Federal Circuit affirms Praxair patent victory against Mallinckrodt

The US Court of Appeals for the Federal Circuit has affirmed a patent victory for industrial gases company Praxair against pharmaceutical business Mallinckrodt.

In the decision, issued on Wednesday, May 16, the court agreed with the Patent Trial and Appeal Board (PTAB) that several claims of a patent assigned to Mallinckrodt are invalid as obvious. It also reversed the decision that one claim is patentable.

The dispute centred on US patent number 8,846,112, called “Methods of distributing a pharmaceutical product comprising nitric oxide gas for inhalation”. The patent covers methods of distributing nitric oxide gas cylinders for pharmaceutical applications.

Praxair had sought an inter partes review (IPR) of 19 claims in the patent, with the PTAB finding all but one (claim 9) to be unpatentable.

After the decision, Praxair appealed against the claim 9 decision, while Mallinckrodt contested the decision on claims 1–8 and 10–11.

Chief Judge Prost and Circuit Judges Newman and Lourie ruled on the case, with Lourie writing the opinion.

“Because we conclude that the board did not err in its conclusions as to claims 1–8 and 10–11, but did err with respect to claim 9, we affirm the board’s decision in part and reverse it in part,” the judges said.

The PTAB had applied the printed matter doctrine in its decision.

According to a 2010 paper for the Indiana Law Journal by Kevin Emerson Collins of Indiana University, the doctrine is a branch of section 101 which, among other things, prevents the patenting of technical texts and diagrams.

But it “borders on incoherency in many of its applications and it lacks any recognised grounding in the Patent Act”, he said, adding that despite this, courts have not abandoned the doctrine.

On the decision surrounding claims 1–8 and 10, Mallinckrodt argued that the board erred in applying the printed matter doctrine during claim construction rather than when it assessed patentability, the court said.

“Mallinckrodt also argues that the board substantively misapplied the printed matter doctrine by extending it to encompass mental steps.”

Praxair argued that, except for claim 9, the PTAB correctly applied the doctrine.

The court agreed with Praxair, finding that the PTAB’s printed matter analysis only required analysing and interpreting the meaning of the claim language. “That is claim construction, which is ultimately a legal inquiry.”

Mallinckrodt also argued that the board erred at the first step of the printed matter analysis by concluding that claim limitations reciting mental steps were not entitled to “patentable weight”, said the court.

“According to Mallinckrodt, whether claims are directed to mental steps may be considered only in determining patent eligibility, not obviousness, and thus the board erred in not giving patentable weight to the evaluating limitation of claim 3.

“We disagree. Like the information claimed by printed matter, mental steps or processes are not patent-eligible subject matter,” the court concluded, finding that the board did not err in applying the printed matter doctrine to claims 1–8 and 10.

On claim 9, the court reversed the previous finding of patentability, as the PTAB had incorrectly assessed the claim. It confirmed that “we do not hold that claim invalid because of the printed matter doctrine, but because it would have been obvious to a person of ordinary skill based on the teachings of the prior art”.

Praxair was awarded costs.

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