Pimavanserin – USA

Pimavanserin – USA

Acadia Pharmaceuticals Inc. v. Aurobindo / Teva / Zydus / MSN 

Case : 20-985

Judge: Judge Richard G. Andrews

Court: District of Delaware

Date: Apr. 06, 2022 – Claim construction (US 10,449,185; US 10,646,480; and US 10,849,891 – all expiring on Aug. 27, 2038)

 

This is a Hatch-Waxman case involving product, Nuplazid® (Pimavanserin) capsule, 34 mg.

 

CONSTRUCTION OF AGREED-UPON TERMS:

Claim Term 1:  “a blended pimavanserin composition” (claim 1 of the ‘185 patent; claims 1, 5, 12, and 14 of the ‘480 patent; and claims 1 and 8 of the ‘ 891 patent)

Construction: “a mixture of pharmaceutical ingredients including pimavanserin or a pharmaceutically acceptable salt thereof and one or more excipients mixed together”

Claim Term 2: . “the blended pimavanserin composition” (claims 3, 6, 7, 12, and 16 of the ‘480 patent; claims 7 and 11 of the ‘ 891 patent)

Construction: The term “the blended pimavanserin composition” refers to the term “a blended pimavanserin composition” which is recited in the same claim or in a parent claim

 

CONSTRUCTION OF DISPUTED TERMS:

1. “40 mg granulated pimavanserin tartrate” (claim 1 of the ‘185 patent; claims 1, 5, 12, and 14 of the ‘480 patent; claim 1 of the ‘891 patent)

a. Plaintiff’s proposed construction: “granulation resulting from an act or process in which particles, including 40 mg pimavanserin tartrate, are made to adhere to form larger, multiparticle entities”
b. Defendants’ proposed construction: “40 mg pimavanserin tartrate granulated alone”
c. Court s construction: “40 mg pimavanserin tartrate granulated alone”

 

Summary: The crux of the dispute between the parties was whether the claimed pimavanserin tartrate can be granulated with excipients or whether it must be granulated alone. Defendants argued that prosecution history disclaimer apply because patentee clearly and unmistakably disclaimed pimavanserin tartrate granulated with excipients during the prosecution of the relevant patents. Plaintiff argued that the statements made by the patentee were ambiguous and do not meet the high burden required to trigger the doctrine of prosecution disclaimer. Court, however, agreed with Defendants.

During the prosecution of the ‘185 patent, the examiner rejected all pending claims as obvious partly because US 2007/0264330 which disclosed an oral formulation comprising pimavanserin tartrate where “the granulated drug has a bulk density of about 0.56 g/ml.” This bulk density was within the claimed range of 0.4 to 0.6 g/ml. Patentee in response differentiated the invention from the prior art. Patentee argued that US’330 prior art starts with non-granulated pimavanserin with low density, in contrast to the claimed novel granulated pimavanserin. The patentee further explained that achieving the claimed pimavanserin bulk density and particle size, without other excipients, was unpredictable and unexpected. Throughout the prosecution, the patentee distinguishes the ‘330 Application by asserting that the claimed invention achieves the claimed high bulk density of the pimavanserin tartrate alone. The
patentee is able to achieve this high bulk density of the API alone because it granulates the API alone. The high bulk density then allows fewer excipients to be added to the blended pimavanserin composition, which in turn results in a formulation that provides 34 mg of the drug in one small capsule. Court thus denied Plaintiff’s construction and agreed with Defendants construction which was supported by claim and specification.

 

2. “the granulated pimavanserin tartrate” (claims 1, 5, 12, 14, and 15 of the ‘480 patent; claim 1 of the ‘891 patent)

a. Plaintiff’s proposed construction: The term “the granulated pimavanserin tartrate” refers to the term “40 mg granulated pimavanserin tartrate” which is recited in the same claim or in a parent claim.
b. Defendants’ proposed construction : “the pimavanserin tartrate that has been granulated alone”
c. Court’s construction: The term “the granulated pimavanserin tartrate” refers to the term “40 mg granulated pimavanserin tartrate” which is recited in the same claim or in a parent claim.

 

3. “the granulated pimavanserin” (claim 1 of the ‘185 patent; claim 20 of the ‘480 patent)

a. Plaintiff’s proposed construction: The term “the granulated pimavanserin” refers to the term “40 mg granulated pimavanserin tartrate” which is recited in the same claim or in a parent claim.
b. Defendants ‘ proposed construction: “the pimavanserin that has been granulated alone”
c. Court ‘s construction: The term “the granulated pimavanserin” refers to the term “40 mg granulated pimavanserin tartrate” which is recited in the same claim or in a parent claim.

 

4. “granulated pimavanserin or a pharmaceutically acceptable salt thereof(claim 8 of the ‘891 patent)

a. Plaintiff’s proposed construction: “granulation resulting from an act or process in which particles, including pimavanserin or a pharmaceutically acceptable salt thereof, are made to adhere to form larger, multiparticle entities”
b. Defendants ‘ proposed construction: “pimavanserin or a pharmaceutically acceptable salt granulated alone”
c. Court ‘s construction: “pimavanserin or a pharmaceutically acceptable salt granulated alone”

 

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