Denise L. Mayfield brings sophisticated scientific, commercial and legal experience combining patent, health care, pharma, biotech and software/AI advances to protect client assets.
For more than 25 years, Denise’s strong science background—which includes an advanced degree in genetics as well as research in pulmonary medicine, fertility and sterility—has enhanced her strategic legal practice.
A skilled and experienced patent attorney (prosecution and litigation), she assists domestic and international clients in identifying, protecting, licensing and litigating bet-the-company technologies.
Always up to date on new IP developments and regulations, Denise works closely with internal corporate and university technology transfer professionals in portfolio development, product commercialization strategies and regulatory compliance resolution.
She represents companies directly in negotiating technology licenses, cooperative research agreements, joint venture agreements, international distribution and marketing programs, patent litigation matters and university pooling arrangements.
Her gift for finding creative options to resolve present and potential problems results in broad and continuing patent protection for clients. Denise partners with clients on a wide range of patent matters, including for genetic testing, disease detection and screening tools, veterinary medicine, vaccines, orthopedic devices, dental devices, chemical purification, extraction techniques, and plant products and medicinal plant products such as cannabis.
She counsels clients on matters such as pharmacophore drug modeling and selection, antibody and stem cell technologies, regenerative medicine and stem cell technology, disease-screening methods and bio-signature development and disease detection.
She also handles IP matters related to medical devices (spine, shoulder, knee), DEA-regulated research, controlled substances (anabolic steroids, cannabinoids) and Bay-Dole compliance and iEdison reporting. Denise is registered to practice before the U.S. Patent and Trademark Office.
She works closely with clients to maximize an effective path to market, especially for products, methods and systems related to technologies requiring the experienced handling of FDA regulatory compliance issues and trade secret and/or patented technologies in the pharmaceutical, cosmeceutical nutraceutical, dietary health supplement and medical device product areas.
Admitted to practice in Washington, D.C., she frequently assists clients in navigating and resolving governmental agency-related issues.
- Extensive experience assisting clients in the protection and management of intellectual property assets associated with diverse medical device portfolios, including:
- Implantable devices for repair of shoulder, spine and knee
- Suture anchors (soft anchors, knotless and knotted; hard body anchors)
- Shoulder, rotator cuff replacement devices
- Sterilized human tissue allografts
- Hemostatic and blood collection materials and devices (specialty blood collection devices, blood loss calibrating devices, blood anti-coagulant coated devices, anti- coagulant formulations, treated blood collection bags)
- Artificial tissue fabrication methods and processed harvested donor tissue fabrication
- Human tissue sterilization techniques and devices for performing human tissue sterilization suitable for human implantation in compliance with FDA requirements
- Stem cell and implantable device systems for rapid bone and tissue healing/regeneration, bone replacement and bone regenerating materials and methods
- FDA compliant testing of laboratory procedures for sterilizing tissue grafts from human donor materials (infectious agent testing and compliance study compliance)
- FDA-related experience:
- Identified and analyzed patents included in Paragraph IV Certification statements in Abbreviated New Drug Applications (ANDA).
- Assisted clients in developing Phase I, Phase II and Phase III protocols/materials and in meetings with Food and Drug Administration (FDA) officials.
- Obtained FDA 510(k) clearance for adult stem cell therapeutic methods, stem cell products and processes for producing stem cell related products.
- Assisted with therapeutic biological products clearance within FDA’s Drug Evaluation and Research (CDER) office.
- Prepared and coordinated the creation of strategic international and domestic patent portfolios in client/corporate target markets.
- Reviewed and developed effective compliant product inserts (FDA, branding) and product packaging.
- J.D., St Mary’s University School of Law
- M.S., University of Texas at San Antonio
- B.A., Trinity University
- District of Columbia
- U.S. Patent and Trademark Office
- U.S. District Court, Western District of Texas
- U.S. Supreme Court
Professional Associations and Memberships :
- American Bar Association, Judiciary Committee, Health Law Committee
- American Chemical Society
- Association of University Technology Managers
- Association of Women in Science (AWIS), founding member, Austin Chapter, Vice President, 2018
- IP Law/Tech Transfer MAPs Committee, Chair
- National Association of College and University Attorneys (NACUA)
- Women in Bio, Texas Chapter, Founding Chair, 2014; President, 2018
- Licensing Executives Society
Rate : $$$