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United States Court of Appeals for the Federal Circuit
August 27, 2019, Decided
[*1002] Prost, Chief Judge.
INO Therapeutics LLC, Mallinckrodt Hospital Products Inc., and Mallinckrodt Hospital Products IP Ltd. (collectively, "Mallinckrodt") sued Praxair Distribution Inc. and Praxair Inc. (collectively, "Praxair") for patent infringement. Mallinckrodt asserted five patents related to methods of administering inhaled nitric oxide, including U.S. Patent Nos. 8,282,966 ("the '966 patent"), 8,293,284 ("the '284 patent"), 8,795,741 ("the '741 patent"), 8,431,163 ("the '163 patent"), and 8,846,112 ("the '112 patent") (collectively, "heart failure patents" or "HF patents"). [**2] Mallinckrodt also asserted five patents related to devices and methods for administering gas, including U.S. Patent Nos. 8,573,209 ("the '209 patent"), 8,776,794 ("the '794 patent"), 8,776,795 ("the '795 patent"), 9,265,911 ("the '911 patent"), and 9,295,802 ("the '802 patent") (collectively, "delivery system infrared patents" or "DSIR patents"). After a bench trial, the United States District Court for the District of Delaware held all claims of the HF patents ineligible and all claims of the DSIR patents not infringed. For the reasons below, we affirm-in-part, vacate-in-part, and remand.
Inhaled nitric oxide ("iNO") is a gas that is well known in the prior art. The U.S. Food and Drug Administration ("FDA") approved New Drug Application ("NDA") No. N020845 for 100 and 800 ppm nitric oxide for inhalation on December 23, 1999.
Use of iNO gas as a treatment has been "studied and reported in the literature." '741 patent col. 1 ll. 25-26. In particular, since at least the early 1990s, iNO gas has been used to treat infants experiencing hypoxic respiratory failure. According to the Background of the Invention of the '741 patent, iNO "is an approved drug product for the treatment of term and near-term neonates . . . having hypoxic respiratory failure associated with clinical or echocardiographic evidence of pulmonary hypertension." Id. at col.1 ll. 20-24. Hypoxic [**3] respiratory failure is "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." Praxair Distrib. v. Mallinckrodt Hosp. Prods. IP, 890 F.3d 1024, 1028 (Fed. Cir. 2018) (citing '112 patent col. 3 ll. 34-56).
A dose of 20 ppm iNO was also well known in the prior art for treatment of hypoxic respiratory failure in infants. J.A. 24-25. For example, one of the asserted patents cites as prior art U.S. Patent No. 5,485,827 ("Zapol"), which discloses administering 20 ppm iNO treatment. The Zapol patent issued in 1996.
Full case includes Shepard's, Headnotes, Legal Analytics from Lex Machina, and more.
782 Fed. Appx. 1001 *; 2019 U.S. App. LEXIS 25756 **; 2019 U.S.P.Q.2D (BNA) 319842; 2019 WL 4023576
INO THERAPEUTICS LLC, MALLINCKRODT HOSPITAL PRODUCTS INC., MALLINCKRODT HOSPITAL PRODUCTS IP LTD., Plaintiffs-Appellants v. PRAXAIR DISTRIBUTION INC., PRAXAIR INC., Defendants-Appellees
Notice: THIS DECISION WAS ISSUED AS UNPUBLISHED OR NONPRECEDENTIAL AND MAY NOT BE CITED AS PRECEDENT. PLEASE REFER TO THE RULES OF THE FEDERAL CIRCUIT COURT OF APPEALS FOR RULES GOVERNING CITATION TO UNPUBLISHED OR NONPRECEDENTIAL OPINIONS OR ORDERS.
Subsequent History: US Supreme Court certiorari denied by Ino Therapeutics Llc v. Praxair Distrib., 2020 U.S. LEXIS 2100 (U.S., Apr. 6, 2020)
Prior History: [**1] Appeal from the United States District Court for the District of Delaware in No. 1:15-cv-00170-GMS, Judge Gregory M. Sleet.
Mallinckrodt Hosp. Prods. IP Ltd. v. Praxair Distrib., Inc., 2017 U.S. Dist. LEXIS 142644 (D. Del., Sept. 5, 2017)
Disposition: AFFIRMED-IN-PART, VACATED-IN-PART, AND REMANDED.
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Civil Procedure, Appeals, Standards of Review, Clearly Erroneous Review, De Novo Review, Patent Law, Subject Matter