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, ANDA litigations, including ANDA litigation involving Pfizer’s blockbuster drugs Viagra® and Celebrex®, medical diagnostics, surgical devices, computers, computer software, and telecommunications. Dan was recently recognized as an “IP Star” by Managing IP Handbook 2015 and recommended by The Legal 500 United States 2015. He has also been named by Best Lawyers in America as Lawyer of the Year for 2012 in the New York City area in the field of biotechnology, by The American Lawyer Magazine as Litigator of the Month, by The American Lawyer Litigation Daily as Litigator of the Week, and by Who's Who Legal in 2012, 2013 and 2016 for patents and in 2011 and 2016 for life sciences in New York. He has been ranked in Best Lawyers in America in biotechnology law since 2008.
Daniel 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. Daniel’s experience also includes litigation against generic drug manufacturers under the Hatch-Waxman Act.
Daniel also has represented clients in telecommunications and computer-related patent disputes. The technologies involved include aspects of TDM and VoIP telephone communications.
Acorda Therapeutics Inc. v. Actavis et al., 1:14-cv-00882-LPS (D. Del.). Counsel for Acorda Therapeutics in a set of patent infringement cases against eight generic drug manufacturers involving AMPYRA® (dalfampridine), an oral medication to improve walking in people with multiple sclerosis (MS).
- Pfizer Inc et al. v. Teva Pharmaceuticals USA, Inc. et al., 2:10-cv-128 (E.D.Va.). Lead counsel for Pfizer in a 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 v. Actavis, Inc. et al., 1:10-cv-08197-TPG, (S.D.N.Y.). Acting as lead counsel for Pfizer in a 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. Lupin Pharma et al., 2:13-cv-121 (E.D. Va.). Acting as trial counsel for Pfizer in a patent infringement case against Apotex, Lupin, Mylan, Teva and Watson, involving Pfizer’s blockbuster drug Celebrex®.
- Apotex v. Pfizer Inc., 0:12-cv-60704 (S.D. Fl.). Acting as trial counsel for Pfizer in defense of a patent infringement case brought by Apotex related to Pfizer’s Accupril® product. The case is scheduled to be tried before a jury in 2014.
Genetic Technologies LTD v. Pfizer Inc., 12-cv-00395 (D. Del.). Acting as lead trial counsel for Pfizer in defense of a patent infringement case brought by GTG related to methods of DNA analysis. The case is scheduled to be tried before a jury.
- Mag Instrument, Inc v. The Coleman Company, 09-cv-1842 (C.D.Ca). Represented the Coleman Company in a patent infringement case against Mag Instrument. The district court granted Coleman’s motion for summary judgment on the grounds that the patent-in-suit is invalid, and the Court of Appeal for the Federal Circuit affirmed.
- Lexicon Genetics v. Deltagen, Inc. (D.Del.). Acted as lead counsel for Deltagen in a 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. (N.D.Ca.). Acted as lead counsel for Deltagen in a 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.
- The Rockefeller University and Chiron Corporation v. Centocor, Inc. and Abbott Laboratories (E.D. Tex.). Represented Rockefeller University and Chiron (now part of Novartis AG) in a 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.
- Pfizer Inc v. Bayer AG et al., 02-cv-1560 (D.Del.). Represented Pfizer in a patent infringement case alleging infringement by Lilly’s erectile dysfunction treatment Levitra®.
- Pfizer Inc v. Eli Lilly et al., 02-cv-1561 (D.Del.). Represented Pfizer in a patent infringement case alleging infringement by Lilly’s erectile dysfunction treatment Cialis®.
- Pfizer Inc v. Novopharm Ltd. (N.D. Ill.). Represented Pfizer in a patent infringement case against Novopharm Ltd. (now part of Teva). The infringement case was based on Novopharm’s ANDA seeking FDA approval to sell a generic antifungal drug Diflucan®. Pfizer won summary judgment that the patent-in-suit was not invalid on the grounds of anticipation. The case settled before trial.
- Pfizer Inc v. Ranbaxy, 02-cv-243 (D.N.J.). Represented Pfizer in a patent infringement case against Ranbaxy. The infringement case was based on Ranbaxy’s ANDA seeking FDA approval to sell a generic antifungal drug Diflucan®. The patent expired before trial.
Daniel has been selected by his peers as a top intellectual property law practitioner for inclusion in:
- Best Lawyers in America in the specialty of Biotechnology Law (2009–2014).
- Managing IP Handbook “IP Star” (2013).
- The International Who’s Who of Patent Lawyers (2010-2013).
- The International Who’s Who of Life Sciences Lawyers (2011-2012).
- The International Who’s Who of Business Lawyers (2014).
- Euromoney/Institutional Investor’s Expert Guide to Patent Practitioners (2013).
- Euromoney Magazine’s Guide to the World’s Leading Patent Law Practitioners (2010).
In The Market
- US News–Best Lawyers Recognizes 32 Kaye Scholer Practices and 41 Lawyers November 1, 2016 • Recognitions
- IAM Patent 1000 2016 Recognizes Kaye Scholer IP Practice and Leading Practitioners June 8, 2016 • Recognitions
- Kaye Scholer Practices and Attorneys Recognized by Chambers USA 2016 May 31, 2016 • Recognitions