Albert Einstein once famously (albeit perhaps apocryphally) said that "[c]ompound interest is the most powerful force in the universe." Not to contradict the creator of 20th Century physics, but it is just as likely that the most powerful force in the universe is the power of unintended consequences. The Federal Circuit illustrated this power in its recent decision in iNo Therapeutics LLC v. Praxair Distribution Inc. with regard to Justice Breyer's exhortation, in his Mayo Collaborative Serv. Inc. v. Prometheus Laboratories opinion, regarding the need to beware of "interpreting patent statutes in ways that make patent eligibility 'depend simply on the draftsman's art' without reference to the 'principles underlying the prohibition against patents for [natural laws],'" citing Flook v. Parker.
Plaintiffs iNO Therapeutics, LLC, Mallinckrodt Hospital Products Inc., and Mallinckrodt Hospital Products IP Inc. asserted U.S. Patent Nos. 8,282,966; 8,293,284; 8,795,741; 8,431,163; and 8,846,112, which the opinion "collectively [termed the] 'heart failure patents' or 'HF patents'" against Praxair Distribution Inc. and Praxair Inc. Plaintiffs also asserted U.S. Patent Nos. 8,573,209; 8,776,794; 8,776,795; 9,265,911; and 9,295,802 which the opinion "collectively [termed the] 'delivery system infrared patents' or 'DSIR patents'" and which were directed to devices for administering nitric oxide gas. As explained in the opinion, inhaled nitric oxide (iNO) gas had been "used to treat infants experiencing hypoxic respiratory failure" since at least the early 1990's. However, in certain cases this treatment results in increased pulmonary edema for infants having a congenital defect, left ventricular hypertrophy. The patents-in-suit were directed to methods and a gas delivery device to ameliorate this side-effect, as exemplified by the following claims:
The '741 patent:
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.
The '794 patent:
1. A gas delivery device comprising:
a gas source to provide therapy gas comprising nitric oxide;
a valve attachable to the gas source, the valve including an inlet and an outlet in fluid communication and a valve actuator to open or close the valve to allow the gas through the valve to a control module that delivers the therapy gas comprising nitric oxide in an amount effective to treat or prevent hypoxic respiratory failure; and
a circuit including:
a memory to store gas data comprising one or more of gas identification, gas expiration date and gas concentration; and
a processor and a transceiver in communication with the memory to send and receive signals to communicate the gas data to the control module that controls gas delivery to a subject and to verify one or more of the gas identification, the gas concentration and that the gas is not expired.
(where the italicized limitations are relevant to the Court's decision). The opinion also notes that the Court had earlier affirmed the PTAB's invalidation of the '112 patent in inter partes review (see "Praxair Distribution, Inc. v. Mallinckrodt Hospital Products IP Ltd. (Fed. Cir. 2018)").
The District Court held the claims of the HF patents to be directed to patent-ineligible subject matter under 35 U.S.C. § 101, and that Praxair did not infringe the claims of the DSIR patents. Mallinckrodt appealed.
The Federal Circuit affirmed-in-part, vacated-in-part, and remanded, in an opinion by Chief Judge Prost joined by Judge Dyk; Judge Newman concurred in part and dissented in part (but the thrust of her opinion dissented from the majority's routine and now conventional, but not capable of being well-understood, affirmance that the claims were not eligible for patenting under § 101). The Court applied its now well-worn (and...
