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  • alexandrabuga started the topic Who should own clinical trial Inventions? in the forum Clinical Research Basics 8 years, 1 month ago

    It is rare for new inventions to arise out of a clinical trial, because there is a protocol that you are to adhere to and it leaves little room for innovations, but sometimes it does happen. If you are conducting a Sponsored clinical trial at a NJ hospital and an invention arises- for example you find a new application for the drug/device or an adverse event that may solve another unmet need, who should own the Intellectual Property (IP)? The Sponsor or the NJ hospital?

    For a sponsored trial where the sponsor is paying for the clinical trial and provides the protocol, I believe the sponsor should own any IP that arises out of the clinical trial. However if it is an investigator initiated trial where the NJ hospital comes up with the protocol, I believe the NJ hospital should own the IP that comes out of the clinical trial.

    A great example of an invention arising out a clinical trial is Pfizer’s Viagra case. The sildenafil compound was originally developed by Pfizer for the treatment of hypertension and angina. During the clinical trials, researchers discovered that the drug was more effective at inducing erections than treating angina. Pfizer realized ED was an unmet medical need and a major opportunity for financial gain.
    https://www.drugs.com/slideshow/viagra-little-blue-pill-1043#