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About Terry

Terry G. Mahn is a senior principal in the Washington, D.C., office of Fish & Richardson P.C., and the leader of the firm’s regulatory and government affairs practice group. He joined the firm in 1991 and his practice is primarily before the U.S. Federal Communications Commission (FCC) and Food and Drug Administration (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.

Testified at U.S. Senate Special Committee on Aging, “From Joint Pain to Pocket Pain: Cost and Competition Among Rheumatoid Arthritis Therapies.” February 7, 2018.


Mr. Mahn is a contributing author to Fish’s IP Law Essentials.

  • COVID, Drug Pricing, And Patents,” Life Science Leader Magazine (December 2020)
  • Introduction to Patent Term Extensions (PTE),” IP Law Essentials Blog (July 2020)
  • The Bad Rap on Pharma: In Defense of Patents,” Pharmaceutical Executive (December 2019)
  • Uncertainty In Patent Term Extension For Biologics,” Law360 (May 2017)
  • 21st Century Cures Act: No Cure for an FDA Patent Bias,” Bloomberg BNA Pharmaceutical Law & Industry Report (January 2017)
  • The First Amendment Does Not Protect All Off-Label Drug Promotion,” Fish Litigation Blog (December 2016)
  • Remedy to Incentivize Innovation as In Vitro Diagnostics Face Patent-Eligibility Challenges and Added Regulatory Scrutiny,” Fish Patent Blog (June 2016)
  • Biologic Patents Are Under Attack,” Law360 (June 2016)
  • “Will the Trans-Pacific Partnership Derail Biologics?,” Pharmaceutical Compliance Monitor, (December 2015)
  • “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)
  • 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 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

  • Approaches to Regulatory Hurdles,” Longwood Healthcare Leaders Fall Meeting (September 22, 2022)
  • Hatch-Waxman 301,” Fish Litigation Webinar (May 2018)
  • Hatch-Waxman 201,” Fish Litigation Webinar (January 2018)
  • “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

Media Mentions

Federal Communications Commission (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.

Food and Drug Administration (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.

  • “IP Star,” Managing Intellectual Property (2018-2022)
  • IP “Life Sciences Star,” LMG Life Sciences (2016-2021)
  • Top Rated – AV Preeminent® Lawyer, Martindale-Hubbell®, Washington, D.C. (2014)
Focus Areas

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

B.S., Science Engineering, University of Michigan (1970)

  • 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.

What's trending with Terry

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September 15, 2022
What to Know About the USPTO’s Duty of Candor Guidance Regarding FDA Submissions
Legal Alerts
September 22nd, 2022 | 2:50 pm EDT
Longwood Healthcare Leaders Fall Meeting
Speaking Engagement
June 16, 2022
26 Fish & Richardson Attorneys Named to the 2021 Capital Pro Bono Honor Roll
Press Release
June 2, 2022
Fish & Richardson Named a Top ITC and Life Sciences Firm by Managing IP; Attorneys Named IP Stars
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October 5, 2021
LMG Life Sciences Awards Top Rankings to Fish & Richardson; 13 Principals Named 2021 “Life Sciences Stars”
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April 7, 2021
Thirty Fish Attorneys Named to 2020 Capital Pro Bono Honor Roll
September 29, 2020
Fish & Richardson Receives Top Firm Rankings and 14 Principals Named 2020 “Life Sciences Stars” by LMG Life Sciences
Press Release
August 4, 2020
32 Fish & Richardson Attorneys Named 2020 “IP Stars” by Managing Intellectual Property Magazine
July 31, 2020
Introduction to Patent Term Extensions (PTE)
Authors: Tina Murphy, CIPP/US, CIPP/E, Jenny Shmuel, Ph.D., Terry G. Mahn
IP Law Essentials
December 19, 2019
Fish Principal Terry Mahn Authored “The Bad Rap on Pharma: In Defense of Patents,” in Pharmaceutical Executive
October 2, 2019
Fish & Richardson Receives Top Firm Rankings from LMG Life Sciences in Four Practice Areas
Press Release
May 22, 2019
Fish & Richardson Announces 32 Attorneys Named “IP Stars” by Managing Intellectual Property Magazine
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