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Otsuka Pharmaceutical

Deal Watch: Teva Signs Agreement with Otsuka for Exclusive Rights to Migraine Antibody in Japan

by Goodwin on

Otsuka announced today that it has agreed to pay Teva $50 million and later milestone payments for the exclusive rights to develop and commercialize Fremanezumab in Japan. Fremanezumab, which targets the calcitonin...more

FDA's 'Active Moiety' Interpretation of the Three-Year Clinical Investigation Exclusivity

by Pepper Hamilton LLP on

The court found that a different interpretation could result in marketing exclusivity for the original innovator drug in perpetuity. In Otsuka Pharmaceutical Co. v. Burwell, the U.S. District Court for the District of...more

Otsuka Phama. Co., Ltd. v. Zydus Pharms. USA, Inc., et al.

by Robins Kaplan LLP on

Case Name: Otsuka Phama. Co., Ltd. v. Zydus Pharms. USA, Inc., et al., Civil Action Nos. 14-3168 (JBS/KMW), 2016 U.S. Dist. LEXIS 48689 (D.N.J. Apr. 12, 2016) (Simandle, C.J.) - Drug Product and Patent(s)-in-Suit:...more

Middle District of Louisiana Gets it Wrong: A Different Product is not an “Alternative Design”

by Reed Smith on

Over the Fourth of July weekend, we in the Philadelphia area learned that 120 of the “new, state-of-the-art” trains in our regional commuter rail system were being pulled out of service. Someone noticed that the trains were...more

A Brand Must Allege Facts to Survive a Motion to Dismiss Induced Infringement Claims - Otsuka Pharmaceutical Co., Ltd. v. Zydus...

by McDermott Will & Emery on

Addressing the pleading standard for induced infringement, the U.S. District Court for the District of New Jersey dismissed Otsuka Pharmaceutical’s claims finding that a formulaic recitation of the legal standard without...more

Court Report - January 2016 #4

About Court Report: Each week we will report briefly on recently filed biotech and pharma cases. Purdue Pharma L.P. et al. v. Amneal Pharmaceuticals LLC 1:15-cv-00831; filed September 17, 2015 in the District Court of...more

Otsuka Pharm. Co., Ltd. v. Zydus Pharms. USA,

by Robins Kaplan LLP on

Case Name: Otsuka Pharm. Co., Ltd. v. Zydus Pharms. USA, C.A. Nos. 14-3168 (JBS/KMW),14-4671 (JBS/KMW),14-5878 (JBS/KMW),14-6398 (JBS/KMW),14-7252 (JBS/KMW), 2015 U.S. Dist. LEXIS 138853 (D.N.J. Oct. 13, 2015) (Simandle,...more

Court Report - November 2015 #5

About Court Report: Each week we will report briefly on recently filed biotech and pharma cases. Merck Sharp & Dohme Corp. v. Savior Lifetec Corp. 5:15-cv-00415; filed August 21, 2015 in the Eastern District of North...more

ANDA Update - October 2015

by McDermott Will & Emery on

Federal Circuit Interprets Statutory Requirements for Biosimilar Regulatory Pathway - Amgen Inc., v. Sandoz Inc., (Fed. Cir. July 21, 2015): In a case of first impression, the U.S. Court of Appeals for the Federal...more

Using divisional applications in Australia to fix your licensing woes

by FPA Patent Attorneys on

The Australian Patents Act provides that only the patentee or exclusive licensee has standing to commence infringement proceedings. For a licence to be exclusive, it must transfer all rights from the patentee to the licensee....more

Otsuka Pharm. Co., Ltd. v. Torrent Pharms. Ltd., Inc.

by Robins Kaplan LLP on

Case Name: Otsuka Pharm. Co., Ltd. v. Torrent Pharms. Ltd., Inc., Civ. No. 14-1078 (JBS/KMW), 2015 U.S. Dist. LEXIS 50082 (D.N.J. Apr. 16, 2015) (Simandle, C.J.) - Drug Product and Patent(s)-in-Suit: Abilify®...more

Swiss-form claims: not the same as methods of medical treatment?

by FPA Patent Attorneys on

Why have a Swiss-form claim in an Australian patent when methods of medical treatment are patentable? In a recent first instance decision of the Federal Court of Australia, Swiss-form claims have been held to be method...more

New Jersey Rulings Allay Personal Jurisdiction Concerns Raised by Daimler and Goodyear

Two judges in the U.S. District Court for the District of New Jersey have denied motions to dismiss for personal jurisdiction in Hatch-Waxman litigations based on the defendants’ compliance with New Jersey’s foreign...more

Otsuka Suit Results in Victory for FDA

by BakerHostetler on

According to a recent decision by a Maryland federal court, the Food and Drug Administration (FDA) acted permissibly when it approved generic versions of Otsuka Pharmaceutical Co. Ltd.’s (Otsuka) product Abilify even though...more

Otsuka’s Orphan Drug Exclusivity Claims: FDA Rips Off the Band-Aid Early

by McGuireWoods LLP on

On April 20, 2015, FDA filed a brief in Opposition to Plaintiff’s Motion for Temporary Restraining Order (“TRO”) or Preliminary Injunction (“PI”), addressed how Otsuka Pharmaceutical Co., Ltd. Otsuka Pharmaceutical...more

Otsuka Pharm. Co., Ltd. v. Mylan Inc.

by Robins Kaplan LLP on

Case Name: Otsuka Pharm. Co., Ltd. v. Mylan Inc., No. 14-4508 (JBS/KMW), 2015 U.S. Dist. LEXIS 35679 (D.N.J. Mar. 23, 2015) (Simandle, C.J.) . Drug Product and Patent(s)-in-Suit: Abilify® (aripiprazole); U.S. Patents...more

Otsuka Files Amended Complaint and Motion for TRO/PI for Abilify®, Pointing to Congressional Intent to Argue Broad Exclusivity

by McGuireWoods LLP on

As discussed in our April 13, 2015 blog, Otsuka Pharmaceutical Co., Ltd. Otsuka Pharmaceutical Development and Commercialization, Inc., and Otsuka America Pharmaceutical, Inc. (collectively “Otsuka”) had until April 15, 2015...more

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