Bruce A. Chabner, MD, Massachusetts General Hospital Cancer Center, Boston, Massachusetts, USA
Authored by Tristan Knight, MD Children’s Hospital of Michigan, Detroit, Michigan, USA
The area of intellectual property rights can be a challenging one, and, done poorly, one potentially fraught with opportunities for conflict and contention. Conversely, it also offers many potentially rewarding and positive opportunities at the personal, institutional, and scientific levels. It is also an area in which the typical MD/DO/PhD trainee receives little-to-no education or instruction; if offered, education is often ad-hoc at best. The purpose of this breakout session, then, was to outline the key areas surrounding this area and to offer a starting point and introduction for forum participants to begin understanding this complex area.
Institutional Roles and Responsibilities:
Academic institutions within which the physician may work, whether hospital or university, typically have well-defined policies regarding the development of intellectual property. Although there is an element of variability between sites, these policies are often broadly similar and cover similar realms. Physicians should familiarize themselves with the policies of their own institutions, which typically include a provision dictating the ownership of discoveries emanating from research performed by that physician; often this remains with the institution itself. Such policy documents also set out the mechanisms and means by which discoveries of potentially patentable materials may be disclosed, both internally and externally.
Bayh-Dole Act (or Patent and Trademark Law Amendments Act):
The Bayh- Dole Act, adopted in 1980, rewrote the legislation concerning ownership of patents derived from government funding. Prior to the passing of the act, the general policy of United States government was that, having provided such resources, it would retain the title to discoveries derived from them and license them non-exclusively. However, lacking a uniform federal policy regarding patents derived from government-sponsored research, those seeking to use such patents found themselves bewildered by a labyrinthine system of regulations and rules which, it was felt, hindered innovation.
As such, the Bayh-Dole act, co-sponsored by senators Birch Bayh of Indiana and Bob Dole of Kansas, sought to rectify the situation via a bill which, simply put, held that the best thing the government could do was to incentivize success. The government could only hurt progress if it sought to actively manage these resources and should ‘get out of the way’ and ensure that a palpable benefit to all was derivable from the government’s efforts. The act therefore divested the responsibility and authority to patent and commercialize intellectual property to the university or business which had received the grant, irrespective of the source of governmental sponsorship.
What is Patentable?:
The definition of patentability is surprisingly broad, and the requirements to obtain a patent may be complex and are easily misunderstood. Broadly speaking, they include:
- Patent-eligible: The words of the 1952 Patent Act perhaps best summarize the situation: “anything under the sun that is made by man.” Patents may cover ‘inventions’ in the physical sense of the word (e.g. new machines or materials) but also less tangible objects such as processes or means of production or ‘composition of matter’ (e.g. chemical compounds or structures). From a medical standpoint, this means that novel drugs or therapeutic agents are patentable, as are the processes, diagnostic assays and/or algorithms used to create them, provided the other requirements are met.
- Useful: To be patentable, the invention must be ‘useful’ or have utility for some purpose and achieve some identifiable goal or benefit. A patent is additionally deemed useful provided the logic/facts underlying the application are sound and the facts upon which the application is based are consistent with the established logic/knowledge pertaining to that area.
- Novel: For intellectual property to be patentable, it must be sufficiently novel so as to warrant patenting. This implies that the innovation under consideration has not previously been patented and that is it sufficiently unique or distinguishable from that which already exists. Somewhat less obviously, for intellectual property to be deemed ‘novel’ and therefore patentable, it must not have previously been disclosed. In practical terms, this means that presentation or publication in any public forum, be it a journal article, conference, oral presentation, et cetera, eliminates patentability.
- Non-obvious or Innovative: This requirement stipulates that intellectual property must not be evident or predictable based on what is presently known or existent. If an innovation would be considered ‘obvious’ to an observer in the relevant field, or easily extrapolatable based upon common knowledge, it is not patentable. This requirement exists to prevent patents being issued for minor and iterative changes such as might be expected to occur normally during the normal process of design and development.
- Adequately described: Finally, to be patentable, the intellectual property under consideration must be disclosed in sufficient detail for the process, device, or concept to be replicable by outside entities. At its simplest level, this requirement stipulates that, in exchange for temporary protection under the law and granting of a monopoly for a certain duration, the public be adequately provisioned so as to allow the intellectual property in question to be replicable at a later date, once the patent has expired. A sub-requirement is that of ‘best mode,’ e.g. the best mode for carrying out or performing processes relevant to the patent must be fully disclosed, and not withheld.
Although it may seem almost anathema to some physicians to consider the financial or legal ownership rights of their discoveries and research, perhaps regarding it as ignoble or vainglorious, it is necessary to reframe this view. Maintaining proper control of one’s intellectual property and protecting the fruits of one’s labors has both scientific and practical value. Besides offering the potential for personal benefit, protecting intellectual property also facilitates further innovation and discovery, can aid in the advancement of medicine as a whole, and offers solutions to challenging clinical problems.