## Facts

- Harvard owned patents covering anti‑p63 monoclonal antibodies and related diagnostic methods.
- Harvard granted Biocare a biological materials license allowing Biocare to make, use, and sell the antibodies; the agreement stated it did not grant patent rights, and it was associated with the life science research market.
- Harvard later granted AsymmetRx an “exclusive commercial license” under the patents limited to clinical/diagnostic sales based on detecting p63 expression or mutation.
- Harvard retained significant rights under the AsymmetRx agreement, including academic research use, the ability to grant research licenses to certain institutions, and rights affecting the exclusivity of AsymmetRx’s license if commercialization or regulatory milestones were not met.
- AsymmetRx sued Biocare for patent infringement, alleging Biocare’s sales invaded AsymmetRx’s exclusive diagnostic field.
- The district court granted summary judgment for Biocare, and AsymmetRx appealed.

## Issues

1. Whether AsymmetRx, as an exclusive licensee, had statutory standing to sue for infringement without joining Harvard, the patent owner.
2. Whether the AsymmetRx license transferred “all substantial rights” in the patents such that AsymmetRx could sue in its own name.

## Decision

- The Federal Circuit held AsymmetRx lacked statutory standing to sue without Harvard.
- The court concluded the AsymmetRx license did not convey all substantial rights because Harvard retained significant rights and control.
- The court vacated the district court’s summary judgment and remanded for further proceedings addressing standing, including joinder of Harvard.

## Legal Principles

- A patent infringement action must be brought by the patentee (legal title holder) or by an exclusive licensee that has received an effective assignment of “all substantial rights.”
- Whether “all substantial rights” were transferred depends on the substance of rights granted and retained, not contractual labels such as “exclusive.”
- Retained rights that commonly defeat “all substantial rights” status include meaningful reservations of use/licensing rights (e.g., research), field-of-use limitations, contractual power to convert exclusivity, and significant control over enforcement or litigation.
- An exclusive licensee lacking all substantial rights generally must join the patent owner; otherwise, the suit is jurisdictionally defective for lack of statutory standing.

## Conclusion

Because Harvard retained substantial rights and control under the AsymmetRx license, AsymmetRx was not an effective assignee of the patents and could not sue Biocare for infringement in its own name; Harvard’s joinder was required, so the judgment was vacated and the case remanded.


AsymmetRx, Inc. v. Biocare Med., LLC, 582 F.3d 1314 (Fed. Cir. 2009)