Galderma Laboratories, L.P. et al v. Sun Pharmaceutical Industries Limited et al

Filing 78

MEMORANDUM OPINION re claim construction. Signed by Judge Leonard P. Stark on 11/21/17. (ntl)

IN THE UNITED STATES DISTRICT COURT
FOR THE DISTRICT OF DELAWARE
GALDERMA LABORATORIES, L.P.;
NESTLE SKIN HEALTH S.A.; and
TCD ROYALTY SUB, LLC,
Plaintiffs,

v.

C.A. No. 16-1003-LPS

SUN PHARMACEUTICAL INDUSTRIES
LIMITED and SUN PHARMACEUTICAL
INDUSTRIES, INC.,
Defendants.

Jack B. Blumenfeld, Maryellen Noreika, Megan Elizabeth Dellinger, MORRIS, NICHOLS, .
ARSHT & TUNNELL, LLP, Wilmington, DE
Gerald J. Flattman, Jr., Evan D. Diamond, Vanessa Y. Yen, Lucas L. Kresse!, PAUL
HASTINGS LLP, New York, NY
· Attorneys for Plaintiffs.

Kelly E. Farnan, Nicole K. Pedi, RICHARDS, LAYTON & FINGER, P.A., Wilmington, DE
Huiya Wu, Brian J. Robinson, GOODWIN PROCTOR LLP, New York, NY
Nicholas K. Mitrokostas, GOODWIN PROCTOR LLP, Boston, MA

Attorneys for Defendants.

MEMORANDUM OPINION

November 21, 2017
Wilmington, Delaware

--f~ f
.

.·.

S~ U.S. District Judge:
. Plaintiffs Galderma Laboratories, L.P., Nestle Skin Health S.A., and TCD Royalty Sub,

LLC (collectively, "Galderma" or "Plaintiffs") filed suit against Defendants Sun Pharmaceutical
Industries Limited and Sun Pharmaceutical Industries, Inc. (collectively, "Sun" or "Defendants")
on October 27, 2016, alleging infringement of two families of patents: the Ashley patents, U.S.
Patent Nos. 7,211,267 (the "'267 patent"); 7,232,572 (the '"572 patent"); 8,603,506 (the "'506
patent"); and 9,241,946 (the "'946 patent") (collectively, the "Ashley patents"), and the Chang
patents, U.S. Patent Nos. 7,749,532 (the "'532 patent"); 8,206,740 (the "'740 patent"); 8,394,405
(the '"405 patent"); 8,394,406 (the '"406 patent"); 8,470,364 (the "'364 patent"); and 8,709,478
(the "'478 patent") (collectively, the "Chang patents"). (See D.I.

1~6)

The patents-in-suit are

generally directed to doxycycline formulations used to treat papules and pustules of acne and
rosacea.
Presently before the Court is the issue of claim construction. The Court previously
construed various terms of the patents-in-suit in the context of other cases. See Galderma Labs.,

L.P. v. Amneal Pharm. LLC, 2017 WL 1882499, at *5 (D. Del. May 9, 2017) ("Amneal If');
Mylan Pharm. fnc. v. Galderma Labs., Inc., 2011 WL 1113383 (D. Del. Mar. 24, 2011) ("Mylan
DJ''). The Patent Trial and Appeal Board ("PTAB") also construed one set of terms in inter
partes proceedings. (See JA Exs. 31-33) ("Amneal IPRs") On July 31, 2017, the parties
stipulated to the use of this Court's Amneal II claim constructions for four terms Jrom the Ashley
patents for the purpose of this litigation. 1 (See D.I. 60) The parties completed briefing on
1

The terms are: (1) "amount that ... results in no reduction of skin microflora during a
six-month treatment," which appears in claims 28-30 of the '267 patent, claims 1 and 20 of the
'572 patent, claims 1 and 8 of the '506 patent, and claims 1 and 7 of the '946 patent;
(2) "wherein the amount re~ults in no reduction of skin microflora during a six-month treatment,"
which appears in claim 15 of the '506 patent and claim 13 of the '946 patent; (3) "sub-

September 8, 2017. (See D.I. 61, 62, -64, 65) The Courtheld a claim construction hearing on
October 2, 2017. ("Tr.")

