While Supreme Court decisions in Myriad and Mayo (and the subsequent Federal Circuit decision in Sequenom) pulled diagnostic claims under the gambit of 35 U.S.C. § 101, method of treatment claims seemingly survived the recent judicial expansion of the patent-(in)eligibility doctrine. Indeed, based in part on these Supreme Court decisions, the USPTO issued guidance stating that “A process claim is not subject to the markedly different analysis for nature-based products used in the process, except in the limited situation where a process claim is drafted in such a way that there is no difference in substance from a product claim (e.g., ‘a method of providing an apple’).” In May 2016, the USPTO released “Life Sciences Examples” confirming that the patent office views treatment claims as patent-eligible. In particular, those examples categorized the following two hypothetical treatment claims as withstanding scrutiny under § 101:
A method of treating a patient with julitis, the method comprising administering an effective amount of anti-TNF antibodies to a patient suffering from julitis.
A method of diagnosing and treating julitis in a patient, said method comprising: a. obtaining a plasma sample from a human patient; b. detecting whether JUL-1 is present in the plasma sample; c. diagnosing the patient with julitis when the presence of JUL-1 in the plasma sample is detected; and d. administering an effective amount of anti-tumor necrosis factor (TNF) antibodies to the diagnosed patient.
Notably, the Life Sciences Examples highlight that the above claims are patent-eligible even though (i) the JUL-1 protein is naturally-correlated with julitis, but this correlation was not previously known and (ii) anti-TNF antibodies were a “conventional” julitis treatment. In both cases, the claim as a whole was judged to be “focused on a process of practically applying the product to treat a particular disease, and not on the product per se.” Moreover, the guidance is explicit that administration steps “are not themselves natural laws,” and therefore not a recognized patent-eligibility exception.
Yet, recent Patent Trial & Appeals Board and District Court decisions take a broader interpretation of the recent Supreme Court decisions and, in the process, call into question the patent-eligibility of method of treatment claims. These decisions are discussed below.
Ex Parte Chettier
The Board in Ex parte Chettier (Appeal No. 2016-003639) evaluated patent-eligibility of claims directed to treating patients carrying novel genetic markers associated with degenerative disc disease (DDD). The appealed independent claim recited:
A method comprising applying at least one DDD condition therapeutic to a patient based on at least one DDD altered risk associated biological marker determined to be present in said patient.
On its face, the claim appears similar to the USPTO’s julitis example discussed above: both claims implicate a previously unknown natural correlation, and treat a condition with a conventional treatment. Under the USPTO’s rubric for evaluating patent-eligibility, the Chettier claims, when analyzed as a whole, seem focused on practically applying a natural correlation to treat a particular disease, and not on the natural correlation per se.
Yet, the Board nevertheless upheld the patent-eligibility rejection under Mayo because “[a]pplying a therapeutic … to a patient having a biological marker indicating susceptibility to DDD was a conventional activity engaged in by those in the relevant field … [T]he addition of this conventional step to the natural phenomenon or law of nature (a genetic marker associated with altered DDD risk) does not ‘transform unpatentable natural correlations into patentable applications of those regularities.’”
Notably, in upholding the § 101 rejection, the Board discounted Applicant’s reliance on the USPTO’s 2014 patent-eligibility guidance because “the Guidelines ‘are not law.’ The Supreme Court’s interpretation of § 101, on the other hand, is controlling case law, and under the standard set out in Mayo, [the claim] is not a patent-eligible method.”
Ex Parte Atwood
In Ex parte Atwood (Appeal No. 2015-001611) the Board assessed patent-eligibility of claims directed to treating Alzheimer’s patients based on genetic risk factors. A representative independent claim is:
A method comprising administering treatment to a patient at risk for developing Alzheimer’s disease (AD) or a patient diagnosed with AD, wherein the patient is homozygous or heterozygous for an Apolipoprotein E4 (APOE4) allele, and the patient has a single nucleotide polymorphism (SNP)…rs4073366, wherein the patient is homozygous for the cytosine allele (C-allele) or the patient is homozygous for the guanine allele (G-allele) at the polymorphic position of rs407336 …
Again, the claim seemingly comports with the patent-eligible julitis examples discussed above. Again though, the Board concluded that the claims do not pass muster—i.e., do not “add enough” to the discovered natural correlation—under Mayo. In upholding the examiner’s rejection, the Board emphasized that “Appellant’s claimed method does no more than identify a sub-population of patients with, or at risk of developing, AD and then administer exactly the same treatment to those patients as was done in the prior art for the entire population of patients with, or at risk of developing, AD. . . . Appellant’s therapy administration step is not based on any identified correlation, because patients are administered exactly the same treatment regimen suggested by the prior art for any AD patient.”
