Pomalidomide – USA

Pomalidomide – USA

Claim Construction (District of New Jersey): Jun. 16, 2020
Civil Action No.: 17-3387
Plaintiff      : CELGENE CORPORATION
Defendants: HETERO LABS / AUROBINDO PHARMA / APOTEX INC. / MYLAN INC. / BRECKENRIDGE PHARMA / TEVA PHARMA

Before the Court is the parties’ request for claim construction. The Court held a Markman hearing on January 30, 2020.
This Markman decision involves four disputed terms from six patents stemming from two patent families: (i) United States Patent No. 8,198,262 (the “ʼ262 Patent”), United States Patent No. 8,673,939 (the “ʼ3,939 Patent”), and United States Patent No. 8,735,428 (the “ʼ428 Patent”), which are method of treatment (“MOT”) patents; and (ii) United States Patent No. 8,828,427 (the “’427 Patent”), United States Patent No. 9,993,467 (the “’467 Patent”), and the 10,555,939 (the ’5,939 Patent), which are formulation patents.
CONSTRUCTION OF DISPUTED TERMS:
1. “A method of treating multiple myeloma
Celgene: “A method of treating multiple myeloma” is limiting, such that the term requires efficacy in treating multiple myeloma
Defendants: “A method of treating multiple myeloma” is not limiting.
The Court: “A method of treating multiple myeloma” is not limiting.
2. “about 1 mg to about 5 mg per day of a compound having the formula [of pomalidomide] or a pharmaceutically acceptable salt, solvate, or stereoisomer thereof” and “about 1 mg to about 5 mg of a compound  having the formula [of pomalidomide] or a solvate thereof
Celgene: “about 1 mg to about 5 mg per day of a compound having the formula [of pomalidomide] or a pharmaceutically acceptable salt, solvate, or stereoisomer containing about 1 mg to about 5 mg per day of a compound having the formula [of pomalidomide]” and “about 1 mg to about 5 mg per day of a compound having the formula [of pomalidomide] or a solvate containing about 1 mg to about 5 mg per day of a compound having the formula [of pomalidomide]”
Defendants: “about 1 mg to 5 mg … of a compound having the formula [of pomalidomide] or about 1 mg to 5 mg of a pharmaceutically acceptable salt or solvate of [pomalidomide] or about 1 mg to 5 mg of any single stereoisomer of [pomalidomide]” and “about 1 mg to 5 mg … of a compound having the formula [of pomalidomide] or about 1 mg to 5 mg of a solvate of [pomalidomide]”
The Court: “about 1 mg to about 5 mg per day of a compound having the formula [of pomalidomide] or a pharmaceutically acceptable salt, solvate, or stereoisomer containing about 1 mg to about 5 mg per day of a compound having the formula [of pomalidomide]” and “about 1 mg to about 5 mg per day of a compound having the formula [of pomalidomide] or a solvate containing about 1 mg to about 5 mg per day of a compound having the formula [of pomalidomide]”
3. “Lubricant”
Celgene: “a substance capable of reducing friction and/or reducing adhesion”
Defendants: “an excipient, in addition to the binder or filler, having the primary function of reducing
The Court: “a substance capable of reducing friction and/or reducing adhesion”

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