Keith J. Harrison is a partner in the firm's Washington, D.C. office, and leader of the Crowell & Moring Trial Practice Team. Having successfully tried more than 75 jury trials to verdict, Keith uses his extensive trial experience to develop winning strategies for firm clients. Keith has tried complex civil and criminal disputes for a variety of businesses, including manufacturers of pharmaceutical products and life sciences companies. He has been selected as a Washington, D.C. "Super Lawyer" in the field of intellectual property litigation by Super Lawyers. Keith is also a member of the firm's Diversity Council.
Keith has won jury verdicts in intellectual property, trade secret, breach of contract, false claims act (FCA), employment defense and white collar criminal trials. He also has a record of winning or resolving cases at the pretrial stage in a wide range of cases involving patents, bioinformatic license arrangements, antitrust and unfair competition claims, class actions, trade secrets, FAA complaints, FDA consent decrees, EPA violations, government healthcare contract disputes, Foreign Corrupt Practices Act (FCPA). Medicaid procurement, and the Federal Employees Health Benefits Program.
As a former prosecutor, Keith has decades of experience in conducting confidential investigations that have ranged from major League Baseball's investigation of Pete Rose to the United Nations Iraq Oil for Food Program. Based on his prosecutorial experience and broad and regulatory litigation expertise many clients look to Keith to establish, review or revise their corporate compliance programs, conduct compliance training or conduct internal investigations. Keith also represents individuals and companies testifying before Congress.
For the past two years, Keith has been lead national trial counsel for one of the world's largest generic drug manufacturers in the nationwide Average Wholesale Price litigation. During this time, Keith has coordinated the defense of more than 15 separate lawsuits pending in state and federal courts around the country, including a qui tam action under the Federal False Claims Act and numerous civil enforcement actions brought by state attorneys general alleging violations of a variety of state statutes, including state false claims acts.
Clients often look to Keith to resolve regulatory enforcement disputes with state or federal government agencies. For example, he recently represented the world's largest water treatment company in obtaining a temporary restraining order and then a permanent injunction against the EPA that prevented the federal government from enforcing a stop-sale order and allowed a multi-million dollar water treatment technology back on the market. A pharmaceutical manufacturing company turned to Keith when U.S. Marshals seized $24 million worth of drug products that were allegedly adulterated. The regulatory enforcement action was quickly resolved, allowing the client to continue to in business.
Keith served as lead trial counsel in MorphoSys v. Cambridge Antibody Technology, where he successfully tried a three-week biotech patent infringement jury trial regarding phage display antibody library technology. Keith was lead trial counsel in Celera Genomics v. Wyeth, Inc., a jury trial concerning Celera Genomic's historic decoding of the human genome and the licensing of its genetic database, which settled after Keith's opening statement. Another of Keith's reported intellectual property cases is Ellis v. Hurson, the leading case in the District of Columbia on trade secrets and noncompetition agreements. In addition, Keith successfully represented jWIN Electronics in patent infringement litigation regarding V-Chips or parental control technology in DVD players in the Eastern District of Texas. Keith's other clients include United Airlines, Actavis, NALCO, Cambridge Antibody Technology, Covidien, Compugen, Celera Genomics, DuPont, AT&T, Caraco Pharmaceutical Laboratories, Innovassynth Technologies, MedStar Health, Inc. and its subsidiary hospitals, including Washington Hospital Center, Georgetown University Hospital, National Rehabilitation Hospital and Good Samaritan Hospital, as well as Kaiser Foundation Health Plan of the Mid-Atlantic States.
After law school, Keith served as an Assistant District Attorney for the County of New York (Manhattan), where he prosecuted over 200 felony cases, including homicide, assault, rape, robbery, arson, embezzlement, counterfeiting and grand larceny. As an Assistant District Attorney, Keith was lead counsel in numerous jury trials, each returning a verdict in his favor.
Keith is a faculty member of the National Institute for Trial Advocacy where he trains lawyers in the art of trial advocacy. Keith is a past member of the Board of Governors for The Federal Circuit Bar Association. He is also a member of the American Bar Association ("ABA") Sections of Litigation and Intellectual Property Law. Keith is admitted to the District of Columbia and New York Bars. He is also admitted to practice before the United States District Court for the District of Columbia; Eastern District of Michigan, the United States Courts of Appeals for the Federal, District of Columbia, Fifth, Sixth and Eleventh Circuits; as well as the United States Court of Federal Claims.
Publications
· "A Comparative Analysis of the United States Biosimilar Pathway," American Health Lawyers Association (July 2010). Author: Keith J. Harrison.
· "International Arbitration In The Middle East: A Case Study of Qatar," The International Dispute Resolution News, Vol. 1, No. 1 (Fall 2009). Authors: Meriam N. Alrashid, Keith J. Harrison, Brian E. Abrams and Jonas B. Lerman.
Alerts & Newsletters
· "Finally-A Regulatory Pathway for Biosimilars in the United States," Life Sciences Alert (March 26, 2010). Contacts: Keith J. Harrison, Kristof Roox.
· "Pharmaceutical and Medical Device Industries are The Top Targets for Foreign Corrupt Practices Act ("FCPA") Enforcement," Life Sciences Alert (November 18, 2009). Contacts: Keith J. Harrison, Stephen M. Byers, Alan W. H. Gourley.
· "The Generic Biologics Debate Heats Up With Introduction of Rival House Bill," Life Sciences Alert (March 24, 2009). Contact: Keith J. Harrison.
· "House Introduces Legislation On Generic Biologics Approval Process," Life Sciences Alert (March 12, 2009). Contact: Keith J. Harrison.
· "The Obama Administration Stakes Out Positions on Generic Biologics, Hatch-Waxman Settlements and Evergreening in Its First Budget," Life Sciences Alert (March 4, 2009). Contact: Keith J. Harrison.
· "Federal Circuit Affirms Extension of The 30 Month Hatch-Waxman Stay Preventing FDA Approval of Generic Version of Evista," IP Insights (February 27, 2009). Contacts: Keith J. Harrison, Mark Supko.
Speaking Engagements
· "U.S. Healthcare Reform: What's in it for Biosimilars?" European Generics Medicines Association's 8th Annual Symposium on Biosimilars, London (September 8-10, 2010). Presenter: Keith J. Harrison.
· "Mapping Out The Latest Developments in European And US Biosimilar Regulation-Achieving Cost Effective Compliance," Biosimilars India 2009 Conference (December 2, 2009). Presenter: Keith J. Harrison.