Criterion 1 requires an agency to consider whether “action is necessary because the contractor or assignee has not taken, or is not expected to take within a reasonable time, effective steps to achieve practical application of the subject invention in such field of use.”13 “Practical application” is defined as the “means to manufacture in the case of a composition or product, to practice in the ca. [...] NIH has consistently determined that the availability and public use of a product is sufficient to establish that “practical application” of the product has been achieved.21 NIH has repeatedly stated that “practical application is evidenced by the ‘manufacture, practice, and operation’ of the invention and the invention’s ‘availability to and use by the public.’”22 For instance, in 2016, NIH decli. [...] NIH has repeatedly rejected calls to exercise march-in rights based on the price of a product.27 In responding to a petition to exercise march-in rights with respect to AbbVie’s drug Norvir, NIH stated that it did “not think that the AbbVie pricing policies and pricing disparities between the United States and the other countries trigger any of the four Bayh-Dole march-in criteria.”28 In addition,. [...] For example, in response to a petition to exercise march-in rights for Norvir, the NIH stated that “[t]he NIH continues to agree with the public testimony in 2004 that the extraordinary remedy of march-in is not an appropriate means of controlling prices of drugs broadly available to physicians and patients. [...] As a result, the NIH Director announced in 1995 the removal of the clause from CRADAs and exclusive licenses.42 Following the removal of the clause, there was a “large increase” in the number of CRADAs, which NIH concluded was “most likely was [due to] the removal of the reasonable pricing clause[.]”43 Similar to when the “reasonable pricing clause” was in effect, if agencies were to consider pric.
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