16 April 2018Americas

Federal Circuit upholds schizophrenia drug ruling

Vanda Pharmaceuticals, a biopharmaceutical company based in Washington, DC, secured a win late last week when the US Court of Appeals for the Federal Circuit found a patent covering its schizophrenia drug to be patentable.

On Friday, April 13, the Federal Circuit affirmed the US District Court for the District of Delaware’s decision.

The dispute centres on US patent number 8,586,610, which relates to a method of treating schizophrenia patients with iloperidone where the dosage range is based on the patient’s genotype.

Vanda owns a New Drug Application for Fanapt (iloperidone), “an atypical antipsychotic”.

In 2013, Hikma subsidiary West-Ward Pharmaceuticals filed an Abbreviated New Drug Application for a generic version of Fanapt for the treatment of schizophrenia.

At that time, the ‘610 patent had not yet been issued (it was issued in November 2013). Another patent for which Vanda held an exclusive licence, US reissue number 39,198, was listed in the Orange Book in relation to Fanapt.

In 2014, Vanda filed a patent infringement lawsuit against West-Ward.

Following a bench trial, the district court found that West-Ward’s proposed products induced infringement of the ‘610 patent and that the asserted claims were not invalid under section 101, section 103 or section 112 for lack of written description. West-Ward was enjoined from making or selling its ANDA product by the court.

The Hikma unit then appealed to the Federal Circuit claiming that, among other things, the asserted claims are ineligible under section 101 because they are directed to a “natural relationship between iloperidone, CYP2D6 metabolism, and QT prolongation, and add nothing inventive to those natural laws and phenomena”.

West-Ward argued that the claims are indistinguishable from those held invalid in Association for Molecular Pathology v Myriad Genetics and Mayo Collaborative Services v Prometheus Laboratories.

The patent in Mayo claimed a method for “optimising” the dosage of thiopurine drugs and, according to the US Supreme Court, did not include any “additional features that provide practical assurance that the process is more than a drafting effort designed to monopolise the law of nature itself”.

In Friday’s 2-1 precedential decision, the Federal Circuit said that the claims in Mayo were not directed to a novel method of treating a disease, but were instead directed to a diagnostic method.

In the current case, the court said: “The inventors recognised the relationships between iloperidone, CYP2D6 metabolism, and QTc prolongation, but that is not what they claimed. They claimed an application of that relationship.”

Circuit Judge Alan Lourie, on behalf the court, added that the ‘610 patent recites the steps of carrying out a dosage regimen based on the results of genetic testing.

West-Ward also argued that the claims were invalid for lack of adequate written description, but the Federal Circuit disagreed.

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