Denise Kettelberger concentrates her practice in intellectual property law, with a particular emphasis on biotechnology patents.
Denise focuses on strategic patent portfolio management for clients in the biotechnology, pharmaceutical and medical device industries. Her work in this area includes patentability assessment, strategic filing, and coordinated prosecution of worldwide patent applications, including prior art management, analysis of individual inventive contributions, proactive and coordinated PTO examiner interviews, appeals, and strategic reexamination and oppositions.
Denise’s technical expertise in the chemical and biotechnology arts includes plant and animal genetics, particularly peptide modulators of angiogenesis, immune responses, cell growth and metabolism, and receptor/ligand function; humanized antibody and antibody fragment design function, therapeutics and screening systems; genetic profiling, diagnostic and prognostic nucleic acid signature systems; hybrid and transgenic plants for food and consumer products; the interface of biomedical data and software platforms; organic and small molecule therapeutics such as nucleoside and nonnucleoside viral inhibitors, tyrosine kinase inhibitors and quinazoline-based cytotoxins; nanoscale enzyme-linked electrochemical analyte sensing systems; photocatalytic films for fluid purification; and self-cleaning architectural structures.
A unique aspect of Denise’s practice involves counseling clients on developments in emerging law related to biologic molecules, including proposed regulation of biosimilars (follow-on biologics). By actively monitoring U.S. and European efforts to develop guidelines and legislation for follow-on versions of successful biotechnology drugs, she helps clients to strategically prepare and position in this changing industry.
In addition to her patent portfolio work, Denise performs intellectual property due diligence for technology and licensing transactions, mergers and acquisitions, product launches and public offerings, including freedom-to-operate, landscape, infringement and validity analysis and opinions. She also provides IP litigation support, with a particular emphasis on biotechnology patent litigation and biotechnology trade secret protection.
Denise is active in the American Intellectual Property Law Association (AIPLA). She is an AIPLA fellow and chair of a new biosimilars subcommittee of the AIPLA Special Committee on Pharmaceutical Regulation. Denise is a frequent speaker and author on biotechnology patent law issues.
Patents
US 7,247,782, Genetic Music, Hennings and Kettelberger
Accolades
IP Law360 Outstanding Women, 2007
Education
• Loyola College, BS, Biology, 1975 University of Maryland School of Medicine, MS, 1982 University of Maryland
• School of Medicine, Ph.D., 1986 Baylor College of Medicine, Post Doctoral Fellow, 1987 – 1988 South Texas
• College of Law, JD, 1983, Order of the Lytae
