On Jun 18, 2018, the Federal Circuit in one-liner order affirmed
PTAB’s decision that method of treatment patent of drug, RAVICTI® is valid.
US 8,642,012
(Hyperion; Exp: Sep. 22, 2030) claims a method of treating a patient having a
urea cycle disorder comprising (a) determining a target urinary phenylacetyl
glutamine (PAGN) output (b) calculating an effective initial dosage of a
phenylacetic acid (PAA) prodrug selected from glyceryl tri-[4-phenylbutyrate]
(HPN-100) and phenylbutyric acid (PBA) or a pharmaceutically acceptable salt of
PBA, wherein the effective dosage of PAA prodrug is calculated based on a mean
conversion of PAA prodrug to urinary PAGN of about 60%; and (c) administering
the effective initial dosage of PAA prodrug to the patient.
Previously, on April 29, 2015, Par Pharmaceutical, Inc. filed
a Petition (IPR2015-01117) requesting an inter partes review of claims 1–12 of US
8,642,012. On Nov. 4, 2015, PTAB instituted trial & Lupin joined (IPR2016-00283)
that petition. On Nov. 3, 2016, PTAB found that Par has failed to carry its
burden of proving by a preponderance of the evidence that claims 1–12 would
have been unpatentable over the prior art.
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