Intellectual Property and Conflict of Interest
If not protected, an idea will not benefit the creator, and industry will be less likely to have an interest in commercializing the concept.
Intellectual property (IP) is a novel idea, creation, invention, or discovery. In science or medicine, IP may have the potential to be used to develop a new product or an extension of existing technology. If the IP is worth pursuing, then it should be protected. IP that is prematurely disclosed and becomes part of the public domain before it has been protected is virtually impossible to protect later. Once the IP becomes public knowledge, the inventor(s) and the institution (if any) cannot benefit in the same way for its invention as if it had been protected.
SEEKING PATENTS OR A COPYRIGHT
IP can be anything from concepts that may be used with an existing product to entirely new inventions, software or hardware, a new instrument, or a diagnostic device—anything that could be useful and novel. Once one has decided to protect an idea, the usual path is to seek a patent or copyright. A patent is a set of exclusive rights granted for a given period of time to the inventor by the government in exchange for public disclosure of the invention. A copyright includes the right to copy, distribute, and adapt the covered work. In both private and academic settings, the process is tedious and time consuming. Outside an academic setting, however, getting a patent can be difficult and expensive. In academic settings, mechanisms are in place to help an inventor manage IP. Academic institutions usually have an office of technology transfer or something similar that will assist people in creating and filing a patent, and institutional policies generally determine the allocation of royalties. Technology transfer offices also subsequently assist with licensing agreements. A physician-inventor in private practice should consult a lawyer to assist with filing a patent or copyrighting an idea.
If IP is not protected and is in the public domain, industry will be less interested in commercializing the concept, because it may not be able profit from it. Exceptions exist. For example, one manufacturer produces a time-domain optical coherence tomography (OCT) device (Carl Zeiss Meditec, Inc., Dublin, CA), and a patent protects the technology. With spectral domain optical coherence tomography, the IP ownership is much less clear. Nine manufacturers currently make products that use spectral domain optical coherence tomography technology, thus demonstrating that, sometimes, even if the fundamental IP is not clearly protected, there may be other protected IP around it such as the software. That situation allows several manufacturers to make instruments that perform similar functions but are different enough that each company believes it can profit from its device.
OCT IN THE LABORATORY
The concept of OCT was generated in James Fujimoto’s laboratory with David Huang, MD, PhD; Charles Lin, PhD; Carmen Puliafito, MD; Eric Swanson, PhD; and myself. The six of us were intimately involved in the invention of OCT. Unlike with a scientific article, for which the scope of each author’s contribution is rather vague, there are specific regulations about what it means to have contributed to IP and to be included on a patent.
Our initial article on OCT1 was published in Science in 1991. The patent was granted in 1994, an example that indicates the length of the process. In the academic setting, a disclosure (ie, describing the idea and how it will work) is made to the university’s office of technology management. In the private sector, one would make the disclosure in accordance with advice from a lawyer. After we made our disclosure, a patent application was written and submitted to the United States Patent and Trademark Office. IP is first assigned a provisional patent, followed by a full patent if there is enough evidence that the IP is novel and not obvious. In other words, the United States Patent and Trademark Office ensures that there is no prior art, meaning no one has had this idea before.
Once the patent has been filed, the inventor can begin discussions with industry about commercialization of the idea. When I first started conducting research, I had a notion of the “snow-white” purity of research and science for the sake of science. That mindset is not actually useful. If an inventor does not commercialize his or her idea and bring it to the community at large, then others cannot benefit from the invention. OCT would have been an interesting laboratory curiosity had we not patented it and transferred the technology to industry. Now OCT is a standard of care all over the world, and the technology has improved patients’ lives. Pure research is important, but applied research must be transferred to industry in order to be useful to patients.
CONFLICT OF INTEREST
Conflict of interest can take many forms, the most common of which is financial or proprietary interest. In such cases, an individual has a conflict of interest related to fees received from consulting, research, lecturing, or patent royalties (among other sources of conflict of interest) in relationship to research or presentations. An example of financial interest or conflict of interest is a person giving a lecture about a drug manufactured by company X who has received honoraria or compensation from company X or from the manufacturer of a competing product, company Y. These are common scenarios.
Many academic institutions manage conflict of interest through a great deal of oversight as to what an individual investigator may be involved in regarding research, consulting, and lecturing. At the University of Pittsburgh, an individual may not be a principal investigator on a study for which he or she has a significant financial interest/conflict of interest. A Data and Safety Monitoring Board ensures the safety of the patients involved and the objectivity of the interpretation of the results of the study. In this way, conflict is managed so that the person with the financial interest can still participate in the trial. It is important to manage conflict of interest so that uniquely qualified individuals may pursue their interests while maintaining the integrity of the research. If the person most intimately involved in a project or discovery is removed from the study, the investigation may wither or flounder. The individual with the greatest interest in the project is often the one with the greatest potential for conflict of interest as well. Over the years, I have learned to involve the university early. I want to ensure that I do not knowingly or unknowingly violate any ethical codes.
Cutting-edge researchers will almost always have some conflict of interest. They often are also the ones generating new IP. These investigators should be encouraged to participate in research, but mechanisms must be in place to ensure that the work being reported is ethical and accurate. Conflicts, should they exist, must be managed appropriately.
Joel S. Schuman, MD, is the Eye and Ear Foundation professor and chairman of the Department of Ophthalmology at the University of Pittsburgh School of Medicine, and he is the director of the UPMC Eye Center. He is also a professor of bioengineering at the University of Pittsburgh School of Engineering and a professor at the Center for the Neural Basis of Cognition, Carnegie Mellon University and University of Pittsburgh. Dr. Schuman has received lecture fees and payment of faculty travel expenses from Pfizer, Inc. He receives royalties from IP licensed by M.I.T. to Carl Zeiss Meditec, Inc., and by the University of Pittsburgh to Bioptigen, Inc. Dr. Schuman may be reached at (412) 647- 2205; email@example.com.
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