Colleen Tracy James joined the firm’s New York office in 2018. Colleen “is a top tier litigator. She has great instincts for litigations and is an excellent strategist. I value her insights immensely” Best Lawyers.
Representing companies in the Life Sciences Industry, Colleen Tracy James focuses her practice on patent infringement litigation, USPTO Patent Trial and Appeal Board proceedings, and other complex intellectual property litigation. She has extensive experience litigating against generic pharmaceutical companies in matters brought under the Hatch-Waxman Act (ANDA litigation) in federal district courts across the U.S. and the Federal Circuit. Many pharmaceutical companies have entrusted Colleen to handle litigations that involve their billion dollar a year products and bet the company cases. Colleen also provides her clients with an array of intellectual property patent services such as freedom to operate opinions and licensing and due diligence advice, among others. In 2019, IAM Patent 1000: The World’s Leading Patent Professionals guide, recognized Colleen as among the firm’s “leading lights of the life sciences practice,” adding that “Colleen has fantastic litigation skills and judgement and does a brilliant job when coming up against top adversaries. She is tremendous to work with and makes the job of in-house counsel so much easier.”
Whether she is handling a high-stakes patent litigation or engaged in IP counseling, due diligence or licensing, Colleen is known for being organized, efficient, cool under pressure and an exceptional communicator. Her skill and dedication in preparing witnesses for depositions has, time and again, allowed her to achieve outcomes that met or exceeded client expectations.
Above all, Colleen puts a premium on listening to her clients and building consensus among stakeholders so that she can craft strategies that respond directly to the client's legal and business needs.
According to Legal 500 U.S., “Colleen Tracy attracted client praise for her 'overall depth of knowledge, dogged advocacy, and unfailing attentiveness to details of concern to the client.'“ Colleen was Recognized as a “Life Science Star” in the 2016 edition of Euromoney’s Legal Media Group (LMG) Life Sciences, and has been recognized as an “IP Star” by Managing Intellectual Property since 2014, she was also recognized as one of the “Top 250 Women in IP” by Managing Intellectual Property in 2016. Colleen was selected as a top Intellectual Property Law and Patent Law practitioner in the 2012-2021 editions of Best Lawyers in America. She was also named a 2013 “Woman Worth Watching” by Profiles in Diversity Journal. Colleen was featured as a rising star by Law360 in 2010 and was named a rising star in intellectual property law in the 2007 edition of Law360.
While in law school, Colleen served as a student law clerk to the Honorable William G. Bassler of the United States District Court for the District of New Jersey. Prior to joining Quinn Emanuel, Colleen was a partner at Mayer Brown.
Represented GlaxoSmithKline in an ANDA case against Aurobindo regarding Lamictal XR.
Represented Gilead in ANDA litigation against Mylan regarding its Complera® drug.
Defended Adams Respiratory Therapeutics, Inc. et al. against Perrigo Company et al., in obtaining a favorable ruling from the US Court of Appeals for the Federal Circuit in Mucinex® patent litigation.
Successfully represented Gilead against TEVA in an ANDA litigation relating to Viread®, Atripla® and Truvada® products.
Advocated on behalf of Gilead in ANDA litigations against CIPLA, Lupin and Mylan regarding their respective HIV antiviral drugs.
Litigated on behalf of AstraZeneca against several generic challengers in an ANDA litigation relating to AstraZeneca's Crestor® product.
Successfully represented Sanofi-Aventis against several generic challengers in an ANDA litigation relating to Sanofi's Eloxatin® product.
Defended Bristol-Myers Squibb against Repligen and Bristol-Myers Squibb against Zymogenetics in two patent infringement suits relating to Bristol-Myers Squibb’s drug Orencia®.
Advocated for Adams Respiratory Therapeutics against Mutual Pharmaceuticals in an ANDA litigation relating to Adams' drug Mucinex®.
Guided GlaxoSmithKline against Dr. Reddy’s Laboratories, Cobalt Pharmaceuticals and Spectrum Pharmaceuticals in ANDA litigations relating to GlaxoSmithKline’s Imitrex® product.
Advocated for AstraZeneca against several generic challengers, including Mylan, Apotex, Impax, and Lek, in an ANDA litigation relating to AstraZeneca’s Prilosec®product.
Litigated on behalf of AstraZeneca against several generic challengers relating to Nexium®.
Defended G.D. Searle and Pharmacia against the University of Rochester in a patent infringment suit relating to G.D. Searle and Pharmacia’s Celebrex®product.
Successfully represented Bausch & Lomb against Alcon Laboratories on technology regarding contact lens disinfectants.
- Seton Hall University Law School
- (J.D., 1996)
- Seton Hall Law Review
- Seton Hall Law Review
- Manhattan College
- (B.S., biology, cum laude, 1992)
- The State Bar of New York
- The State Bar of New Jersey
- United States Supreme Court
- United States Court of Appeals
- Second Circuit
- Federal Circuit
- United States District Court
- Southern District of New York
- Eastern District of New York
- Western District of New York
- District of New Jersey
- United States Patent and Trademark Office
- Mayer Brown:
- Partner, 2014-2018
- Partner, 2014-2018
- Fitzpatrick, Cella, Harper & Scinto:
- Managing Partner, 1999-2014
- Managing Partner, 1999-2014
- Law Clerk to the Honorable William G. Bassler:
- United States District Court for the District of New Jersey, 1996-1999
- IAM 1000’s The World’s Leading Patent Professionals, 2015-2021
- Managing Intellectual Property’s “IP Stars - Top 250 Women in IP”, 2016, 2017, 2019, 2020
- "Life Sciences Star" in the 2016 and 2018 editions of Euromoney’s Legal Media Group (LMG) Life Sciences
- Super Lawyers New York-Metro Edition, 2011-2019
- Best Lawyers in America, 2011-2020
- Best Lawyers New York City Edition, 2012-2018
- "IP Star" in Managing IP's World IP Handbook and Survey, 2015-2017
- Best Lawyers Business Edition’s 2017 Women of Influence
- Managing IP, IP Stars Rankings: New York, 2014-2017
- Best Lawyers Business Edition, 2012-2017
- Best Lawyers March 2016 Business Edition’s Special Edition for Women in the Law
- The World’s Leading Patent Professionals 2015
- Top Women Attorneys in Metro NY in The New York Times, 2015
- Top Attorneys in Metro NY in The New York Times, 2015
- 2013 Woman Worth Watching in Profiles in Diversity Journal
- Profiled in “Top 10 Rising Intellectual Property Stars under 40” in the 2010 edition of Law360 Corporate Counsel, March 2008
- “Rising Star in Intellectual Property Law” in the 2007 edition of Law360
- American Intellectual Property Law Association, Patent Litigation Committee Member
- American Intellectual Property Law Association Model Patent, Jury Instructions Subcommittee, Member
- Law360 Intellectual Property Editorial Board, Member 2017-2018
- Seton Hall University Law School, Board of Visitors, Member
- Gibbons Institute of Law, Science & Technology, Advisory Board Member
- Manhattan College Jasper IP Alumni Advisory Counsel
- Manhattan College School of Science, Board of Advisors, Member
- Best Lawyers, Board of Advisors, Member
- Women in Law Empowerment Forum, Former Board Member
- Co-chair Mayer Brown Life Sciences Symposium