Ex Parte Chamberlin
The claims at issue in Ex parte Chamberlin (Appeal No. 2014-009849) relate to treating a bone disorder in a subject based on a newly-discovered associated between a genetic polymorphism and increased risk of bone disorder. A representative claims is:
A method of treating osteoporosis in a human individual having a BMD T score of -1 or less, the method comprising:
determining in a nucleic acid sample obtained from the individual, the presence of a TT genotype at single nucleotide polymorphism rs2297480 (SNP rs2297480) in the farnesyl diphosphate synthase (FDPS) gene,
wherein the presence of the TT genotype is determined by hybridizing the nucleic acid sample to a nucleic acid probe which comprises SEQ ID NO: 1 or the complement thereof; wherein the probe or the nucleic acid sample is immobilized in a nucleic acid array, and;
administering intravenous palmadronate [sic, pamidronate2] to the individual if the TT genotype is present in the sample.
While the USPTO’s examples indicate that the patent office would consider such a claim patent-eligible (the claimed steps align closely with those in the above-mentioned julitis example), the Board reached an opposite conclusion. According to the Board, the claims at issue were “directed to” a law of nature—i.e., the correlation between rs2297480 and bone disease—and the recited administration step was merely “a well understood and routine treatment step for such patients,” and the treatment step, “does not transform the claim into something significantly more than the discovered law of nature itself.”
Patent-Eligibility At The District Court Level
Like the Board, at least one district court has similarly adjudged treatment claims to be patent-ineligible based on Mayo. In particular, the United States District Court for the District of New Jersey determined that claims directed to a method of treating and/or preventing a disease D in a targeted patient population having a contraindication C against a compound A, by administering a drug in the same dose as for a patient without the contraindiction C, was not patent-eligible.
The court reasoned that because the administration step “does not require any prior determination that natural body levels [of proteins targeted by the drug] have changed or altered before performing the step of administering [the drug] … the act of administering [the drug] to the target population . . . is an abstract idea.” The Court concluded that the claimed administration step was thus directed to an “abstract idea”, that the additional claim limitations did not add “significantly more” to the abstract idea, and therefore the claim was not patent-eligible.
While the analysis undertaken from the district court in this case departs from the one recently applied by the Board, the end-result is nevertheless the same: the treatment claim at issue was determined to be not patent-eligible.
Limits to Mayo’s Dicta?
While the Board, and at least one district court, call into question the patent-eligibility of treatment claims, it bears noting that briefing in each of the above cases preceded the USPTO’s release of the julitis examples discussed above (though the actual decisions post-date the release of these examples). Even though these examples are not governing law, perhaps future arguments at the Board that draw parallels between the julitis examples and appealed treatment claims will cause the Board to consider a different interpretation of Mayo’s dicta.
It also bears noting that the Federal Circuit seemingly interprets Mayo’s dicta regarding “administration” steps in a different light that the Board did in the above decisions. For example, in Rapid Litigation Management v. Cellzdirect, the Federal Circuit stated, albeit in dicta, that method of treatment claims “recite processes to achieve a desired outcome,” and therefore are patent-eligible. Thus, there is at least a chance, if not a likelihood, that the Federal Circuit would reach a different outcome than the Board/Court in each of the above cases.
One thing seems clear: the state of patent-eligibility remains in flux, even for method of treatment claims. It seems likely, at this point, that a Federal Circuit decision directly addressing patent-eligibility of treatment claims will be required to insert some level of certainty into how such claims should be treated at the Board (and thus the examiner level too) and at the district court level.