Clinical Trials as Potentially Invalidating Public Uses: Current Issues and Future Questions Under the Leahy-Smith America Invents Act


Originally published in BNA’s Patent, Trademark & Copyright Journal on 09/28/2012.

When is a clinical trial an invalidating public use of an invention? Courts have struggled with this question — one particularly important in the pharmaceutical, biotechnology, and medical device industries — for years

Patent protection is one of the primary reasons investors are willing to risk money in developing new pharmaceuticals and medical devices. However, U.S. patent law prohibits an inventor from obtaining a patent on any invention that was in ‘‘public use’’ more than one year before the application leading to the patent was filed, unless the use was primarily experimental in nature.

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