## Facts

- IGEN International, Inc. (IGEN) developed and patented a diagnostic process based on electrochemiluminescence (ECL).
- In 1992, IGEN and Roche Diagnostics GmbH (Roche) entered a license agreement giving Roche rights to develop and market products using IGEN’s ECL technology within a defined field of use.
- The licensed field permitted use in hospitals, blood banks, and clinical reference laboratories.
- The agreement expressly excluded use “in the presence or proximity of a patient,” including settings such as homes, patient bedsides, and physician offices.
- IGEN reserved for itself the right to develop ECL applications for the patient point-of-care market.
- Roche developed Elecsys, an ECL-based diagnostic instrument weighing roughly 150–200 pounds and intended for laboratory settings.
- IGEN worked on a smaller ECL instrument (ECLM) designed for point-of-care use, including bedside testing.
- Beginning in 1997, Roche sales representatives visited physicians’ offices and marketed Elecsys units for use in physicians’ in-office laboratories.
- At least five physicians’ offices purchased Elecsys products for use in their office laboratories.
- IGEN sued Roche, alleging the physicians’ office sales violated the field-of-use restriction, threatened IGEN’s reserved point-of-care market, reduced the prospective market for ECLM, and discouraged potential partners from investing in ECLM.
- The U.S. District Court for the District of Maryland granted a preliminary injunction barring Roche from further sales of Elecsys to physicians’ offices for use in in-office laboratories, and Roche appealed.

## Issues

1. Did the district court abuse its discretion by granting a preliminary injunction barring Roche from selling Elecsys systems to physicians’ offices for use in physicians’ office laboratories as outside the license’s field of use?
2. Did the district court clearly err in finding that the preliminary-injunction factors (including irreparable harm, balance of harms, and public interest) supported interim relief pending a final decision?

## Decision

- The Fourth Circuit affirmed the district court’s order granting a preliminary injunction.
- The court held the district court did not abuse its discretion in concluding that IGEN made a sufficient showing that Roche’s physicians’ office sales likely violated the license’s field-of-use limits.
- The court accepted the district court’s determination that continued out-of-field sales threatened harm that was difficult to remedy fully with money damages, including loss of a reserved market opportunity and harm to IGEN’s ability to secure business partners for ECLM.
- The court agreed that the balance of harms favored IGEN because the injunction restricted only the disputed sales channel while leaving Roche free to sell within the contract’s permitted laboratory field.
- The court concluded the public interest supported enforcing negotiated licensing boundaries and preserving the parties’ contractual allocation of markets while the case proceeded.

## Legal Principles

- A preliminary injunction is reviewed on appeal for abuse of discretion; factual findings are reviewed for clear error and legal conclusions are reviewed de novo.
- A court considering preliminary injunctive relief weighs: (1) the movant’s likely irreparable harm without an injunction, (2) the harm to the nonmovant if an injunction issues, (3) the movant’s likelihood of success on the merits (or, under a sliding-scale approach, sufficiently serious merits questions when the balance of harms strongly favors the movant), and (4) the public interest.
- Field-of-use restrictions in a technology license are enforceable as contractual limits on the licensee’s authorized market activities.
- Irreparable harm may be shown where challenged conduct threatens to take or impair a market segment reserved by contract and to disrupt the licensor’s commercialization plans in ways not readily measured or repaired through damages (including harm to partner and investor interest).
- An injunction that restricts only allegedly unauthorized conduct, while allowing continued activity within the undisputed licensed field, may be appropriate to preserve the parties’ pre-dispute market allocation pending final adjudication.

## Conclusion

The Fourth Circuit affirmed a preliminary injunction preventing Roche from selling Elecsys ECL diagnostic systems to physicians’ offices for use in physicians’ office laboratories, concluding the district court acted within its discretion in enforcing the license’s field-of-use limits and finding that continued out-of-field sales threatened harm to IGEN’s reserved point-of-care market and related commercialization efforts that could not be adequately remedied by damages alone.


IGEN International v. Roche Diagnostics GmbH, 203 F.3d 821 (1999)