Intellectual Property Issues: The Basics

Part I - What Qualifies As An Invention?

As members of the faculty of a major research university, who are expected to create new knowledge as well as to transmit accumulated wisdom to students, Stony Brook researchers frequently perform activities that result in inventions, whose broad dissemination may produce broad public benefits. We recognize that it isn’t always easy to determine what constitutes an invention. Since disclosure of inventions made in University facilities is a SUNY obligation, this review is presented to clarify what qualifies as information that should be disclosed to the Office of Technology Licensing and Industry Relations (OTLIR) for evaluation as a possible invention.  The most familiar things that qualify as inventions are any manufactured article (including prototypes and various devices that may be developed as an aid to conducting a research program, as well as resulting therefrom), newly created substances (ditto), software, and algorithms, as well as methods of their use.  New uses of already patented inventions can also qualify as inventions.

In addition, however, the following types of information, data, and results can also qualify as inventions:

• Any data resulting from basic or applied research (including assays and clinical tests);
  
• Any technical data and specifications;
  
• Both pre-clinical and clinical protocols, methods, and results; and
  
• Both business and operational methods and results.

It is apparent from these descriptors that determining whether an invention has been made is a blend of art and science and involves experienced judgment. We strongly recommend, as the best practice in any situation where you think an invention may have been made or where you have any question relating to intellectual property, that you contact OTLIR for advice. Its professionals have decades of experience.  The OTLIR office is located at N5002 Melville Library (around the corner from the Offices of Grants Management and Research Compliance) and can be reached at 632-9009. Basic information is maintained on the OVPR Website at http://www.research.sunysb.edu/ottl/index.html.

The SUNY Patents and Inventions Policy requires that all inventions made by faculty members, employees, students, and any other individuals using university facilities be owned by SUNY through the assignment of the rights to these inventions by the inventors to the Research Foundation.  Federal law and regulations also oblige universities to take ownership of any inventions arising during the performance of government-funded research.  Disclosure of any such inventions by Stony Brook inventors to OTLIR is the critical first step enabling both the individual researcher and the institution to comply with these requirements.

Future Monday Memos will address other intellectual property issues, including the ongoing need to disclose possible inventions and guidance for clinicians submitting investigational new drug (IND) applications.

Part II - The Continuing Obligation to Disclose Inventions

As discussed in the last Monday Memo, disclosure of inventions made in University facilities is an obligation for all Stony Brook researchers. This review is presented to stress the need to be aware that this obligation is an ongoing one for all researchers.
All disclosures submitted to OTLIR do not result in a patent being filed. There are many reasons for this. For example, the data supporting a new technology disclosure (NTD) may not yet be robust enough to support the filing of a patent. Usually in this situation, the researcher is asked to resubmit the NTD for reconsideration at a later time when more supporting data are available. Sometimes, there simply does not appear to be significant commercial potential, at least at the present time. And, at various points in time, it can even be the case that OTLIR does not have the funds in its patent budget to file a patent at the time a particular NTD is submitted. Often when these situations arise, when so requested, OTLIR will release the rights to the invention so that the researcher can file a patent application.

While these situations can be disappointing, both for the researcher and the OTLIR Case Manager, they should not prevent researchers from returning to OTLIR for services relating to these disclosures or subsequent ones, whether they are related or not. And researchers should remember that they still have an ongoing obligation to disclose potential inventions to OTLIR as a result of the SUNY Patents and Inventions Policy and because federal law and regulations oblige universities to take ownership of any inventions arising during the performance of government-funded research. This even includes the situation where the rights to anything patentable in previous disclosures to OTLIR have been released to the researcher who submitted the disclosure. This is true because technology developed after this release, even if similar in nature to that originally disclosed, can be separately patentable and commercially distinct from the initial disclosure. Also, this follow on work is often done at the university. Since the ultimate responsibility for making decisions on what constitutes an invention resides with OTLIR, the office must be contacted so that this evaluation can be made.

We strongly recommend that any time you have questions about your obligation to disclose information that relates to intellectual property that you contact OTLIR for advice. Its professionals have many years of experience. The OTLIR office is located at N5002 Melville Library (around the corner from the Offices of Grants Management and Research Compliance) and can be reached at 632-9009. Basic information is maintained on the OVPR Website at-
http://www.research.sunysb.edu/ottl/index.html
Future Monday Memos will address other intellectual property issues and provide guidance for clinicians submitting Investigational New Drug (IND) applications.

Part III - Disclosures in the Clinical Setting

Previous Monday Memos have discussed some basic intellectual property issues that university investigators need to be aware of in the course of their research. This third installment addresses some specific issues that arise in the clinical setting at Stony Brook.

In the first installment of this series, we attempted to clarify what qualifies as information that should be disclosed to OTLIR for evaluation as a possible invention. While most researchers are familiar with the fact that newly created substances, manufactured articles, and software, as well as methods of their use, can be inventions, many other less commonly occurring situations can involve the creation of intellectual property. In the clinic, there are some instances specific to the patient setting in which an investigator needs to contact OTLIR. As examples, when a clinical researcher submits an investigational new drug (IND) application or applies for an Orphan Drug Act designation, s/he may be disclosing protocols and clinically relevant information that could contain significant intellectual property. This is the case because the work leading to these applications may include commercially significant disclosures of new uses of drugs. Therefore, these applications need to be evaluated for potential new inventions. As a general rule, clinical investigators who are applying for a government designation for a treatment should be aware that drug or medical device companies will likely find these applications of commercial value, so the investigators should consult with OTLIR concerning these applications early in the process of their submission.

We strongly recommend, any time you have questions about your obligation to disclose information that relates to intellectual property or wonder whether you might need to disclose, that you contact OTLIR for advice. Its professionals have many years of experience. The OTLIR office is located at N5002 Melville Library (around the corner from the Offices of Grants Management and Research Compliance) and can be reached at 632-9009. Basic information is maintained on the OVPR Website at-
http://www.research.sunysb.edu/ottl/index.html

–Contributed by Chester Bisbee, Director of Technology Licensing and Industry Relations, 632-9009, email Chester.Bisbee@stonybrook.edu