Kaye Scholer

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.

Representative Matters

• 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^®.
  
  
• 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.

Rankings

Mr. DiNapoli 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 (2009–2012).
  
  
• The International Who’s Who of Life Sciences Lawyers (2012).
  
  
• The International Who’s Who of Life Sciences Lawyers (2011).
  
  
• The International Who’s Who of Patent Lawyers (2010–2011).
  
  
• The International Who’s Who of Business Lawyers (2012).
  
  
• Euromoney Magazine’s Guide to the World’s Leading Patent Law Practitioners (2010).