gies to validate the results of particular clinical tests. The committee agreed that this may present a problem and encourages patent owners to consider entering into licenses that will permit others to use the patented technologies for the purpose of independently confirming the results of a diagnostic test.

Recommendation 13:

Owners of patents that control access to genomic- or proteomic-based diagnostic tests should establish procedures that provide for independent verification of test results. Congress should consider whether it is in the interest of the public’s health to create an exemption to patent infringement liability to deal with situations where patent owners decline to allow independent verification of their tests.

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