Although the Hypersomnia Foundation is not currently accepting new submissions for its Ask the Doctor series, we are working to answer previously submitted questions that are of general interest to our hypersomnia community. Today we have Andrew Powell, Esquire, a longtime pharmaceutical company executive (and now the Hypersomnia Foundation’s Corporate Outreach Officer) to answer a question concerning whether researchers can legally test a drug that is still on patent (but no longer being manufactured) for possible new uses.
When a drug is still on patent but is not being manufactured, can researchers still test that drug for new uses?
RESPONSE from ANDREW POWELL:
Yes. In most countries there are exemptions in the patent laws that provide that it is not a patent infringement if a patented compound is simply used for experimentation. In the U.S., that exemption would apply if the testing is intended to develop information that may form part of a future drug approval application. There are detailed interpretations of what this actually means, but presumably in the case in question the desired end result would be an application to FDA for a new drug or a new use for an existing drug. Note that this exemption would not alter the fact that any commercial developer of the compound would require a license to the patent from the patent owner.
The exemption is not affected by whether or not the patented compound is currently being manufactured. This fact would, however, influence whether or not the patent owner might actually sue to enforce their patent. There is little incentive to go to the effort of suing an unauthorized user if the alleged infringement does not result in any damages to the patent owner. So any risk to someone planning experiments with a patented compound are diminished if that compound is not being manufactured.
It is also worth noting that, if a compound is not currently being manufactured, there is every incentive for the owner to license the patent covering that compound to another manufacturer. In some countries, it is also possible to petition the government for a “compulsory license” to allow development of patented ideas or compounds that are not being developed by their owners.
Disclaimer for Ask the Doctor: The medical and/or legal information provided is meant for educational purposes only, and not as a substitute for professional medical care or advice (or as a substitute for legal advice). Questions about a personal health condition should be discussed with your healthcare professional. Similarly, questions about a personal legal issue or matter should be discussed with your own legal advisor.