In view of the Federal Circuit’s April 13, 2018 decision in Vanda Pharms. Inc. v. West-Ward Pharms., 877 F.3d 1117(Fed. Cir. 2018), regarding subject matter patent eligibility, the USPTO issued a memorandum on June 7, 2018, to “address the limited question of how to evaluate the patent eligibility of ‘method of treatment’ claims” and announce modifications to life sciences example 29 of the PTO’s current patent-eligibility guidance. Memo at 3.
In Vanda, the Federal Circuit affirmed a district court holding that claims reciting a method of treating a schizophrenia patient with a specific dosage of the antipsychotic drug iloperidone, based on the patient’s genotype of the cytochrome P450 2D6 gene (“CYP2D6”), were patent eligible under 35 U.S.C. § 101. Vanda at 1136. The CYP2D6 enzyme metabolizes iloperidone, which is pre-disposed to cause “QTc prolongation,” a disruption of the heart’s normal rhythm. As taught in U.S. Patent No. 8,586,610, patients with lower CYP2D6 enzymatic activity (poor drug metabolizers) can be administered iloperidone more safely with a reduced dose of iloperidone compared to a dose given to someone with normal CYP2D6 activity. Id. at 1121.
The court looked to the two-step test from Alice and Mayo (“Alice/Mayo test”) to determine subject matter patent eligibility of the claims, which is also set forth in the PTO’s subject matter eligibility guidance in MPEP § 2106.III. (“PTO’s guidance”). Vanda at 1133. Step one of the Alice/Mayo test (step 2A in the PTO’s guidance) asks whether a claim as a whole is “directed to” a judicial exception, such as an abstract idea, natural phenomenon, or law of nature. If the answer is no, then the claim is patent eligible and should be examined for patentability. If the claim is “directed to” a judicial exception, then step two of the Alice/Mayo test (step 2B in the PTO’s guidance) requires that the claim as a whole amount to “significantly more” than the judicial exception itself. Id.
In Vanda, the district court determined that the method claims were patent eligible under step two of the Alice/Mayo test; the Federal Circuit found, however, that the claims were not “directed to” a judicial exception and were therefore patent eligible under step one of the Alice/Mayo test. Id. at 1123, 1134. In doing so, the Federal Circuit distinguished the claims in Vanda from the claims in Mayo that the Supreme Court held were patent ineligible. Id. at 1123, 1134.
The Federal Circuit stated that the representative claim in Mayo was not a treatment claim, but was instead “directed to a diagnostic method based on the 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.” Id. at 1134 (quoting Mayo, 566 U.S. at 77). The court explained that the Mayo claim “did not go beyond recognizing (i.e., indicates) a need to increase or decrease a dose” and therefore the claim “does not involve doctors using the natural relationship[.]” Id. at 1135. Under such a broad claim to the natural law in Mayo, the Court found that “a doctor . . . could violate the patent even if he did not actually alter his treatment decision in the light of the test.” Id. (quoting Mayo, 566 U.S. at 77). Hence, Mayo claims would “tie up the doctor’s subsequent treatment decision[.]” Id.
In contrast to the Mayo claim, the Federal Circuit found that the Vanda claims were patent eligible because they were not “directed to” the natural relationship between iloperidone, CYP2D6 metabolizer genotype, and an identified side effect, QTc prolongation, but recited more than the natural relationship. Id. at 1135–36. The inventors “claimed an application of that relationship.” Id. at 1135. The claims in Vanda recited a dosage regimen based on a relationship, in contrast to the Mayo claim that merely recited a relationship and left it to the doctor to determine a regimen. The Vanda court stated, “the claims here are directed to a specific method of treatment for specific patients using a specific compound at specific doses to achieve a specific outcome. They are different from Mayo.” Id. at 1136.
The PTO’s memo states that Vanda “illustrated several important points regarding the subject matter eligibility analysis”:
• The claims must be analyzed as a whole in Alice/Mayo step one (step 2A of PTO’s guidance), the importance of which was also emphasized in Finjan Inc. v. Blue Coat Sys., Inc. and Core Wireless Licensing S.A.R.L. v. LG Elecs., Inc.. 879 F.3d 1299 (Fed. Cir. 2018); 880 F.3d 1356 (Fed. Cir. 2018); Id.
• The distinctions between Mayo’s patent-ineligible claims and Vanda’s eligible methods of treatment claims, “which apply natural relationships as opposed to being ‘directed to’ them[.]” Id. (emphasis in original). The ineligible Mayo claims recited administering a drug to a patient, but “that step was performed in order to gather data about the natural relationships, and thus was ancillary to the overall diagnostic focus of the claims.” Id. Thus, “[t]he Mayo claims were not ‘method of treatment’ claims that practically apply a natural relationship.” Id.
• The Federal Circuit found the claims patent eligible under Alice/Mayo step one (step 2A of PTO’s guidance) and therefore the court did not have to consider whether the claims were routine or conventional under step two (step 2B of PTO’s guidance). Id. Memo at 2.
The memo also stated that the current guidance and training examples are still consistent with the Vanda decision and emphasized that method of treatment claims that “practically apply natural relationships should be considered patent eligible under Step 2A of the USPTO’s subject matter eligibility guidance[.]” Id. (emphasis in original). Further, the memo explained that method of treatment claims found to practically apply natural relationships do not also need nonroutine or unconventional steps to be patent eligible. Finally, the memo explained that, in light of Vanda, claims 5 and 6 of the life sciences example 29 of the PTO’s current eligibility guidance should now be considered to be patent eligible under step 2A of the PTO’s guidance (step one of the Alice/Mayo test). Memo at 3.