“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