Mallinckrodt, Inc. v. Medipart, Inc.

976 F.2d 700 (1992)

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Nature of the Case

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Facts

P's patented device is an apparatus for delivery of radioactive or therapeutic material in aerosol mist form to the lungs of a patient, for diagnosis and treatment of pulmonary disease. P sells it to hospitals as a unitary kit that consists of a 'nebulizer' which generates a mist of the radioactive material or the prescribed drug, a 'manifold' that directs the flow of oxygen or air and the active material, a filter, tubing, a mouthpiece, and a nose clip. In use, the radioactive material or drug is placed in the nebulizer, is atomized, and the patient inhales and exhales through the closed system. The device traps and retains any radioactive or other toxic material in the exhalate. The device fits into a lead-shielded container that is provided by Mallinckrodt to minimize exposure to radiation and for safe disposal after use. The device is marked with the inscription 'Single Use Only.' The package insert states 'For Single Patient Use Only' and instructs that the entire contaminated apparatus be disposed of in accordance with procedures for the disposal of biohazardous waste. Some hospitals ship the used product to D. D sends them to Radiation Sterilizers Inc., who exposes the packages to at least 2.5 megarads of gamma radiation, and returns them to D. D then does a quality check and puts the assembly in a plastic bag together with a new filter, tubing, mouthpiece, and nose clip. D's refurbishment does not test the units for any residual biological activity or for radioactivity. The assemblies still bear the inscription 'Single Use Only' with P's trademarks. P sued D for patent infringement as well as trademark infringement, unfair competition under section 43(a) of the Lanham Trademark Act, and violation of Illinois unfair competition statutes. The court granted D's summary judgment holding that the activities were permissible repair, not impermissible reconstruction, of the patented apparatus. The court reserved for trial the actions for trademark infringement and unfair competition. The court enjoined D pendente lite from distributing a new notice to its hospital customers. P appealed.