Terry Mahn | Attorney, Washington, DC

Background

Terry G. Mahn is Managing Principal of the Washington, DC, office, and the Regulatory and Government Affairs Practice Group Leader. He joined the firm in 1991 and his practice is primarily before the FCC and FDA with emphasis on complex product authorizations. Mr. Mahn’s FCC practice includes all facets of spectrum allocation, wireless technology and licensing, and equipment approvals. He actively participates in domestic and international product standards development, harmonization, and compliance in the areas of radio communications, EMC, electrical, medical, and RF safety.

He is an active member of the international standards organization IEC/CISPR (International Electrochemical Commission/International Special Committee on Radio Interference) and is the U.S. Technical Advisor to CISPR Subcommittee B in charge of developing international radiofrequency interference standards for industrial, scientific, and medical devices (ISM). He has extensive knowledge on international EMC and radio regulations and spectrum allocations for many types of licensed and unlicensed communications technologies. He also represents the American National Standards Institute (ANSI) C63 Committee before the FCC and other federal agencies on various radiofrequency interference matters involving digital devices and many types of RF emitters.

His FDA practice involves pharmaceutical and medical device approvals with special emphasis on drug exclusivities and patent protection under Hatch-Waxman; “safe harbor” counseling and patent term extension applications; biosimilar approvals, brand exclusivities and patent litigation procedures under the Biologics Price Competition and Innovation Act. He also has extensive experience in the regulation of digital health, telemedicine, and wireless medical device technologies. Mr. Mahn is on the Advisory Board for the Bloomberg BNA Pharmaceutical Law and Industry Report.

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Education

J.D., Catholic University of America Columbus School of Law 1975

B.S., University of Michigan 1970
Science Engineering

Admissions

District of Columbia 1977
Virginia 1975
Supreme Court of the United States 2011

Memberships & Affiliations

IEC CISPR/B and CISPR/H Technical Advisor, Committee Member and Head U.S. Delegate.
Advisory Board Member for BNA's Pharmaceutical Law & Industry Report.
Recognized as a 2013-2016 "IP Star" by Managing Intellectual Property.
Martindale-Hubbell®, Top Rated - AV Preeminent® Lawyer, Washington, DC (2014)

Other Distinctions

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.

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Experience

FCC
Experienced in a wide range of electronic technology licensing/certification issues involving computers, medical devices, spread spectrum transmitters, ultra wideband, RFID, LAN’s satellite and mobile radio transceivers, cable TV and video distribution systems, PBX and small telephone systems, scientific instrumentation, ISM equipment, ultrasound, RF lighting devices, wireless alarms and door openers, cordless telephones, field disturbance sensors, radar and radar detectors, walkie-talkies, and bio-medical telemetry devices.

FDA and Hatch-Waxman
Experienced in a wide range of FDA product approvals including small molecule drugs, biologics, and medical devices. Client work includes gene and cell therapies, antihypertensives, ophthalmics, anti-inflammatories, immunologics, antibiotics, anti-anxieties, hormone therapies, and medical gases. Device work includes research and screening technologies, dialysis, dental devices, implants, imaging agents, medical telemetry, PARS, catheters, cardiovascular devices, microwave therapies, pressure monitors, oximeters, and various types of drug delivery technologies. Also experienced in x-ray, MRI, PET, and medical lasers.

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