I.

LEGAL STANDARDS
· The ultimate question of the proper construction of a patent is a question of law. See

Teva Pharm. USA, Inc. v. Sandoz, Inc., 135 S. Ct. 831, 837 (2015) (citing Markman v. Westview
Instruments, Inc., 517 U.S. 370, 388-91 (1996)). "It is a bedrock principle of patent law that the
claims of a patent define the invention to which the patentee is entitled the right to exclude."
Phillips v. AWHCorp., 415 F.3d 1303, 1312 (Fed. Cir. 2005) (citation and internal quotation
marks omitted). "[T]here is no magic formula or catechism for conducting claim construction."
Id. at 1324. Instead, the court is free to attach the appropriate weight to appropriate sources "in
light of the statutes and policies that inform patent law." Id.
"[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 in
question at the time of the invention, i.e., as of the effective filing date of the patent application."
Id. at 1312-13 (internal citations and quotation marks omitted). "[T]he ordinary meaning of a
claim term is its meaning to the ordinary artisan after reading the entire patent." Id. at 1321
(internal quotation marks omitted). The patent "specification is always highly relevant to the
claim 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).

antibacterial amount," which appears in claims 1 and 28-30 of the '267 patent; and (4) "an
amount that is effective to treat the papules and pustules of rosacea, but has substantially no
antibiotic activity," which appears in claims 1 and 20 of the '572 patent. (See D.I. 54, 60) The
Court will adopt the parties' agreed-upon constructions for these terms.

2

While "the claims themselves provide substantial guidance as to the meaning of particular
claim 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 asserted
and unasserted, can also be valuable sources of enlightenment .... [b]ecause claim terms are
normally used consistently throughout the patent." Id. (internal citation omitted).
It is likewise true that "[d]ifferences among claims can also be a useful guide .... For

example, the presence of a dependent claim that adds a particular limitation gives rise to a
presumption that the limitation in question is not present in the.independent claim." Id. at 131415 (internal citation omitted). This "presumption is especially strong when the limitation in
dispute is the only meaningful difference between an independent and dependent claim, and one
party is urging that the limitation in the dependent claim should be read into the independent
claim." SunRace Roots Enter. Co., Ltd. v. SRAM Corp., 336 F.3d 1298, 1303 (Fed. Cir. 2003).
It is also possible that "the specification may reveal a special definition given to a claim

term by the patentee that differs from the meaning it would otherwise possess. In such cases, the
inventor's lexicography governs." Phillips, 415 F.3d at 1316. It bears emphasis that "[e]ven
when the specification describes only a single embodiment, the claims of the patent will not be
read restrictively unless the patentee has demonstrated a clear intention to limit the claim scope
using words or expressions of manifest exclusion or restriction." Hill-Rom Servs., Inc. v. Stryker

Corp., 755 F.3d 1367, 1372 (Fed. Cir. 2014) (quoting Liebel-Flarsheim Co. v. Medrad, Inc., 358
F.3d 898, ·906 (Fed. Cir. 2004)) (alteration in original) (internal quotation marks omitted).
In addition to the specification, a court "should also consider the patent's prosecution
history, if it is in evidence." Markman v. Westview Instruments, Inc., 52 F.3d 967, 980 (Fed. Cir.

