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Category Archives: Litigation

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Susan Winckler Featured Keynote Speaker This Week at 8th Annual Pharmaceutical and Medical Device Conference in Chicago on November 10

Posted in Advertising and Promotion, Animal Drugs, Antitrust, Biological Products, Clinical Studies, Drugs, Emerging Growth, Enforcement, European Union, FDA Organization, Healthcare, Intellectual Property, Legislation, Litigation, Medical Devices, Meetings, Patents, Regulation

159161119On November 10, 2016, McGuireWoods LLP and McGuireWoods Consulting (“McGuireWoods”) will be holding its 8th Annual Pharmaceutical and Medical Device Conference in Chicago.  Kicking off the Conference will be Keynote Speaker, Susan Winckler, the Chief Risk Management Officer for Continue Reading

Abbott Secures Preliminary Injunction in Gray Market Case

Posted in Drug Quality and Security Act, Drug Supply Chain Security Act, Intellectual Property, Litigation, Medical Devices, Risk Management

Medical equipmentOn November 6, 2015, Abbott Laboratories and its diabetes care units secured a preliminary injunction against multiple pharmacies, distributors and associated individuals engaged in the sale of gray market Abbott FreeStyle diabetes test strips designed for sale internationally to U.S. Continue Reading

Challenge to FDA Therapeutic Equivalence Down-Rating Denied as Not Final Agency Action for Now

Posted in Drugs, Litigation

Pharmaceutical Patent Litigation (ANDA) 122530349On July 29, 2015, the District of Maryland Judge Deborah Chasanow denied Mallinckrodt Inc.‘s (“Mallinckrodt’s”) attempt to obtain judicial review of FDA’s determination that its methylphenidate hydrochloride extended-release tablets ANDA referencing Janssen Pharmaceutical Inc.’s Concerta® (“Mallinckrodt’s ANDA”) would be … Continue Reading

Abilify®’s Saga Continues: Otsuka’s Eight-Day Streak of Generic-Free Competition Ends, For Now

Posted in Antitrust, Drugs, Generic Drugs, Litigation, Rare Diseases

antibioticsOn May 27, 2015, the U.S. District Court for the District of Maryland granted FDA and the Defendant-Intervenors summary judgment against Otsuka Pharmaceutical Co., Ltd. Otsuka Pharmaceutical Development and Commercialization, Inc., and Otsuka America Pharmaceutical, Inc. (collectively “Otsuka”), holding that … Continue Reading

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

Posted in Drugs, Labeling, Litigation, Rare Diseases

antibioticsAs 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 to file an amended complaint and a temporary restraining … Continue Reading

European Generics and Biosimilars – Legal Trends and More Discussed at 11th Annual Legal Affairs Forum – Part Two of Two

Posted in Biosimilars, Clinical Studies, Drugs, European Union, Generic Drugs, Litigation, Meetings, Rare Diseases

EGA Legal Affairs ForumOn the second day of the 11th Annual Legal Affairs Forum held by the European Generic and Biosimilar Medicines Association, additional exclusivity and intellectual property concerns were covered, including key case updates and strategies (see here for a … Continue Reading

EGA’s 11th Legal Affairs Forum in Brussels Later This Week: Still Time to Register!

Posted in Biosimilars, Drugs, European Union, Generic Drugs, Intellectual Property, Legislation, Litigation

EGA Legal Affairs ForumLater this week in Brussels, Belgium, the European Generic and Biosimilar Medicines Association (EGA) will host its 11th Legal Affairs Forum. The Forum will be held on March 26-27, 2015 utilizing an interactive format that provides ample opportunities … Continue Reading

11th Legal Affairs Forum in Brussels, Belgium on March 26-27, 2015

Posted in Biological Products, Biosimilars, Drugs, European Union, Generic Drugs, Intellectual Property, Litigation, Meetings, Patents

EGA Legal Affairs ForumOn March 26-27, 2015, the European Generic and Biosimilar Medicines Association (EGA) will host its 11th Legal Affairs Forum in Brussels, Belgium. The Forum will focus particularly on:

–       EGA 2020: Where Are the Latest Trends Leading this Sector?

A … Continue Reading

NYSBA Food, Drug and Cosmetic Section Annual Meeting Features Medical Device Advertising (FDA and FTC), Laboratory Developed Tests, Attorney Ethics Representing Medical Marijuana Clients, and Important Case Updates Featuring New York’s Chief of the Antitrust Bureau

Posted in Advertising and Promotion, Drugs, Enforcement, Generic Drugs, Healthcare, Legislation, Litigation, Medical Devices, Meetings

On January 29, 2015, the Food, Drug and Cosmetic Law Section (FDC Section) of the New York State Bar Association (NYSBA) will hold its Annual Meeting at the New York Hilton Midtown, New York City.  This year’s meeting includes a Continue Reading