Colleen Tracy James
Representing companies in the Life Sciences Industry, Colleen Tracy James focuses her practice on patent infringement litigation, US Patent and Trademark Office (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.
Seton Hall Law Review
Represented Janssen in ANDA litigation regarding its Invokana®, Invokamet® and Invokamet® XR products.
Represented Allergan in ANDA litigation regarding its Viberzi® product.
Represented Takeda in ANDA litigation regarding its Iclusig® product.
Represented Chiesi in ANDA litigations regarding its Cleviprex® and Kengreal® products.
Represented Gilead in ANDA litigation against Mylan regarding its Complera® drug.
Represented Gilead against TEVA in an ANDA litigation relating to Viread®, Atripla® and Truvada® products.
Represented Gilead in ANDA litigations against CIPLA, Lupin and Mylan regarding their respective HIV antiviral drugs.
Represented Sanoﬁ-Aventis in an ANDA litigation relating to Sanoﬁ's Eloxatin® product.
Represented Bristol-Myers Squibb against Repligen and Bristol-Myers Squibb against Zymogenetics in two patent infringement suits relating to Bristol-Myers Squibb’s drug Orencia®.
Represented Adams Respiratory Therapeutics in an ANDA litigation relating to Adams' drug Mucinex®.
Represented GlaxoSmithKline in ANDA litigations relating to GlaxoSmithKline’s Imitrex® product.
Represented AstraZeneca in an ANDA litigation relating to AstraZeneca's Crestor® product.
Represented AstraZeneca in an ANDA litigation relating to AstraZeneca’s Prilosec® product.
Represented AstraZeneca against several generic challengers relating to Nexium®.
Represented 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.
Represented Bausch & Lomb against Alcon Laboratories on technology regarding contact lens disinfectants.
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