Concentration

Worldwide intellectual property counseling and strategic planning, patent procurement, due diligence, opinion work, licensing and pharmaceutical litigation

Summary

Sandra Lee is a partner in the Intellectual Property Practice in the firm’s New York office. She has a broad range of experience in domestic and foreign patent procurement, opinion and counseling matters in the pharmaceutical, chemical and consumer products areas.

Ms. Lee’s practice includes client counseling and strategic portfolio management, patent prosecution, freedom to operate and clearance investigations, validity/infringement opinion work and inventorship disputes.

Ms. Lee also counsels her clients in Orange Book and Hatch-Waxman related issues, and is involved in pharmaceutical litigation matters from pre-suit investigation and continuing through trial. Ms. Lee has focused primarily on pharmaceutical litigation related to Hatch-Waxman.

Ms. Lee also has vast experience with due diligence investigations on proposed transactions across a broad range of technologies, and assists her clients with IP-related agreements associated with technology transfers through acquisition or licensing opportunities.

Prior to her legal career, Ms. Lee was in biomedical research in the Department of Anesthesia at the Brigham & Women’s Hospital in Boston.

Representative Engagements

• Major pharmaceutical companies
• Start-up biopharmaceutical companies
• Value-added specialty products manufacturers
• Consumer products companies
• University clients
• Chemical development and processing manufacturers

Publications, Speeches and Presentations

Speeches and Presentations

• Panelist, “Navigating the America Invents Act - What Your Company Needs to Know Now to Manage Changes to the Patent Laws,” Baker Botts IP Law Roundtable, September 2012
• Panelist, “Patent Reform Update: The America Invents Act,” Baker Botts IP Law Roundtable, November 2011

Publications

• “Facing the patent cliff head-on,” Drug Discovery News, May 2013
• “Parachuting off the Patent Cliff,” The Scientist, December 6, 2012
• “Momenta v. Amphastar - New Implications on Patents Claiming Testing Methods and the Biosimilars Industry,” AIPLA Antitrust News, October 2012 (Sean McDonagh, co-author)
• “Overview Of The USPTO’s New Rules Regarding Inventor’s Oath Or Declaration, Application For A Patent By A Non-Inventor, Pre-Issuance Submissions And Supplemental Examination,” Baker Botts IP Report, September 2012 (Jason German, co-author)
• “Teva v. AstraZeneca: Secret Prior Art Under 102(g)(2),” Nature Biotechnology, September 2012 (Michael Knierem, co-author); previously published in Baker Botts IP Report, March 2012
• “Q&A With Baker Botts’ Sandra Lee,” Life Sciences Law360, June 5, 2012
• “The Future of Skinny Labels,” Baker Botts IP Report, August 2011 (Anna Volftsun, co-author)
• “Combination Drug Patents in the Post-KSR World,” Patent Strategy & Management, October 2009 (Yong Chen, co-author)
• “Recent Developments in ANDA Settlements-Getting Past the Antitrust Hurdle,” AIPLA Antitrust News, May 2009 (Paul Ragusa, co-author)
• “ANDA Litigation Discovery: What the Patent Owner Should Seek,” Patent Strategy & Management, June 2008 (Paul Ragusa, co-author)
• “Recent Patent Cases Affecting the Pharmaceutical Industry,” Baker Botts IP Report, April 2007
• “Strategies for Attacking and Defending Pharmaceutical Patents: A Modern Take on ‘The Art of War,’” Intellectual Property & Technology Law Journal, December 2005 (David Tellekson and Elizabeth Richardson, co-authors)
• “Patenting Life Forms,” Biotechnology Law 2003: Biotechnology Patent & Business Strategies (S. Peter Ludwig and Samuel Woodley, co-authors)
• “Preparing Legal Opinions for Biotechnology Patents,” Biotechnology Law 2002: Biotechnology Patent & Business Strategies (S. Peter Ludwig and John Todaro, co-authors)
• “Festo and the U.S. Supreme Court: Be Careful What You Wish For,” Nature Biotechnology, 2002 (Adda Gogoris, co-author)