Donald R. Ware

  • Partner
  • Boston
  • 617 832 1167 direct
  • 617 832 7000 fax

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, 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. Most recently, he has worked on behalf of these clients to help shape proposed federal legislation affecting their intellectual property rights.

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 and in the U.S. Courts of Appeals for the Federal Circuit, and many others. He also has extensive experience in alternative dispute resolution, including mediation and arbitration, both as counsel and as an arbitrator in the American Arbitration Association and the International Chamber of Commerce.

Bars and Court Admissions

  • Massachusetts
  • U.S. District Court for the District of Massachusetts
  • U.S. District Court for the Eastern District of Texas
  • U.S. Court of Appeals, Federal Circuit
  • U.S. Court of Appeals, First Circuit
  • Supreme Court of the United States

Representative Experience

The following is a brief summary of Donald's experience and accomplishments:

  • Filed an amicus brief in the United States Supreme Court on behalf of the Association of University Technology Managers 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. i41, concerning the standard of proof required to invalidate a patent

  • Currently representing Becton Dickinson 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 the Classen Immunotherapies case on remand from Supreme Court to the Federal Circuit involving the scope of patentable subject matter under 35 U.S.C. § 101.

  • 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)
  • Currently 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

  • Represented Biogen Idec, Genzyme and Baxter Healthcare in multidistrict litigation against Columbia University challenging patent on recombinant DNA technology, resulting in Columbia’s grant of a royalty-free covenant not to sue

  • Defended Becton, Dickinson and Company 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)

  • Defended Atrix Laboratories in patent infringement suit brought by Takeda Pharmaceuticals involving biodegradable polymers used for drug delivery, resulting in a settlement by which Atrix obtained a royalty-free license under Takeda’s past and future patents to make and sell Atrix’s prostate cancer drug Eligard®

  • 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)

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

  • Don 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)