James M. Flaherty, Jr. represents clients in intellectual property litigation disputes, with a focus on biomedical patent controversies. He also advises medical device, pharmaceutical, and biotechnology companies on federal legislative and regulatory issues relating to FDA law and regulation. In addition, Jim's litigation experience includes representing insured businesses in coverage disputes with insurers, and his patent experience includes preparing and prosecuting patent applications and providing clients 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 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 has held the Certified Regulatory Affairs Professional (RAC) designation of the Regulatory Affairs Professional Society (RAPS) since 1997.
Representative Experience
The following is a brief summary of James's experience and accomplishments:
· Filed an amicus brief in the United States Supreme Court on behalf of the Association of University Technology Managers (AUTM) in Mayo Collaborative and Mayo Clinic Rochester v. Prometheus Laboratories, Inc., arguing the importance of patents in the transfer of early-stage research for further development and commercialization
· Filed an amicus brief in the United States Supreme Court on behalf of the American Intellectual Property Law Association in Microsoft Corp. v. i4i, concerning the standard of proof required to invalidate a patent
· Representing Fresenius Medical Care in Hatch-Waxman patent litigation against multiple generic drug manufacturers arising out of the filing of Abbreviated New Drug Applications to market generic versions of Fresenius's patented PhosLo® brand calcium acetate drug for end stage renal disease
· Representing a medical device manufacturer in an effort to obtain reimbursement of more than $100 million from excess insurance carriers that have declined coverage based on alleged FDA regulatory noncompliance among other allegations
· Won summary judgment on liability of insurer to indemnify insured for loss arising from dishonesty of IT director, who diverted substantial company funds to entities he owned or controlled. Case settled following summary judgment rulings. See EaglePicher Mgmt. Co. v. Zurich Am. Ins. Co., 640 F. Supp. 2d 1109 (D. Ariz. 2009)
· Represented 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
· Represented Prospect Therapeutics, Inc. in a contract and trade secret dispute relating to the use of carbohydrate-based drugs to treat cancer 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 patent-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
· Represented multiple clients in lawsuits seeking recovery under commercial crime insurance policies for losses sustained due to employee theft
· 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
Professional / Civic Involvement
· Boston Patent Law Association (BPLA)
- Co-Chair, Medical Devices Committee
· Food and Drug Law Institute (FDLI)
- Invited Member, Austern Writing Awards Committee-Short Papers
· MassMEDIC-Massachusetts Medical Device Industry Council
· Regulatory Affairs Professional Society (RAPS)
· American Bar Association (ABA)
· Massachusetts Bar Association (MBA)
· Boston Bar Association (BBA)
· Alumni Interviewer, Harvard University
Speeches and Conferences
· Speaker, FDA and the 510(k) Process: What to Expect Now and Down the Road, Medical Development Group (MDG) Forum (December 2011)
· Speaker, First Impressions Discussion: Therasense v. Beckton, Dickinson, Boston Bar Association (BBA) Intellectual Property Law Section (June 2011)
· Speaker, Biosimilars: Data Exclusivity and Patent Enforcement, Regulatory Affairs Professional Society (RAPS) 2010 Annual Conference and Exhibition (October 2010)
· Panelist, From Science to Compliance: Navigating the Regulatory Maze (June 2009)
· Speaker, Recent CDRH Developments Following the GAO 510(k) Report, Massachusetts College of Pharmacy and Health Sciences (MCPHS) Regulatory Affairs and Health Policy (RAHP) Annual Meeting (May 2009)
· Speaker, Patents 101, Defense Research Institute (DRI) Webconference (June 2008)
· Speaker, Substantial Equivalence in 510(k)s: Interpretations and Pitfalls, Drug Information Association (DIA) 44th Annual Meeting (June 2008)
· Speaker, Premarket Regulatory Activities and Patent Infringement: Just How Safe is the "Safe Harbor"?, Regulatory Affairs Professional Society (RAPS) 2003 Annual Conference and Exhibition (October 2003)
· Speaker, General Regulatory Requirements Across Differing Regions: Requirements, Coordination, and Tracking, New England Biomedical Discussion Group (ASQ Biomedical Division) conference entitled "International Regulatory Requirements," (September 2001)
Publications
· Co-Author, FDA Deviations in Menaflex Knee Device Clearance, Law360 (October 5, 2009)
· Defending Substantial Equivalence: An Argument for the Continuing Validity of the 510(k) Premarket Notification Process, 63 FOOD DRUG L.J. 901 (2008) (with permission from FDLI)
· 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) (with permission from FDLI)
· Contributed to Chapter 18: Food and Drug Law, Developments in Administrative Law and Regulatory Practice 2000-2001 (2002)
Industries
Life Sciences
Honors/Awards
Listed as a 'Rising Star' in Intellectual Property Litigation, Super Lawyers' Massachusetts Rising Stars: A Comprehensive Listing of the Best Young Lawyers in Massachusetts (2005-2008)
Suffolk University Law School Intellectual Property Concentration, with Distinction
Suffolk University Law Review, Editorial Board
2001 Food and Drug Law Institute (FDLI) H. Thomas Austern Memorial Award Competition, Second Place
Codman & Shurtleff, Inc. President's Award, April 2001
Johnson & Johnson Signature of Quality (SOQ) Award, August 1998
Related Professional Experience
Adjunct faculty member at Northeastern University, teaching Biomedical Intellectual Property Management