3

1995), aff'd, 517 U.S. 370 (1996). The prosecution history, which is "intrinsic evidence,"
"consists of the complete record of the proceedings before the [Patent and Trademark Office] and
includes the prior art cited during the examination of the patent." Phillips, 415 F .3 d at 131 7.
"[T]he prosecution history can often inform the meaning of the claim language by demonstrating
how the inventor understood the invention and whether the inventor limited the invention in the
course of prosecution, making the claim scope narrower than it' would otherwise be." Id.
"In some cases, ... the district court will need to look beyond the patent's intrinsic

evidence and to consult extrinsic evidence in order to understand, for example, the background
science or the meaning of a term in the relevant art during the relevant time period." Teva, 135
S. Ct. at 841. "Extrinsic evidence consists of all evidence external to the patent and prosecution
history, including expert and inventor testimony, dictionaries, and learned treatises." Markman,
52 F.3d at 980. For instance, technical dictionaries can assist the court in determining the
meaning of a term to those of skill in the relevant art because such dictionaries "endeavor to
collectthe accepted meanings of terms used in various fields of science and technology."
Phillips, 415 F.3dat 1318. In addition, expert testimony can be useful "to ensure that the court's

understanding of the technical aspects of the patent is consistent with that of a person of skill in
the art, or to establish that a particular term in the patent or the prior art has a particular meaning
in the pertinent field." Id. Nonetheless, courts must not lose sight of the fact that "expert reports
and testimony [are] generated at the time of and for the purpose of litigation ~nd thus can suffer
from bias that is not present in intrinsic evidence." Id. Overall, while extrinsic evidence "may
be useful to the court," it is "less reliable" than intrinsic evidence, and its consideration "is
unlikely to result in a reliable interpretation of patent claim scope unless considered in the
4

context of the intrinsic evidence." Id. at 1318-19. Where the intrinsic record unambiguously
describes the scope of the patented invention, reliance on any extrinsic evidence is improper. See

Pitney Bowes, Inc. v. Hewlett-Packard Co., 182 F.3d 1298, 1308 (Fed. Cir. 1999) (citing
Vitronics, 90 F.3d at 1583).
Finally, "[t]he construction that stays true to the claim language and most naturally aligns
with the patent's description of the invention will be, in the end, the correct construction."

Renishaw PLC v. Marposs Societa 'per Azioni, 158 F.3d 1243, 1250 (Fed. Cir. 1998). It follows
that "a claim interpretation that would exclude the inventor's device is rarely the correct
interpretation." Osram GmbHv. lnt'l Trade Comm'n, 505F.3d1351, 1358 (Fed. Cir. 2007)
(quoting Modine Mfg. Co. v. US. Int'! Trade Comm 'n, 75 F.3d 1545, 1550 (Fed. Cir. 1996)).
II.

CONSTRUCTION OF DISPUTED TERMS

A.

"delayed release" 2 I "DR" 3

Plaintiffs
release of a drug at a time other than immediately following oral administration
Defendants
release of a drug at a time other than immediately following oral administration, excluding
formats that result in release of drug starting promptly after oral administration
Court
release of a drug at a time other than immediately following oral administration

2

This term appears in claims 1, 15, and 20 of the '532 patent; claims 1, 19, 22, 23, and
26-28 of the '740 patent; claims 1, 17, and 20 of the '405 patent; claims 1, 17; and 21 of the '406
patent; claims 1, 2, 16, and 17 of the '364 patent; and claims 1 and 20 of the '478 patent.
3

This term appears in claims 1, 15, and 20 of the '532 patent; claims 1, 10, 11, 19, 22, 23,
26, and 28 of the '740 patent; claims 1, 3, 8, 9, 17, and 20 of the '405 patent; claims 1, 3, 7, 8,
17, and 21 of the '406 patent; claims 1, 2, 7, 8, 16, and 17 of the '364 patent; and claims .1, 5, 19,
20, 24, and 37 of the '478 patent.
5

The parties agree that "delayed release" and its shorthand, "DR" (the "delayed release
-

'

terms"), have a consistent meaning across the patents-in-suit. (See D.l. 54 at 4) The Court
previously construed the delayed release terms according to their plain and ordinary meaning as
"release of a drug at a time other than immediately following oral administration." See Amneal
11, 2017 WL 1882499, at *5. The PTAB provided the same construction in its Final Written

