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

Amgen Inc. et al. v. Apotex Inc. et al.
0:15-cv-61631; filed August 6, 2015 in the Southern District of Florida

• Plaintiffs:  Amgen Inc.; Amgen Manufacturing Ltd.
• Defendants:  Apotex Inc.; Apotex Corp.

Infringement of U.S. Patent Nos. 8,952,138 ("Refolding Proteins Using a Chemically Controlled Redox State," issued February 10, 2015) and 5,824,784 ("N-Terminally Chemically Modified Protein Compositions and Methods," issued October 20, 1998) based on Apotex's filing of a BLA 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.

Purdue Pharma, L.P. et al. v. Collegium Pharmaceutical, Inc.
1:15-cv-13099; filed August 6, 2015 in the District Court of Massachusetts

• Plaintiffs:  Purdue Pharma, L.P.; The P.F. Laboratories Inc.; Purdue Pharmaceuticals L.P.; Rhodes Technologies
• Defendant:  Collegium Pharmaceutical, Inc.

Infringement of U.S. Patent Nos. 7,674,799 ("Oxycodone Hydrochloride Having Less Than 25 PPM 14-Hydroxycodeinone," issued March 9, 2010), 7,674,800 (same title, issued March 9, 2010), and 7,683,072 (same title, issued March 23, 2010) following a Paragraph IV certification as part of Collegium's filing of an NDA (under § 505(b)(2) of the Food, Drug and Cosmetic Act) to manufacture its Xtampza ER product (oxycodone myristate), comparable to Purdue Pharma's OxyContin® (controlled release oxycodone hydrochloride, used to treat pain).   Also, infringement of U.S. Patent No. 8,652,497 ("Pharmaceutical Formulation Containing Irritant," issued February 18, 2014) based on Collegium's filing of its Xtampza ER NDA.  View the complaint here.

Purdue Pharmaceuticals Products L.P. et al. v. Lannett Holdings, Inc. et al.
2:15-cv-06036; filed August 6, 2015 in the District Court of New Jersey

• Plaintiffs:  Purdue Pharmaceuticals Products L.P.; Purdue Pharma L.P.; Purdue Pharma Technologies Inc.
• Defendants:  Lannett Holdings, Inc.; Lannett Co., Inc.

Infringement of U.S. Patent No. 6,589,960 ("Hydromorphone And Hydrocodone Compositions And Methods For Their Synthesis," issued July 8, 2003) following a Paragraph IV certification as part of Lannett's filing of an ANDA to manufacture a generic version of Purdue Pharma's Dilaudid® (hydromorphone hydrochloride for injection, used to treat moderate to severe pain).  View the complaint here.

AstraZeneca Pharmaceuticals LP et al. v. Agila Specialties, Inc et al.
1:15-cv-06039; filed August 6, 2015 in the District Court of New Jersey

• Plaintiffs:  AstraZeneca Pharmaceuticals LP; AstraZeneca UK Ltd.; AstraZeneca AB
• Defendants:  Agila Specialties, Inc; Onco Therapies Ltd.; Mylan Laboratories Ltd.; Mylan Inc.; Mylan 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 Agila'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.

Merck Sharp & Dohme Corp. v. Actavis Laboratories FL, Inc. et al.
3:15-cv-06075; filed August 6, 2015 in the District Court of New Jersey

• Plaintiff:  Merck Sharp & Dohme Corp.
• Defendants:  Actavis Laboratories FL, Inc.; Andrx Corp.; Andrx Corp.; Actavis, Inc.

Infringement of U.S. Patent No. 5,661,151 ("Tetrahydrofuran Antifungals," issued August 26, 1997), following a Paragraph IV certification as part of Actavis' filing of an ANDA to manufacture a generic version of Merck's Noxafil® (posaconazole, used in the prophylaxis of fungal infections in immunocompromised patients, and in the treatment of oropharyngeal candidiasis).  View the complaint here.

Collegium Pharmaceutical Inc. v. Purdue Pharma L.P. et al.
1:15-cv-06179; filed August 6, 2015 in the Southern District of New York

• Plaintiff:  Collegium Pharmaceutical Inc.
• Defendants:  Purdue Pharma L.P.; The P.F. Laboratories, Inc.; Purdue Pharmaceuticals L.P.; Rhodes Technologies

Declaratory judgment of non-infringement and invalidity of U.S. Patent Nos. 7,674,799 ("Oxycodone Hydrochloride Having Less Than 25 PPM 14-Hydroxycodeinone," issued March 9, 2010), 7,674,800 (same title, issued March 9, 2010), and 7,683,072 (same title, issued March 23, 2010) following a Paragraph IV certification as part of Collegium's filing of an NDA (under § 505(b)(2) of the Food, Drug and Cosmetic Act) to manufacture its Xtampza ER product (oxycodone myristate).  View the complaint here.  [NB: The complaint was later voluntarily dismissed.]