On June 7, 2018 the United States Patent and Trademark Office (USPTO) issued a new Memorandum that clarifies its view of Subject Matter Eligibility, under 35 U.S.C. § 101, regarding the patentability of Personalized Medicine discoveries.
The Memorandum was prompted by the Federal Circuit’s recent Vanda decision, where the Court provided its own insights as to the Subject Matter Eligibility of Personalized Medicine patent claims. [1] The claims in Vanda recited a method of treating a patient suffering from schizophrenia with the drug, iloperidone, and included specific steps, such as administering iloperidone to the patient in an amount guided by the genotype of the patient, which can predict the rate of drug metabolism. The Court summarized Vanda by stating: “The inventors recognized the relationships between iloperidone, CYP2D6 metabolism, and QTc prolongation, but that is not what they claimed. They claimed an application of that relationship.”
Claim 1 of Vanda is representative and is shown below:
- A method for treating a patient with iloperidone, wherein the patient is suffering from schizophrenia, the method comprising the steps of:
determining whether the patient is a CYP2D6 poor metabolizer by:
obtaining or having obtained a biological sample from the patient; and
performing or having performed a genotyping assay on the biological sample to determine if the patient has a CYP2D6 poor metabolizer genotype; and
if the patient has a CYP2D6 poor metabolizer genotype, then internally administering iloperidone to the patient in an amount of 12 mg/day or less, and
if the patient does not have a CYP2D6 poor metabolizer genotype, then internally administering iloperidone to the patient in an amount that is greater than 12 mg/day, up to 24 mg/day, wherein a risk of QTc prolongation for a patient having a CYP2D6 poor metabolizer genotype is lower following the internal administration of 12 mg/day or less than it would be if the iloperidone were administered in an amount of greater than 12 mg/day, up to 24 mg/day.
(U.S. Patent No. 8,586,610)
As the Memorandum explains, the Federal Circuit distinguished Vanda from recent jurisprudence concerning Subject Matter Eligibility, particularly the U.S. Supreme Court’s Mayo decision. [2] The distinction relies on a key point differentiation: the claims in Vanda described an application of the relationship between iloperidone, drug metabolism, and side effects from iloperidone, which, the Court stated, is different than Mayo’s approach.
Claim 1 of Mayo is representative and is shown below:
- A method of optimizing therapeutic efficacy for treatment of an immune-mediated gastrointestinal disorder, comprising:
(a) administering a drug providing 6-thioguanine to a subject having said immune-mediated gastrointestinal disorder; and
(b) determining the level of 6-thioguanine in said subject having said immune-mediated gastrointestinal disorder,
wherein the level of 6-thioguanine less than about 230 pmol per 8×108 red blood cells indicates a need to increase the amount of said drug subsequently administered to said subject and
wherein the level of 6-thioguanine greater than about 400 pmol per 8×108 red blood cells indicates a need to decrease the amount of said drug subsequently administered to said subject.
(U.S. Patent No. 6,355,623)
A comparison of Claim 1 in Mayo and Vanda, both of which are representative, reveals the difference that the Memorandum seeks to emphasize. [3] According to the Memorandum—and despite certain similarities of the claims—the relevant claims in Mayo “recited a step of administering a drug to a patient, 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. The Mayo claims were not ‘method of treatment’ claims that practically apply a natural relationship.”
The Memorandum emphasizes that Vanda’s claims’ “primary steps include ‘determining’ with a genotyping assay, and then ‘administering’ a certain quantity of drug based on that determination, in order to ‘treat a particular disease,’” quoting Vanda at 1134 (emphasis added). It is likely that examiners will be looking for this language to be present in patent claims when deciding Subject Matter Eligibility, and as such, patent attorneys would do well to include these key terms in proposed claims.
