Famotidine & Ibuprofen – USA

Famotidine & Ibuprofen – USA

Claim construction (US 8,067,451)

Plaintiff: Horizon Medicines LLC

Defendant: Alkem Laboratories Ltd.

Case No.: 18-1014

Court: District of Delaware

Date: August 7, 2020 

Claim 1 of the ’451 patent is representative:

An oral dosage in tablet form comprising a first portion that comprises 800 mg ibuprofen and a second portion that comprises 26.6 mg famotidine, wherein a barrier layer comprising hydroxyl propyl methyl cellulose 2910, polyoxyethylene glycol 400, polysorbate 80, and titanium dioxide surrounds the second portion completely separating it from the first portion, wherein upon storage of the oral dosage in tablet form at 40° C. and 75% humidity for one month, no more than about 0.5% total famotidine impurities is present in the oral dosage in tablet form; wherein the oral dosage in tablet form is formulated so that release of both the ibuprofen and the famotidine occurs rapidly at about the same time, wherein none of the oral dosage in tablet form, the famotidine, and the ibuprofen is enterically coated or formulated for sustained or delayed release, wherein the oral dosage in tablet form is for use according to a TID (three times per day) administration schedule for reducing the risk of developing ibuprofen-induced ulcers in a human patient requiring ibuprofen for an ibuprofen-responsive condition selected from the group consisting of rheumatoid arthritis, osteoarthritis, and pain from a condition other than rheumatoid arthritis and osteoarthritis wherein the human patient does not suffer at the times of administering from a condition characterized by hypersecretion of gastric acid and/or from active severe oesophagitis and/or Barrett’s ulceration, and/or from gastroesophageal reflux disease.

Construction of disputed term:

“a barrier layer comprising hydroxyl propyl methyl cellulose 2910, polyoxyethylene glycol 400, polysorbate 80, and titanium dioxide surrounds the second portion completely separating it from the first portion” (claims 1, 10)

a. Plaintiff’s proposed construction: no construction needed

b. Defendant’s proposed construction: a single barrier layer consisting essentially of hydroxyl propyl methyl cellulose 2910, polyoxyethylene glycol 400, polysorbate 80, and titanium dioxide surrounds the famotidine portion completely separating it from the ibuprofen portion.

c. Court’s construction: a barrier layer consisting essentially of hydroxyl propyl methyl cellulose 2910, polyoxyethylene glycol 400, polysorbate 80, and titanium dioxide surrounds the famotidine portion completely separating it from the ibuprofen portion.

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