Ware

Donald R. Ware

Partner
Boston
Don Ware is a past Chair of the firm’s Intellectual Property Department and represents leading biopharma manufacturers, research institutions, and universities in patent and inventorship disputes, technology transfer issues, and intellectual property strategy. He advises clients on FDA matters, including the FDA's regulatory pathway for approval of biosimilars, and issues arising under the Bayh-Dole Act. He has represented the patent holders in several Bayh-Dole March-In proceedings, including the first such proceeding, In re CellPro, Inc.

In 2024, Don was named to the Massachusetts Lawyers Weekly Hall of Fame. His award noted that he has “litigated and prevailed in some of the most consequential and complex patent cases of the last 50 years, helping shape IP law in the state as counsel to many of the world’s leading research institutions and biopharma companies." This year, Don was named as a finalist for the Life Sciences Patent Network's innaugural Lifetime Acheivement Award. Don was also named the 2021 General Patent Litigator of the Year – New England by LMG Life Sciences in recognition of his notable work, dedication to clients and significant influence on the life sciences industry. Chambers USA reports “The spectacular Donald Ware is recognized for his strength handling patent infringement claims. Commentators say "He is very, very smart, very litigation savvy, an exceptionally good writer of briefs and papers, and a good litigation strategist." IAM’s Patent 1000 describes Don as “imaginative and solutions-oriented,” quoting clients as saying he makes opposing parties “crazy in the best possible way. He is always out in front of issues. Litigating against him is like playing chess - it is necessary to think at leas[t] several moves ahead, which makes him a challenging opponent.” Don is also ranked as a leading IP attorney in The Best Lawyers in America, Managing Intellectual Property’s IP Stars and Massachusetts SuperLawyers.

Don’s patent litigation experience involves a wide range of technologies. In the field of life sciences, he has successfully litigated major cases involving recombinant DNA, monoclonal antibodies, fusion proteins, 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 is also experienced in alternative dispute resolution, including mediation and arbitration, both as party counsel and as an arbitrator in the International Chamber of Commerce and the International Centre for Dispute Resolution.

Education

  • Harvard Law School, J.D., magna cum laude
  • Yale College, A.B., magna cum laude

Experience

  • Represented Dana-Farber as lead counsel in second case against Bristol-Myers Squibb and Ono Pharmaceuticals, asserting claims for unjust enrichment and unfair competition for depriving Dana-Farber of its co-ownership rights under eight patents directed to cancer immunotherapy. On the eve of trial, in the face of Dana-Farber’s claim for hundreds of millions of dollars in damages, Defendants settled, making a substantial lump sum payment to Dana-Farber and agreeing to make potential additional payments, contingent on future events.  
  • Represented Dana-Farber Cancer Institute in patent litigation against Bristol-Myers Squibb and Ono Pharmaceutical concerning inventorship and ownership of groundbreaking patents directed to PD-1/PD-L1 cancer immunotherapy.  As lead counsel in 9-day federal court trial, obtained judgment for Dana-Farber correcting inventorship, making Dana-Farber a co-owner of all the patents.  The Court of Appeals for the Federal Circuit affirmed the judgment in all respects, 964 F.3d 1365 (Fed. Cir. 2020), and the United States Supreme Court denied Defendants’ petition for writ of certiorari (May 2021).
  • Represents Geneoscopy, Inc. in patent litigation brought by Exact Sciences, Inc. accusing Geneoscopy's RNA-based test for colorectal cancer of infringing patents acquired by Exact Sciences directed to fecal sample processing.  Also represents Geneoscopy in IPR proceedings in the USPTO PTAB challenging the validity of the asserted patents.
  • Represented leading medical school in confidential commercial arbitration seeking substantial damages under a profit-sharing affiliation agreement. 
  • Defended Biogen in a litigation brought by Knopp Neurosciences concerning ownership of patient biosamples obtained by Biogen in a phase 3 clinical trial investigating the treatment of ALS. Obtained dismissal with prejudice of Knopp's claim just before trial.
  • Represented 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. Obtained favorable settlement, including global license to patent estate, just before trial.
  • Represented Biogen in a patent litigation with Sanofi-Aventis involving patents directed to human CMV regulatory sequences.  Obtained Writ of Mandamus ordering transfer of venue from Eastern District of Texas. 566 F.3d 1338 (Fed. Cir. 2009).  Obtained judgment of non-infringement, affirmed on appeal. 473 Fed. Appx. 885 (Fed. Cir. Mar. 22, 2012)
  • Represented University of Massachusetts Biologic Laboratories in dispute with MedImmune over royalty obligations under technology license agreement covering MedImmune's Synagis® drug for treatment of RSV. Obtained judgment after trial requiring MedImmune to continue paying eight-figure royalties. Judgment affirmed on appeal.
  • 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.
  • Defended 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, Genzyme and Baxter Healthcare in multidistrict litigation challenging Columbia University's Axel patent on recombinant DNA technology, resulting in a 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 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 Supreme Court briefs in Amgen v. Sandoz, Cuozzo Speed Technologies, LLC v. Lee, Octane Fitness v. Icon, Mayo Clinic v. Prometheus Laboratories, and Microsoft v. i4i.

