Intellectual Property Terms in Research Agreements
By Melissa Archer
Negotiating a clinical trial agreement can seem like a daunting task, but the Clinical Trials Office has a dedicated team to represent and usher you through the process. Our goal is to ensure that faculty at USC has access to cutting edge therapeutics and external financial support to conduct innovative research that will both improve the lives of our patients while strengthening our reputation as a research institute. But we need to balance the importance of our policies with the commercial interests of our industry partners.
It is the industry standard amongst academic centers that all inventions made by its employees or contractors are owned by the institution/academic center. This position ensures a certain amount of control in how important new healthcare improvements are introduced to the market. However, when research includes intellectual contributions from our collaborators, we have a process in place to consider these contributions in our handling of IP ownership.
Types of agreements negotiated by CTO
Confidential Disclosure Agreement (CDA): Established before the exchange of proprietary information. These agreements ensure that parties maintain ownership of valuable and proprietary protocols, ideas, data sets, inventions, etc.
Clinical Trial Agreement – Investigator Initiated Trial (IIT) vs. Sponsor-Authored Trial: These agreements cover obligations for conducting research involving human subjects. With IITs, it is standard in the non-profit research community that academic institutions maintain ownership to inventions where investigators have authored the protocol. On the other hand, Sponsor-Authored Trials are solely designed by the commercial partner and USC is simply carrying out the protocol without creative input. For this class of studies, sponsors file broad patents for the anticipated use of a drug or device and new inventions are unlikely. If this is the case, USC may consider a policy exception and allow commercial sponsors to own inventions that result from performing their protocol.
IP Positions within Agreements: U.S. patent law defines ownership as following inventorship, meaning he/she who conceives of a new invention is also the owner. In many ways, USC’s policy follows this idea, protecting inventions that our faculty and staff contribute to, whether alone or with others. Although commercial partners have their own set of for-profit obligations when providing proprietary information/products and/or funding and would prefer a quid pro quo exchange of their support for ownership to new IP, inventions are made available to our biotech, pharmaceutical and medical device partners via reasonable royalty bearing licensing options. This ensures USC may reinvest revenues into our research mission while working with industry partners best suited to bring new IP to market.
The Negotiating Process
The CTO and USC Stevens work together to customize IP terms that suit the needs of each study and the negotiation process can include multiple draft exchanges with our sponsor’s legal team. Although most IP negotiations are successful, we will encounter challenges. We do not want to stifle our faculty’s ability to participate in research, which in turn may limit access to innovative care for our patients and scientific benefit to the general public, so if IP terms are in conflict with institutional policy, we will engage principal investigators to assist with sponsor discussions. We then, collectively with USC Stevens, conduct a risk analysis, allowing all potential stakeholders to make an informed decision as to risks and potential benefits of working outside of established policy. CTO and USC Stevens are here to assist in this analysis and preserve your rights to current and future research endeavors.