Kathleen Madden Williams, Ph.D.
Firm: Sunstein Kann Murphy & Timbers LLP
Address: 125 Summer Street
Boston, MA 2110
University: Smith College, B.A., with high honors, 1977; Brown University, Ph.D., with distinction, 1986, New England School of Law, J.D., 1991
Admitted: 1992, Massachusetts; 1993, U.S. Court of Appeals for the Federal Circuit; 1996, U.S. Supreme Court; U.S. District Court, District of Massachusetts; registered to practice before U.S. Patent and Trademark Office, 1991
Biography: Dr. Williams is an intellectual property attorney who specializes in complex legal issues surrounding the protection of discoveries in the life sciences. Her technology focus spans biology, molecular biology, biochemistry, medicinal chemistry, chemistry, pharmacology, and devices in commercial space such as biotech, pharmaceuticals, therapeutics, diagnostics, nanotechnologies, bio-energy, cleantech and medical devices. She has extensive experience advising biotech and pharmaceutical clients on strategic legal issues relating to intellectual property, which includes helping companies avoid roadblocks and laying the groundwork for new commercial efforts. She provides advice to clients on patent portfolio creation and management, patentability and freedom to operate legal opinions, patent prosecution, and intellectual property due diligence for investments. Kathy works closely with companies to ensure that intellectual property is effectively protected and/or avoided in their business deals. Her clients include start-up life sciences companies, as well as pharmaceutical companies, research institutions and investors. Kathy has been named a "Life Science Star" by LMG Life Sciences 2012. Recent Speaking Engagements and Publications · "Human Genes as Company Property Tested by Myriad Patent Case", quoted, BloombergBusinessWeek, July 19, 2012. · "The Small RNA Intellectual Property and Deal Landscape: Still Early and Evolving," speaker, BIT's 1st World Congress of Small RNAs, November 5, 2011, Shenzhen, China. · "IP Overview for Drugs and Biologics: Hatch-Waxman, BPCIA, Trade Dress, and More," speaker, Paragraph IV Biosimilars, American Conference Institute, New York, New York, May 3, 2011. · "RNAi IP Landscape in 2011," speaker, Select Biosciences, RNA and miRNA World Congress, Boston, Massachusetts, April 20, 2011. · "Intellectual Property and Regulatory Interplay for Biosimilars," speaker, CHI Characterization and Comparability of Biologics, Bethesda, Maryland, April 7, 2011. · "IP Foundations for Early Stage Biotechs," speaker, Brandeis University, Rosensteil Center Biotech Conference, Waltham, Massachusetts, Feb. 11, 2011. · "Getting Beyond the Basics of Ariad v. Lilly: Having Claim Drafting Strategies Changed in Ariad's Wake?," 12th Advanced Forum on Biotech Patents, November 30 - December 1, 2010. · "Patent and IP Overview: Hatch-Waxman, Trade Dress and More," FDA Boot Camp, ACI, Boston, September 27 - 28, 2010. · "Diagnostics Intellectual Property: Bright Opportunities but Sophisticated Burdens," qPCR Europe, Dublin, Ireland, September 14 - 15, 2010. · "Bioequivalence and the "Same Active Ingredient" vis-a-vis Patentability, and the Biosimilars Legislation", Hatch-Waxman Boot Camp, ACI, Boston, July 2010. · "Intellectual Property Issues Relating to Therapeutic Oligos and Peptides", Tides, IBC, Boston, Massachusetts, April 2010. · "Patenting and Protecting Diagnostic Methods", Biotech Patenting, C5, Munich, Germany, March 2010. · "RNAi and Peptide Intellectual Property Landscapes: Early and Evolving", AsiaTides, Oligonucleotides and Peptides, IBC, Tokyo, February 2010. · "Patents on Biologics, Follow-ons and