United States Court of Appeals for the Federal Circuit in Regents of the University of South Florida v. United States Government (22-2248) The ruling in the Federal government implied that "Baidu act" (Bayh-Dole Act) Enjoy a wide range of licensing rights.

The case arose in federal court (Court of Federal Claims) basis "United States Code" The first28ranking1498 (a) Article heard a patent infringement dispute case. University of South Florida (USF) Proprietary rights to patents on genetically modified mice for Alzheimer's research, The university sued the federal government on the grounds that a government contractor created and used the genetically modified mice covered by the patent with the authorization and consent of the federal government. For the defense, The federal government argued: On the basis of "Baidu act" , It has a license on the invention, Because the invention was developed with government funding, A federal court of appeals sided with the government, Found that the government did not infringe.

During the appeal process, The Court of Appeals for the Federal Circuit upheld the government's decision to license the patented invention. The Court of Appeals for the Federal Circuit held, The research that led to the invention was "Work under the funding agreement" ——This is despite the fact that the study was conducted a few months before the effective date of the funding agreement. therefore, It is licensed by the government "Object of invention" .

The patent was funded by the National Institutes of Health (NIH) To approve the grant to the Mayo Clinic, But part of the research——This is actually the first practice of the patented invention——Be atUSFongoing. As a result of this arrangement, NIHIn practice "Baidu act" The policy requires Mayo Clinic andUSFsubcontract, In order to pay for the Mayo Clinic grantUSFConduct research. The Mayo Clinic andUSFOnly inUSFThe contract was signed months after the scientists completed the first practice of the patented invention.

The Court of Appeals for the Federal Circuit held, "Baidu act" There is no requirement that the funding agreement be signed prior to the realization of the invention. On the contrary, The court held that "Baidu act" The wording is very broad, stipulated "Payment shall be made for work completed prior to the implementation or effective date of the subcontract" . On account ofUSFA funding deal with the Mayo Clinic, And accepted a grant agreement before Mayo Clinic was signed to pay for the completion of the studyNIHFund of, The court held that "Baidu act" Applicable to the study.

The Court of Appeals for the Federal Circuit explained, The case file strongly supports the court's conclusion, Because of the fact pattern shown in this case——Subcontracts are not executed until funding is granted, However, the work covered by the funding can be carried out without waiting for subcontracts to be signed——Is a common pattern. The court's reasoning is, This fact model allows the development of useful knowledge to be advanced without waiting for the grant process to be finalized.

The ruling was issued in the executive branch of government regarding the agency's power to intervene in deciding whether to exercise it (march-in rights) May be considered when (Including price and other terms) The draft guidance was made at the time. The draft guidance was put forward by the White House, Is part of an effort to improve the affordability of taxpayer-funded drugs and other inventions, But the proposed policy has raised concerns about the impact of innovation.

To sum up, Innovators and licensees are looking for funding, Draft a license agreement, When doing due diligence on past and current research inputs and how you intend to price your product or method, Keep in mind the potential rights of the US federal government over its inventions. (Be compiled fromwww. mondaq. com)

TRANSLATORS: Wu Xian　proofread: Wang Dan



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