Leslie McDonell

Leslie A. McDonell, managing partner of the firm’s Boston office, provides strategic counseling to both startups and larger companies on the procurement and protection of intellectual property in the pharmaceutical and biotechnology industries.

She has extensive experience in conducting due diligence investigations and preparing companies to be the target of a due diligence, pre-litigation analyses, and offensive and defensive post-grant proceedings.

Leslie has represented clients before the U.S. Patent and Trademark Office (USPTO) in patent appeals, interferences, reissues, reexaminations, and inter partes reviews (IPRs). Her U.S. litigation experience includes representation of both plaintiffs and defendants in biotechnology and pharmaceutical cases.

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.

In addition, she 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).

She has patent experience in the fields of immunology, virology, molecular and cellular biology, and small molecule and natural product pharmaceuticals, including antibody technologies, RNA-based gene therapies, vaccines and diagnostics, inflammatory and autoimmune disease therapies, metabolic disorder therapies, pluripotent and stem cell therapies, and cancer therapies.

Leslie represented Biogen against Medeva for infringement of patents covering hepatitis B antigens in the U.K. Patent Court, Court of Appeals, and House of Lords. She also assisted in the successful defense against opposition of these same patents at the EPO’s Technical Board of Appeals.

She represented Institut Pasteur in a series of inter partes reexaminations of patents involving homologous recombination technology. Leslie successfully appealed USPTO decisions on key patent applications for Syntonix Pharmaceuticals and University of Edinburgh.

She has represented Biogen, Genetics Institute, Wyeth, and Creative BioMolecules in interferences involving molecular biology inventions. Leslie is a frequent guest speaker on the affirmative use of and best defense to inter partes reexamination and IPRs.

She has extensively studied and is a guest speaker on the impact of the America Invents Act (AIA) on the biotechnology and pharmaceutical industries. Various recognitions of Leslie’s practice include being named as a leader in the field of intellectual property law by Chambers USA, and a WIPR Leader for patents in the United States by World IP Review.

The Legal 500 U.S. listed Leslie for patent prosecution, re-examinations, and post-grant proceedings, and for patent portfolio management and licensing. Managing Intellectual Property recognized her as an “IP Star Top 250 Women in IP,” and as an “IP Star” in Massachusetts. And LMG Life Sciences has consistently ranked Leslie as an Intellectual Property: Life Sciences Star.

Education :

• University of San Diego School of Law J.D., 1988
• Eastern Virginia Medical School Biomedical Sciences Program, 1983-1984
• Virginia Polytechnic Institute & State University B.S., Microbiology, 1981

Clerkships :

• U.S. District Court, S.D. California

Admissions :

• California
• District of Columbia
• Massachusetts
• New York
• U.S. Patent and Trademark Office

Professional Activities :

• BIO Intellectual Property Counsels’ Committee
• American Intellectual Property Law Association
• American Bar Association (Subcommittee chair, Intellectual Property Law Committee -present)
• Boston Bar Association (Subcommittee chair, Intellectual Property Section -present)
• Boston Patent Law Association (Co-chair, Amicus Committee -present)
• Massachusetts Biotechnology Council