Sucroferric oxyhydroxide - USA

Claim Construction (District of Delaware): Sep 05, 2019

Plaintiffs Vifor Fresenius Medical Care Renal Pharma Ltd. and Vifor Fresenius Medical Care Renal Pharma France S.A.S. ("Plaintiffs") filed suit against Defendants Lupin Atlantis Holdings SA, Lupin Pharmaceuticals, Inc., and Teva Pharmaceuticals USA, Inc. ("Defendants") on March 12, 2018, alleging infringement of U.S. Patent No. 9,561 ,251 (the '"251 Patent").  The patent-in-suit relates to pharmaceutical compositions of iron oxy-hydroxide in high loading.

II. CONSTRUCTION OF DISPUTED TERMS:

A. "essentially non-bioabsorbable"

Plaintiff: Plain and ordinary meaning, otherwise: upon oral administration, the iron oxyhydroxide is not absorbed by the human body in a clinically significant amount

Defendant: Indefinite

Court: Upon oral administration, the iron oxyhydroxide is not absorbed by the human body in a clinically significant amount

B. "iron release rate below 2.5% w/w"

Plaintiff: The iron release measured in water at a pH of 3 according to European Pharmacopeia chapter 2.9.3 using standard dissolution equipment and parameters as described in the monograph, where iron content is analyzed by titration after 2 hours, wherein the quantity of iron dissolved after 2 hours is less than 2.5% w/w

Defendant: Indefinite

Court: The iron release measured in water at a pH of 3 according to European Pharmacopeia chapter 2.9.3 using standard dissolution equipment and parameters as described in the monograph, where iron content is analyzed by titration after 2 hours, wherein the quantity of iron dissolved after 2 hours is less than 2.5% w/w

C. "not bound as a complex compound"

Plaintiff: Plain and ordinary meaning, otherwise: not forming any intramolecular bonds such that a water-soluble stabilization agent can be removed by washing the stabilized iron oxy-hydroxide with water

Defendant: Indefinite

Court: Not forming any intramolecular bonds such that a water-soluble stabilization agent can be removed by washing the stabilized iron oxy-hydroxide with water

D. "rapid disintegration"

Plaintiff: Plain and ordinary meaning

Defendant: Indefinite

Court: Disintegration that begins upon administration and, on average, takes no longer than 3 minutes to complete