Other Publications

  • Co-author with Martha Born, "Big Case Management and the Pursuit of Happiness"
  • Co-author with 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))
  • Co-author with Janice M. Mueller, "A Trial Lawyer's Guide to Presenting Evidence on Claim Construction," 22 The Trial Lawyer 152 (1999)

Honors & Involvement

HONORS
  • Best Lawyers: Biotechnology and Life Sciences Practice, Litigation Intellectual Property; Litigation - Patent (2027)
  • Massachusetts Lawyers Weekly: Hall of Fame (2024)
  • Managing IP - Notable Practitioner Nationally and for Massachusetts (2023, 2024)
  • Listed in Who's Who Legal 2022: Life Sciences – Patent Litigation (Global Guide)
  • Listed in IAM Global Leaders Guide (2025, 2026)
  • LMG Life Sciences
    • Recognized as 2021 General Patent Litigator of the Year – New England
    • Recognized as 2024 General Patent Litigation Life Science Star
    • Listed in 2025 U.S. Firm & Lawyer Rankings for General Patent Litigation
  • Recognized by IAM Patent 1000 as a top-ranked patent litigator and life sciences patent litigator (2019, 2023-2025)
  • Recognized by The Best Lawyers in America for intellectual property law 
  • Recognized by Chambers USA: Senior Statespeople Category
  • 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
BAR INVOLVEMENT 
  • American Intellectual Property Law Association, Committee on Legislation
  • BIO Intellectual Property Counsels Committee
  • Federal Circuit Bar Association, Member
  • Boston Intellectual Property Law Association (BIPLA), Member
  • Boston Bar Association, Member

COMMUNITY INVOLVEMENT 
  • Board of Advisors, Yale School of Drama
  • Board of Overseers, WGBH (public television and radio)
  • Board of Trustees, The Nature Conservancy, New Hampshire
  • Past Chairman of Board of Trustees, American Repertory Theater

Speaking Engagements

  • “Navigating the Road of Joint Inventorship," 2025 BIO IP Conference (November 2025)
  • "Inflation Reduction Act, March-in Rights & Other Developments in Pricing," Pharma Law USA (October 2024)
  • "Intellectual Property and Trademark Considerations and Timing," Foley Hoag FDA and Life Sciences Summit (May 2024)
  • "March-in Power and Patent Rights: Bayh-Dole Act, NIST Framework, Implications for Patent Rights and Innovation," Strafford Webinar (April 2024)
  • "The New Framework for March-In Rights: Potential Impact on University Partnerships and IP Licensing," Tech Transfer Central Webinar (February 2024)
  • Frequent speaker on patent law issues and biosimilars legislation at conferences and hearings, including: Co-Chairman, ACI's Annual Summit on Biosimilars; FTC Hearings on the Evolving IP Marketplace; BIO Annual Meeting; BIO IP Counsels Committee; AIPLA; Licensing Executives Society; ACI's FDA Boot Camp; Windhover's FDA/CMS Summit; NACUA Workshops; Suffolk Law School IP Conferences; CBI's Biopharma Forum, and others.