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Medical Devices / Regulatory Affairs

Praxair Prevails in Mallinckrodt Patent Challenge

Sept. 3, 2019

A federal appeals court ruled that Praxair did not infringe on Mallinckrodt patents for its gas cylinder for inhaled nitric oxide.

Mallinckrodt, the name-brand manufacturer of INOmax (nitric oxide gas), sued Praxair in 2015 for alleged patent infringement by its generic product Noxivent. The complaint in the U.S. District Court of Delaware claimed in part that Praxair’s NOxBOXi delivery mechanism infringed on several device patents, and that the gas itself infringes the patent when used with Mallinckrodt’s cylinder.

In a 2017 trial, the judge ruled that Mallinckrodt’s patents for the drug were invalid, and that Praxair had not infringed on the device patents. In an Aug. 27 ruling, the Third Circuit Court of Appeals upheld the decision, noting the Delaware district court correctly interpreted the “plain language” of how the cylinder “verifies” the nitric oxide being released.

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