James M. Flaherty, Jr.
James M. Flaherty, Jr. represents clients in intellectual property litigation disputes, with a focus on biomedical patent controversies. His litigation experience also includes representing insured businesses in coverage disputes with insurers. In addition, Jim’s patent experience includes preparing and prosecuting patent applications and providing clients with opinions concerning patent validity and infringement. He also advises medical device, pharmaceutical, and biotechnology companies on federal legislative and regulatory issues relating to drug and device law.
Clients benefit from the extensive technical and regulatory background that Jim has in advanced biomedical technology and regulation. His medical device industry background includes significant experience with the FDA Quality System Regulation (QSR) and ISO 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 Johnson & Johnson, most recently as Regulatory Affairs Manager at J&J’s Codman 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:
- Representing Johns Hopkins University and Xanthus Pharmaceuticals in a dispute over ownership of intellectual property relating to a novel method of treating autoimmune disorders pending in Delaware Court of Chancery
- Representing Prospect Therapeutics, Inc. in a contract and trade secret dispute relating to the use of carbohydrate-based drugs to treat cancer pending in Massachusetts Superior Court
- 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. (eventually resolved by settlement) relating to split-tip hemodialysis catheters
- Represented Bard Access Systems, Inc. in a patent infringement action against Arrow International, Inc. (eventually resolved by settlement) 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
- Representing 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
- Representing 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
- Commercial Litigation Committee, Member
- Drug and Medical Device Committee, Member
- Regulatory Affairs Professional Society (RAPS), Member
- Alumni Interviewer, Harvard University
SPEECHES AND CONFERENCES
- Speaker, Defense Research Institute (DRI) Patents 101 Webconference (June 2008)
- Speaker, Drug Information Association (DIA) 44th Annual Meeting, Substantial Equivalence in 510(k)s: Interpretations and Pitfalls (June 2008)
- Speaker, Regulatory Affairs Professional Society (RAPS) 2003 Annual Conference and Exhibition, Premarket Regulatory Activities and Patent Infringement: Just How Safe is the “Safe Harbor”? (October 2003)
- Speaker, New England Biomedical Discussion Group (ASQ Biomedical Division) conference entitled “International Regulatory Requirements," General Regulatory Requirements Across Differing Regions: Requirements, Coordination, and Tracking (September 2001)
publications
- Defending Substantial Equivalence: An Argument for the Continuing Validity of the 510(k) Premarket Notification Process, 63 FOOD DRUG L.J. (forthcoming 2008)
- PMA Primacy: Synthesizing the 35 U.S.C. § 156 Patent Term Extension, 35 U.S.C. § 271(e)(1) Patent Infringement Exemption as Currently Applied to Medical Devices, and Medical Device Preemption Jurisprudence to Yield a Cohesive Solution Regarding Scope of Coverage, 56 FOOD DRUG L.J. 339 (2001)
- Contributed to Chapter 18: Food and Drug Law, Developments in Administrative Law and Regulatory Practice 2000-2001 (2002)