Decisions in theAmneal IPRs. (See JA Ex. 31at8; JA Ex. 32 at 13; JA Ex. 33 at 13) Sun seeks
to supplement this construction to specify that the delayed release terms exclude formats that
result in release of drug promptly after oral administration, based on what it contends was a
disclaimer during the Amneal IPRs. (See D.l. 61 at 5) Galderma contends that Sun's
construction "adds an extraneous negative limitation" lacking a valid basis. (Tr. at 7)
Disclaimer of claim scope must be "clear and unmistakable." Avid Tech., Inc. v.

Harmonic, Inc., 812 F.3d 1040, 1045 (Fed. Cir. 2016) (internal quotation marks omitted). The
· record here does not support a finding of disclaimer.
During the Amneal IPRs, the patent owner distinguished prior art, U.S. Patent No.
5,348,748 ("Sheth '748"), by arguing that the polymer disclosed in Sheth '748 provided a
"modified sustained release," rather than a "delayed release," because in Sheth '748 release
"beg[an] slowly but promptly in the stomach, followed by rapid release in the intestine." (JA Ex.
31 at 12) The patent owner's expert, Dr. Rudnic, offered supporting testimony. (See JA Ex. 31
at 12-13; JA Ex. 88 at 103-05) Both the patent owner and Dr. Rudnic used "promptly" and
"immediately" interchangeably to describe the release in Sheth '748. (See, e.g., JA Ex. 42 at
50:17-20; JA Ex. 67 at 18-20; JA Ex. 70 at 25)
These statements do not meet the "high" and "demanding" standard for disclaimer. See

6

Avid Tech., 812 F.3d at_l045. Having heard the statements on which Sun now relies, the PTAB
adopted the same construction proposed here by Galderma, and noted, "we discern nothing in the
use of the term 'delayed release' in the '740 patent specification that is inconsistent with those
[plain and ordinary meaning] definitions or more limiting than them." (JA Ex. 31 at 8)
While the patent owner consistently distinguished Sheth '748 based on the timing of release, and
the overall release profile of Sheth '748 is not a delayed release format - and, therefore, is not
within the claim scope (see Tr. at 10, 21-22)- at no point did the patent owner clearly and
unambiguously disclaim all embodiments that release drug at a time other than immediately after
oral administration solely because they also release some amount of drug "starting promptly after
oral administration."

B.

"Comprising" terms
1.

"comprising 30 mg doxycycline"4

Plaintiffs
Plain and ordinary meaning
Defendants
with 30 mg doxycycline
Court
Plain and ordinary meaning
2.

I

"comprising.10 mg doxycycline" 5

Plaintiffs
Plain and ordinary meaning

4

This term appears in claims 1, 19, 22, 23, and 28 of the '740 patent.

5

This term appears in claims 1, 19, 22, 23, and 28 of the '740 patent.
7

Defendants
with 10 mg doxycycline
Court
Plain and ordinary meaning

"Comprising" is a term of art with a well-established meaning. See Glaxo Grp. Ltd. v.
Teva Pharm. USA Inc., 2009 WL 1220544, at *2 (D. Del. Apr. 30, 2009). Comprising '"means
that the named elements are essential, but other elements may be added and still form a construct
within the scope of the claim."' Id. (quoting Genentech, Inc. v. Chiron Corp., 112 F.3d 495, 501
(Fed. Cir. 1997)). Sun essentially asks the Court to construe "comprising" as "with." (See D.I.
61 at 14)
The Court agrees with Galderma that Sun is asking the Court to depart from the plain and
ordinary meaning. The Court further agrees with Galderma that there is no persuasive reason to
adopt Sun's proposed construction. (See D.I. 62 at 15; D.I. 65 at 13)
The term "with" - as well as "no more, no less," a phrase Sun also suggests for
"comprising" in the context of the disputed claim terms (D.I. 61 at 14)- does not appear in
connection with any milligram amount of doxycycline anywhere in the '740 patent. Rather, the
claims consistently use "comprising," and no intrinsic evidence suggests that the patentee
intended to depart from the customary meaning of "comprising." (See, e.g., JA Ex. 6 at col.
11:56-64; col. 13:12-17; col. 14:19-22)
During the IPR, the patent owner stated to the PTAB, "I don't think [the comprising
language] opens up the term 30 milligrams to something different." (JA Ex. 42 at 37) But this is
not a clear and unmistakable disclaimer. The patentee was not unambigu-ously stating that, for
example, "comprising 30 mg doxycycline" means that any formulation containing any amount·
8

