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"
