Nitric Oxide - USA

On Sep 05, 2017, District of Delaware issued its decision in INOmax® (Nitric Oxide) case & found patents-in-suit are invalid & not infringed by Defendants.

In this patent infringement action, Mallinckrodt Hospital Products IP Ltd., INO Therapeutics LLC, and Ikaria, Inc. (collectively, "Plaintiffs" or "Ikaria") alleged that Praxair Distribution, Inc. and Praxair, Inc. (collectively, "Defendants" or "Praxair") infringed the asserted claims of the patents-in-suit. The court held a seven-day bench trial in this matter, beginning on March 13, 2017. Specifically, Defendants alleged that U.S. Patent Nos. 8,282,966, 8,293,284, 8,795,741, 8,431,163, and 8,846112 (collectively, the "HF patents") are invalid under 35 U.S.C. § 101; Defendants argued that they do not infringe U.S. Patent Nos. 8,573,209, 8,776,794, 8,776,795, 9,265,911, and 9,295,802 (collectively, the "DSIR patents"); and U.S. Patent No. 9.279,794 (the "Sensor Drift Patent").

Invalidation:

The court's conclusion that the HF patents are invalid under§ 101 is supported by the marked similarity between the HF patents and the patents at issue in Mayo. The Court determined that, though human action is required by the "administering" step, the relationship between concentrations of metabolites in the blood and the effect of a dose of a thiopurine drug is a mere consequence of how a patient's body metabolizes thiopurine-an entirely natural process. Here, just like in Mayo, some of the claimed steps require human action. Nonetheless, the core of the alleged invention is the increased risk of pulmonary-capillary wedge pressure that develops when administering iNO to term or near-term patients with both hypoxic respiratory failure and left-ventricular dysfunction. That "invention" is really a patient populations' natural physiological response to 20 ppm of inhaled nitric oxide treatment. The court finds it abundantly clear that the claim limitations of the HF patents recite routine, conventional activity that does nothing to transform the law of nature at the core of the "invention." The court thus concluded that the HF patents are invalid under 35 U.S.C. § 101 because they disclose patent-ineligible subject matter without an inventive step that transforms that nature of the invention into something worthy of patent protection.

Infringement:

Praxair advanced a two-part non-infringement argument with regard to its ANDA for Noxivent. First, use of Noxivent with the DSIR device cannot directly infringe the claims of the DSIR patent because Noxivent is incompatible with the DSIR device. Second, even if the Praxair cylinder was "reasonably capable" of use with a DSIR device, as Plaintiffs' contend, such use would not satisfy the device or method claims of the DSIR patents. The court agreed with Praxair that its cylinders are incompatible with the DSIR system. There is no dispute that, without an INOmeter, the DSIR device will not deliver nitric oxide-the "therapy gas"-as required by all of the asserted claims of the DSIR patents.

Defendants did not dispute the validity of the sensor drift patent. Instead, they argued that they do not infringe. Because the sensor drift patent discloses a method and system implemented as a software upgrade to the DSIR. Defendant’s arguments for non-infringement closely followed their arguments for non-infringement of the DSIR device. The court, therefore, found that there could be no direct infringement of the sensor drift patent for similar reasons as those articulated above. Because the court finds no direct infringement, there also cannot be induced infringement of the '794 patent's method claims. Even if there was direct infringement, however, Praxair still does not induce infringement. The court will apply the same infringement standard it used when considering infringement of the DSIR patents.

Court finally having considered the entire record in this case and the applicable law concluded that the HF patents are invalid under § 101, and that Defendants do not infringe the “DSIR” or the “Sensor Drift” patents.