March 21, 2023
For many life-science researchers at universities and other institutions, documenting and disseminating discoveries through publication is the natural culmination of their work. It is the process by which researchers, a group that includes principal investigators (PIs), postdoctoral researchers, and graduate students, advance their careers. It is a core piece of their continual efforts to secure funding for future work.
Most researchers are rewarded for the number and quality of their publications, which are judged, in part, by their impact factor (1). By publishing discoveries in respected, peer-reviewed journals, researchers build their reputations and credentials, smoothing the process of securing grants to fund additional research and discovery, leading to a cycle of success and job security. Although that research-to-funding ecosystem fuels important discoveries and groundbreaking innovations, a glaring gap often remains ignored: the protection of intellectual property (IP) rights. The emphasis on publication sometimes relegates the patent application process to a secondary consideration. That can be detrimental, not only for individual researchers, but also to research institutions and the general public.
Prioritizing publishing over patenting creates multiple problems, starting with its effect on financial interests. Research institutions routinely share licensing proceeds with inventors. The percentage differs by institution and can be contingent upon costs incurred for obtaining and maintaining patents. Other factors, such as a total inventor-compensation cap from licensing (e.g., a yearly maximum), also can influence an inventor’s earnings. Separate avenues for financial compensation can open up when a company licenses a researcher’s IP. That company can hire the researcher as a scientific advisor or consultant to assist with developing a technology.
Commercialization of a medically relevant innovation provides the best chance for a researcher’s work to deliver its greatest societal benefit, beyond mere publication and its associated impact factor. Although obtaining IP protection may provide a financial incentive to a researcher, it also financially incentivizes the development of new treatments. In turn, those treatments can be administered to people who need them. However, commercialization happens only when investors have an assurance of protection, which can be attained through patenting.
Researchers might inadvertently create their own “prior art” by disclosing central aspects of an invention in a publication or at a conference before they file a patent application. In doing so, scientists can run the risk of missing a financial windfall that also provides therapeutic relief to potentially millions of people.
Researchers should seek IP protection for their inventions before sharing the details of their discoveries publicly. To do so, researchers must reconsider the traditional emphasis on publication and the well-established incentives in the research-to-funding ecosystem. Fortunately, that can be accomplished through collaboration between researchers and technology transfer offices (TTOs).
The Key Role of TTOs
TTOs operate out of institutions of higher education and scientific and/or medical research institutions. The TTO charter is twofold: To identify innovations that have commercial potential and help bring those innovations to market. TTOs focus on helping researchers secure IP rights and recognize the commercial potential of their inventions. However, convincing scientists to prioritize the pursuit of IP protection alongside publication can be a Herculean task. One TTO professional told me, “It’s the hardest issue I deal with.”
Another TTO professional cited an example of a faculty member who published extensively in the life-sciences space. By the time he contacted the TTO, his prolific writing had created a significant amount of prior art, hindering the TTO’s ability to protect the faculty member’s innovations. The TTO professional admitted that the proliferation of prior art had “severely restricted our ability to secure valuable IP, and we were not able to license the narrow patent application we filed.”
By contrast, a different TTO professional shared a success story. In this case, a new assistant professor reached out to the TTO before submitting a manuscript that described her research. The TTO worked with that professor to file a provisional patent application before she published her paper. As her research and resulting technology developed, the TTO helped license her technology to a third party, which now aims to move it into clinical trials.
When scientists inform TTOs of their research at the right time, such as when it is nearly ready for publication, a TTO can facilitate the optimal path forward from an IP perspective. Still, the pressure to publish persists and competes with TTOs’ efforts to advance the IP protection process.
Undercutting Commercialization with Prior Art
To obtain a patent in the United States, a patentee must first prepare and submit an application to the United States Patent and Trademark Office (USPTO). Such applications are typically provisional or utility applications, which cover new and useful processes, machines, articles of manufacture, compositions of matter, and improvements thereof. In the life-sciences space, those could be new methods of treatment, diagnostics, pharmaceutical dosage forms, new chemical entities, and the like.
To be patentable, an invention must be new and nonobvious. According to the USPTO, “the subject matter sought to be patented must be sufficiently different from what has been used or described before that it may be said to be nonobvious to a person having ordinary skill in the area of technology related to the invention.” Therefore, prior art must not disclose or suggest an invention (2).
