Don Ware is chair of the firm's Intellectual Property Department and past member of the firm's Executive Committee. He is recognized by Chambers USA, The Best Lawyers in America, IAM Patent Litigation 250, PLC Which Lawyer? and Massachusetts SuperLawyers for his prominence in intellectual property. A special emphasis of his practice is representation of biopharma companies and universities in patent and inventorship disputes, technology transfer issues, and intellectual property strategy.
Don's patent litigation experience involves a wide range of technologies. He has successfully litigated major cases involving recombinant DNA, monoclonal antibodies, siRNAs, small molecule compounds, drug delivery, molecular diagnostics, research tool patents, and medical devices. Don has also litigated patent disputes in a variety of other fields, ranging from Internet search engines to integrated circuits.
In addition to his trial practice, Don has extensive experience in appellate litigation, including appearances before the United States Supreme Court, the U.S. Court of Appeals for the Federal Circuit, and many other state and federal courts. He also has extensive experience in alternative dispute resolution, including mediation and arbitration, both as counsel and as an arbitrator in the International Chamber of Commerce and the International Centre for Dispute Resolution.
Representative Experience
The following is a brief summary of Donald's experience and accomplishments:
· Currently representing Becton, Dickinson and Company in a patent infringement suit brought by Gen-Probe involving methods of automating nucleic acid diagnostic assays and related consumable products.
· Currently representing Biogen Idec in a patent dispute with Sanofi-Aventis involving patents directed to human CMV regulatory sequences. See In re Genentech, Inc. and Biogen Idec Inc., 566 F.3d 1338 (Fed. Cir. 2009). Obtained summary judgment of non-infringement.
· Currently representing University of Massachusetts Biologic Laboratories in dispute with MedImmune over royalty obligations under technology license agreement covering MedImmune's Syangis® drug for treatment of RSV. Separate actions pending in District of Massachusetts and Maryland state court.
· Represented Johns Hopkins University and Xanthus Pharmaceuticals in Delaware Court of Chancery in a dispute over ownership of intellectual property relating to a novel method of treating autoimmune disorders, resulting in negotiation of patent license.
· Represented University of Massachusetts (UMass) in federal court action brought by Max Planck Institute and Alnylam Pharmaceuticals against three co-owners of patent applications directed to therapeutic uses of RNA interference. Obtained judgment in favor of UMass on all damages claims asserted against it. Thereafter, negotiated global settlement agreement by which UMass became a co-owner of Max Planck's competing patent applications on RNA interference.
· Represented Biogen Idec, Genzyme and Baxter Healthcare in multidistrict litigation against Columbia University challenging Axel patent on recombinant DNA technology, resulting in Columbia's grant of a royalty-free covenant not to sue.
· Defended Becton, Dickinson in a patent infringement suit brought by Enzo Biochem involving nucleotide sequences used in genetic probes. Summary judgment of invalidity was affirmed in Enzo Biochem, Inc. v. Gen-Probe, Inc. et al., 424 F.3d 1276 (Fed. Cir. 2005)
· Represented Johns Hopkins University and Baxter Healthcare in patent litigation against CellPro involving human stem cell technology. Won jury verdict of willful infringement and awards of treble damages and attorneys' fees. Judgments affirmed in Johns Hopkins Univ. v. CellPro, Inc., 152 F.3d 1342 (Fed. Cir. 1998).
· Author of numerous amicus briefs on behalf of professional and trade associations, including recent Supreme Court briefs in Mayo Clinic v. Prometheus Laboratories, and Microsoft v. i4i.
Professional / Civic Involvement
· Federal Circuit Bar Association, Member
· American Intellectual Property Law Association, Member
· Boston Patent Law Association, Member
· Boston Bar Association, Member
· Chairman, Board of Trustees, American Repertory Theater
· Master Plan Committee, Hopkinton, New Hampshire
Speeches and Conferences
Frequent speaker on patent law issues and biosimilars legislation at conferences and hearings, including: FTC Hearings on the Evolving IP Marketplace; BIO Annual Meeting; BIO IP Counsels Committee; AIPLA; Licensing Executives Society; ACI's Follow-On Biologics (Co-Chairman); ACI's FDA Boot Camp; Windhover's FDA/CMS Summit; NACUA Workshops; Suffolk Law School IP Conferences; CBI's Biopharma Forum, and others.
Publications
· Donald Ware and Nick Littlefield, Follow-on Biologics and Patent Reform, VENTURE CAPITAL REVIEW (Fall 2007)
· Patented research tool infringement - the reach-through royalties risk, LIFE SCIENCES LAW & BUSINESS (December 2004/January 2005)
· Research Tool Patents: Judicial Remedies, 30 AIPLA Q.J. 267 (2002) (cited in Integra Life Sciences v. Merck, 331 F.3d 860 (Fed. Cir. 2003))
· Donald R. Ware and Prof. Janice M. Mueller, A Trial Lawyer's Guide to Presenting Evidence on Claim Construction, 22 THE TRIAL LAWYER 152 (1999)
Industries
Life Sciences
Honors/Awards
Recognized in the 2011 IAM PATENT LITIGATION 250 as a top-ranked individual patent litigator and life sciences patent litigator
Listed in THE BEST LAWYERS IN AMERICA for intellectual property law
Recognized by CHAMBERS USA: AMERICA'S LEADING LAWYERS FOR BUSINESS as a top-ranked intellectual property lawyer (2010, 2011)
Recognized by PLC WHICH LAWYER? as a LEADING INDIVIDUAL for intellectual property
Listed in MASSACHUSETTS SUPER LAWYERS for intellectual property
Profiled in IP LAW AND BUSINESS ("The Science Guy," September 2003)
Editor, HARVARD LAW REVIEW, Harvard Law School