Sitagliptin – USA

Sitagliptin – USA

Claim Construction:

Case No.: 19-2902

Date of opinion: Nov. 17, 2020

Judge: Richard G. Andrews

Court: District of Delaware

 

Construction of disputed terms:

Term 1: “the salt of claim 1 [or 2] . . .” (’708 pat. claims 2, 3, and 21)

a. Plaintiff’s proposed construction: Does not exclude hydrates.

b. Defendant’s proposed construction: Excludes hydrates of the claimed salt.

c. Court’s construction: Does not exclude hydrates.

Term 2: “crystallizing the dihydrogenphosphate salt of [sitagliptin] at 25°C” (’708 pat. claim 24)

a. Plaintiff’s proposed construction: performing the crystallization of the dihydrogenphosphate salt of sitagliptin wherein some or all of the crystallization occurs at 25°C.

b. Defendant’s proposed construction: performing the crystallization of the monohydrate of sitagliptin dihydrogenphosphate wherein the formation of crystalline solids begin at 25°C.

c. Court’s construction: crystallizing the dihydrogenphosphate salt of sitagliptin wherein the greatest amount of crystallization occurs at 25°C.

Term 3: “surfactant” (’921 pat. claims 1, 3, 5-8, 10, 11, and 21)

a. Plaintiff’s proposed construction: plain and ordinary meaning.

b. Defendant’s proposed construction: an agent used as a wetting agent to facilitate liquid ingress into the composition to increase the dissolution of sitagliptin and metformin in a single granulation.

c. Court’s construction: surfactant that works as a wetting agent to increase the dissolution of sitagliptin.

Term 4: “sitagliptin” (’921 pat. claims 1, 3, 5, 7, 10, and 12-14)

a. Plaintiff’s proposed construction: sitagliptin.

b. Defendant’s proposed construction: the dihydrogenphosphate salt of sitagliptin in the form of a monohydrate.

c. Court’s construction: sitagliptin.

Term 5: “sodium lauryl sulfate” (’921 pat. claims 11, 22, 24, and 26)

a. Plaintiff’s proposed construction: sodium lauryl sulfate.

b. Defendant’s proposed construction: a surfactant used as a wetting agent to facilitate liquid ingress into the composition to increase the dissolution of sitagliptin and metformin in a single granulation, in which the surfactant is sodium lauryl sulfate.

c. Court’s construction: sodium lauryl sulfate.

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