other than precisely 30 mg doxycycline is outside the scope of the claims. See Glaxo Grp., 2009
WL 1220544, at *2 (refusing to adopt "specialized definition" of"comprising" absent intrinsic
evidence requiring court to do so). "Comprising" is a term of art to patent claim drafters and
permits some flexibility (here, for instance, in terms of the amount of doxycycline in a claimed
formulation) and no persuasive basis has been given to adopt Sun's more restrictive construction.
C.

"About" terms
1.

"about 30 mg doxycycline" 6

Plaintiffs
30 mg doxycycline, within the pharmaceutically acceptable limits found in the United States
Pharmacopeia (USP-NF 21), 2003 Annual Edition, pp. 666-71
Defendants
30 mg doxycycline, within the pharmaceutically acceptable limits found in the United States
Pharmacopeia (USP-NF 21), 2003 Annual Edition, which excludes amounts less than 27 mg
and more than 33 mg of doxycycline
Court
30 mg doxycycline, within the pharmaceutically acceptable limits found in the United States
Pharmacopeia (USP-NF 21), 2003 Annual Edition
2.

"about 10 mg doxycycline"7

Plaintiffs
10 mg doxycycline, within the pharmaceutically acceptable limits found in the United States
Pharmacopeia (USP-NF 21), 2003 Annual Edition, pp. 666-71
Defendants
10 mg doxycycline, within the pharmaceutically acceptable limits found in the United States
Pharmacopeia (USP-NF 21), 2003 Annual Edition, which excludes amounts less than 9 mg
and more than 11 mg of doxycycline

6

This term appears in claims 1, 15, and 20 of the '532 patent; claims 1, 2, 16, and 17 of
the '364 patent; and claims 1 and 20 of the '478 patent.
7

This term appears in claims 1, 15, and 20 of the '532 patent; claims 1, 2, 16, and 17 of
the '364 patent; and claims 1 and 20 of the '478 patent.
9

Court
10 mg doxycycline, within the pharmaceutically acceptable limits found in the United States
Pharmacopeia (USP-NF 21), 2003 Annual Edition
The Chang patent specifications expressly define "about" to mean "within the
pharmaceutically acceptable limits found in the United States Pharmacop[e]ia (USP-NF-21),
2003 Annual Edition [("USP 2003")] ... for amount of active pharmaceutical ingredients." (JA
Ex. 5 at col. 3:66-4:2; JA Ex. 9 at col. 4:8-11; JA Ex. 10 at col. 3:66-4:2) The parties dispute
which portion of the USP 2003 is relevant to discerning the "pharmaceutically acceptable limits"
of doxycycline. Galderma' s proposed construction incorporates the pages of the USP 2003' s
official monograph for ·doxycycline, which describe various oral dosage forms containing
doxycyline as an active ingredient. (See D.I. 62 at 13; see also JA Ex. 46 at 666-71) Sun's
proposed construction relies on the "General Notices and Requirements" section of the USP
2003, which defines "about" in the context of "the appropriate quantities to be taken for assays
and tests." (D.I. 61 at 10-11; see also JA Ex. 46 at 7)
The Court is not persuaded by either parties' proposal to limit the portion of the USP
2003 to be considered to only a few pages. Rather, the Court views the entire USP 2003 to be
relevant to determining the meaning of "about." The Court's construction is consistent with the
express definition provided by the patentee, which does not limit the reference to the USP 2003
to certain sections or pages. See Sinorgchem Co., Shandong v. Int 'l Trade Comm 'n, 511 F .3d
1132, 1138 (Fed. Cir. 2007) ("When the specification explains and defines a t~rm ... , without
ambiguity or incompleteness, there is no need to search further for the meaning of the term.")
(internal quotation marks omitted). Hence, the Court will not place a limitation on the portion of
the USP 2003 that may be relevant to understanding the scope of the claims.
10

