## Facts

- Cetus Corporation developed PCR technology and collaborated with Stanford researchers on HIV-related work.
- Stanford research fellow Mark Holodniy signed a Stanford agreement stating he “agree[d] to assign” to Stanford his rights in inventions resulting from his employment.
- To gain access to Cetus and learn PCR, Holodniy signed a Cetus agreement stating he “will assign and do[es] hereby assign” to Cetus his rights in inventions made as a consequence of that access.
- Holodniy and Cetus scientists developed a PCR-based method to measure HIV levels in blood; Stanford later obtained patents covering the HIV quantification process.
- Roche acquired Cetus’s PCR-related assets and commercialized an HIV test kit using the technology.
- Some of the research used federal funding, implicating the Bayh–Dole Act; Stanford notified NIH that it elected to retain title and granted the government the statutory license.
- Stanford sued Roche for patent infringement; Roche asserted it was a co-owner based on Holodniy’s assignment to Cetus.

## Issues

1. Whether the Bayh–Dole Act automatically vests title to federally funded inventions in the federal contractor or authorizes the contractor to unilaterally take title from the inventor.
2. Whether an inventor’s prior assignment to a third party remains effective notwithstanding the contractor’s Bayh–Dole election to retain title.
3. Whether a contractor lacking sole ownership has standing to sue an alleged infringer that is a co-owner.

## Decision

- The Supreme Court affirmed the Federal Circuit in a 7–2 decision.
- The Court held that the Bayh–Dole Act does not automatically vest title in federal contractors and does not permit contractors to unilaterally take title from inventors.
- The Court applied the rule that patent rights initially vest in the inventor, who may transfer them by assignment.
- Accepting the lower court’s contract construction, the Court treated Stanford’s “agree to assign” as a future promise and Cetus’s “do hereby assign” as a present assignment that transferred Holodniy’s rights to Cetus (and thus to Roche as successor).
- Because Roche was a co-owner, Stanford lacked standing to sue Roche for infringement without Roche’s consent.

## Legal Principles

- Patent ownership initially vests in the inventor unless validly assigned.
- Bayh–Dole regulates allocation of rights between the federal government and contractors after a contractor has obtained an invention; it does not itself transfer title from inventors to contractors.
- A contractor’s right to “elect to retain title” presupposes the contractor has acquired title; it is not a statutory vesting provision.
- Private assignment agreements are not displaced by Bayh–Dole absent clear statutory language.
- A patent co-owner generally cannot be sued for infringement by another co-owner without the defendant co-owner’s consent; absence of sole ownership defeats standing.

## Conclusion

The Court held that federally funded research does not change the default rule that inventors initially own patent rights; Bayh–Dole does not vest title in universities, so effective assignment language is required to secure ownership and standing to sue.


Bd. of Trs. of Leland Stanford Junior Univ. v. Roche Molecular Sys., Inc., 563 U.S. 776 (2011)