Mallinckrodt respiratory patents invalidated by court

Industrial gases company Praxair has been cleared of patent infringement in a district court ruling after Mallinckrodt accused the company of infringing its respiratory treatment Inomax (nitric oxide).

Yesterday, September 5, the US District Court for the District of Delaware ruled that Mallinckrodt’s patents, numbers 8,282,966; 8,293,284; 8,795,741; 8,431,163; and 8,846,112 (collectively the HF patents), were invalid and that Praxair did not infringe them.

Praxair had also argued that it didn’t infringe a group of patents called the DSIR patents, and a patent called the “Sensor drift patent”.

Inomax is used to treat respiratory failure in newborns.

Praxair filed an Abbreviated New Drug Application (ANDA) with the Food and Drug Administration, and notified Mallinckrodt of its ANDA in January 2015.

Mallinckrodt responded by filing a patent infringement suit against Praxair back in July 2016.

In March this year, the court held a seven-day bench trial on the matter.

Judge Gregory Sleet handed down a memorandum yesterday, holding that Praxair had proved, “by clear and convincing evidence”, that some of the patents were invalid under section 101.

“The court’s conclusion that the HF patents are invalid under section 101 is also supported by the marked similarity between the HF patents and the patents at issue in Mayo,” he added, referencing the US Supreme Court’s Mayo v Prometheus decision in 2012.

Sleet also held that Mallinckrodt had failed to prove that Praxair had infringed the DSIR and “Sensor drift” patents.

In a press release, published yesterday, Mallinckrodt said: “We are aware of and disappointed in Judge Sleet’s ruling today in Mallinckrodt’s case against Praxair for patent infringement.”

Mallinckrodt confirmed it would appeal against the decision.

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