Where Are West Ward Pharmaceuticals Reviews and Fda Issues
By Donald Zuhn --
In a memorandum distributed to the patent examining corps last month by Robert W. Bahr, Deputy Commissioner for Patent Examination Policy at the U.S. Patent and Trademark Office, the Office addresses a recent conclusion by the Federal Circuit in Vanda Pharmaceuticals Inc. v. West-Ward Pharmaceuticals. The memorandum notes that claims at outcome in Vanda "recite a method of treating a patient having schizophrenia with iloperidone, a drug known to cause QTc prolongation (a disruption of the middle's normal rhythm that can atomic number 82 to serious health bug) in patients having a item genotype associated with poor drug metabolism," and sets forth the post-obit representative claim:
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 decide 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 non have a CYP2D6 poor metabolizer genotype, so internally administering iloperidone to the patient in an amount that is greater than 12 mg/mean solar day, up to 24 mg/mean solar day,
wherein a chance of QTc prolongation for a patient having a CYP2D6 poor metabolizer genotype is lower following the internal administration of 12 mg/twenty-four hours 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 [emphasis in memorandum].
The memorandum explains that in Vanda, the Federal Circuit determined that the claims at upshot are "patent eligible under 35 The statesC. § 101 because they are not 'directed to' a judicial exception" (emphasis in memorandum).
Co-ordinate to the memorandum, "[t]he Federal Circuit's conclusion in Vanda illustrates several important points regarding the subject affair eligibility assay." The memorandum sets forth three such points:
• "[T]he Federal Excursion evaluated the claims as a whole, including the arguably conventional genotyping and treatment steps, when determining that the claim was not 'directed to' the recited natural relationship between the patient's genotype and the chance of QTc prolongation."
• "[T]he Federal Circuit cited the Supreme Court '[t]o further underscore the distinction betwixt method of handling claims and those in Mayo.' . . . Method of treatment claims (which apply natural relationships as opposed to being 'directed to' them) were identified by the Supreme Court as non being implicated by its decisions in Mayo and Myriad considering they 'confine their reach to detail applications'" (accent in memorandum).
• "[T]he Federal Excursion did not consider whether or non the treatment steps were routine or conventional when making its 'directed to' decision" (emphasis in memorandum).
The memorandum concludes by stating that:
The USPTO's electric current subject affair eligibility guidance and preparation examples are consistent with the Federal Circuit'south decision in Vanda, with the understanding that: (1) "method of treatment" claims that practically apply natural relationships should be considered patent eligible nether Step 2A of the USPTO's subject field matter eligibility guidance; and (2) it is not necessary for "method of handling" claims that practically apply natural relationships to include nonroutine or unconventional steps to exist considered patent eligible nether 35 U.Southward .C. § 101. For case, claims 5 and 6 of USPTO Case 29 (Diagnosing and Treating Julitis) should be considered patent eligible under Step 2A of the USPTO's field of study matter eligibility guidance in light of the Federal Circuit determination in Vanda.
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Source: https://www.patentdocs.org/2018/07/uspto-issues-memorandum-on-vanda-pharmaceuticals-v-west-ward-pharmaceuticals.html