Delcor Asset Corporation et al v. Glenmark Pharmaceuticals Limited et al

Filing 93

MEMORANDUM ORDER providing claim construction for multiple terms in U.S. Patent Nos. 7,141,237 and 7,374,747. Signed by Judge Richard G. Andrews on 10/31/2018. (nms)

IN THE UNITED STATES DISTRICT COURT
FOR THE DISTRICT OF DELAWARE
DELCOR ASSET CORP. and MYLAN
PHARMACEUTICALS INC.,
Plaintiffs,
V.

C.A. No. 17-cv-1653-RGA
GLENMARK PHARMACEUTICALS
LTD., GLENMARK
PHARMACEUTICALS INC., USA, and
STIEFEL WEST COAST, LLC,
Defendants.

MEMORANDUM ORDER
Presently before the Court is the issue of claim construction of multiple terms in U.S .
Patent Nos. 7,141 ,237 ("the '237 patent") and 7,374,747 ("the ' 747 patent"). I have considered
the parties' joint claim construction brief. (D.I. 84). I heard oral argument on October 19, 2018 .
I.

BACKGROUND
On November 15, 2017, Delcor Asset Corp. ("Delcor") and Mylan Pharmaceuticals Inc.

("Mylan") brought this action against Glenmark Pharmaceuticals Ltd. and Glenmark
Pharmaceuticals Inc., USA (collectively "Glenmark"), and Stiefel West Coast, LLC ("Stiefel")
for infringement of the ' 237 and ' 747 patents. This action relates to Abbreviated New Drug
Application ("ANDA") No. 210778, filed by Glenmark for approval to market a generic version
of the branded product Evoclin. (D.I. 1 ,r 1). Mylan holds the NDA on Evoclin and Delcor is the
exclusive licensee of the ' 237 and ' 747 patents. (D.I. 1 ,r,r 19- 20). Stiefel owns the asserted

patents but was joined as an involuntary defendant and has taken no position on the issues in this
case. (D.I. 1 ,r 5; D.I. 84 at 8 n.4).
II.

LEGAL STANDARD
"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. AWH Corp., 415 F.3d 1303 , 1312
(Fed. Cir. 2005) (en bane) (citation omitted). "' [T]here is no magic formula or catechism for
conducting claim construction.' Instead, the court is free to attach the appropriate weight to
appropriate sources 'in light of the statutes and policies that inform patent law. "' Soft View LLC v.
Apple Inc., 2013 WL 4758195, at *1 (D. Del. Sept. 4, 2013) (quoting Phillips, 415 F.3d at 1324).

When construing patent claims, a court considers the literal language of the claim, the patent
specification, and the prosecution history. Markman v. Westview Instruments, Inc., 52 F.3d 967,
979-80 (Fed. Cir. 1995) (en bane), aff'd, 517 U.S. 370 (1996). Of these sources, "the 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. " Phillips, 415 F.3d at 1315.
"[T]he words of a claim are generally given their ordinary and customary meaning . . ..
[This 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. "[T]he ordinary meaning of a claim term is its meaning to [an] ordinary artisan after
reading the entire patent." Id. at 1321. "In some cases, the ordinary meaning of claim language
as understood by a person of skill in the art may be readily apparent even to lay judges, and claim
construction in such cases involves little more than the application of the widely accepted meaning
of commonly understood words." Id. at 1314.

2

When a court relies solely upon the intrinsic evidence-the patent claims, the specification,
and the prosecution history-the court's construction is a determination oflaw. See Teva Pharm.

USA, Inc. v. Sandoz, Inc., 135 S. Ct. 831,841 (2015). The court may also make factual findings
based upon consideration of extrinsic evidence, which "consists of all evidence external to the
patent and prosecution history, including expert and inventor testimony, dictionaries, and learned
treatises." Phillips, 415 F.3d at 1317- 19. Extrinsic evidence may assist the court in understanding
the underlying technology, the meaning of terms to one skilled in the art, and how the invention
works. Id. Extrinsic evidence, however, is less reliable and less useful in claim construction than
the patent and its prosecution history. Id.
"A claim construction is persuasive, not because it follows a certain rule, but because it
defines terms in the context of the whole patent." 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 GMBH v. Int '! Trade Comm 'n,
505 F.3d 1351 , 1358 (Fed. Cir. 2007) (citation omitted).

Ill.

PATENTS AT ISSUE
The '747 patent is a continuation of the '237 patent and the specifications are

substantively identical. (D.I. 84 at 6 n.3). The '237 patent has four independent claims-claims
1, 28, 32, and 33-all of which are asserted. I believe claim 1 may be considered representative
for the purposes of claim construction. The '747 patent has only one independent claim-claim
1.

