Denise Mayfield is a partner in the award-winning patent prosecution practice and a registered patent attorney with significant experience advising clients in the healthcare and life sciences sectors. Drawing on her advanced academic background in biology, genetics, and physiology, as well as her prior work as a research scientist, Denise delivers sophisticated intellectual property strategies tailored to the complex needs of innovative medical and scientific organizations.

Denise focuses her practice on the drafting and prosecution of patents primarily in life science, chemistry, biotechnology, medical devices, and bio-electrical (sensor) technologies. She also creates and manages client patent portfolios, performs various due diligence services (pre- and post-litigation), prepares/negotiates technology licensing and other corporate agreements (collaborative research agreements, joint venture agreements, joint research and development agreements, partnership agreements, physician agreements, non-disclosure agreements, drug/chemical pharmaceutical agent development protocols and agreements, etc.), conducts freedom-to-operate investigations, and provides support services in patent litigation matters.

Additionally, Denise has an active trademark practice and drafts various types of branding and co-branding agreements concerning use of marks among numerous parties. Her strong background in life sciences, pharmaceuticals, and medical devices have expanded MWM’s biotechnology and life sciences practices.

Denise represents a diverse range of clients, including academic medical centers, physician groups, health science institutions, and emerging biotech companies. She is known for her strategic counsel, technical precision, and commitment to protecting and maximizing the value of her clients’ innovations.

A dedicated advocate for the advancement of women in science and technology, Denise actively mentors and supports initiatives that promote gender equity in STEM fields. She is the founding chair of Women in Bio, a national organization dedicated to advancing diversity and leadership in STEM. She is also a member of the Greater Austin Hispanic Chamber of Commerce, the Association of University Technology Managers (AUTM), and the Notre Dame Club of Austin. Before entering the legal profession, Denise trained as a classical opera singer—an experience that underscores her discipline, poise, and creative perspective.

Medical Device, Bone Repair/Regeneration, 3-D Bioengineering

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)
  • Soft tissue repair systems
  • Hard-body anchors
  • Bone drill sets
  • Shoulder, rotator cuff replacement devices
  • Orthopedic screws and pins (hip)
  • Surgical adhesive materials
  • Sterilized human tissue allografts
  • PTFE grafts
  • Biologically engineered surgical materials (bone putty/bone slurries (demineralized), collagen matrix materials, skin tissue gels, tissue adhesives)
  • Wound repair materials (tissue skin graft materials (sheets), wound repair and healing preparations, drug-releasing wound repair materials)
  • 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
  • Human amniotic membrane preparations
  • Placenta tissue derived tissue patch
  • Medical device coatings (polymer, anti-bacterial, drug release)
  • Stem cell and implantable device systems for rapid bone and tissue healing/regeneration, bone replacement and bone regenerating materials and methods
  • In vivo cranial bone regeneration 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
  • Reviewed clients’ website materials to remove/edit representations concerning potentially FDA-regulated activity
  • Advised on physician/clinic client’s exemption for “off label” use and “practice of medicine” exemption of products
  • Advised numerous clients during FDA on-site inspection visits
  • Assisted with therapeutic biological products clearance within FDA’s Drug Evaluation and Research (CDER) office
  • Advised multiple clients on FDA labeling/branding requirements and misbranding of products, drug or device under the FDCA, “Rx only” labeling

Additional Experience:

  • Developed proprietary and non-proprietary product and business services commodity pipelines for biologics divisions/spin-offs of large domestic and foreign companies, including Samsung Biologics
  • Prepared and coordinated the creation of strategic international and domestic patent portfolios in client/corporate target markets
  • Developed international patent and proprietary information licensing strategies to facilitate new product launches
  • Developed and secured compliant and coordinated branding (trademark) strategies for domestic and/or international product launches
  • Negotiated client services agreements and created client materials for providers/manufacturers (quality/specification of materials received, return/refund provisions, suitability for specific commercial uses)
  • Reviewed and developed effective compliant product inserts (FDA, branding) and product packaging
  • Developed suitable product delivery protocols for perishable and/or limited shelf-life product delivery to consumers/purchasers
  • Developed appropriate delivery protocols of perishable materials (biological tissues, sensitive biological reagents, etc.)
  • Handled import/export of numerous perishable and/or border-regulated materials

Press Releases

Munck Wilson Mandala welcomes life sciences partner Denise Mayfield

Mayfield focuses her practice on the drafting and prosecution of patents primarily in life science, chemistry, biotechnology, medical devices, and bio-electrical (sensor) technologies. She also creates and manages client patent portfolios, performs various due diligence services (pre- and post-litigation), prepares/negotiates technology licensing and other corporate agreements (collaborative research agreements, joint venture agreements, joint research and

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St. Mary’s University School of Law, JD

University of Texas at San Antonio, MS

Genetics and Physiology

Trinity University, BA

Biology

  • Women in Bio, Founding Chair
  • Greater Hispanic Chamber of Commerce, International Committee, Vice Chair
  • Association of University Technology Managers (AUTM)
  • Notre Dame Club of Austin

Texas, 1988

Colorado, 2000

District of Columbia

United States Patent & Trademark Office