Innovative, with an Eye To Improved Properties", Immunogenicity Summit, CHI, Philadelphia, October 2009. · "Developing Global Biotech Patent Strategies and Identifying Key Rule Changes in Foreign Patent Offices", speaker, American Conference Institute's (ACI) 11th Advanced Forum on Biotech Patents, September 30 - October 1, 2009. · "RNAi: The Intellectual Property Landscape - Early and Evolving," speaker, RNA Interference Summit, June 8 - 10, 2009. · "Protecting Your IP and Commercializing Your Technology: The Devil is in the Details," speaker, The Business of Genomics: Bridging the Gap from Concepts to Realization Symposium, June 8 - 10, 2009. · "Synergistic IP Protection for U.S. and European Patents," speaker, 4th BioTrinity Oxford, April 2, 2009. · "Biotechnology Companies, Outlook 2009," Panel Chair, 5th BioExecutive Institute, March 5, 2009. · "RNAi: The Intellectual Property Landscape: Early and Evolving, " speaker, CBI, January 27, 2009. · "Intellectual Property in the Life Sciences," speaker, Brown University, November 7, 2008. · "The Intersection of Patent and FDA: Maximizing Protection," speaker, American Intellectual Property Law Association, Annual Conference, November 4, 2008. · "Drafting Patent Claims to Maximize Coverage/Patent Enforcement Power," presenter, as part of the "Everything an IP Lawyer Needs to Know About FDA Law," AIPLA 2008 Annual Meeting, Washington, DC, October 23, 2008. · "Does Unambiguous Proof of A Target Binding Region (Epitope) Permit Enhanced Patent Protection," speaker, CHI PSS Biologics Conference, May 1, 2008. · "Patent Counsel's Vital Role in & Guide to Important Corporate Transactions," instructor, presented by Patent Resource Group, Indian Wells, California, October 25 - 27, 2007. · "The Master Class on Drafting Successful Patent Applications for Biotechnology Related Inventions," workshop co-leader, ACI's 9th Advanced Forum on Biotech Patents, Boston, Massachusetts, September 28, 2007. · "Debating the Validity and Future of Follow-Ons," speaker, ACI's 9th Advanced Forum on Biotech Patents, Boston, Massachusetts, September 26, 2007. · "RNAi Intellectual Property Landscape," speaker, Select Biosciences - RNAi Europe, September 20-21, 2007. · "Strategic Issues in Patent Protection of Antibody and other Protein Therapeutics," speaker, CHI PSS Biologics Conference, May 18, 2007. · "Analysis, Opinion Writing Strategies for Minimizing Risks in the Pharmaceutical and Biotech Industries," speaker, C5s's 4th International FTO Forum, March 29 and 30th, 2007. · "Diagnostic Testing - What is Patentable?" speaker, ACI 7th Advanced Forum on Biotech Patents, Boston, Massachusetts, November 29- December 1, 2006. · "The Master Class on Drafting Successful Patent Applications for Biotechnology Related Inventions," workshop co-leader, ACI 7th Advanced Forum on Biotech Patents, Boston, Massachusetts, November 29 - December 1, 2006. · "Who Owns New IP? Protecting Key IP Rights in Collaborative Agreements," speaker, Pharma and Biotech Collaborative Agreements, New York, New York, November 13 - 14, 2006. · "Trendspotting: betting strong but playing safe," co-author, Nature Biotechnology, Volume 24, Number 7, July 2006. · "Trendspotting: A shift in intellectual property focus," co-author, Nature Biotechnology, Volume 24, Number 6, June 2006. News & Publications February 5, 2013, Edwards Wildman Closes Stemline Therapeutics IPO in First Biotech IPO of 2013 August 30, 2012, Trio of Edwards Wildman Attorneys Quoted on Landmark Myriad Case October 12, 2011, Boston Team Advises Zosano Pharma in Partnership with Asahi Kasei Pharmaceuticals October 18, 2010, Kathy Williams Breaks Down