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”