Claim 1 of the '237 patent reads:
1. A topical delivery composition in a pressurized container, said composition
compnsmg:
up to 15% w/w of clindamycin phosphate;

3

1

from about 83% to about 97.9% w/w of a quick-breaking foaming agent, wherein
said quick-breaking foaming agent comprises a C1-C6 alcohol, a C14-C22 alcohol,
water, and a surfactant; and
from about 2% to about 7% w/w of an aerosol propellant selected from the group
consisting of a hydrocarbon, a chlorofluorocarbon, dimethyl ether,
hydrofluorocarbons and a mixture thereof,
a base; and
wherein said composition is a quick-breaking temperature sensitive foam after
release from said container.
Claim 1 of the ' 747 patent reads:
1. A method for treating a bacteria-mediated disease, said method comprising:

applying a quick-breaking temperature sensitive foam composition to the skin of a
subject in need thereof, said composition comprising:
up to 15% w/w of clindamycin phosphate;
from about 83% to about 97.9% w/w of a quick-breaking foaming agent, wherein
said quick-breaking foaming agent comprises a C1-C6 alcohol, a C14-C22 alcohol,
water, and a surfactant;
from about 2% to about 7% w/w of an aerosol propellant selected from the group
consisting of a hydrocarbon, a chlorofluorocarbon, dimethyl ether,
hydrofluorocarbons and a mixture thereof; and
a base, to treat said bacteria-mediated disease.

IV.

CONSTRUCTION OF DISPUTED TERMS
1. "base"

a. Plaintiffs ' Proposed Construction: Plain and ordinary meaning, i.e. , "a
compound that has an available lone pair of electrons for forming a chemical
bond"
b. Glenmark 's Proposed Construction: "a pH adjusting agent to increase the
pH and does not include propylene glycol, glycerin, ethanol, cetyl or stearyl
alcohol, or polysorbate"
c. Court's Construction: Plain and ordinary meaning as understood by a person
of ordinary skill in the art.

4

Glenmark seeks to add two separate limitations to its construction of "base"-a
functional limitation ("pH adjusting agent to increase the pH") and a negative limitation ("does
not include propylene glycol, glycerin, ethanol, cetyl or stearyl alcohol, or polysorbate"). I do
not think the intrinsic evidence supports either.
To support its functional limitation, Glenmark relies on example 3 in the specification,
which describes potassium hydroxide being used to adjust the composition from a "natural" pH
of 4.5 to a pH of 5.0. (D.I. 84 at 23 (citing ' 237 patent at 15:23--41)). Example 3 does not
identify potassium hydroxide as a "base," but a different portion of the specification states that
"[i]n one particular embodiment, the pH adjusting agent is a base," and "[p]referably, the pH
adjusting agent is potassium hydroxide." '237 patent at 6:55-61. Here, Glenmark is essentially
asking the Court to read in limitations from particular embodiments, contrary to the principles of
claim construction. See Phillips v. AWHCorp., 415 F.3d 1303, 1323 (Fed. Cir. 2005). I do not
think this case warrants an exception to the general rule-the specification does not make clear
that the claimed invention must include certain features from the embodiments. Compare
Howmedica Osteonics Corp. v. Wright Med. Tech. , Inc. , 540 F.3d 1337, 1344--46 (Fed. Cir.

2008), with SciMed Life Sys., Inc. v. Advanced Cardiovascular Sys., Inc., 242 F.3d 1337, 134044 (Fed. Cir. 2001).
To support its negative limitation, Glenmark first argues that claim 1 of the ' 237 patent,
considered with non-asserted dependent claims 10, 11 , and 12, shows that "base" is a separate
limitation from "emollient." See discussion of "emollient" infra. Because the dependent claims
explicitly define "emollient" as including propylene glycol and glycerol, Glenmark argues that
"base" cannot include those elements. (D.I. 84 at 25). Glenmark' s argument relies on the
assumption that "base" and "emollient" are mutually exclusive. In response, Plaintiffs argue that