Furthermore, the Memorandum highlighted that method of treatment claims that apply natural relationships were distinguished by the U.S. Supreme Court as not being implicated by its decisions in Mayo or Myriad because such claims “confine their reach to particular applications.” [4] Specifically, the Memorandum quoted the Federal Circuit’s statement that “while the ‘claim in Mayo recited administering a thiopurine drug to a patient, the claim as a whole was not directed to the application of a drug to treat a particular disease.’” The emphasis on the “claims as a whole” was reiterated where the Memorandum again stated the claims of Vanda did not simply describe the natural relationship between the patient’s genotype and the risk of the side effect (QTc prolongation of the heart rhythm). Besides Vanda, the memorandum noted the Federal Circuit’s consideration of two other very recent cases that evaluated the “claims as a whole.” [5]
The Memorandum also expressed that the Federal Circuit’s Vanda decision did not consider whether the treatment steps were routine or conventional, referring to Step 2B of the two-step Alice/Mayo test. In that test, Step 1 asks whether the claim is directed to a process, machine, or composition of matter. If the answer to Step 1 is no, then the claim is not directed to patent eligible subject matter. If the answer to Step 1 is yes, then Step 2A asks whether the claim is directed to a law of nature, a natural phenomenon, or an abstract idea. These are judicially recognized exceptions to patentability. If the answer to Step 2A is no, then the claim is directed to patent eligible subject matter. If the answer to Step 2A is yes, then Step 2B asks if the claim recites additional elements that amount to significantly more than the judicial exception. If the answer to Step 2B is yes, then the claim is directed to patent eligible subject matter. If the answer to Step 2B is no, then the claim is not directed to patent eligible subject matter and is not patentable. Because the Vanda claims were found not to be directed to a law of nature in Step 2A, the claim was determined to be directed to patent eligible subject matter and there was no need to consider Step 2B.
Additionally, the Memorandum provided further advice as to the optimum wording of claims having Subject Matter Eligibility by citing its Training Materials on Subject Matter Eligibility—Life Sciences Examples, published May 4, 2016. There, Example 29 contains claims 5 and 6 which are directed to a hypothetic treatment method (Diagnosing and Treating Julitis) and provide examples of the language of claims that are Subject Matter Eligible according to Step 2A of the Alice/Mayo test.
It should be noted that claims 5 and 6 contain a series of steps directed to diagnosing and treating a disease, similar to the claims of Vanda and Mayo. There are differences however. One difference is that the final step of claims 5 and 6 concerns administering a certain drug to treat a particular disease, which is different than the claims of Mayo that were, as a whole, directed to the diagnosis of the disease. Another difference is that the final step of claims 5 and 6 recites administering “an effective amount” of a certain drug to treat a particular disease whereas Vanda recited a specific amount of the drug to be administered. These recommended examples with their broad claim language suggest that when drafting these types of claims, it would be worthwhile to include a broader claim reciting the administration of “an effective amount” of a drug in addition to a narrower claim reciting the administration of a specific amount of a drug as the final step of the claim.
In summary, the new Memorandum from the USPTO provides additional guidance as to Subject Matter Eligibility under 35 U.S.C. § 101 for “method of treatment claims” and Personalized Medicine discoveries in light of Vanda. The key point to remember when drafting such a claim is to use precise language describing the administration of a certain drug in a specific amount or “an effective amount” to treat a particular disease. Although the claim can have a diagnostic component, the ultimate step should be the administration of the drug to treat the disease.
[1] Vanda Pharmaceuticals Inc. v. West-Ward Pharmaceuticals, 887 F.3d 1117 (Fed. Cir. 2018).
[2] Mayo Collaborative Servs. v. Prometheus Labs., Inc., 566 U.S. 66 (2012).
[3] See U.S. Patent No. 6,355,623 (the Mayo patent) and U.S. Patent No. 8,586,610 (the Vanda patent).
[4] Association for Molecular Pathology v. Myriad Genetics, Inc., 569 U.S. 576 (2013).
[5] See Finjan, Inc. v. Blue Coat Systems, Inc., 879 F.3d 1299 (Fed. Cir. 2018) and Core Wireless Licensing S.A.R.L., v. LG Electronics, Inc., 880 F.3d 1356 (Fed. Cir. 2018).