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Ino v. Praxair

Representative Claim(s)

‘741 – 1. A method of treating patients who are candidates for inhaled nitric oxide treatment, which method reduces the risk that inhalation of nitric oxide gas will induce an increase in pulmonary capillary wedge pressure (PCWP) leading to pulmonary edema in neonatal patients with hypoxic respiratory failure, the method comprising:
(a) identifying a plurality of term or near-term neonatal patients who have hypoxic respiratory failure and are candidates for 20 ppm inhaled nitric oxide treatment;
(b) determining that a first patient of the plurality does not have left ventricular dysfunction;
(c) determining that a second patient of the plurality has left ventricular dysfunction, so is at particular risk of increased PCWP leading to pulmonary edema upon treatment with inhaled nitric oxide;
(d) administering 20 ppm inhaled nitric oxide treatment to the first patient; and
(e) excluding the second patient from treatment with inhaled nitric oxide, based on the determination that the second patient has left ventricular dysfunction, so is at particular risk of increased PCWP leading to pulmonary edema upon treatment with inhaled nitric oxide.


Appeal from decision of the District Court

Exception Category: Natural Phenomenon

“The natural phenomenon here is undisputed. A neonate patient’s body will react to iNO gas in a certain way depending on whether or not the patient has a congenital heart condition called LVD. Namely, if the patient has LVD, iNO gas can induce a life-threatening event known as pulmonary edema.”

“As drafted, the claim instructs a physician to administer iNO gas to non-LVD patients as before, while now excluding the LVD patients. The exclusion step merely restates the natural law.”

“Properly understood, this added step is simply an instruction not to act. In effect, the claim is directed to detecting the presence of LVD in a patient and then doing nothing but leaving the natural processes taking place in the body alone for the group of LVD patients. Accordingly, the claim is directed to the natural phenomenon.”

“A treatment step of administering a prior art dosage is also present. But that step is plainly not the focus of the claimed invention. Mallinckrodt concedes this step is not innovative.”

Significantly More: No

“Mallinckrodt does not meaningfully dispute the district court’s findings that the various steps of claim 1 of the ’741 patent are routine and conventional.”

“As discussed above at length, this ‘do not treat’ step essentially embodies the natural phenomenon at issue in this case—the insight that nitric oxide will adversely affect a neonate with LVD. … This would be quite a different case if the inventors had invented a new way of titrating the dose. But this claim, unaccompanied by a recitation of some affirmative treatment, is directed to the natural law.”

“[W]hether viewed individually or as an ordered combination, the claims here do not recite a patent eligible application under the second step of Mayo/Alice.”

Judge Newman dissented

“The majority does not acknowledge that the claimed multi-step method of treatment of hypoxic respiratory failure does not occur in nature. The majority improperly separates the claims into old and new steps, describes some claim steps as a ‘natural phenomenon’ and some steps as ‘well-understood, routine, and conventional steps,’ and avoids the requirement that a claimed invention is considered as a whole.”

“Mallinckrodt’s method of treatment may or may not pass the tests of sections 102 or 103, but this court’s precedent and that of the Supreme Court do not exclude methods of treatment from access to the patent system under section 101. Today’s change of law adds to the inconsistency and unpredictability of this area of patent-supported innovation.”

“The claims recite a multi-step method of administering inhaled nitric oxide so that patients with left ventricular dysfunction are at reduced risk of adverse events. This method is not a law of nature, it is not a natural phenomenon.”