For a long time, the hallmarks of patentability of an invention were basically two: is it new? is it non-obvious? If both answers were “yes,” then—provided that the patent itself was properly written—you’d get your patent. A third hallmark was much less used: is the invention per se eligible for patentability? Things like slot machines (considered not to have moral utility), hair-regrowth elixirs (“known” not to work), laws of nature, natural phenomena and abstract ideas were not granted patents. The policy underlying these last exceptions to patentability is that they are already part of nature, and access to them cannot be withdrawn by patenting them.
Nowadays slot machines can be patented; hair-regrowth formulations are also patented since they’ve been demonstrated to work. But the other questions involving laws of nature, natural phenomena, and abstract ideas have gained renewed vitality in the context of patents for isolated or purified therapeutic substances, and treatments using those substances. The US Supreme Court has laid down the basic framework in two cases—Mayo and Myriad.
But first we state the statutory requirement for patent eligibility, at 35 U.S.C. § 101:
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, subject to the conditions and requirements of this title.
The question in Mayo was whether patent eligibility applied to a claim—i.e. directing doctors to administer a thiopurine drug providing a 6-thioguanine metabolite to treat autoimmune-diseased patients, and to check 6-thioguanine levels to determine if the administered dosage levels were too high or too low. The test was important because different patients metabolized thiopurine drugs differently, and thus may have needed more or less thiopurine than other patients.
To determine patent eligibility, the Mayo Court noted that “Prometheus’ patents [set out] laws of nature: relationships between concentrations of certain metabolites in the blood and the likelihood that a dosage of a thiopurine drug will prove ineffective or cause harm.” The question, then, was whether the claims did more than describe these natural relationships, i.e. did the claims describe processes that actually applied natural laws. The answer was no: the “administering” and “determining” language just instructed doctors to do what they’d been doing long before these patent claims—and the “administering” and “determining” conventional-step language tacked on to the description of the natural laws did not impart patentability to the claims. “The upshot is that the three steps [in the claim] simply tell doctors to gather data from which they may draw an inference in light of the correlations.” The Mayo case alarmed many patent holders with diagnostic-method patent claims.
While Mayo focused on therapeutic method claims, Myriad focused on therapeutic targets: genes, in particular. Myriad had discovered the precise location and sequence of the human BRCA1 and BRAC2 genes, mutations in which dramatically increased an individual’s risk of developing breast and ovarian cancer. Myriad’s discovery allowed doctors to check for mutations in these genes, and thus assess the patient’s risk of cancer.
Myriad obtained a number of patents, including a ’282 patent, the first claim of which was to “An isolated DNA coding for a BRCA1 polypeptide . . .” The implication here is that this claim—if patent eligible—would give Myriad the exclusive right to isolate an individual’s BRCA1 gene by breaking the covalent bonds that connect the DNA to the rest of the individual’s genome. And indeed Myriad asserted its DNA patents against many other research entities that were isolating these gene sequences.
The US Supreme Court rejected the Federal Circuit’s ruling that the act of isolating NDA—breaking covalent bonds at both ends of the gene and thus liberating the DNA—created a new molecule that was patent eligible. Rather, the Supreme Court found these claims to isolated, naturally occurring molecules, ineligible for a patent (despite the fact that they retained their informational content to, e.g., create mutated proteins that could lead to cancer). The Court acknowledged that Myriad had found the location of the BRCA genes, but that discovery did not render those genes “new . . . composition[s] of matter,” § 101, that are patent eligible. These gene sequences were not new: they were naturally occurring. And the mere chemical isolation of the genes did not render the claims patentable, because Myriad’s claims focused on the genetic information encoded in the BRCA genes—not the genes as merely chemicals. By contrast, a different form of DNA, called “cDNA,” which only exists when it is created in a lab, can indeed be patented if all other requirements are met. Finally, the Court was clear to say that the ruling was not directed to method claims, which could well be patent eligible. Many at the time were quite concerned about the fate of purity patents after Myriad, i.e. claims to naturally occurring substances that were artificially purified and used therapeutically.
On the ides of March 2019, the Federal Circuit in Natural Alternatives clarified the law of patent eligibility for patents that claimed methods of using purified natural substances, while side-stepping the issue of whether the purified natural substance per se was patent eligible.
Natural Alternatives (“NA”) had patents to the use of purified natural substances (e.g. beta-alanine) as a dietary supplement to “increase[e] the anaerobic working capacity of muscle and other tissues.” Rather than rely directly on either Mayo or Myriad, the Federal Circuit relied on another US Supreme Court case on patent eligibility—Alice —for its bipartite test: (1) are the claims directed to a patent-ineligible concept? if so, (2) considering the elements of each claim both individually and as an ordered combination, do additional elements transform the nature of the claim into a patent-eligible application, i.e. is there is an inventive concept?
These method-of-treatment claims the court found patent eligible. For instance, the ’084 patent claimed:
1. A method of regulating hydronium ion concentrations in a human tissue comprising:
providing an amount of beta-alanine to blood or blood plasma effective to increase beta-alanylhistidine dipeptide synthesis in the human tissue; and
exposing the tissue to the blood or blood plasma, whereby the concentration of beta-alanylhistidine is increased in the human tissue.
The court found that “[a]dministering certain quantities of beta-alanine to a human subject alters that subject’s natural state . . .generating greater levels of creatine . . . in turn, results in specific physiological benefits for athletes engaged in certain intensive exercise. . . . The claims not only embody this discovery, they require that an infringer actually administer the dosage form claimed in the manner claimed, altering the athlete’s physiology to provide the described benefits. These are treatment claims and as such they are patent eligible.”
Notably, the court drew a bright line between such “treatment” claims, and the claims in Mayo, which didn’t expressly require treatment. The Mayo claims were strictly diagnostic, in the sense that they covered only observations of the results of the operation of natural laws: “The claims did not, however, require any actual action be taken based on the measured level of metabolite . . . . The [Mayo] claim, therefore, ‘was not a treatment claim’ . . .” The takeaway message from NA for patent prosecutors is to draft claims that therapeutically apply the results of observations. Such claims may be expected to satisfy the requirement for more than a recitation of natural relationships and their observation.
Interestingly, some unasserted NA patents were to the purified natural substance. Given that isolated/extracted DNA is not “new” despite its isolation, might claims to purified natural substances similarly not be patent eligible? The NA court noted that Myriad distinguished methods of using natural products from claims to the natural products themselves, and then said of NA’s substance claims, “these claims are not properly before this court in this appeal. This does not prejudice the patentee’s ability to defend the eligibility of the ’947 [substance] patent in future proceedings.”
So this leaves the question open. Is Myriad’s rejection of claims to isolated DNA a principle that applies to all natural substances that are isolated, extracted, purified, or otherwise yanked out of nature? Or did Myriad turn specifically on the informational nature of the DNA? Could one argue that the beta-alanine in the NA patents is informational too, in the sense that it directs the body to increase beta-alanylhistidine dipeptide synthesis, as DNA directs protein synthesis?
Section 101 has proven to be a formidable hurdle to patents: even more formidable is trying to anticipate precisely what height adjustments the courts will effect on the hurdle down the road.