Budesonide - USA

Claim Construction (District of Delaware): Aug 02, 2019

Plaintiffs Valeant Pharmaceuticals International, Salix Pharmaceuticals Ltd., and Cosmo Technology Ltd. ("Plaintiffs") filed suit against Actavis Laboratories Fl., Inc., Actavis Pharma Inc., Teva Pharmaceuticals USA Inc., and Teva Pharmaceutical Industries, Ltd. ("Defendants") on August 22, 2018, alleging infringement of U.S. Patent Nos. 10,052,286; 10,064,878; 10,105,374; 10,143,698; 10,154,964  and 10,172,799 (collectively "the patents-in-suit"). These patents claim "controlled release budesonide formulations with a tablet core inside a gastroresistant coating."

Consolidated claim construction briefing was submitted on June 17,2019, an amended version was filed on June 27,2019, and the Court held a claim construction hearing on July 2, 2019.

Construction of Disputed Terms:

1. "Matrix":

Plaintiffs: "a structure for controlling the release of an active ingredient that does not have layers"

Defendants: "a homogeneous structure in all its volume"

Court: "a homogeneous structure in all its volume"

2. "Mixture" and "Compressed Blend"

Plaintiffs: "a composition of two or more substances that have been mixed" and

"a composition of two or more substances that have been mixed and compressed"

Defendants: "a homogeneous composition of two or more substances" and

"a compressed matrix (or homogeneous structure in all its volume)"

Court: "a homogeneous composition of two or more substances" and

"a compressed matrix (or homogeneous structure in all its volume)"

3. "Pharmacokinetic terms

The Court will adopt the parties' stipulated constructions for the "pharmacokinetic terms."

Claim term	Court’s construction
"an AUCo-infinity of said budesonide in   said human of about 16431.2±1 0519.8(pg)x(h)/mL" and "an AUC of said budesonide in said human of about 16.43 ±10.52 (ng)x (h)lmL"	"an AUCO-infinity of said budesonide in said human of approximately 16431.2±10519.8 (pg)x(h)/mL, i.e. approximately between 5,911.4 (pg)x(h)/mL and approximately 26,951 (pg)x(h)/mL" and "an AUC of said budesonide in said human of approximately 16.43±10.52 (ng)x(h)/mL, i.e. between approximately 5.91 (ng)x(h)/mL and approximately 26.95 (ng)x(h)/mL"
"a Cmax of said budesonide in said human of about 1348.8±958.8 pg/mL" and "a Cmax of said budesonide in said human of about 1.35±0.96 ng/mL"	"a Cmax of said budesonide in said human of approximately 1348.8±958.8 pg/mL, i.e. between approximately 390 pg/mL and approximately 2307.6 pg/mL" and "a Cmax of said budesonide in said human of approximately 1.35±0.96 ng/mL, i.e. between approximately 0.39 ng/mL and approximately 2.31 ng/mL"
"a T max of said budesonide in " said human of about 13.3±5.9 hour[s]"	“a T max of said budesonide in said human of approximately 13.3±5.9 hours, i.e. between approximately 7.4 hours and approximately 19.2 hours"
“oral administration of the oral dosage form to a human" and "oral administration of the tablet to a human"	"No constructions necessary”
"said human"	“No construction necessary”

4. "Controls the release kinetics

Plaintiffs: Plain and ordinary meaning, i.e. "controls the release kinetics"

Defendants: "controls the release kinetics without effects from physically discrete elements"

Court: Plain and ordinary meaning, i.e. "controls the release kinetics"