INOmax® - USA

On May 16, 2018, Federal Circuit upheld the Patent Trial and Appeal Board’s decision to invalidate Mallinckrodt patent on respiratory drug Inomax.

Mallinckrodt owns U.S. Patent 8,846,112, which is directed to methods of distributing nitric oxide gas cylinders for pharmaceutical applications. Inhaled nitric oxide is approved by the USFDA for treating neonates with hypoxic respiratory failure, a condition where oxygen levels in the blood are too low. Mallinckrodt exclusively supplies inhaled nitric oxide in the United States for pharmaceutical use under the brand name INOmax®. The claims of the ’112 patent generally require supplying a medical provider with a cylinder of nitric oxide gas and providing the medical provider with certain prescribing information relating to the harmful side effects of nitric oxide for certain patients. Certain dependent claims add additional steps directing what a recipient of the provided information should do with it. Praxair petitioned for inter partes review of claims 1– 19 of the ’112 patent, which the Board instituted. The Board held that claims 1–8 and 10–19 would have been obvious over the INOmax Label, Bernasconi, Loh, and Goyal. Mallinckrodt appealed.

During appeal, Mallinckrodt argued that the Board erred in applying the printed matter doctrine during claim construction rather than when it assessed patentability. Furthermore, Mallinckrodt contended that the Board erred in construing the term “pharmaceutically acceptable,” and that the broadest reasonable interpretation of the term supplies a functional relationship between any claimed printed matter and the other limitations of the claims of the ’112 patent. If a claim limitation is directed to printed matter, then the next step is to ascertain whether the printed matter is functionally related to its “substrate.” Printed matter that is functionally related to its substrate is given patentable weight. [DiStefano, 808 F.3d at 850]. Likewise, “[w]here the printed matter is not functionally related to the substrate, the printed matter will not distinguish the invention from the prior art in terms of patentability.” [In re Ngai, 367 F.3d 1336, 1339 (Fed. Cir. 2004)]. Merely adding an instruction sheet or other informational content to a drug product is not sufficient to create a functional relationship, even if required by the FDA for approval. [AstraZeneca, 633 F.3d at 1065; (holding that FDA-required instructions did not create functional relationship to drug)].

Federal circuit while applying precedent to this case, agreed with Praxair that the Board properly addressed the printed matter doctrine during claim construction. Because claim limitations directed to mental steps may attempt to capture informational content, they may be considered printed matter lacking patentable weight in an obviousness analysis. According to Mallinckrodt, this is because the term “pharmaceutically acceptable” incorporates the claimed information into the concrete step of supplying nitric oxide gas. Court agreed with the Board that the ordinary meaning of “pharmaceutically acceptable” here only refers to the physical condition of the gas, not prescribing information that may accompany it. And even if “pharmaceutically acceptable” did include the informational content, it would only make the claim redundant, not supply a functional relationship, as “providing” a drug product together with FDA-required prescribing information does not suffice to create a functional relationship between the information and methods of providing and potentially administering the drug. Thus, the Board did not err either in construing “pharmaceutically acceptable” or in concluding that the term did not create a functional relationship.

Mallinckrodt’s final argument regarding claims 1–8 and 10 was that the Board improperly discounted evidence of secondary considerations. Mallinckrodt contended that one must weigh secondary considerations of nonobviousness even if the secondary considerations only relate to printed matter lacking patentable weight. Specifically, Mallinckrodt argued that the INOT22 study unexpectedly uncovered the potentially harmful effect of inhaled nitric oxide on neonates with preexisting LVD. Court agreed with Mallinckrodt and held that relevant evidence of secondary considerations must be considered in an obviousness analysis, the evidence submitted here was not relevant to claims 1–8 and 10. The only secondary consideration Mallinckrodt alleges was based on the information claimed in the providing information limitation, which court have held lacks any functional relationship to the non-printed matter limitations in claims 1–8 and 10. That claimed information has no patentable weight in an obviousness analysis because printed matter without a functional relationship to a substrate is not eligible subject matter. Such printed matter cannot be brought within the ambit of patent eligibility by showing that it was surprising. No patentable weight means no patentable weight. Thus, court affirmed the Board’s decision holding claims 1–8 and 10 unpatentable as obvious.

Praxair argued in its principal appeal that the Board erred in holding claim 9 not unpatentable as obvious. Praxair contended that the Board improperly construed “in accordance with” in claim 9. Properly construed, Praxair argued that there is no functional relationship between the discontinuing step of claim 9 and the recommendation limitation. And even accepting the Board’s construction, Praxair argued that claim 9 would have been obvious. By interrelating the claimed information regarding correlations between nitric oxide, LVD, and pulmonary edema with the concrete step of discontinuing treatment because of the information, court agreed with Mallinckrodt that the Board did not err in concluding that the printed matter in claim 9 has a functional relationship to the rest of the claim and giving the printed matter patentable weight. Therefore, Board held that Bernasconi did not render claim 9 obvious. Court, however, rejected the Board’s conclusion and held that Board’s finding is premised on an incorrect reading of claim 9. In sum, both the Board’s findings regarding the differences between the prior art and claim 9 and its findings on secondary considerations depended on an incorrect interpretation of that claim, and court therefore held that they are not supported by substantial evidence.

Thus, Court affirmed the Board’s decision with respect to claims 1–8 and 10–11, and reversed the Board’s decision with respect to claim 9.