Michele M. Simkin

Michele M. Simkin

Michele M. Simkin is a partner with Foley & Lardner LLP, where she serves as chair of the Biotechnology & Pharmaceutical Practice and vice-chair of the Intellectual Property Department. Ms. Simkin provides strategic business counseling to life sciences clients relating to all aspects of intellectual property, including patent procurement and portfolio management, licensing agreements, and validity, non-infringement, and freedom to operate analyses. Ms. Simkin has over 19 years of experience in the patent field. She is also a member of the firm's Chemical & Pharmaceutical Practice and Life Sciences and Nanotechnology Industry Teams.

Ms. Simkin is a former patent examiner in the biotechnology group of the U.S. Patent and Trademark Office. Her technical experience encompasses drug delivery systems, including nanotechnology drug delivery systems, pharmaceuticals, biologics, virology, and immunology. Ms. Simkin was selected by her peers for inclusion in the 2008 and 2010 editions of The Best Lawyers in America® for her work in biotechnology law.

Ms. Simkin graduated from the University of Wisconsin-Madison (B.S., biochemistry and molecular biology, 1988) and The George Washington University National Law Center (J.D., 1993). She is registered to practice before the U.S. Patent and Trademark Office, and is admitted to practice in the District of Columbia, the U.S. Court of Appeals for the Federal Circuit, and the District Court for the District of Columbia. She is also a member of the American Intellectual Property Law Association and the American Bar Association. Ms. Simkin has lectured on and has authored a number of articles on intellectual property topics, including:

· "How Will Intellectual Property Factors Affect the Commercialization of Stem Cell Therapeutics," BioEurope 2005

· "Squeak Squeak: Patenting of the Harvard Mouse and Where We Go From Here," Intellectual Property Today, Vol. 11, No. 2 (February 2004)

· "US as a Biotech and Pharmaceutical Marketplace: Strategies for European-based Companies to Avoid US Patent Infringement," BioEurope 2003

· "Application of Nanotechnology: A Case Study in the Pharmaceutical Arena," Boston, MA (June 2003) (co-chair of the conference)

· "Licensing and Intellectual Property Concerns Relative to Pharmaceutical & Biotechnology Collaborations," New York, NY (May 2003)

· "Structuring Biotech Transactions with U.S. Partners: Practical Tips for Identifying Challenges and Minimizing Risks," presentation in Martinsried, Germany (April 2005)

· "Follow-on Biologics: Forecasting the FDA White Paper," Webinar presentation (September 2005)

· "How Will Patents Affect the Commercialization of Stem Cell Therapeutics?" Poster presentation at ISSCR conference (2006)

· "How Will Patents Impact the Commercialization of Stem Cell Therapeutics," ISPE Journal of Pharmaceutical Innovation, by Todd Spalding and Michele Simkin (October 2007)