Q: Does researching feasibility of patent claims in eg a prototype or a pilot product require licensing?
The prototype/pilot is not to be sold or used for anything more that research as PoC or the feasibility of a final product?
I understand that if I use a patent for a working instrument in my lab the licensing is required, but not if it applies to an object of research?
A: The general rule is that developing a prototype is not immune from patent infringement. I have seen a suit against a university for doing qualification tests of a new device that arguably infringed a patented method.
As a practical matter, it is unlikely that a patent owner will know or care about your prototype so you may want to take your chances doing some preliminary work before seeking to review whether your evolving prototype infringes any patents. You may also be able to work with a patent attorney to adjust your design to be outside of the scope of a patent for a similar device.
There is a special carve out to do whatever is necessary to get the test data needed for FDA clearance (See 35 USC 271 (e)). The US Supreme Court deems this section to apply to medical devices in addition to drugs.
The details of what is protected by this carve out is very fact specific and would need analysis of your device if you have a medical device that will seek FDA approval.
If you found this answer helpful, you may want to look at my answers to other questions about patent law are available at the bottom of my profile page at
Kevin E Flynn
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