In the recent case of INO Therapeutics v. Praxair Distribution, a Delaware district court held as patent-ineligible a group of patents for treatment of neonatal (newborn) patients with inhaled nitric oxide (iNO). The court’s reasoning hinged upon the principle that patents are not to be granted to scientific discoveries.
Specifically, the court found that the core of the patent claim was the discovery of a natural human physiological response: an increased risk of adverse reaction to treatment with iNO on the part of neonatal patients with left ventricular dysfunction (LVD). In holding the claim to embody a law of nature, the court stated that “[w]hile man discovered the adverse physiological response that occurs when some patients receive iNO, such a discovery does not amount to innovation.” It further held that the patent claim’s step of excluding neonatal patents with LVD from INO treatment failed to confer patent eligibility, citing judicial pronouncements that “even valuable contributions [to science] can fall short of statutory patentable subject matter” and that “[g]roundbreaking, innovative, or even brilliant discovery does not by itself satisfy the § 101 inquiry.”
The blanket exclusion of scientific discoveries from the possibility of patenting might seem a curious one, given the explicit inclusion of discoveries in the relevant constitutional and statutory language. Article 1, Section 8 of the U.S. Constitution refers to granting exclusive rights to “discoveries.” Similarly, § 101 of the Patent Act states that whoever “invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor,” thereby specifically including discoveries as well as inventions within the scope of patent eligibility (emphasis added).
Assuming that the discovery in INO Therapeutics of the connection between LVD and pulmonary edema was indeed useful and novel, why was it deemed ineligible for patent?
One explanation lies in the U.S. Supreme Court’s articulated exceptions to both inventions and discoveries based on constitutional aims. In Le Roy v. Tatham (1852), the Court stated, with reference to sources of power: “the invention is not in discovering them, but in applying them to useful objects.” In Gottschalk v. Benson (1972), the Court used an expanded articulation of the exception when barring a claim to conversions of numeric representations in computers, stating that “[p]henomena of nature, though just discovered, mental processes, and abstract intellectual concepts are not patentable, as they are the basic tools of scientific and technological work” (emphasis added). Thus, the exception was not limited to inherent natural phenomena, but rather expanded to additionally cover specific techniques devised by human inventors. And in Parker v. Flook(1978), the Court further held ineligible a patent application involving use of a formula, even though the claims did not wholly preempt the formula. The Court’s approach may be characterized as pragmatic rather than philosophical, attempting to carry out the Article 1, Section 8 goal of “promot[ing] the progress” of science by denying patents where it feels that patenting would tend more to impede science than to promote it.
Another possible explanation for the exclusion of discoveries from patent eligibility could lie in the Patent Act’s use of the word “new.” A new insight into a phenomenon that had previously been occurring naturally (e.g., a property or consequence of a natural process) might be deemed not to constitute a “new” discovery of a process since the process was already taking place. In contrast, a discovery of a process that does not occur without human action (e.g., the mixture of two manufactured chemicals), even if inadvertent, could be deemed to involve a “new” process. Viewed in this way, the patentee’s invention did not involve a “new” process, since the invention involved an additional insight into the natural, pre-existing reaction to a particular treatment of human bodies having a particular dysfunction, rather than (for example) inducing a new type of reaction.
Unfortunately, the district court's decision in INO v. Praxair, like many others before it addressing the patent eligibility of discoveries, does not include detailed explanation for what particular portion of Section 101 is believed to be unmet by the claimed subject matter. It would be helpful for future courts to be explicit in providing such analysis. Without it, decisions can appear to be arbitrary and even contrary to the statutory provisions.