## Facts

- Mallinckrodt owned a patent covering a medical device that delivered a radioactive or medicated mist to the lungs and collected exhaust for diagnostic purposes.
- Mallinckrodt sold the device to hospitals with a prominent label stating “Single Use Only,” and instructions directing disposal after one use.
- Medipart refurbished used devices for hospitals by arranging sterilization, replacing certain parts, and returning the devices for additional use.
- Mallinckrodt did not provide a refurbishing service and alleged Medipart’s reprocessing reduced sales of new devices.
- Mallinckrodt sued, asserting that the “Single Use Only” label created a lawful condition of sale; hospitals infringed by reusing the device and Medipart infringed (including by inducement) by enabling reuse.

## Issues

1. Whether patent exhaustion bars enforcement of a post-sale “single use only” restriction through a patent infringement action.
2. If the restriction is legally effective, whether Medipart’s refurbishing constitutes permissible repair or infringing reconstruction.
3. Whether an injunction may bar the patentee from sending infringement notices to the alleged infringer’s customers absent bad faith.

## Decision

- The Federal Circuit reversed summary judgment of noninfringement and remanded.
- The court rejected a categorical rule that no post-sale restriction can be enforced under patent law after an authorized sale.
- The court held that if the “single use only” notice is a valid condition of sale within the patent grant and not barred by antitrust or patent misuse principles, violation can constitute infringement.
- The court held that, assuming a valid single-use restriction, reuse beyond the authorized scope would be infringing, making the repair/reconstruction characterization secondary on the alleged facts.
- The court held the broad injunction against Mallinckrodt’s customer notice efforts was improper because patentees may provide infringement notice in good faith; an injunction requires a showing of bad faith or comparable impropriety.

## Legal Principles

- Patent exhaustion does not categorically preclude enforcement of post-sale restrictions; enforceability turns on whether the restriction is a valid condition of sale within the patent grant and consistent with other legal limits.
- A purchaser’s use outside a valid, communicated condition of sale may exceed the authorized scope and support an infringement claim.
- Post-sale restrictions are subject to scrutiny for patent misuse and antitrust violations; restraints such as price-fixing or unlawful tie-ins are not enforceable through infringement remedies.
- A patentee may notify alleged infringers and customers of its patent rights in good faith; restraining such communications generally requires proof of bad faith.

## Conclusion

The Federal Circuit held that a “single use only” condition attached to the sale of a patented device can be enforced through patent law if it is a valid, within-scope condition and not misuse or anticompetitive, and it vacated both the noninfringement summary judgment and the broad injunction against good-faith infringement notices, remanding for factual and legal determinations on validity, scope, and misuse/antitrust defenses.


Mallinckrodt, Inc. v. Medipart, Inc., 976 F.2d 700 (Fed. Cir. 1992)