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James M. Flaherty, Jr.
Associate
Registered Patent Attorney
Boston
James Flaherty, Jr. represents clients in intellectual property litigation disputes, with a focus on biomedical and telecommunications patent controversies. Jim's litigation experience also includes representing insured businesses in coverage disputes with insurers. In addition, he advises medical device, pharmaceutical, and biotechnology companies on federal legislative and regulatory issues relating to food, drug, and device law.
Jim has experience preparing and prosecuting patent applications involving medical devices, biomedical technologies, Internet commerce, and mechanical devices. He provides clients in these and other industries with opinions concerning patent validity and infringement.
Clients benefit from the extensive technical and regulatory background that Jim has in advanced biomedical technology and regulation. His industry background in quality systems compliance includes significant experience with the FDA Quality System Regulation (QSR) and ISO 9000-series standards, and he has handled such domestic and international medical device regulatory submissions as PMAs, 510(k)s and European CE Mark Design Dossiers. Prior to joining Foley Hoag, Jim spent five years with one of the world's largest providers of health care products, most recently as Regulatory Affairs Manager at the company's neurosurgical devices division. He holds the Certified Regulatory Affairs Professional (RAC) designation of the Regulatory Affairs Professional Society (RAPS).
Bars and Court Admissions
Massachusetts
U.S. District Court for the District of Massachusetts
U.S. Court of Appeals, First Circuit
U.S. Court of Appeals, Federal Circuit
U.S. Patent & Trademark Office (Agency)
Representative Experience
The following is a brief summary of James's experience and accomplishments:
Defended a pharmaceutical manufacturer in a patent infringement suit (eventually resolved by settlement) involving biodegradable polymers used for drug delivery
Defended a wireless service company in a patent infringement action relating to prepaid wireless technology that resulted in a settlement that enabled the provider to obtain licenses under the patents-in-suit
Represented Bard Access Systems, Inc. and a French inventor in a patent infringement action against Arrow International, Inc. and Diatek, Inc. relating to split-tip hemodialysis catheters
Represented Bard Access Systems, Inc. in a patent infringement action against Arrow International, Inc. relating to catheter guidewires
Represented and secured a favorable settlement for Meretek Diagnostics, Inc. in a patent infringement action against Oridion BreathID, Inc. relating to methods for diagnosing the presence Helicobacter pylori though breath testing
Filed an amicus brief in the Court of Appeals for the Federal Circuit on behalf of the American Intellectual Property Law Association in In re Bilski, concerning the scope of statutory subject matter under 35 U.S.C. § 101
Represents a medical device manufacturer in an effort to obtain reimbursement of more than $100 million from excess insurance carriers in connection with alleged device failure
Represents multiple clients in lawsuits seeking recovery under commercial crime insurance policies for losses sustained due to employee theft
professional / civic involvement
American Bar Association (ABA), Member
Intellectual Property Law Section, Member
Federal Trial Practice and Procedure Committee, Member
Massachusetts Bar Association (MBA), Member
Boston Bar Association (BBA), Member
Defense Research Institute (DRI), Member
Regulatory Affairs Professional Society (RAPS), Member
SPEECHES AND CONFERENCES
Premarket Regulatory Activities and Patent Infringement: Just How Safe is the "Safe Harbor"?, given at the Regulatory Affairs Professional Society (RAPS) 2003 Annual Conference and Exhibition (October 2003).
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