Terry G. Mahn

IP “Life Science Star,” LMG Life Sciences 2016

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

Selected publications

Co-authored “Uncertainty In Patent Term Extension For Biologics,” Law360, May 19, 2017.

Quoted in “Surveying The Current Legal Landscape For Biosimilars,” Biosimilar Development, May 3, 2017.

Quoted in “Amgen Vs. Sandoz: Who Will Win Over The Supreme Court?” Biosimilar Development, April 26, 2017.

Quoted in “Generic Drugmaker Sues FDA to Get Its Exclusivity Back,” Bloomberg BNA, February 2, 2017.

“21st Century Cures Act: No Cure for an FDA Patent Bias,” Bloomberg BNA Pharmaceutical Law & Industry Report, January 6, 2017.

“The First Amendment Does Not Protect All Off-Label Drug Promotion,” with Gina Nellesen, Fish Litigation Blog, December 23, 2016.

“Remedy to Incentivize Innovation as In Vitro Diagnostics Face Patent-Eligibility Challenges and Added Regulatory Scrutiny” with Gina Nellesen Fish Patent Blog, June 30, 2016.

“Biologic Patents Are Under Attack,” Law360, June 29, 2016.

“Will the Trans-Pacific Partnership Derail Biologics?,” with Tasha Francis, Pharmaceutical Compliance Monitor, December 7, 2015.

“Patent Infringement at the ITC: Implications for Brand-Name Drug Companies,” with Erin L. Baker, Ph.D., Pharmaceutical Compliance Monitor, September 22, 2015.

“The BPCIA “Patent Dance”–Waiting for the Music to Begin,” with Ron Vogel, Pharmaceutical Compliance Monitor, January 22, 2015.

“The Patent Use Code Conundrum–or Why FDA Can’t Read (Patents),” Pharmaceutical Compliance Monitor, November 4, 2014.

“The Efficiency of Bringing Drugs to Market Versus the Fairness of Making Drugs Accessible,” with Erin L. Baker, Ph.D., Pharmaceutical Compliance Monitor, October 7, 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 22, 2013.

“The Safe Harbor may be Too Safe for Certain Biologic Patents—what this Portends for Biologic Patent Owners,” Pharmaceutical Compliance Monitor, August 9, 2013.

“To Carve Out or Not to Carve Out,” Pharmaceutical Compliance Monitor, May 15, 2013.

“Caraco Brings New Challenges for Drafting Use Codes,” Pharmaceutical Compliance Monitor, April 17, 2013.

“Personalized Medicine – Slowing Down for Free Riders,” Pharmaceutical Compliance Monitor, January 14, 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 13, 2012.

“Orange Book Listing Opportunities for Drug-Device Combinations,” BNA Pharmaceutical Law & Industry Report, December 2011.

“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 12, 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. Please click here to visit the Food and Drug Law Institute (FDLI) website.

“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”, May 2005 (a detailed treatise covering Hatch Waxman, Pediatric Exclusivity and Orphan Drug Exclusivity).

“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 (PDF of PowerPoint presentation).

Hatch-Waxman Strategies for the New Millennium, AIPLA Spring Meeting April 2002.