Patents, licenses key to bringing discoveries to patients

I think it’s fair to say that most of us received very little exposure to the topics of patents and intellectual property during our education or postdoctoral fellowships.

To my mind the beginning of the modern era of educational institutions applying for patents began with the Bayh-Dole Act. In essence, this law allowed universities to retain intellectual property rights for discoveries made with federal grants. The act was intended to help alleviate the “valley of death” (see graphic below), which describes the gap between scientific discoveries in medicine and their translation to useful technology (drugs, devices, diagnostics) for patients. It was recognized then, as is still the case, that there is significant risk in traversing this divide between discovery and practice.

Graphic depicts “The Great Divide between Science and Translation to Patient Care.”

In virtually all cases, bringing the discovery to the patient requires commercialization. And in general, universities (or the federal government) alone cannot take the discovery “to the next step.” Indeed, taking a scientific discovery to a final product is estimated to cost about $800 million (for a new drug). So know it is perfectly acceptable, and in fact expected, for NIH-funded investigators to pursue patents on their discoveries. As a college and university, we are monitored and, in some cases, rated on patent-related activities. Recent changes in Morsani College of Medicine guidelines have emphasized such activity as relevant for appointment, promotion and tenure.

At most universities, including USF, the process of submitting a patent begins with completing an Invention Disclosure Form to the USF Office of Technology Transfer. This relatively simple form can be found at www.usf.edu/research-innovation/pl/documents/invention-disclosure-form-final.pdf. From this action a series of discussions will develop about whether to proceed to submitting a patent.

An important concept here is that patents must represent something novel, and if someone has published or presented this information in the past (called “prior art”) then your patent will be denied. In fact, even if you publish (or present) your own data before filing a patent, your patent will be denied based on prior art! So, the lesson here is to file the patent before publication or presentation. If you browse the U.S. Patents and Trademark Office website for patents in the biomedical sciences, you quickly realize that patents are not scientific papers. Particularly, one often sees a paucity of replicated experiments and frequently a lack of extensive exploration of basic mechanisms, which would be expected in a paper.

Thus, it is a mistake to hold back on a disclosure or application because you don’t understand the “full picture.” The USF Office of Technology Transfer can help you not only in checking for prior art and potential partners to move the invention forward, but also in ascertaining how much information is needed for the application. (Some patents are awarded for “teaching against prior art,” such as a drug with an opposite effect than what has already been published/patented.)

Once the patent is formally submitted, it acts as a placeholder for your invention. You can proceed with presentations and publications, since these occur after patent filing and thus are not prior art. Filing the patent is sufficient (as opposed to having the patent awarded) for this purpose. Depending on the type of patent, the content of your application generally remains confidential for 12 to 18 months, after which time it can be viewed online. In fact, even if the patent is not awarded, the content becomes prior art, because it falls in the public domain.

Don’t be surprised if you find a company using your patented or patent-pending technology without discussing it with you. The Hatch-Waxman Act and its amendments provide a “research exception.” This act protects generic drug manufacturers from patent infringement as they prepare to produce generic drugs while patents are held by the original innovator company. I have seen this used by companies to explore new technologies to confirm the essential data, without considering a submitted or awarded patent by another entity. Such activity can approach, or in fact be, patent infringement.

While I am not a fan of this type of behavior, it is here to stay for the foreseeable future. It should motivate us to continue to develop inventions within the economic realities of our grants and USF resources, and to pursue commercial partners. A project director from a major pharmaceutical company once called me to say that they were interested in something we had published, and they had replicated all the experiments in our Nature Medicine paper. I asked why he seemed surprised about this replication, and he told me that in certain areas (such as cancer biology) the company was unable to replicate critical experiments in greater than 90 percent of 53 published studies from “those tabloid journals.” (1). So, in the context of this discussion, the Hatch-Waxman Act may serve to limit false starts.

I hope that this discussion will promote an increase in invention disclosures, patent applications, and licenses from MCOM faculty. If you need assistance, please do not hesitate to contact me or Valerie McDevitt, JD, associate vice president of Technology Transfer & Business Partnerships (vmcdevitt@usf.edu).

1. Begley, C. G., & Ellis, L. M. (2012). Drug development: Raise standards for preclinical cancer research. Nature, 483(7391), 531-533.

Stephen Liggett, MD
Associate Vice President for Research, USF Health
Vice Dean for Research, USF Health Morsani College of Medicine
Professor of Medicine, Molecular Pharmacology and Physiology

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