Tracey Davies is co-chair of the firm’s Life Sciences practice and is a member of the firm’s Intellectual Property and Litigation practice groups.
Ms. Davies serves as lead trial counsel in matters involving technology-based disputes. Ms. Davies has substantial trial experience representing innovator pharmaceutical and biologics clients as well as industrial and agricultural biotechnology clients in both jury and bench trials across a diverse range of legal matters, including patent litigation, breach of contract and false claims act cases. A licensed patent attorney, Ms. Davies also counsels clients on strategic intellectual property-driven acquisitions, divestitures and financings; patent portfolio development and management; licensing and forming strategic partnerships; and other transactions that optimize intellectual property value to the client.
Recognized by The Best Lawyers in America® in litigation – intellectual property, litigation – patent, patent law, and biotechnology law (2008-2016), Ms. Davies advises clients with respect to a wide array of technologies, including pharmaceutical formulation and drug delivery systems, small molecule and biologic therapies, stem cells and tissue engineering, recombinant industrial enzymes, coated nanoparticles, software programs for health care delivery, telemedicine and medical devices. Her scientific experience is in toxicology research, where she has studied the role of aldehyde dehydrogenases in fetal metabolism and the toxic effects of pesticides.
Before joining Gibson Dunn in 2012, Ms. Davies was a partner at Vinson & Elkins, where she was a member of the Executive Management Committee and leader of the firm’s Intellectual Property, Technology and Life Science practices.
Ms. Davies received her J.D. cum laude from the University of Minnesota in 1997, where she served as an Editor of the Minnesota Journal of Global Trade. She also holds her M.P.H. in toxicology from the University of Minnesota. In 1989, Ms. Davies graduated with her B.A. in biology with honors from the University of Tennessee, and she holds a B.A. in philosophy from the Katholieke Universiteit, in Leuven, Belgium.
Ms. Davies is admitted to practice in Texas and before the United States Patent and Trademark Office, as well as various United States District Courts and United States Courts of Appeals including the United States Court of Appeals for the Federal Circuit and Ninth Circuit.
Representative Experience – Litigation*
- Lead counsel in patent litigation for a drug-device combination for delivery of the third best-selling prescription drug in the United States. The litigation involved assertion of both drug and device patents against another innovator seeking to market a competitive product through the 505(b)(2) FDA approval pathway. On the morning of trial, just before opening statements, the defendant consented to, and the District of Delaware entered, an order enjoining the defendant from selling its proposed product for more than a year. As part of the negotiated resolution of this dispute, the Defendant further agreed to a royalty-bearing license to certain of our client’s patents. (October 2015)
- Lead counsel in week long evidentiary hearing in a False Claims Act case alleging over $7billion in damages. At issue were pharmaceutical development experiments that the Relator claimed revealed a pharmaceutical company had misled a federal agency to obtain an illegal monopoly over a drug product thereby fraudulently inducing the government to reimburse inflated prices for the drug when the cost of its use was reimbursed under Medicare and Medicaid. (July 2015). The Judge ruled favorably for Ms. Davies’s client, dismissing all claims with prejudice, and the case is now on appeal.
- Co-lead counsel successfully securing take nothing summary judgment of non-infringement for U.S. mobile phone carrier in Eastern District of Texas (March 2013)
- Won on summary judgment, a take nothing defense jury verdict of non-infringement and invalidity for U.S. mobile phone carrier in Eastern District of Texas (February 2013)
- Lead counsel successfully representing branded pharmaceutical plaintiff in paragraph IV Hatch-Waxman patent litigation against four ANDA applicants in the first Hatch-Waxman case tried to verdict in the Eastern District of Texas; judgment of infringement of all patent claims asserted, and a finding that all asserted patents were not invalid was affirmed by the Court of Appeals for the Federal Circuit (2013)
- Lead counsel representing defendant in two-week jury trial in patent infringement matter involving industrial enzyme, where patent was held invalid for lack of written description at the trial court level, and this decision was affirmed by the Court of Appeals for the Federal Circuit (2013)
- Co-lead counsel in a three-week jury trial in Michigan; successfully defended a California life science company in a contract dispute regarding recombinant proteins used in pharmaceutical research.
* Includes matters handled prior to joining Gibson, Dunn & Crutcher LLP