Chapter 1: Research Integrity

1.8 Intellectual Property

Intellectual property (IP) includes patents, copyrights, trademarks, trade secrets, and tangible research materials. The most common type of IP resulting from the research enterprise is the patent, which protects ideas and their practical embodiments.

Prior to the 1980 Bayh-Dole Act, academic institutions were unable to hold title to inventions or discoveries resulting from federally-funded research. The Bayh-Dole Act enabled recipients of federal research funding to own IP created from research. In return, universities and other institutions are obligated to use discoveries for the public good through protecting and licensing those inventions or IPs. In U.S. academic institutions, commercialization of IP has since resulted in over two billion dollars in revenue.

Without IP protection, industry will not develop a discovery, thereby preventing it from reaching the marketplace and serving the public good. The Children's Hospital of Philadelphia Research Institute's Office of Technology Transfer is responsible for evaluating discoveries for commercial potential and managing the IP protection process. The Hospital's Patent Policy governs management, royalty-sharing and ownership of IP created at Children's Hospital.

As a recipient of federal funding, Children's Hospital must ensure that research results are utilized for the public good. Usually, this means publishing in journals to advance the field of study. However, in cases where discoveries will potentially be developed into products that could improve public health, the CHOP Research Institute is obligated to seek commercial partners who will develop products and transfer them into the marketplace.

IP is also protected via agreements including non-disclosure (confidentiality disclosure, CDA), material transfer (MTA) and clinical trial agreements (CTA). These agreements ensure that publication and other rights are protected for Children's Hospital and the investigator. The Office of Technology Transfer is the only department at the Hospital authorized to negotiate, approve and sign these contracts and agreements. Investigators are not authorized to sign CDAs, MTAs, CTAs, or other agreements. Investigators and clinicians who plan to engage in outside consulting activities must have their engagements reviewed and approved by Children's Hospital prior to the engagement. The Office of Technology Transfer is the contact point for the review process.

Publishing and patenting are not mutually exclusive. For a discovery to be patentable, it must be new, non-obvious and have utility. "New" means never having been publicly disclosed in a paper, journal, poster, seminar or conversations with scientists or others outside Children's Hospital (without the benefit of a Non-Disclosure Agreement). However, this is easy to manage through early conversations with the Office of Technology Transfer. The Office will, if appropriate, file for patent protection prior to any disclosure.

Once the application is filed, anything in the application can be published or presented and maintain full protection.

The Office of Technology Transfer exists to provide services to researchers that ensure the results of their work are utilized in the manner that will most benefit the researchers, Children's Hospital and the general public.

Developed by the Office of Responsible Research Training