Praxair Distribution, Inc. v. Mallinckrodt Hosp. Prods. Ip Ltd.

• Decision Date: 16 May 2018
• Docket Number: 2016-2616, 2016-2656
• Citation: 890 F.3d 1024
• Parties: PRAXAIR DISTRIBUTION, INC., Appellant v. MALLINCKRODT HOSPITAL PRODUCTS IP LTD., Cross–Appellant
• Court: U.S. Court of Appeals — Federal Circuit

890 F.3d 1024

PRAXAIR DISTRIBUTION, INC., Appellant

v.MALLINCKRODT HOSPITAL PRODUCTS IP LTD., Cross–Appellant

2016-2616, 2016-2656

United States Court of Appeals, Federal Circuit.

Decided: May 16, 2018

William R. Peterson, Morgan, Lewis & Bockius LLP, Houston, TX, argued for appellant. Also represented by Sanjay K. Murthy, Michael J. Abernathy, Maria Doukas, Chicago, IL; Julie S. Goldemberg, Philadelphia, PA.

Kenneth G. Schuler, Latham & Watkins LLP, Chicago, IL, argued for cross-appellant. Also represented by David K. Callahan, Marc Nathan Zubick ; Gabriel Bell, Inge Osman, Jonathan M. Strang, Washington, DC; Robert Steinberg, Los Angeles, CA.

Before Prost, Chief Judge, Newman and Lourie, Circuit Judges.

Opinion filed by Circuit Judge Newman, concurring in the judgment.

Lourie, Circuit Judge.

Praxair Distribution, Inc. ("Praxair") appeals from the inter partes review decision of the United States Patent and Trademark Office Patent Trial and Appeal Board ("the Board") holding claim 9 of U.S. Patent 8,846,112 (the "'112 patent") not unpatentable as obvious under 35 U.S.C. § 103 (2006).¹ Praxair Distrib., Inc. v. Mallinckrodt Hosp. Prods. IP Ltd. , No. IPR2015-00529, 2016 WL 3648375 (P.T.A.B. July 7, 2016) (" Decision "). Mallinckrodt Hospital Products IP Ltd. ("Mallinckrodt") cross-appeals from the same decision holding, inter alia , claims 1–8 and 10–11 unpatentable as obvious. 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.

BACKGROUND

Mallinckrodt owns the '112 patent, which is directed to methods of distributing nitric oxide gas cylinders for pharmaceutical applications. Inhaled nitric oxide is approved by the U.S. Food and Drug Administration ("FDA") for treating neonates with hypoxic respiratory failure, '112 patent col. 1 ll. 21–25, a condition where oxygen levels in the blood are too low. Nitric oxide functions to dilate blood vessels in the lungs and can thereby improve blood oxygenation. Id. col. 3 ll. 34–56. Mallinckrodt exclusively supplies inhaled nitric oxide in the United States for pharmaceutical use under the brand name INOmax^®.

Administering nitric oxide may cause harmful side effects. For example, the specification of the '112 patent describes a clinical study, INOT22, which identified patients with preexisting left ventricular dysfunction ("LVD") as having an increased risk of serious adverse events ("SAEs"), which include pulmonary edema ("PE"), when administered nitric oxide. Id. col. 14 ll. 17–25. Patients with preexisting LVD are characterized by having a pulmonary capillary wedge pressure ("PCWP") greater than 20 mm Hg. Id. col. 1 ll. 56–61. Accordingly, after identifying the relationship between preexisting LVD and SAEs in patients administered nitric oxide, the INOT22 protocol was updated to exclude from the study patients having PCWP greater than 20 mm Hg. Id. col. 14 ll. 19–21. The specification of the '112 patent, however, advises only that "[t]he benefit/risk of using [inhaled nitric oxide ] in patients with clinically significant LVD should be evaluated on a case by case basis," id. col. 14 ll. 21–25, and further proposes amending the INOmax prescribing information to include "a precaution for patients with LVD," id. col. 9 ll. 51–53.

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 identified in the INOT22 study. Claim 1 is illustrative and reads as follows:

1. A method of providing pharmaceutically acceptable nitric oxide gas, the method comprising:

obtaining a cylinder containing compressed nitric oxide gas in the form of a gaseous blend of nitric oxide and nitrogen;

supplying the cylinder containing compressed nitric oxide gas to a medical provider responsible for treating neonates who have hypoxic respiratory failure, including some who do not have left ventricular dysfunction ;

providing to the medical provider (i) information that a recommended dose of inhaled nitric oxide gas for treatment of neonates with hypoxic respiratory failure is 20 ppm nitric oxide

and (ii) information that, in patients with preexisting left ventricular dysfunction, inhaled nitric oxide may increase pulmonary capillary wedge pressure (PCWP), leading to pulmonary edema, the information of (ii) being sufficient to cause a medical provider considering inhaled nitric oxide treatment for a plurality of neonatal patients who (a) are suffering from a condition for which inhaled nitric oxide is indicated, and (b) have pre-existing left ventricular dysfunction, to elect to avoid treating one or more of the plurality of patients with inhaled nitric oxide in order to avoid putting the one or more patients at risk of pulmonary edema.

