Additional insights


  • “Patent Infringement at the ITC: Implications for Brand-Name Drug Companies,” Pharmaceutical Compliance Monitor (September 2015)
  • “The BPCIA 'Patent Dance' — Waiting for the Music to Begin,” Pharmaceutical Compliance Monitor (January 2015)
  • “The Patent Use Code Conundrum — or Why FDA Can’t Read (Patents),” Pharmaceutical Compliance Monitor (November 2014)
  • “The Efficiency of Bringing Drugs to Market Versus the Fairness of Making Drugs Accessible,” Pharmaceutical Compliance Monitor (October 2014)
  • “Drug Labeling Games — Skinny Labels Getting an FDA Assist,” Pharmaceutical Compliance Monitor (March 7, 2014)
  • “Hatch-Waxman Developments: Artificial Infringement by Artificial Drugs,” Pharmaceutical Compliance Monitor (November 2013)
  • “The Safe Harbor may be Too Safe for Certain Biologic Patents — what this Portends for Biologic Patent Owners,” Pharmaceutical Compliance Monitor (August 2013)
  • “To Carve Out or Not to Carve Out,” Pharmaceutical Compliance Monitor (May 2013)
  • “Caraco Brings New Challenges for Drafting Use Codes,” Pharmaceutical Compliance Monitor (April 2013)
  • “Personalized Medicine — Slowing Down for Free Riders,” Pharmaceutical Compliance Monitor (January 2013)
  • “Interchangeable Biosimilars — Time to Reform the Orange Book,” Bloomberg BNA Pharmaceutical Law & Industry Report (October 2012)
  • “Biosimilars v. Generics — Major Differences in the Regulatory Model,” Pharmaceutical Compliance Monitor (March 2012)
  • “Is It Time for FDA to Revise Its Orange Book Rules to Deal with Skinny Labeled Generic Drugs?” FDLI’s Food and Drug Policy Forum, Volume 1, Issue 19 (October 2011)
  • “Skinny Labeling and the Inducement of Patent Infringement,” FDLI Update (November/December 2010)
  • “New FDA Requirements for Post-Marketing Studies and Clinical Trials — Using Patents as a Strategy for Recovering Costs Prior to Generic Entry,” Bloomberg Law Reports: Health Law (November 2009)
  • Co-author and lecturer for PRG Advanced Patent Law Course, Pharma & Biotech Strategies for Patent Prosecution, Hatch-Waxman, Litigation and Licensing since 2000
  • “Protecting New Investments in Old Drugs,” FDLI Update (March/April 2009)
  • “Drug Labels: The New Orange Book,” FDLI Update (July/August 2006)
  • “Reissue Patents and the Orange Book: A New Wrinkle,” BNA’s Pharmaceutical Law & Industry Report (March 2006)
  • “The Role of Patent and Non-Patent Exclusivity Under the Hatch-Waxman Act,” A detailed treatise covering Hatch-Waxman, Pediatric Exclusivity and Orphan Drug Exclusivity (May 2005)
  • “Biotechnology — Patent Prosecution, Licensing, Litigation and Hatch-Waxman; Part VI: The Role of Patent and Non-Patent Exclusivity Under the Hatch-Waxman Act” (May 2005)
  • “Hatch-Waxman Strategies for the New Millennium,” AIPLA Spring Meeting (April 2002)

 Speaking engagements

  • “Hatch-Waxman and Biosimilars: A Total Immersion Course Encompassing Strategies for Prosecution, FDA Regulation, Post-Grant Challenge, Litigation and Appeal,” Patent Resources Group Advanced Patent Law Course