the Biosimilars Act in the Boston Business Journal October 14, 2010, Understand the Intricacies of Generic Biologic Drugs Boston Business Journal November 1, 2006, Edwards Angell Palmer & Dodge Attorneys Honored as Massachusetts Super Lawyers July 1, 2006, Trendspotting: betting strong but playing safe Nature Biotechnology - Volume 24, Number 7 June 1, 2006, Trendspotting: A shift in intellectual property focus Nature Biotechnology, Volume 24, Number 6 2005, How Should Inventors be Compensated for Their Contributions to U.S. Patents? May 8, 2005, Can A Strong Patent Position Be Illegal? May 5, 2005, Clash of the Titans: Federal Regulations in Conflict via Drug Re-Importation June 2, 2004, Changes in the U.S. Patent System? November 6, 2003, Drug Screening and Patent Infringement June 25, 2003, Does Drug Screening Fall Under the FDA Safe Harbor April 18, 2003, The State of the Art at the U.S. Patent and Trandemark Office January 29, 2003, Legal Uses of a Patented Invention in the U.S.: Do Your Company's Activities Fall Under the Legal Exceptions to Patent Infringement- Part II December 24, 2002, Legal Uses of a Patented Invention in the U.S.: Do Your Company's Activities Fall Under the Legal Exceptions to Patent Infringement? Part I October 1, 2002, Are There Benefits to Patent Harmonization? June 19, 2002, The Supreme Court Unanimously Agrees that the Doctrine of Equivalents is Alive and Well April 26, 2002, Intellectual Property: Due Diligence March 5, 2002, "Provisional" Patent Rights Permit Damages on a Published Patent Application! January 10, 2002, What a Biotech Up-Start Should Know About a Successful Patent Strategy: The Sword and the Shield January 10, 2002, hat a Biotech Up-Start Should Know About A Successful Patent Strategy: The Sword and The Shield November 7, 2001, Inventorship vs. Authorship June 11, 2001, New Draconian Restrictions on U.S. Patent Scope: FESTO January 16, 2001, U.S. Patent Law Changes Take Effect December 21, 2000, Advice of Counsel, November 2000 July 24, 2000, Genome success means difficult patent questions Events November 3-5, 2011, Shenzhen, China, BIT's 1st World Congress of Small RNAs May 2 - 4, 2011, New York, NY, Paragraph IV Disputes Expert Insights on Hatch-Waxman Litigation Strategies for Brand Names and Generics November 30 - December 1, 2010, Boston, MA, 12th Advanced Forum on Biotech Patents September 27 - 28, 2010, Boston, MA, FDA Boot Camp Basic Training for Products Liability and Patent Lawyers September 14 - 15, 2010, Dublin, Ireland, qPCR Europe September 30 - October 1, 2009, Boston, MA, 11th Advanced Forum on Biotech Patents June 8-10, 2009, San Francisco, CA, The Business of Genomics: Bridging the Gap from Concepts to Realization Symposium June 8-10, 2009, San Francisco, CA, RNA Interference Summit April 2, 2009 - April 3, 2009, Oxford, United Kingdom, BioTrinity 2009 October 23, 2008 - October 25, 2008, Washington, DC, American Intellectual Property Law Association's (AIPLA) 2008 Annual Meeting October 25, 2007, Indian Wells, CA, Patent Counsel's Vital Role in & Guide to Important Corporate Transactions September 26, 2007 - September 28, 2007, Boston, MA, ACI's 9th Advanced Forum on Biotech Patents Analysis, Insights and Strategies for New Challenges in Biotech Patent Practice November 29, 2006 - December 1, 2006, Boston, MA, ACI 7th Advanced Forum on Biotech Patents November 13, 2006 - November 15, 2006, New York, NY, Pharma and Biotech Collaborative Agreements: Allocating Risk, Responsibilities & Rewards in In-Licensing, Co-Development & Co-Promotion Deals Industries · Life Sciences · Educational Institutions · Education Memberships · AIPLA