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Galderma Laboratories Inc. v. Amneal Phamaceuticals, LLC, C.A. No. 11-1106-LPS (D. Del. July 30, 2013).

Galderma Laboratories Inc. v. Amneal Phamaceuticals, LLC, C.A. No. 11-1106-LPS (D. Del. July 30, 2013).

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claim construction
claim construction

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11/06/2013

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IN THE UNITED STATES DISTRICT COURTFOR THE DISTRICT OF DELAWARE
GALDERMA LABORATORIES INC.,GALDERMA LAB
ORA
TORIES, L.P
,
andSUPERNUS PHARMACEUTICALS, INC.,Plaintiffs,
V.
AMNEAL PHARMACEUTICALS, LLCand AMNEAL PHARMACEUTICALS CO.
(I)
PVT. LTD.,Defendants.C.A. No. 11-1106-LPSJack
B.
Blumenfeld, Esquire and Maryellen Noreika, Esquire
of
MORRIS, NICHOLS, ARSHT
&
TUNNELL LLP, Wilmington, DE.
Of
Counsel: Gerald
J.
Flattmann, Jr., Esquire and Christine Willgoos, Esquire
ofPAUL
HASTINGS, New York, NY.Attorneys for Plaintiffs.Mary
B.
Matterer, Esquire, Kenneth
L.
Dorsney, Esquire, and Richard K. Herrmann, Esquire
of
MORRIS JAMES LLP, Wilmington, DE.
Of
Counsel: H. Keeto Sabharwal, Esquire, Paul
A.
Ainsworth, Esquire, Jonathan Tuminaro,Esquire, and Dennies Varughese, Esquire
of
STERNE, KESSLER, GOLDSTEIN
&
FOX, PLLC,Washington, DC.Attorneys for Defendants.July 30, 2013Wilmington, Delaware
MEMORANDUM OPINION
 
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STARK, U.S. District Judge:
I.
INTRODUCTION
Plaintiffs Galderma Laboratories, Inc., Galderma Laboratories, L.P., and SupemusPharmaceuticals, Inc. (collectively, "Plaintiffs" or "Galderma") filed suit against defendantsAmneal Pharmaceuticals, LLC and Amneal Pharmaceuticals Co.
(I)
PVT. LTD. (collectively,"Defendants" or "Amneal"), alleging infringement
of
United States Patent Nos. 7,749,532 ("the'532 patent") and 8,206,740 ("the
'740
patent") (collectively, the "patents-in-suit" or "Changpatents").
1
(See
Docket Item ("D.I.")
1,
128) The patents-in-suit are each entitled "Once DailyFormulations
of
Tetracyclines" and relate to the Oracea® drug product, a delayed-releasedoxycycline capsule approved for the treatment
of
rosacea.The Court held a Markman hearing
on
November
30,2012.
(See
Transcript
of
November30, 2012 Markman hearing (D.I. 158) (hereinafter "Tr."))
2
II. LEGALSTANDARDS
"It is a bedrock principle
of
patent law that the claims
of
a patent define the invention towhich the patentee is entitled the right to exclude."
Phillips
v.
AWH
Corp.,
415 F.3d 1303, 1312(Fed. Cir. 2005) (internal quotation marks omitted). Construing the claims
of
a patent presents aquestion
oflaw.
See Markman
v.
Westview Instruments, Inc.,
52 F.3d 967, 977-78 (Fed. Cir.
1
The '53 2 patent may be found at D
I.
115, J A. C Ex.
1
the
'7
40 patent may be found at
id.
Ex.
2.
Dr. Richard Chang is the lead inventor
ofthe
patents-in-suit.
(See
D.I. 143 at 10; '532patent;
'7
40 patent)
2
The parties have reached agreement as to the proper construction
of
two terms -"steadystate blood levels
of
doxycycline
of
a minimum
of
0.1 f.lg/ml
and a maximum
of
1.0 f.lg/ml" and"steady state blood levels
ofthe
doxycycline
ofbetween
0.3
f.!g/ml
to 0.8 f.lg/ml" (D.I. 114 at 1-2)-and the Court will adopt their agreed-upon constructions.
1
 
l
I
1995),
aff'd,
517 U.S. 370, 388-90 (1996). "[T]here is no magic formula
or
catechism forconducting claim construction."
Phillips,
415 F.3d at 1324. Instead, the Court is free to attachthe appropriate weight to appropriate sources "in light
of
the statutes and policies that informpatent law."
!d.
"[T]he words
of
a claim are generally given their ordinary and customary meaning
...
[which
is]
the meaning that the term would have to a person
of
ordinary skill in the art inquestion at the time
of
the invention, i.e., as
of
the effective filing date
of
the patent application."
!d.
at 1312-13 (internal citations and quotation marks omitted). "[T]he ordinary meaning
of
aclaim term is its meaning to the ordinary artisan after reading the entire patent."
!d.
at
1321
(internal quotation marks omitted). The patent specification "is always highly relevant to theclaim construction analysis. Usually, it is dispositive; it is the single best guide to the meaning
of
a disputed term."
Vitronics Corp.
v.
Conceptronic, Inc.,
90 F.3d 1576, 1582 (Fed. Cir. 1996).While "the claims themselves provide substantial guidance as to the meaning
of
particularclaim terms," the context
of
the surrounding words
of
the claim also must be considered.
Phillips,
415 F.3d at 1314. Furthermore, "[o]ther claims
of
the patent in question, both assertedand unasserted, can also be valuable sources
of
enlightenment
...
[b ]ecause claim terms arenormally used consistently throughout the patent
....
!d.
(internal citation omitted)."Differences among claims can also be a useful guide
....
For example, the presence
of
adependent claim that adds a particular limitation gives rise to a presumption that the limitation inquestion is not present in the independent claim."
!d.
at 1314-15 (internal citation omitted). This"presumption is especially strong when the limitation in dispute is the only meaningful differencebetween an independent and dependent claim, and one party is urging that the limitation in the2

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