In Brief: A Digest of Pharmaceutical Manufacturers Projects

Client Success

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.
Represented TWi Pharmaceuticals, Inc. in a patent infringement case alleging its generic version of Par Pharmaceutical’s Megace ES infringed Alkermes’ (formerly, lan) patent for nanocrystal megestrol acetate. After a seven-day bench trial, the court entered judgment for TWi in February 2014 finding Alkermes’ patent invalid as obvious.
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.
Represented TWi Pharmaceuticals Inc. (and its predecessor Anchen Pharmaceuticals Inc.) in a patent infringement case alleging its generic version of Cephalon’s Amrix infringed several patents. After conducting a seven-day bench trial, the court issued an opinion in May 2011 finding TWi’s product did not infringe any claims of the patents and entered judgment in its favor. Following the decision, TWi filed a motion to deem the case exceptional and for fees. The court granted TWi’s motion and awarded TWi attorneys’ fees.
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.