Prior art is a broad category that can include existing US and international patents and applications, nonpatent literature, and public disclosures of innovations that occurred before the filing date of a patent application. The USPTO lists numerous examples of public disclosures that fall under the definition of prior art. Those include oral presentations at scientific meetings, tradeshow demonstrations, website content discoverable online, and disclosures made over radio broadcast.
In certain jurisdictions, including the United States, inventors are granted a grace period. If a researcher publicly discloses an invention, that person has a year before the disclosure becomes prior art to a subsequently filed patent application directed to the invention. However, such grace periods are not internationally uniform. Whereas researchers may be able to obtain patent protection in the United States, they may be foreclosed from doing so in other important markets, such as in European countries that are members of the European Patent Convention, which requires “absolute novelty” with no previous public disclosure.
Sometimes the pressure to publish can force researchers and TTOs to file patent applications before the relevant research has matured fully. As one TTO professional explained to me, “Constant public disclosure means we have to file patents without the development we’d like to see, or risk those disclosures being art that causes obviousness issues as the technology matures.”
Another TTO professional echoed that sentiment, saying that researchers are sometimes forced to file early to beat publication. “The article might have some enabling information, but not enough for a great patent application. But it might be enough to be prior art.” Unfortunately, filing too early can lead to patents that, at best, cover narrow applications of an innovation that are less commercially valuable and more difficult to protect than they might have been otherwise. Such patents often draw minimal attention from potential licensees, who might face an uphill battle to secure funding from potential investors due to a limited market.
When a researcher publishes a discovery before filing a patent application to protect it, that public disclosure destroys absolute novelty. That destruction can occur even if the scientist presents an abstract, poster, or slide deck at a scientific conference. Doing so forfeits the potential for valuable international protection and starts the clock on the grace period in the United States, pressuring the researcher and TTO to secure patent rights immediately — assuming that the remaining potential market share is worth the effort and expense.
By contrast, fortunately, filing a patent application does not affect publication negatively. Initially, that is because patent applications can take more than a year to become public. Also, the work a researcher puts into an article is similar to the effort required to prepare a patent application. When drafting a manuscript for submission to a peer-reviewed journal, a researcher will document the state of art for the research being presented, describe the materials and methods used to achieve the results in such detail that other scientists could repeat the experiments, present the results and describe how they differ from a standard reference point (e.g., controls, standard-of-care treatments), and discuss the significance and possible application of the discovery.
Those steps also are core components of the patent-application drafting process. However, that process should push researchers to think of their innovations more broadly than they had before. What other classes of drugs could be used in a similar way? What other types of cancer would be susceptible to this treatment regimen? What other types of diseases could be treated based on these observations? Although synergies exist between the drafting processes for patents and publications, the patent-drafting process also can help researchers reframe how they see their future research. It is therefore advantageous for scientists to blend the patenting and publication processes to strengthen their credentials and maintain (or improve) the health of their funding pipeline while maximizing the commercial potential of their inventions.
The Path Forward: Embedding IP Into the Research Process
Life scientists devote their professional lives to finding novel ways to treat diseases, ease suffering, and improve patient outcomes. To maximize the potential benefits of discoveries that happen on university campuses and at other institutions, scientists should embed the pursuit of IP protection into their research and funding life cycles. They must recognize the crucial role TTOs play in helping to obtain patents and secure licensing, using the professional knowledge that TTOs have to guide them through the process. By working together, researchers and TTOs can ensure that important innovations have a greater impact on the broader healthcare system.
References
1 Measuring Your Impact: Impact Factor, Citation Analysis, and other Metrics: Journal Impact Factor (IF). University of Illinois Chicago: Chicago, IL, 9 January 2023; https://researchguides.uic.edu/if/impact.
2 General Information Concerning Patents. United States Patent and Trademark Office, Alexandria, VA, 10 January 2023; https://www.uspto.gov/patents/basics/general-information-patents.
Corresponding author John E. Conour, PhD, is a partner with intellectual property law firm MBHB. McDonnell Boehnen Hulbert & Berghoff LLP 300 S Wacker Dr #3100, Chicago, IL 60606; [email protected] 312-913-3317; http://www.mbhb.com.
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