Leslie A. McDonell

Partner

Leslie McDonell provides strategic counseling regarding the protection of intellectual property in the pharmaceutical, biotechnology, and medical device industries. She coordinates worldwide patent portfolio strategies, evaluates and analyzes competitors' patent positions around the world, and advises and renders opinions on issues of patentability, inventorship, validity, claim scope, infringement, and freedom to operate. She has managed due diligence investigations, pre-Orange Book analyses, and pre-litigation analyses.

In addition, she has represented clients before the U.S. Patent and Trademark Office in patent appeals, interferences, reissues, and reexaminations. Her U.S. litigation experience includes representation of both plaintiff and defendants in biotechnology and pharmaceutical cases.

Ms. McDonell has prepared and prosecuted patent applications throughout the world and has been involved in opposition and appeal proceedings in numerous countries and at the European Patent Office (EPO). Her experience includes immunology, virology, and molecular and cellular biology, including antibody technology, gene cloning and expression, gene therapy, vaccines and diagnostics, inflammatory and autoimmune disease therapies, cancer therapies, synthetic organic chemistry, and small molecules.

Ms. McDonell is a frequent guest speaker on the affirmative use of and best defense to inter partes reexamination and has extensively studied post issuance procedures available under the 2011 patent reform legislation. In addition, she is a regular contributor to International Chamber of Commerce's IP publication Current and Emerging Intellectual Property Issues for Business: A Roadmap for Business and Policy Makers.

Highlights

• Represented Eli Lilly against charges of infringement in the development of an HCV small molecule therapeutic in N.D. California resulting in a favorable settlement.
• Represented American Home Products in a Paragraph IV ANDA litigation involving generic loratadine products.
• Participated in actions by Biogen against Medeva for infringement of patents covering hepatitis B antigens in the U.K. Patent Court, Court of Appeals, and House of Lords. Also assisted in the successful defense against opposition of these same patents at the EPO’s Technical Board of Appeals.
• Serves on Law360's Intellectual Property Editorial Advisory Board, 2011.
• Represented Biogen, Genetics Institute, Wyeth, and Creative BioMolecules in interferences involving molecular biology inventions.
• Served as judicial extern to the Honorable Judith N. Keep of the Southern District of California, 1988.
• Former research associate at University of Chicago’s Michael Reese Hospital, concentrating on the study of the molecular control of epithelial transport and proton chemistry, 1984-1985.

Professional Recognition

• Recognized as a leader in patent counseling in the field of life sciences in the U.S. by Practical Law Company’s Which Lawyer, 2010.
• Listed in Massachusetts Super Lawyers, 2007; featured as a rising star, 2005.

Professional Activities

• BIO Intellectual Property Counsels' Committee
• American Intellectual Property Law Association
• American Bar Association (subcommittee chair, Intellectual Property Law Committee)
• Boston Bar Association (subcommittee chair, Intellectual Property Section)
• Boston Patent Law Association
• Massachusetts Biotechnology Council

Select Publications

• "Patent Reform May Not Cure a Potential for Bias Against Patentee in Inter Partes Reexamination," IP Strategist, Aug. 2011.
• "Patent Term After Wyeth v. Kappos," Massachusetts Lawyers Weekly, March 22, 2010.
• Coauthor. "From Clones to Claims, The European Patent Office's Case Law on the Patentability of Biotechnology Inventions in Comparison to the United States and Japanese Practice," Heymanns, 2006.
• "'Radical' Changes Proposed by USPTO Will Alter Patent Process," Massachusetts Lawyers Weekly, May 1, 2006.
• "Supreme Court to Clarify What Can Be Patented," Massachusetts High Tech, April 10, 2006.