Daniel DiNapoli concentrates his practice in patent, trade secret, and unfair competition litigation and counseling. His intellectual property practice includes litigation, arbitration, and advice regarding patents and trade secrets in biotechnology, pharmaceuticals, and ANDA litigations, including ANDA litigation involving Pfizer's blockbuster drugs Viagra® and Celebrex®, medical diagnostics, surgical devices, computers, computer software, and telecommunications.
Mr. DiNapoli has represented leading research-based pharmaceutical and biotechnology companies, such as Pfizer Inc. and Chiron Corporation (now part of Novartis), in all aspects of complex patent litigations. His experience includes patent infringement actions concerning antibiotics, anti-hypertensive drugs, antifungal drugs, treatments for erectile dysfunction, treatments for bacterial infections, anti-clotting drugs, pharmaceutical formulations, the cloning of alpha-interferon, the cloning of rennet, monoclonal antibodies, surgical devices, and methods for producing transgenic mice. Mr. DiNapoli's experience also includes litigation against generic drug manufacturers under the Hatch-Waxman Act.
Mr. DiNapoli also has represented clients in telecommunications and computer-related patent disputes. The technologies involved include aspects of TDM and VoIP telephone communications.
- Pfizer, patent infringement ANDA cases involving Xeljanz®, a medication for the treatment of rheumatoid arthritis. E.g., Pfizer Inc. et al. v. Prinston Pharmaceutical, Inc, 17-cv-123 (D. Del.)
- Pfizer, patent infringement ANDA cases involving Bosulif®, a medication for the treatment of leukemia. E.g., Wyeth LLC v. MSN Laboratories Private Ltd et al, , 17-cv-233 (D. Del.)
- Acorda Therapeutics, patent infringement cases against ten generic drug manufacturers involving AMPYRA® (dalfampridine), an oral medication to improve walking in people with multiple sclerosis (MS). Acorda Therapeutics Inc. v. Actavis et al., 1:14-cv-00882-LPS (D. Del.).
- Cephalon, patent infringement case against ANDA-filer seeking FDA approval to market generic version of Cephalon's Treanda® injection product. Cephalon Inc. v. Fresenius Kabi USA, LLC, 1:15-cv-oo536-LPS (D. Del.)
- Pfizer, patent infringement case against Teva. Successfully preserved Pfizer's market exclusivity for its blockbuster drug Viagra®, defeating a challenge by Teva Pharmaceuticals USA Inc., which sought FDA approval to sell a generic version of the drug. The court rejected Teva's assertions that the patent, which expires in 2019, is invalid as having been obvious and unenforceable under the doctrine of inequitable conduct. Pfizer Inc. et al. v. Teva Pharmaceuticals USA, Inc. et al., 2:10-cv-128 (E.D. Va.)
- Pfizer, patent infringement case against generic drug manufacturers Actavis, Amneal, Apotex and Mylan. The infringement case is based on each defendants' filing of an ANDA seeking FDA approval for generic Viagra®. Pfizer Inc. v. Actavis, Inc. et al., 1:10-cv-08197-TPG, (S.D.N.Y.)
- Pfizer, patent infringement case against Apotex, Lupin, Mylan, Teva and Watson, involving Pfizer's blockbuster drug Celebrex®. Pfizer Inc. v. Lupin Pharma et al., 2:13-cv-121 (E.D. Va.)
- Pfizer, patent infringement defense against Apotex related to Pfizer's Accupril® product. The case is scheduled to be tried before a jury in 2014. Apotex v. Pfizer Inc., 0:12-cv-60704 (S.D. Fl.)
- Pfizer, patent infringement defense against GTG related to methods of DNA analysis. The case is scheduled to be tried before a jury. Genetic Technologies LTD v. Pfizer Inc., 12-cv-00395 (D. Del.)
- Deltagen, patent infringement defense against Lexicon Genetics' allegations that Deltagen's genetically altered "knockout" mice infringed several of Lexicon's patents. The patents-in-suit generally related to technology developed by Nobel Prize-winner Mario Capecchi's methods and vectors for using positive-negative selection to produce gene-targeted, or "knockout," stem cells and animals. The case settled before trial. Lexicon Genetics v. Deltagen, Inc. (D. Del.)
- Deltagen, patent infringement defense against Lexicon Genetics. The patents-in-suit generally related to the use of isogenic DNA in homologous recombination to create "knockout" stem cells and mice. The case settled before trial. Lexicon Genetics v. Deltagen Inc. (N.D. Ca.).
- Rockefeller University and Chiron (now part of Novartis AG), patent infringement case alleging infringement by Centocor's anti-TNF antibody product Remicade® and Abbott's anti-TNF antibody product Humira®. The litigation resulted in settlements in which each defendant took a royalty-bearing license to the patents. The Rockefeller University and Chiron Corporation v. Centocor, Inc. and Abbott Laboratories (E.D. Tex.)
"Life Sciences Star"—Hatch-Waxman Patent Litigation (2017–2022)
"Life Sciences Star"—Intellectual Property (NY) (2016)
"New York Lawyer of the Year" – Biotechnology and Life Sciences (2019)
"New York Lawyer of the Year" – Biotechnology Law (2012)
- J.D., University of Pennsylvania Law School, 1988
- M.S., Electrical Engineering, Columbia University, 1985
- B.S., Electrical Engineering, Columbia University, 1983
- New York
- U.S. District Court, Southern District of New York