Modified Protein Compositions and Methods," issued October 20, 1998) based on Sandoz's filing of an aBLA to market a biosimilar version of Amgen's Neulasta® (pegfilgrastim, used to decrease the incidence of infection in patients receiving myelosuppressive anti-cancer drugs).  View the complaint here.

Rhodes Pharmaceuticals L.P. v. Actavis, Inc. et al.
2:16-cv-02667; filed May 11, 2016 in the District Court of New Jersey

• Plaintiff:  Rhodes Pharmaceuticals L.P.
• Defendants:  Actavis, Inc.; Actavis Elizabeth LLC; Actavis LLC; Allergan PLC

Infringement of U.S. Patent Nos. 6,419,960 ("Controlled Release Formulations Having Rapid Onset and Rapid Decline of Effective Plasma Drug Concentrations," issued July 16, 2002), 7,083,808 ("Controlled/Modified Release Oral Methylphenidate Formulations," issued August 1, 2006), 7,247,318 ("Controlled Release Formulations Having Rapid Onset and Rapid Decline of Effective Plasma Drug Concentrations," issued July 24, 2007), 7,438,930 (same title, issued October 21, 2008), 8,580,310 (same title, issued November 12, 2013), and 9,066,869 (same title, issued June 30, 2015) following a Paragraph IV certification as part of Actavis' filing of an ANDA to manufacture a generic version of Rhodes' Aptensio XR® (methylphenidate hydrochloride extended-release capsules, used for the treatment of Attention Deficit Hyperactivity Disorder (ADHD)).  View the complaint here.

Mylan Institutional LLC et al. v. Aurobindo Pharma Ltd. et al.
2:16-cv-00491; filed May 11, 2016 in the Eastern District of Texas

• Plaintiffs:  Mylan Institutional LLC; Apicore US LLC
• Defendants:  Aurobindo Pharma Ltd.; Aurobindo Pharma USA Inc.; AuroMedics Pharma LLC

Infringement of U.S. Patent Nos. 7,662,992 ("Process for Preparation of Isosulfan Blue," issued February 16, 2010) and 8,969,616 (same title, issued March 3, 2015) based on defendants' filing and approval of an ANDA to manufacture isosulfan blue products.  View the complaint here.

Ajinomoto Co., Inc. et al. v. CJ Cheiljedang Corp. et al.
1:16-cv-03498; filed May 10, 2016 in the Southern District of New York

• Plaintiffs:  Ajinomoto Co., Inc.; Ajinomoto Heartland Inc.
• Defendants:  CJ Cheiljedang Corp.; CJ America, Inc.; PT Cheiljedang Indonesia

Infringement of U.S. Patent Nos. 7,666,655 ("Escherichia Bacteria Transformed with the yddG Gene to Enhance L-Amino Acid Producing Activity," issued February 23, 2010) and 6,180,373 ("Microorganisms for the Production of Tryptophan and Process for the Preparation Thereof," issued January 30, 2001) based on defendants' manufacture and sale of its BestAminoTM feed-grade L-tryptophan product.  View the complaint here.

AstraZeneca LP et al. v. Watson Laboratories Inc.
1:16-cv-00338; filed May 9, 2016 in the District Court of Delaware

• Plaintiffs:  AstraZeneca LP; AstraZeneca AB; AstraZeneca UK Ltd.; AstraZeneca Pharmaceuticals LP
• Defendant:  Watson Laboratories Inc.

Infringement of U.S. Patent Nos. 6,525,060 ("Triazolo(4,5-d)pyrimidine Compounds," issued February 25, 2003), 7,250,419 ("Trisubstituted Triazolopyrimidines for Use in Platelet Aggregation Inhibition," issued July 31, 2007), and 7,265,124 ("Cristalline and Amorphous Form of a Triazolo (4,5-D) Pyridimine Compound," issued September 4, 2007) following a Paragraph IV certification as part of Watson's filing of an ANDA to manufacture a generic version of AstraZeneca's Brilinta® (ticagrelor, used to reduce the rate of cardiovascular death, myocardial infarction, and stroke in patients with acute coronary syndrome or a history of myocardial infarction).  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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