PerspectivesAre you interested in submitting a Perspective Article? Be sure to read The Science Advisory Board's Editorial Guides for Perspective Articles. Click here. BIOENTREPRENEUR SERIES Promoting Entrepreneurial Opportunities: The Technology Interface at the Public:Private Sector by Tamara Zemlo, Ph.D., MPH The following text is based upon an interview with Richard Rodriguez, Supervisory Technology Licensing Specialist, The Office of Technology Transfer, The National Institutes of Health The Office of Technology Transfer (OTT) at the National Institutes of Health (NIH) is primarily responsible for patenting and licensing the inventions of the NIH’s and the Food and Drug Agency’s (FDA) intramural investigators. OTT is also responsible for developing and implementing technology transfer policies for the four arms of the United States Public Health Service: the NIH, the FDA, the Centers for Disease Control and Prevention, and the Agency for Healthcare Research and Quality. The office is divided into three major specialty areas: cancer, bioresponse modifiers and gene therapy; general medicine; and infectious diseases. Overview of the Licensing Process Last year, 341 inventions were disclosed at NIH and FDA laboratories. This number represents a 26% increase over the number of inventions in 1995. OTT transfers these inventions by licensing them to industry with the aim that they will be developed for the public’s benefit. In 2003, NIH and FDA investigators were awarded 179 patents, and OTT executed 205 licenses. The amount of royalties these licenses secured in 2003 ($53.7) was almost three times the total amount of royalties earned in 1995 ($19.4 million. Often, companies in the private sector require patent protection to justify the expenditure of resources needed to fully develop a particular invention. When necessary to ensure the efficient development of a certain invention, the OTT will seek intellectual property protection on scientific and medical inventions. Securing Technology Protection When an invention is brought to the attention of OTT, the office assembles a team of patent advisors and licensing specialists to evaluate it. This team will determine the invention’s likelihood of being patented and also assess its commercial viability. OTT generally seeks the broadest possible patent protection for commercially valuable inventions and initiates this process by filing a patent application with the U.S. Patent and Trademark Office (USPTO). One of the most challenging concepts to explain to inventors is that of “authorship versus invention.” Scientists and physicians must put together a list of inventors that will be listed on the patent application. Unlike publishing conventions where someone could be listed on a paper because they performed key experiments or prepared a vital reagent, the criteria for invention is much narrower. Only individuals who contributed intellectually to the creation of an invention should be included in the patent disclosure. This precision is critical, because inaccurate information on a patent application can result in its invalidation. Within one calendar year of filing a U.S. patent application, OTT will update its initial patentability and market assessments and will file international patent applications as appropriate. Typically, where international filing is possible and commercial interest in the invention is anticipated, OTT will at least file a preliminary international application under the Patent Cooperation Treaty. Approximately one year after the filing of an international application, OTT again reevaluates the commercial potential of the invention. It then decides whether or not to file national stage patent applications in countries where it believes that patent protection is required for the full development of the invention. GeneratingTechnology Licensing If a company, either located in the U.S. or abroad, would like to acquire rights to use or commercialize either an un-patented material, or a patented or patent-pending invention developed at the NIH or the FDA, a license is required. A license is a legal agreement by which the inventor promises not to take action to exclude the licensed party (i.e., company) from making, using, and/or selling the invention. Most biomedical companies seek worldwide patent protection to secure foreign markets or to use their assets in establishing strategic alliances that can accelerate the invention’s further development or distribution. OTT publishes its licensing opportunities in the Federal Register (http://www.gpoaccess.gov/fr/). Companies interested in licensing biomedical technology can also subscribe to an email listserv (http://ott.od.nih.gov/). The ultimate goal of OTT, with input from the specific NIH Institute and/or the FDA, is to transfer technology to the marketplace for the public good. The benefits to public health-in terms of lifesaving drugs, vaccines, diagnostics, biomedical products and research tools-represent the tangible successes of the government-industry partnerships that OTT establishes. ### Dr. Tamara Zemlo is the Director of The Science Advisory Board. If you'd like to discuss this perspective or share your ideas on entrepreneurship in the medical and life sciences please click here. ### << Previous Next >> [ View All Perspectives ] |
|
