Vanda Pharmaceuticals Inc. v. West-Ward Pharmaceuticals
887 F.3d 1117 (2018)
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Rule of Law:
A method of treatment claim that directs a specific application of a discovered natural law, by requiring particular administration of a drug at specific dosage levels based on a patient's genetic makeup, is patent-eligible subject matter under 35 U.S.C. § 101.
Facts:
- Vanda Pharmaceuticals Inc. ('Vanda') owns U.S. Patent 8,586,610 ('the '610 patent'), which covers a method of treating schizophrenia patients with the drug iloperidone.
- The patent is based on the discovery that patients with a particular genotype (CYP2D6 poor metabolizers) metabolize iloperidone more slowly, which increases their risk of a serious cardiac side effect known as QTc prolongation.
- The patented method comprises the steps of first determining a patient's CYP2D6 genotype by obtaining a biological sample and performing a genotyping assay.
- Based on the genetic test result, the method instructs administering a lower dose of iloperidone (12 mg/day or less) to CYP2D6 poor metabolizers.
- For patients without the poor metabolizer genotype, the method instructs administering a higher dose of iloperidone (greater than 12 mg/day, up to 24 mg/day).
- This genotype-based dosage adjustment makes the treatment safer by reducing the risk of QTc prolongation in the susceptible patient population.
- Vanda markets iloperidone for the treatment of schizophrenia under the brand name Fanapt®.
- West-Ward Pharmaceuticals Corp. ('West-Ward') sought approval from the Food and Drug Administration (FDA) to market a generic version of Fanapt®.
Procedural Posture:
- West-Ward filed an Abbreviated New Drug Application (ANDA) with the FDA seeking approval to market a generic version of Vanda's drug, Fanapt®.
- Vanda sued West-Ward in the U.S. District Court for the District of Delaware, alleging that West-Ward's proposed generic product would infringe its '610 patent.
- After a bench trial, the District Court found that West-Ward's proposed product would induce infringement of the '610 patent.
- The District Court also held that the asserted claims of the '610 patent were not invalid for being directed to patent-ineligible subject matter under 35 U.S.C. § 101.
- The District Court entered a final judgment and injunction in favor of Vanda, prohibiting West-Ward from marketing its generic drug before the '610 patent's expiration.
- West-Ward (appellant) appealed the District Court's judgment to the U.S. Court of Appeals for the Federal Circuit; Vanda is the appellee.
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Issue:
Is a method of treatment claim, which requires doctors to administer a specific dosage range of a drug to a patient based on their determined genetic makeup to reduce a known side effect, patent-ineligible under 35 U.S.C. § 101 because it is directed to a natural law?
Opinions:
Majority - Lourie, Circuit Judge
No. The method of treatment claim is patent-eligible because it is not directed to a law of nature but to a specific application of that law. The court reasoned that the claims do not simply state the natural relationship between the CYP2D6 genotype, iloperidone metabolism, and QTc prolongation. Instead, the claims recite a concrete method of treatment that applies this relationship by requiring specific actions: genotyping a patient and then administering one of two specific, different dosage ranges of iloperidone depending on the result. Distinguishing this case from Mayo v. Prometheus, the court noted that the claims here are a 'new way of using an existing drug' that results in a safer treatment, which the Supreme Court in Mayo suggested would be patentable. Unlike the claims in Mayo, which merely identified a correlation and indicated a need for adjustment, these claims command a specific treatment regimen and do not preempt all uses of the natural law.
Dissenting - Prost, Chief Judge
Yes. The method of treatment claim is patent-ineligible because it is directed to a law of nature and lacks an inventive concept. The dissent argued that the majority's effort to distinguish Mayo v. Prometheus fails because the core of the invention is the discovery of the natural law itself—the relationship between genotype and drug side effects. The additional steps in the claim, such as performing a conventional genotyping test and adjusting a dose, are merely routine activities that instruct a doctor to 'apply' the newly discovered natural law. The specific dosage amounts are part of the natural law itself, akin to the specific metabolite levels in Mayo. Therefore, the claims do nothing more than monopolize a natural law with conventional, well-understood steps, failing to add the 'inventive concept' required for patent eligibility under § 101.
Analysis:
This decision provides significant guidance on the patent eligibility of personalized medicine and diagnostic method claims after the Supreme Court's restrictive rulings in Mayo and Alice. The court draws a critical distinction between claims that merely state a natural law (ineligible) and claims that apply a natural law through a specific, concrete method of treatment (eligible). By upholding a claim that ties a diagnostic step to a specific therapeutic action (a defined dosage regimen), the Federal Circuit created a potential safe harbor for inventions that tailor medical treatments to individual patient characteristics. This ruling reinforces the patentability of 'method of treatment' claims and may encourage innovation in pharmacogenomics by providing a clearer path to patent protection.
