Duchesnay Inc. et al v. Actavis Inc. et al
MEMORANDUM ORDER re: Claim Construction. Signed by Judge Sue L. Robinson on 11/18/2015. (nmfn)
IN THE UNITED STATES DISTRICT COURT
FOR THE DISTRICT OF DELAWARE
DUCH ESNAY INC. and DUCH ESNAY
) Civ. No. 14-912-SLR
ACTAVIS LABORATORIES FL, INC.,
ACTAVIS, INC., ACTAVIS PHARMA, INC., and)
MYLAN PHARMACEUTICALS INC.,
At Wilmington this 181h day of November, 2015, having heard argument on, and
having reviewed the papers submitted in connection with, the parties' proposed claim
IT IS ORDERED that the disputed claim language of U.S. Patent No. 6,340,695
("the '695 patent") shall be construed consistent with the tenets of claim construction set
forth by the United States Court of Appeals for the Federal Circuit in Phillips v. AWH
Corp., 415 F.3d 1303 (Fed. Cir. 2005), as follows:
1. "Rapid onset formulation:" 1 "A formulation that rapidly releases the active
ingredients at about pH 6.8 as shown by its in vitro dissolution profile." The
specification explains that the invention "seeks to provide a pharmaceutical composition
having specific in-vitro dissolution profiles indicative of rapid onset of the active
ingredients." (2:13-15) Figures 1 and 2 depict "examples of dissolution profiles in
accordance to the rapid onset formulation." (2:30-33) The patentee concludes that "[i]t
Found in claims 1-30.
follows from these results that the novel formulation demonstrates a rapid onset as
shown by its dissolution profile." (7:32-34)
2. "Dissolution profile" and "dissolution characteristics:" 2 "Average results
of a dissolution test in which the amount of pyridoxine HCL and doxylamine succinate
released in measured in 1000 ml phosphate buffer at pH 6.8 and 37° C using a USP
(United States Pharmacopeia) type 2 dissolution apparatus at 100 rpm." The
[A]ny reference to dissolution profile should be construed as referring to
the results of a dissolution test in which the amount of pyridoxine HCI and
of doxylamine succinate released is measured in 1000 ml phosphate
buffer at pH 6.8 and 37° C. using a USP (United States Pharmacopoeia)
type 2 dissolution apparatus at 100 rpm; preferably measured by high
performance liquid chromatography.
(3:21-28) The specification describes the results of the dissolution testing using the
average of six runs (as shown in table 6):
[T]he novel formulation demonstrates a rapid onset as shown by its
dissolution profile. Pyridoxine HCI presents an average dissolution profile
of over 90% within 120 minutes of starting the measurements. Similarly,
Doxylamine succinate displays an average dissolution profile of over 90%
within 120 minutes of starting the measurements.
(7:32-39, table 6)
3. The court has provided a construction in quotes for the claim limitations at
issue. The parties are expected to present the claim construction consistently with any
explanation or clarification herein provided by the court, even if such language is not
included within the quotes.
Found in claims 1-30.
4. The parties agree3 that the preamble is limiting.
5. The parties agree that "enterically-coated ... formulation" means "a
formulation coated with an enteric coating."
6. The parties agree that "enteric coating" means "a coating comprising one or
more layers generally resistant to disintegration in human gastric fluids, but which will
disintegrate in human intestinal fluids, as well as coatings which disintegrate very slowly
in human gastric fluids, but more rapidly in human."
7. The parties agree that "at least about [X]% of the total amounts of each of
pyridoxine HCI and doxylamine succinate are dissolved after [X] minutes of
measurement" means "at least approximately [X]% of each of doxylamine succinate
and pyridoxine hydrochloride is dissolved in relation to starting quantities after [X]
8. The parties agree that "at least about 40% of the total amounts of each of
pyridoxine HCI and doxylamine succinate are dissolved within 5 minutes" means
"at least approximately 40% of each of doxylamine succinate and pyridoxine
hydrochloride is dissolved in relation to starting quantities within 5 minutes."
As requested by the parties, the court includes herein the agreed upon constructions.
(See D.I. 36)
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