Leslie A. McDonell

Partner

Leslie McDonell provides strategic counseling to clients 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, due diligence, and freedom to operate.

Ms. McDonell has represented clients before the United States 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. The technologies involved have included involving 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.

Highlights

• Represented Eli Lilly against charges of infringement by Chiron in the development of an HCV small molecule therapeutic in the Northern District of California resulting in a favorable settlement.
• Represented Wyeth against charges of infringement by Schering Plough for the sale of loratidine in the District of New Jersey.
• Participated in actions by Biogen against Medeva for infringement of patents covering hepatitis B antigens in the UK 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.
• 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.
• 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.

Professional Recognition

• Listed as a rising star in Massachusetts Super Lawyers (2005).

Professional Activities

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

Select Publications

• 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," 4^th Edition, 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, Apr. 10, 2006.