Insights

Additional insights

Publications

  • Process Patents are Vital in Biotech-Why Not Extend Them?,”Law360 August 10, 2015
  • “Life Sciences Update – Spring 2012” (S. Peter Ludwig, et al.)
  • “Stem Cell Law, Regulation and Intellectual Property: A Fundamental Pillar of Success” World Stem CellReport (2009
  • “Potholes & Roadblocks on the Road to Patent Protection” Medical Innovations & Business, pp. 12-19(October 2009)
  • “Generic Drug-Approval Process: Hatch-Waxman Update” Chapter in The Pharmaceutical Regulatory Process Second Edition, I. Berry, Editor (2008)
  • “Biotechnology and Pharmaceutical Patents: Law and Practice,” Aspen Publishers (2008)
  • “Biotechnology and Pharmaceutical Patents, Law and Practice," Aspen Publishers (2007)
  • “Hatch-Waxman in the Federal Courts: From 1994-2004 Drug Development and Industrial Pharmacy, 31(2): 15-22 (2005)
  • “Generic Drug Approval Process: Post 1984: Hatch-Waxman Reform,” Chapter in Introduction to the Pharmaceutical Regulatory Process, I. Berry, Editor (2005)
  • “Patents and Polymorphs,” Chapter in Biotechnology and Pharmaceutical Law 2004:  Patents and Business Strategies, Practising Law Institute Intellectual Property Course Handbook Series (2004)
  • “Patenting Life Forms” Chapter in Biotechnology Law 2003: Biotechnology Patents & Business Strategies, Practising Law Institute Intellectual Property Course Handbook Series (2003)
  • “No room for experiment: The Federal Circuit’s Narrow Construction of the  Experimental Use Defense,”Nature Biotechnology 21:453 (April 2003)
  • “Preparing Legal Opinions for Biotechnology Patents,” Biotechnology Law 2002:  Biotechnology Patent & Business Strategies (2002)
  • “Life After Eli Lilly: Planning for Compliance with the Written Description Requirement,” Chapter in Biotechnology Law 2001: Biotechnology Patents & Business Strategies in the New Millennium, Practising Law Institute Intellectual Property Course Handbook Series (2001)
  • “Inadvertent Disclosure of Privileged Information,” New York Law Journal, pp. 6, 14-15 (October 18, 1999)