Contributed by Lesley Watts, Director of B-BIC Operations & Finance
Intellectual property is the product of a person’s creativity and it can take several forms including patents, copyright, trademarks, and trade secrets. Patents play a key role in innovation and economic development, particularly in the life sciences, because they allow the patent holder to capture the value of an invention and thus, provide incentives to develop inventions into marketable products. A patent can be described as a business tool because it allows innovators and entrepreneurs to gain a limited monopoly for a new invention, strengthen their marketing position, and earn revenue through sale or licensing.
A patent provides the owner with the legal right to exclude others from making, using, or selling the invention. A patent is a set of exclusive rights granted by a national government, or through an international treaty, for a limited period of time (usually for 20 years) in exchange for detailed public disclosure of the invention. Importantly however, a patent does not give one the right to make or use the invention. Freedom to operate must still be assessed; one needs to determine whether commercializing or even testing the invention can be done without infringing upon the IP rights of others. It is also worth noting that a single product can be covered by a range of patents and an individual patent may be part of a larger technology solution.
When considering potential commercialization paths for your technology, patentability of the invention needs to be assessed by conducting a search of existing and pending patents (https://b-bic.org/2017/02/27/online-patent-search/ ), as well as the published literature, to know the breadth of the claims that can be obtained. A patent application must contain one or more claims that define the invention and meet the requirements for patentability, including novelty, usefulness, and non-obviousness. Novelty and obviousness are defined relative to the existence of prior art related to the invention. Prior art is any evidence that the invention is already known (and the evidence does not need to exist physically or be commercially available).
A public disclosure is also considered prior art and can act as a bar to patentability if it is “enabling.” A disclosure is considered enabling if it gives enough information to someone “of ordinary skill in the art” to duplicate or practice the invention. Patent law places a low threshold on what is considered a public disclosure; it is enough that someone, somewhere, sometime previously has described something that contains a use of technology that is very similar to your invention. Printed publications such as book chapters, journal articles, and theses can be considered public disclosures. Importantly, public disclosure can also include:
- Email correspondence: Providing information to individuals outside of your organization without indicating that the information is confidential may be considered a disclosure;
- Grant proposals: Grant proposals submitted to federal agencies are deemed publications if the proposal is funded because they are accessible under the Freedom of Information Act. You can ensure that the information you provide in grant proposals is maintained in confidence however. The first page of the proposal should state: “Confidential Information–Pages __ to __ of this proposal contain potentially patentable information” and write “CONFIDENTIAL” on each of the pages that contains the confidential information;
- Posters, Abstracts, Proceedings, Websites, and Blogs may be considered public disclosures;
- Oral disclosures: Oral presentations are a gray area in terms of whether they constitute disclosure. A talk that is open for the public to attend would constitute a public disclosure. If at a formal talk, you distribute a copy of your presentation in which your invention is disclosed, it is a public disclosure. However, even if handouts are not provided but someone in the audience takes detailed notes that describe the invention, this also could constitute a disclosure;
- Distribution of research materials and prototypes that embody the invention, may constitute disclosure if the materials are provided without any restriction on their use or further distribution.
Timing the disclosure and filing of an invention is therefore an essential and critical consideration for the commercial development of a technology. In addition, if your invention was conceived, or first reduced to practice in performance of work using funding provided by the Federal government, once a technology is disclosed to the institution by the inventor, the institution has two months to disclose the invention to the Federal agency that provided the funding, and then two years after that to elect whether to take title to the invention. If the institution elects to take title to the invention, an initial patent application must then be filed within one year. It is worth stating that recipients of Federal funding (ie. institutions or companies) are obligated by the Bayh Dole Act (PL 96-517, 37 CFR 401) to require, by written agreement, that employees disclose their inventions and assign them to the recipient of the funding (ie. the institution or company that receives the grant, cooperative agreement, or contract). If the institution fails to meet the requirements laid out in Bayh-Dole, the patent can be invalidated.
Contact your technology transfer office before making a public disclosure. The Innovation Office or Technology Transfer Office at your institution will evaluate your technology and if it is determined that the invention may have commercial potential, the office will pursue IP protections. The technology transfer office is also responsible for pursuing commercialization of the technology via industry development partnerships and licensing deals. When you submit your application to a technology development program such as B-BIC, or pitch your idea to potential investors, it is critical to describe the IP that you and your institution hold or are in the process of obtaining. IP is the critical component that enables commercialization of the technology because it grants exclusive rights to secure the value of the invention and provides a sustainable competitive advantage to recoup the costs of further developing your technology.