## Facts

- Burroughs Wellcome Co. owned six related patents claiming pharmaceutical preparations and therapeutic methods involving 3′-azidothymidine (AZT) for treating HIV/AIDS; one patent (the ’750 patent) claimed a method of using AZT to increase T-lymphocyte counts in HIV-infected persons.
- During the AIDS crisis, the National Institutes of Health (NIH) solicited candidate compounds for testing; Burroughs Wellcome submitted AZT for NIH evaluation and, at the same time, prepared patent filings directed to AZT’s therapeutic use.
- NIH researchers performed in vitro testing and reported AZT activity against HIV, while Burroughs Wellcome pursued regulatory approval.
- Barr Laboratories and Novopharm entities sought to market generic AZT and filed ANDAs; Burroughs Wellcome sued for patent infringement.
- Defendants attacked validity by arguing (among other theories) that NIH scientists were omitted co-inventors and that Burroughs Wellcome had not conceived the claimed therapeutic inventions before NIH’s results.

## Issues

1. Whether omission of NIH researchers as co-inventors rendered the patents invalid due to incorrect inventorship.
2. Whether Burroughs Wellcome’s scientists had conceived the claimed AZT therapeutic methods before NIH’s confirmatory testing.
3. Whether judgment as a matter of law (JMOL) upholding validity and infringement was proper as to all six patents, including the ’750 patent.

## Decision

- The Federal Circuit affirmed in part, vacated in part, and remanded.
- It affirmed JMOL that five patents were not invalid and were infringed, rejecting the claim that NIH researchers were co-inventors of the subject matter of those patents.
- It vacated JMOL as to the ’750 patent and remanded for further proceedings because the record did not support JMOL that Burroughs Wellcome had conceived that specific claimed method (increasing T-lymphocyte counts) before relevant events.

## Legal Principles

- Conception is the touchstone of inventorship.
- Conception requires a definite and permanent idea of the complete and operative invention as it is to be applied in practice.
- Conception does not require reduction to practice; it is not postponed until experiments confirm operability.
- A person is not a co-inventor by merely performing tests or providing verification that an already-conceived invention works as intended; co-inventorship requires contribution to conception of the claimed subject matter.
- JMOL is improper where the evidentiary record does not permit the court to conclude, as a matter of law, that conception of the particular claimed invention occurred at the asserted time.

## Conclusion

The court held that Burroughs Wellcome’s inventors conceived the AZT treatment inventions claimed in five patents before NIH’s confirmatory experiments, so NIH testers were not co-inventors and those patents were upheld as valid and infringed; however, it required further proceedings on the separate T-lymphocyte-count method patent because conception of that specific claimed effect was not established as a matter of law.


Burroughs Wellcome Co. v. Barr Lab'ys, Inc., 40 F.3d 1223 (Fed. Cir. 1994)