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Overview

Denise is a registered patent attorney with more than 25 years’ experience and advises pharmaceutical and biotechnology companies in strategies for identifying, protecting and commercializing their intellectual property assets.

Denise also works closely with internal corporate/university technology transfer professionals in technology portfolio development, product commercialization strategies and regulatory compliance matter resolution. Denise 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. Denise is a skilled and experienced patent prosecutor and has been writing and prosecuting domestic and international patent applications for clients around the world her entire career.

Denise’s practice focuses on the patenting of chemical, genetic and biochemical inventions, including plant products, medicinal plant products, pharmaceuticals,  chemical processes, stem cell products, stem cell processing, vaccines, hormonal preparations and hormone-related diseases, reproductive medicine (fertility and sterility screening/treatment and in vitro/in vivo assisted reproductive technologies), genetic testing, disease detection and screening tools, cancer therapeutics, cancer detection methods and screening tools, veterinary medicine, vaccines, orthopedic devices, dental devices and chemical purification and extraction techniques. She was a medical researcher for many years, and earned her graduate degree in genetics and physiology from the University of Texas prior to her career in law. 

Denise counsels clients on matters such as:

  • Pharmacophore drug modeling and selection
  • Immunosuppressive agents 
  • Antibody and stem cell technologies
  • Plant cell biology
  • Oncology and Hematology
  • Assisted Reproduction Technologies/Fertility and Sterility
  • Disease-screening methods and Bio-signature Development and Disease Detection
  • Drug-delivery formulations
  • Medical Devices (Spine, Shoulder, Knee) 
  • DEA-regulated Research, Controlled Substances (anabolic steroids, cannabinoids)
  • Bayh-Dole Compliance, iEdison reporting

Denise is registered to practice before the U.S. Patent and Trademark Office. She works closely with clients to maximize effective path to market, especially relating to those products, methods and systems relating 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. Denise is also admitted to practice in Washington, D.C., and frequently assists clients in navigating and resolving governmental agency related issues as they arise.


Industries

Services

Education

  • J.D., St Mary's University School of Law
  • M.S., University of Texas at San Antonio
    • Genetics and Physiology
  • B.A., Trinity University
    • Biology

Admissions

  • Texas
  • U.S. Court of Appeals, Federal Circuit
  • Colorado
  • U.S. District Court, Western District of Texas
  • District of Columbia
  • U.S. Patent and Trademark Office
  • U.S. Supreme Court

Professional Associations and Memberships

  • American Bar Association, Judiciary Committee, Health Law Committee
  • American Chemical Society
  • American Intellectual Property Law Association, Biotechnology and Chemical Practice Committee
  • Association of University Technology Managers
  • Association of Women in Science (AWIS), founding member, Austin, Texas
  • Intellectual Property Owners Association
  • National Association of College and University Attorneys (NACUA)
  • Women in Bio, Texas, Founding Chair
Experience

FDA-related experience:

  • Identifying and analyzing patents included in Paragraph IV Certification statements in Abbreviated New Drug Applications (ANDA).
  • Assisting clients in developing Phase I, Phase II and Phase III protocols/materials and in meetings with Food and Drug Administration (FDA) officials.
  • Obtaining FDA 510(k) clearance for adult stem cell therapeutic methods, stem cell products and processes for producing stem cell related products.
  • Reviewing client web-site materials to remove/edit representations concerning potentially FDA regulated activity.
  • Advising on physician/clinic client’s exemption  for “off label” use and “practice of medicine” exemption of products.
  • Advising clients during FDA on-site inspection visits.
  • Assisting clients in addressing issues in FDA “Warning Letters.”
  • Analyzing  FDA's "Same Surgical Procedure" Guidelines in view of clinic/physician operations.
  • Assisting with therapeutic biological products clearance within FDA’s Drug Evaluation and Research (CDER) office.
  • Advising on FDA labeling/branding requirements and misbranding of products, drug or devise under the FDCA, “Rx only” labeling.
  • Advising on classification of products (drug, device or use) and advising on regulation and/or exemption of product from FDA clearance/compliance.

Additional Experience:

  • Developing proprietary and non-proprietary product and business services commodity pipelines for biologics divisions/spin-offs of large domestic and foreign companies (Samsung biologics).
  • Preparing and coordinating the creation of strategic international and domestic patent portfolios in client/corporate target markets.
  • Developing international patent and proprietary information licensing strategies to facilitate new product launches.
  • Developing and securing a compliant and coordinated branding (trademark) strategy for domestic and/or international product launch.
  • Negotiating client services agreements, client materials providers/manufacturers (quality/specification of materials received, return/refund provisions, suitability for specific commercial uses).
  • Reviewing and developing compliant product inserts (FDA, branding) and product packaging.
  • Developing suitable product delivery protocols for perishable and/or limited shelf-life product delivery to consumers/purchasers.
  • Developing appropriate delivery protocols of perishable materials (biological tissues, sensitive biological reagents, etc.).
  • Handling import/export of perishable and/or border-regulated materials.

Patents:

  • 9,283,266 Metastasis inhibition preparations and methods
  • 9,220,770 Extracellular matrix materials as vaccine adjuvants for diseases associated with infectious pathogens or toxins
  • 9,157,909 Male reproductive health panel and uses thereof
  • 9,125,858 Compositions and methods relating to resveratrol
  • 9,006,393 Molecular constructs and uses thereof in ribosomal translational events
  • 8,992,214 Orthodontic self-ligating brackets
  • 8,846,059 Extracellular matrix adjuvant and methods for prevention and/or inhibition of ovarian tumors and ovarian cancer
  • 8,802,113 Extracellular matrix cancer vaccine adjuvant
  • 8,778,362 Anti-tumor/cancer heterologous acellular collagenous preparations and uses thereof
  • 8,778,360 Extracellular matrix cancer vaccine adjuvant
  • 8,637,265 Cathepsin E as a marker of colon cancer
  • 8,597,885 Accelerated progression relapse test
  • 8,512,754 Stabilized products, processes and devices for preparing the same
  • 8,491,947 Paeoniflorin preparations and uses thereof for fat reduction
  • 8,293,088 Direct determination of carbohydrates, amino acids and antibiotics by microchip electrophoresis with pulsed amperometric detection
  • 8,257,715 Tissue vaccines and uses thereof
  • 8,062,646 Tissue vaccines and uses thereof
  • 8,013,022 Stabilized products, process and devices for preparing same
  • 7,943,187 Paeoniflorin preparations and uses thereof for fat reduction
  • 7,932,088 High efficiency transformation of Plasmodium falciparum by the lepidopteran transposon, piggyBac