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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.

In his role as U.S. Delegate to IEC/CISPR (International Electrochemical Commission/International Special Committee on Radio Interference), and as the U.S. Technical Advisor to IEC/CISPR/B Subcommittee, Mr. Mahn works on developing international radiofrequency interference standards for industrial, scientific, and medical devices. 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.

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 US 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

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," April 16-18, 2015.

Selected publications

"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.

Experience

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What's trending with Terry

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News
June 30, 2016
Biologic Patents Are Under Attack
Articles
Fish Litigation Blog
July 7, 2015
FDA's Latest ANDA Guidance: Patent Carve Outs Become a Guessing Game
Stopping the Launch at Risk: In re Cyclobenzaprine
Author: Terry G. Mahn
IP Litigation
Life Sciences
Fish Litigation Blog
June 25, 2015
Predictions for the Outcome of Amgen v. Sandoz
FDA Guidance
Author: Terry G. Mahn
Federal Circuit
Life Sciences
Fish Litigation Blog
March 9, 2015
FDA Approves First Biosimilar Drug for US
FDA Approves First Biosimilar Drug for US
Authors: Sara Koblitz, Terry G. Mahn
Life Sciences
News
March 9, 2015
FDA Approves First Biosimilar Drug for U.S.
Media Coverage
Articles
Fish Patent Blog
June 30, 2016
Remedy to Incentivize Innovation as In Vitro Diagnostics Face Patent-Eligibility Challenges and Added Regulatory Scrutiny
Remedy to Incentivize Innovation as In Vitro Diagnostics Face Patent-Eligibility Challenges and Added Regulatory Scrutiny
Authors: Gina Nellesen, Terry G. Mahn
News
June 2, 2016
Fish & Richardson Announces 37 Attorneys Named “IP Stars” by Managing Intellectual Property Magazine
Press Releases
News
December 7, 2015
Will the Trans-Pacific Partnership Derail Biologics?
Articles
News
December 2, 2015
Patent Infringement at the ITC: Implications for Brand-Name Drug Companies
Articles
News
August 10, 2015
FCC Releases Notice of Proposed Rulemaking on Approval Procedures for Radiofrequency Devices
Client Alerts
News
July 8, 2015
Terry Mahn Quoted in Law360's "Medical Device Co. Pushes FCC For Ultra-Wideband Waiver"
Media Coverage
Articles
News
February 18, 2015
Fish’s Terry Mahn Quoted in Bloomberg BNA’s Pharmaceutical Law & Industry Report “Takeda, Colcrys Investors Appeal Ruling Upholding FDA’s Approval of Competing Drug”
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