Univ. of South Florida Bd. of Trustees v. United States, Appeal No. 2022-2248 (Fed. Cir. Feb. 9, 2024)

In this week’s Case of the Week, the Federal Circuit examined the scope of a provision of the Bayh-Dole Act of 1980 (35 U.S.C. §§ 200 et seq.) which provides the U.S. government with a nonexclusive license to practice inventions that were paid for with federal funding.  The Bayh-Dole Act specifically applies to inventions “conceived or first actually reduced to practice in the performance of work under a funding agreement,” and the Court held that in order to be “work under a funding agreement,” a funding agreement need not actually have been in place at the time the work was performed.  Instead, the Federal Circuit held that the Act also applies to work that was only retroactively paid for out of a qualifying funding agreement.

The appeal arose out of appellant USF’s lawsuit against the United States for infringement of a patent covering mice that have been genetically altered for medical research purposes to prematurely develop symptoms of Alzheimer’s disease.  The patented invention arose out of work commenced by four USF scientists in the mid-1990s, with one of the scientists—Dr. Hardy—having applied in September 1995 for a National Institutes of Health grant to cover the project.  The first litter of mice containing the altered genes was born in August 1996, and the grant was approved the following month.  During this same period, Dr. Hardy and another project scientist moved from USF to Mayo, and the grant application was amended to name Mayo as the grantee instead of USF.

The mice remained at USF to be cared for by the two project scientists who also remained there, and testing for the project was performed at both USF and Mayo.  The invention asserted in USF’s patent was ultimately reduced to practice in April 1997, which is when the first mice were confirmed to have prematurely developed amyloid plaques as claimed.  However, it was not until November 1997 that USF and Mayo entered into a formal subcontract for disposition of the NIH grant funds, pursuant to federal guidelines that require a written agreement for sharing of funds among members of a research consortium.  The record showed that Mayo did transfer funds to USF at some point to cover work that occurred in April 1997, although it was unclear whether the funds were actually transferred at that time or whether USF underwrote the costs for later reimbursement.

The trial court found the government retained a license to the patent under 35 U.S.C. § 202(c)(4), based in part on a finding that USF and Mayo had an implied contract for the disposition of the funds in April 1997; i.e., that at the time the invention was reduced to practice, there was an understanding the work would be paid for out of the NIH funds.  However, the Federal Circuit found no need to review that finding, since it held that the November 1997 agreement itself was sufficient to render the April 1997 efforts “work under a funding agreement” for purposes of the Bayh-Dole Act.  The Court reasoned from common contract principles that past consideration can support a promise for present performance. The Court also observed as a matter of fact that government-funded research typically did not stop to await finalization of consortium subcontracts, which frequently were not formalized until some time after the funds were awarded.  As such, the Court found that the policy principles underlying the Act would be frustrated if all subcontracts were required to be in place before qualifying work was performed.

Accordingly, the Court affirmed the district court’s finding of a valid license to the invention and its judgment of non-infringement.

The opinion can be found here.

By Jason A. Wrubleski


RAI Strategic Holdings, Inc. v. Philip Morris Products S.A., Appeal No. 2022-1862 (Fed. Cir. Feb. 9, 2024)

In an appeal from the Patent Trial and Appeal Board’s final written decision in a post-grant review, the Federal Circuit addressed whether the Board erred in holding that U.S. Patent No. 10,492,542—relating to electrically powered smoking articles—was unpatentable as obvious or lacking written description.  The Federal Circuit affirmed in part, vacated in part, and remanded, specifically holding that substantial evidence supported the Board’s obviousness finding but did not support its finding that certain range claims lacked written description support under 35 U.S.C. § 112.  As to the former, the Federal Circuit found there was substantial evidence to support the Board’s finding that a skilled artisan would have been motivated to combine prior art (heater and smoking article) to create the claimed electrically powered smoking article.  As to the latter, the Federal Circuit found that no reasonable fact finder could find that under the particular facts of the case there was no evidence that the claimed subrange resulted in a different invention from the one disclosed in the specifications.

The opinion can be found here.

By Mario E. Delegato

Weber, Inc. v. Provisur Technologies, Inc., Appeal Nos. 2022-1751, -1813 (Fed. Cir. Feb. 8, 2024)

Also this Week, the Federal Circuit reviewed and reversed the Patent Trial and Appeal Board’s inter partes review determinations that challenger Weber’s operating manuals were not “printed publication” for prior art purposes, finding that the manuals were in fact printed publications. The Court remanded for further proceedings.

In two inter partes review proceedings, Weber argued that Provisur’s patents were obvious over a combination of two U.S. patents and certain operating manuals published by Weber.  In its institution decisions, the Board found that Weber provided evidence to “support the public availability” of the operating manuals.  However, in its final written decisions, the Board found the manuals were not publically available, due to their having been distributed to a limited number of customers and subject to confidentiality restrictions and copyright protections.  The Board further found that even if the operating manuals did count as prior art publications, they did not disclose relevant limitations in the claims under review.  The Federal Circuit reversed, explaining that where “a publication’s purpose is ‘dialogue with the intended audience,’ that purpose indicates public accessibility.”  The record showed Weber’s manuals were created to provide instructions as to how to assemble, use, clean, and maintain Weber’s equipment, had been made available at trade shows and Weber’s showrooms, and were provided with the purchase of Weber’s equipment.  The Federal Circuit also found that the Board overemphasized the confidentiality restrictions and copyright protections.  These restrictions and protections did not prevent customers from using and disclosing the manuals internally; customers were expressly instructed to transfer the manuals to any purchaser to whom the customer sold their Weber equipment; and ultimately, the confidentiality and copyright restrictions “[had] no dispositive bearing” on whether Weber’s manuals were publically disseminated.  The Federal Circuit concluded by finding there was also not substantial evidence to support the Board’s findings that Weber’s manuals did not disclose limitations in the claims under review, and remanded to the Board for further proceedings.

The opinion can be found here.

By Tyler Hall

Google LLC v. Ecofactor, Inc., Appeal Nos. 2022-1750, -1767 (Fed. Cir. Feb. 7, 2024)

In an appeal from the Board’s decision in an inter partes review that the petitioner failed to show the prior art taught the disputed claim limitation, the Court reviewed whether the Board’s “findings” amounted to claim construction.  The Court clarified that the point in the proceeding at which the analysis occurs is not dispositive, and determined that the Board had engaged in claim construction because it relied on cited cases to determine the scope and meaning of a claim limitation.

Having concluded that the Board did engage in claim construction, the Court then concluded that, although the Board’s claim did not violate the Administrative Procedure Act as argued by the petitioner, the Board’s claim construction was nevertheless erroneous because it was unsupported by the intrinsic record.  For this reason, the Court vacated the Board’s Final Written Decision and remanded the case for further proceedings under the correct construction of the relevant claim limitation.

The opinion can be found here.

This article summarizes aspects of the law and does not constitute legal advice. For legal advice for your situation, you should contact an attorney.

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