Pharmaceutical Manufacturers

Representative Experience

• Successfully defended an active pharmaceutical ingredient manufacturer at the International Trade Commission and U.S. District Court on certain patents claiming a composition and method of using a synthetically produced active metabolite of folic acid.
• Invalidated Pfizer, Inc.’s patent covering amlodipine besylate, the active ingredient in Pfizer’s multibillion-dollar drug Norvasc. We represented Apotex during trial and appeal and successfully established that amlodipine besylate would have been obvious to someone with ordinary skill in the field. The Federal Circuit agreed, clearing the way for Apotex to introduce a generic version of the drug. Pfizer filed for a writ of certiorari in the Supreme Court seeking to vacate and remand the Federal Circuit decision. We were successful in getting the Court to deny that writ.
• Designed and implemented defense strategies in Hatch-Waxman litigations, preparing Hatch-Waxman Paragraph IV letters as well as patentability and freedom to operate letters of opinion.
• Represented TWi Pharmaceuticals, Inc. and Teh Seng Pharmaceutical Mfg. Ltd. in a patent infringement case alleging their generic version of Endo’s Lidoderm infringed several patents. The case was favorably settled on the eve of trial.
• Implemented strategy with FDA that resulted in the lifting of a warning letter, allowing a leading medical-technology manufacturer to get new products to market.
• Lead counsel for Apotex in successfully obtaining summary judgment of patent invalidity in the U.S. District Court for the District of Delaware in a case involving a generic version of Warner Chilcott’s osteoporosis drug Actonel (risedronate).
• Counseled dietary supplement clients on labeling compliance and permissible marketing claims.
• Lead counsel for Apotex Inc. in defeating Hoffman Roche’s motion for preliminary injunction to prevent the launch by Apotex of a generic version of the osteoporosis drug, Boniva (ibandronate), which enabled client to launch as a first filer. Subsequently, the district court granted motion for summary judgment finding that Hoffman La Roche’s patents were invalid for obviousness.
• Filed Investigational New Drug Applications, drafted clinical trial agreements and subsequently filed New Drug Applications for numerous novel human drugs.
• Successfully defeated Roche’s motion for preliminary injunction to prevent our client, Apotex, Inc., from launching a generic version of the osteoporosis drug, Boniva (ibandronate), which enabled our client to launch as a first filer. Subsequently, the district court granted our motion for summary judgment finding that Roche’s patents were invalid for obviousness.
• Represented Apotex, which obtained summary judgment of noninfringement on patents related to the drug Antara, and avoided prolonged discovery while demonstrating that our client’s formulation did not infringe.
• Represented clients in civil investigations and disputes with the FDA and FTC, including but not limited to fraud and marketing claims.
• Represented TWi Pharmaceuticals Inc. (and its predecessor Anchen Pharmaceuticals Inc.) in a patent infringement case alleging its generic version of Shire’s Intuniv infringed several patents. The case was favorably settled after the filing of a motion for summary judgment.
• Counseled clients regarding FDA marketing exclusivities arising out of ANDA patent litigation.
• Assisted clients with a wide-range of FDA regulatory issues, including post-market reporting obligations for manufacturers, product recalls, product labeling, establishment registration, investigation and compliance plans and product sales and distribution requirements.
• Handled a variety of product liability litigation involving numerous drugs, vaccines and various antidepressants.
• Defended pharmaceutical companies in cases involving product liability claims, pricing issues, False Claims Act matters, contract and fraud allegations, consumer and third-party class action cases. These cases involved multidistrict litigation, whistleblower claims, advertising lawsuits, marketing disputes with regulatory bodies, off-label promotions and failure-to-adequately-warn claims.
• Represented pharmaceutical companies in a wide range of civil and criminal healthcare matters, including class action cases and government investigations.
• Obtained summary judgment of noninfringement on Lupin’s Orange Book listed patents on behalf of our client, Apotex. We were successful in avoiding prolonged discovery and preventing Lupin’s counsel from engaging in a fishing expedition and in limiting our client’s overall expenses by demonstrating that our client’s formulation did not infringe.
• Secured victory for TruPharma, LLC in federal court litigation brought by a competitor alleging false advertising and unjust enrichment, among other counts, in connection with the manufacture and sale of a medical cream. Complaint dismissed with prejudice and affirmed on appeal.
• Secured judgment of noninfringement on behalf of a generic pharmaceutical manufacturer in Delaware District Court. The ruling was not appealed.