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This is something I've run into several times now. A lot of biological samples are shared for research with a caveat in the MTA that they are "not for commercial use". What exactly does this cover? The specific example I'd like to know about is where DNA samples are used to validate a diagnostic test that might eventually be developed for commercial use. When does this become commercial? If I use materials for something that I don't expect to be commercial but I later want to develop it commercially, what happens?

I've asked the people sharing the materials but generally this results in "I don't know, better play it safe", partly because in many cases multiple partners and historical MTAs are involved and no one person wants to take responsibility for a decision. I'm looking for pointers to a clear set of criteria ("good subjective" - from personal experience of what works), ideally with an explanation of the wider legal context and any key legislation or decisions.

I'm in the UK but the samples are coming from (and going back out to) partners in South America (Brazil) and Europe (Greece, Italy, France).

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There is no single definition of "commercial use" that would apply in all these cases. That would depend on the definition, if any, included in each contrast or license, and on the interpretation of that term under the governing law form each contract. In many cases that would be the law of the source country of the sample.

At a minimum, where the sample is used solely in scientific investigations, leading to scientific papers published in standard ways, that is not going to be considered to be "commercial use". Where the sample is directly used to manufacture a commercial product, that would, clearly be "commercial use". If the sample is used directly to develop a commercial product, that is probably "commercial use". Between those points there is a grey area, and in that grey area the result would depend on the factual details, the language of the contract, and the specific governing law.

I suspect that much of the prevalence of this language is a result of the case of the HeLa cell line . This line is derisive from a sample of cells taken from Henrietta Lacks without her knowledge or consent, ostensibly for her individual medical treatment. These cells have been widely used commercially, with no compensation or right of approval granted to the heirs or family of Lacks. See The Immortal Life of Henrietta Lacks by Rebecca Skloot (ISBN 978-0-307-71250-9),.

In the case of *Moore v. Regents of the University of California * (1990) 51 C3d 120 The supreme Court of California held that a person had no property right in his or her discarded cells or tissues, and that the doctor or hospital could make commercial use of them. However the court held that the doctor had an obligation to reveal his financial interest in the materials that were harvested, and to obtain informed consent.

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A good rule of thumb would be that if the use is made by a for profit company, it is commercial use.

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