Id. col. 14 ll. 28–52. We refer to the last two claim limitations of claim 1 collectively as the "providing information" limitation.

Certain dependent claims add additional steps directing what a recipient of the provided information should do with it. Claim 3 depends from claim 1 and requires determining that a neonatal patient has preexisting LVD and then "evaluating the potential benefit of treating the [neonatal patient] with 20 ppm inhaled nitric oxide vs. the potential risk that inhaled nitric oxide could cause an increase in PCWP leading to pulmonary edema" (the "evaluating" limitation). Id. col. 14 ll. 57–66. Claim 9 depends from independent claim 7. Claim 7 concludes with a "recommendation that, if pulmonary edema occurs in a patient who has pre-existing [LVD] and is treated with inhaled nitric oxide, the treatment with inhaled nitric oxide should be discontinued" (the "recommendation" limitation). Id. col. 15 ll. 60–63. Claim 9 then reads:

9. The method of claim 7, further comprising:

performing at least one diagnostic process to identify a neonatal patient who has hypoxic respiratory failure and is a candidate for inhaled nitric oxide treatment;

determining prior to treatment with inhaled nitric oxide that the neonatal patient has pre-existing left ventricular dysfunction ;

treating the neonatal patient with 20 ppm inhaled nitric oxide, whereupon the neonatal patient experiences pulmonary edema ; and

in accordance with the recommendation of [claim 7], discontinuing the treatment with inhaled nitric oxide due to the neonatal patient's pulmonary edema.

Id. col. 16 ll. 2–13 (emphases added).

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,² Bernasconi,³ Loh,⁴ and Goyal.⁵

Decision , 2016 WL 3648375, at *22. But the Board concluded that claim 9 was not unpatentable as obvious over those same references. Id. at *19.

The present appeal involves several disputes over the Board's claim constructions and obviousness analysis. The Board found that a person of ordinary skill was at least a physician with experience treating pediatric heart and lung disease and administering vasodilators, and found "that the overall level of skill in the art is high." Id. at *4. In construing the claims, the Board applied the printed matter doctrine. The Board interpreted the providing information, evaluating, and recommendation claim limitations to be either printed matter or purely mental steps not entitled to patentable weight, as those limitations lacked a functional relationship to the other claim limitations except in claim 9. Id. at *9–10. For claim 9, however, the Board interpreted "in accordance with" to mean "based on, or as a result of" the recommendation to discontinue nitric oxide treatment from claim 7, thereby establishing a functional relationship to the recommendation limitation. Id. at *11.

The Board also construed "pharmaceutically acceptable nitric oxide gas" in the preambles of claims 1 and 7 as "nitric oxide gas that is suitable for pharmaceutical use," and rejected Mallinckrodt's proposed construction of "pharmaceutically acceptable" that would require considering information provided in the label of the supplied product. Id. at *6–7.

Turning to patentability, the Board found that the cited prior art collectively taught each limitation of claims 1–8 and 10–19 that did have patentable weight, and that a person of ordinary skill in the art would have been motivated to combine the INOmax Label, Bernasconi, Loh, and Goyal references. Id. at *14–18. The Board therefore held claims 1–8 and 10–19 unpatentable for obviousness. Id. However, the Board did not so conclude with respect to claim 9. The only reference considered by the Board regarding claim 9 was Bernasconi. Id. at *19. Bernasconi disclosed administering nitric oxide to newborns with hypoxic respiratory failure at the FDA-recommended dose of 20 ppm. Bernasconi also discussed several reports of "negative effects of inhaled [nitric oxide ] in patients with [LVD]," including "rapid left heart failure and pulmonary oedema." J.A. 249. Accordingly, Bernasconi emphasized "the need for careful observation and intensive monitoring during [nitric oxide ] inhalation in patients with left ventricular failure." Id.

The Board found that Bernasconi did not teach or suggest discontinuing nitric oxide treatment when a patient with LVD experiences a pulmonary edema, but rather, "contrary to the claim language," contemplated administering nitric oxide to patients with LVD as long as they were carefully monitored. Decision , 2016 WL 3648375, at *19. Furthermore, the Board found "compelling" Mallinckrodt's argument based on secondary considerations, namely that "if it were obvious to a person of ordinary skill in the art to exclude children with LVD from treatment with [nitric oxide], the experts in the field who designed the [INOT22] study would have excluded those children...