Eluxadoline – USA

Eluxadoline – USA

Claim construction:

Allergan USA, Inc. et al v. Aurobindo pharma ltd. et al

Court: District of Delaware

Case: 19-1727

Date: Jan. 11, 2021

Judge: Richard J Andrews

 

Before the Court was the issue of claim construction of various terms in U.S. Patent Nos. 8,691,860 (“the ’860 patent”), 9,115,091 (“the ʼ091 patent”), 9,364,489 (“the ʼ489 patent”), 9,789,125 (“the ʼ125 patent”), 9,675,587 (“the ʼ587 patent”), and 10,188,632 (“the ʼ632 patent”). The Court heard oral argument on December 21, 2020.

 

III. CONSTRUCTION OF AGREED-UPON TERMS:

Claim Term

Construction

“A method of treating a mammal suffering from irritable bowel syndrome, pain or another opioid receptor disorder” (’860 Patent, Claim 9)

Preamble is limiting.

“A method of treating a disease in a mammal, wherein the disease is an opioid receptor disorder” (’091 Patent, Claim 15)

Preamble is limiting.

“A method of treating a mammal suffering from irritable bowel syndrome” (’489 Patent, Claim 1)

Preamble is limiting.

“A method of treating a mammal suffering from pain” (’489 Patent, Claim 9)

Preamble is limiting.

“A method of treating an opioid receptor disorder in a mammal” (’125 Patent, Claim 17)

Preamble is limiting.

“An abuse-deterrent, monophasic pharmaceutical composition suitable for single dose administration for treating a condition mediated by an opioid receptor” (’587 Patent, Claims 1, 5, and 7)

Preamble is limiting.

“A solid pharmaceutical dosage formulation” (’632 Patent, Claim 1)

Preamble is limiting.

“A pharmaceutical composition” (’632 Patent, Claims 14 and 15)

Preamble is limiting.

“about 0.65%-0.85% by weight of colloidal silica” (’587 Patent, Claim 2; ’632 Patent, Claim 8)

0.60-0.90% by weight of colloidal silica

“about 0.65-0.85% by weight of magnesium stearate” (’587 Patent, Claim 2; ’632 Patent, Claim 8)

0.60-0.90% by weight of magnesium stearate

“about 0.75% by weight of colloidal silica” (’587 Patent, Claim 3; ’632 Patent, Claim 9)

0.70-0.80% by weight of colloidal silica

“about 0.75% by weight of magnesium stearate” (’587 Patent, Claim 3; ’632 Patent, Claim 9)

0.70-0.80% by weight of magnesium stearate

“about 4.5 mg of colloidal silica” (’587 Patent, Claim 5; ’632 Patent, Claim 14)

4.2-4.8 mg of colloidal silica

“about 4.5 mg by weight of magnesium stearate” (’587 Patent, Claim 5; ’632 Patent, Claim 14)

4.2-4.8 mg of magnesium stearate

“about 6 mg of colloidal silica” (’587 Patent, Claim 7; ’632 Patent, Claim 15)

5.5-6.4 mg of colloidal silica

“about 6 mg by weight of magnesium stearate” (’587 Patent, Claim 7; ’632 Patent, Claim 15)

5.5-6.4 mg of magnesium stearate

 

IV. CONSTRUCTION OF DISPUTED TERMS

 

1. “single dose administration” 

a. Plaintiffs’ proposed construction: “administration all at one time”

b. Defendants’ proposed construction: “once daily administration”

c. Court’s construction: “administration all at one time”

 

2. “silicified microcrystalline cellulose”

a. Plaintiffs’ proposed construction: “a mixture of microcrystalline cellulose and colloidal silicon dioxide”

b. Defendants’ proposed construction: “a co-dried or co-sprayed combination of only microcrystalline cellulose (98%) and colloidal silicon dioxide (2%)”

c. Court’s construction: “a coprocessed combination of microcrystalline cellulose (98%) and colloidal silicon dioxide (2%)”

 

3. “colloidal silica” / “colloidal silicon dioxide”

a. Plaintiffs’ proposed construction: plain meaning or “submicroscopic fumed silicon dioxide”

b. Defendants’ proposed construction: “an amount of [colloidal silica/colloidal silicon dioxide] separate from the amount of colloidal silicon dioxide present in the silicified microcrystalline cellulose”

c. Court’s construction: “an amount of [colloidal silica/colloidal silicon dioxide] distinct from the amount of colloidal silicon dioxide present in the silicified microcrystalline cellulose”

 

4. “about 0.55%-0.95% by weight of [colloidal silica/colloidal silicon dioxide]”

a. Plaintiffs’ proposed construction: “0.50-1.00% by weight of [colloidal silica/colloidal silicon dioxide]

b. Defendants’ proposed construction: “0.50-0.98% by weight of [colloidal silica/colloidal silicon dioxide]

c. Court’s construction: “0.50-1.00% by weight of [colloidal silica/colloidal silicon dioxide]

 

5. “about 0.55%-0.95% by weight of magnesium stearate”

a. Plaintiffs’ proposed construction: “0.50-1.00% by weight of magnesium stearate”

b. Defendants’ proposed construction: “0.50-0.98% by weight of magnesium stearate”

c. Court’s construction: 0.50-1.00% by weight of magnesium stearate

 

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