D.

"Blood level" terms 8
1.

"steady state blood levels of doxycycline of a
minimum of 0.1 µg/ml and a maximum of 1.0 µg/ml" 9

Plaintiffs
steady state plasma concentrations of doxycycline of a minimum of 0.1 µg/ml and a maximum
of 1.0 µg/ml
Defendants
steady state plasma concentrations of doxycycline of a minimum of 0.1 µg/ml and a maximum
of 1.0 µg/ml maintained over a 24-hour period
Court
steady state plasma concentrations of doxycycline of a minimum of 0.1 µg/ml and a maximum
of 1.0 µg/ml
2.

"steady state blood levels of the doxycycline
of between 0.3 µg/ml to 0.8 µg/ml" 10

Plaintiffs
steady state plasma concentrations of the doxycycline ofbetween 0.3 µg/ml to 0.8 µg/ml
Defendants
steady state plasma concentrations of the doxycycline of between 0.3 µg/ml to 0.8 µg/ml
maintained over a 24-hour period
Court
steady state plasma concentrations of the doxycycline of between 0.3 µg/ml to 0.8 µg/ml
The Court has previously construed the "blood levels" terms. See Mylan DJ, 2011 WL
1113383. The parties agree that "blood levels" should be construed consistent with this Court's

8

The parties agree that the two disputed terms listed and discussed here are representative
of their disputes with respect to the blood level terms.
9

This term appears in claims 1, 15, and 20 of the '532 patent; claims 1, 19, 23, and 28 of
the '740 patent; and claims 1 and 17 of the '405 patent.
10

This term appears in claims 4 and 18 of the '532 patent; claims 2, 21, and 25 of the '740
patent; claims 2 and 19 of the '405 patent; and claims 2 and 19 of the '406 patent.
11

previous construction to mean "plasma concentrations." (D.I. 54 at 5-6) Sun asks the Court to
clarify that the specified concentrations must be "maintained over a 24-hour period." (See D.I.
61 at 17) Galderma contends that Sun's construction "add[s] unnecessary extraneous language."
(See D.I. 62 at 3)
The Court is not persuaded that imposing the additional limitation Sun seeks is . ·.· ·
warranted. The claim language provides that the dosage must be "once-daily," and the
specification consistently refers to "once daily" or "once-a-day" dosages. (See, e.g., JA Ex. 5 at
col. 1:6-7, 2:26-27, 3:48-49, 11 :65, 12:11-12) The claim language, which is directed to the
frequency of administration, does not require that the blood levels be maintained over "24hours;" nor do the specification nor the patent owner's statements during the Amneal IPRs
support such a reading. (See JA Ex. 5 at col. 3:55-57 ("Preferably, the blood levels stay within
the preferred blood level, with daily dosing, for the entire course of treatment."); id. at col. 8:6364 (discussing formulations "to achieve the desired levels of the drug ... over the course of

about 24 hours at steady state") (emphasis added); JA Ex. 70 at 4 ("Goal was to achieve a oncedaily doxycyline formulation.")) While it is preferable that a particular blood level be
maintained over approximately 24 hours, based on daily dosing, Sun's construction appears to
more narrowly constrain the claim scope, which is not supported.

III.

CONCLUSION
The Court will construe the disputed terms as explained above. An appropriate Order

follows.

12