Edwards, R. Gregg

MJ Edwards is a counsel in the firm's Intellectual Property Department and a member of the Intellectual Property Litigation Practice Group and Life Sciences Group. She joined the firm in 2002.

Practice

Ms. Edwards focuses her practice on patent prosecution, litigation and opinion work in the fields of pharmaceuticals, chemistry, chemical engineering and materials science. Ms. Edwards counsels clients regularly on issues related to patent protection, such as whether and when to file patent applications, where to file foreign patent applications, and inventorship determinations. She is experienced in developing patent protection strategies and managing patent portfolios for an array of products, including small molecule pharmaceutical compounds, compositions and excipients. Her experience includes drafting patent applications as well as prosecuting patent applications in the United States and worldwide. Ms. Edwards also has experience procuring patent protection for clients in the fields of battery technology, chemical and industrial waste recycling, and medical- and chemical-based software. Ms. Edwards is experienced with post-grant patent prosecution including reissue and reexamination proceedings and analysis of patent term restoration.

Ms. Edwards has been involved in the preparation of patentability, infringement and validity opinions. She has experience performing diligence investigations of target companies as part of potential corporate deals. Her experience includes conducting and analyzing results of chemical structure-based searches of patent and non-patent literature.

Ms. Edwards has represented clients in patent litigation in the areas of pharmaceuticals and medical devices. In particular, she has represented innovator pharmaceutical companies in ANDA litigation, defending against generic challenges to branded drug products. Her experience also includes conducting a pre-litigation investigation in anticipation of a Paragraph IV challenge from a generic drugmaker.

Prior to joining WilmerHale, Ms. Edwards worked as an analytical chemist at Eli Lilly and Company for five years, where her work involved shepherding products from discovery R&D through the regulatory approval process and into manufacturing. She is experienced in the development and validation of analytical methods, including ensuring regulatory compliance with United States (FDA) and European standards. She has experience with the development and submission of regulatory applications, including Investigational New Drug (IND) applications and supplemental New Drug Applications (NDA) and is experienced with International Committee for Harmonization (ICH) guidelines for the development of pharmaceutical products. Also prior to joining WilmerHale, Ms. Edwards worked for a small Boston-based start-up pharmaceutical company that was preparing for its first NDA submission.

At Boston College Law School, Ms. Edwards served as executive editor of the Boston College Law Review.

Representative Client Matters

• Coordinated day-to-day prosecution of a specialty pharmaceutical company’s patent portfolio in the area of novel delivery systems. The portfolio included over 50 U.S. applications and their associated foreign applications.
• Performed prelitigation investigation for a large pharmaceutical client in anticipation of an ANDA Paragraph IV challenge to a patented drug
• Represented a medical device company in a patent dispute in the Northern District of California concerning angioplasty catheter technology
• Represented innovator drug companies in ANDA litigation involving Paragraph IV challenges from generic drug companies
• Performed freedom-to-operate diligence analysis of patent landscape in the area of chemistry and electrochemistry to local technology company
• In pro bono representation, successfully represented an artist whose work was copied without permission in having a large mural removed from a public wall

Professional Activities

Ms. Edwards currently serves on the Board of Directors of the Massachusetts Lesbian and Gay Bar Association.

Ms. Edwards is a member of the Boston Patent Lawyers Association, Intellectual Property Law section of the American Bar Association, and the American Intellectual Property Law Association.

Honors and Awards

Ms. Edwards was named a "Massachusetts Super Lawyers' Rising Star" in the May 2006, 2007 and 2008 issues of Boston Magazine.

Publications

MJ Edwards, Colleen Superko, Hollie L. Baker, “New Legislative Approval Pathway For Biosimilars,” WilmerHale Intellectual Property Alert, April 1, 2010

MJ Edwards and Donald Steinberg, “The Implications of Bilski: Patentable Subject Matter in the United States” IDEA: The Intellectual Property Law Review, Vol. 49: No.3 – 2009