5

"there is no blanket prohibition against a single component satisfying separately stated claim
elements so long as it is capable of performing the function of both." (See D.I. 84 at 43 (citing
Powell v. Home Depot USA, Inc. , 663 F.3d 1221 , 1231- 32 (Fed. Cir. 2011)). I think Plaintiffs

are correct. Further, I do not think the plain language of the claims, including the relationship
between claim 1 and dependent claim 10, requires finding "base" and "emollient" to be mutually
exclusive.
Second, Glenmark argues that "the specification lists and describes the [excluded]
compounds separately from 'base."' (Id. at 26). Glenmark relies on table 2 in the specification,
which is titled, "Some of the functions of ingredients in clindamycin phosphate compositions of
the present invention," and describes several of Glenmark's excluded elements as having a
"purpose" not related to pH adjustment. '237 patent at 11 :30-32. I do not find Glenmark' s
argument persuasive. Table 2 does not classify any ingredient as a "base," and regardless, only
lists "some" of the ingredients' functions.
Third, Glenmark argues that the inventors disclaimed Glenmark's excluded elements in
response to a rejection of the claims as obvious over Jones (U.S. Patent Pub. No. US
2003/0118511). (D.I. 84 at 27-29). The inventors first amended their claims to include the
limitation "a pH adjusting agent selected from a group consisting of an acid or a base" (D.I. 74-1 ,
Ex. G), and then amended that limitation to just "a base" (id. , Ex. F). Glenmark asserts, "The
examiner recognized that Jones disclosed a quick-breaking foaming agent with ethanol, cetyl and
stearyl alcohol, polysorbate, propylene glycol, and a buffering agent." (D.I. 84 at 28).
Therefore, Glenmark argues that the inventors disclaimed a construction of "base" that includes
those elements. (D.I. 84 at 32).

6

I think Glenmark rnischaracterizes the prosecution history. Although the examiner
recognized that Jones disclosed Glenmark' s excluded elements as part of its formulation (D.I.
74-1, Ex. Mat 3), I do not think the inventors distinguished Jones based on those disclosures.
Instead, it appears that the inventors overcame the rejection by showing that Jones did not teach
the use of clindamycin phosphate, and specifically did not teach the use of clindamycin
phosphate with a base, rather than a buffer. (D.I. 74-1, Ex.Fat 12 ("Jones teaches the use of a
buffer to stabilize the active agent[.] . .. Jones does not teach or suggest the use of an antibiotic
agent, especially clindamycin phosphate, and its unique properties formulated into a foam . ...
[C]lindamycin phosphate in a traditional buffer system is degraded. However, with the addition
of a base, the composition is unexpectedly stable and efficacious.")). The fact that some of the
elements disclosed in Jones may also be bases is not, in itself, sufficient to show disclaimer.
Therefore, I reject Glenmark' s proposed construction. I am not convinced, however, that
I should adopt Plaintiffs' proposed construction. The parties' experts disagree on what a person
of ordinary skill in the art would consider the plain and ordinary meaning of "base" in the
present context. (See D.I. 85, Ex. 9 ,i,i 15, 19-20). I believe further expert testimony is required
to make a final determination. Thus, I will allow the parties to meet and confer to consider
whether they wish to present testimony at a hearing prior to trial, or simply to resolve the issue at
trial. The parties should inform the Court of their preferences in a joint status report.

2. "quick-breaking foaming agent"
a. Plaintiffs ' Proposed Construction: No construction necessary. In the
alternative, to the extent construction is deemed necessary: "quick-breaking
foaming agent" has the meaning recited in the asserted claims, i.e., "a C1- C6
alcohol, a C1 4-C22 alcohol, water, and a surfactant."
b. Glenmark 's Proposed Construction: "one or more alcohols, water, and a
surfactant, and can include an emollient"
c. Court 's Construction : No construction necessary.
7

Claim 1 of both asserted patents states: "wherein said quick-breaking foaming agent
comprises a C1-C6 alcohol, a C1 4-C22 alcohol, water, and a surfactant." At oral argument,
Glenrnark indicated that the purpose behind its proposed construction was to ensure that the
quick-breaking foaming agent may also include an emollient, in addition to the items listed in the
claims. (Markman Tr. at 36:5-17). The use of "comprises" clearly allows for additional
unrecited elements. Plaintiffs do not dispute this. (Id. at 39:9-22, 40:6-24). Therefore, I find
there is no actual dispute and no construction is necessary.
3. "emollient"

a. Plaintiffs ' Proposed Construction: Construction is legally improper. In the
alternative, and to the extent necessary: The compositions covered by the
asserted claims of the '237 and ' 747 patents do not recite an "emollient,"
which would have its plain and ordinary meaning.
b. Glenmark 's Proposed Construction : "one or more agents for softening or
moisturizing, such as polyol, a mixture of pol yo ls, propylene glycol, or
glycerin"
c. Court 's Construction: As the term is not in any asserted claim, the Court
does not construe it.
The term "emollient" is not in any of the asserted claims. It appears in a series of nonasserted dependent claims:

10. The composition of claim 1, further comprising an emollient.
11. The composition of claim 10, wherein said emollient is a polyol.
12. The composition of claim 11 , wherein said polyol is selected from the group
consisting of a propylene glycol, glycerol, and a mixture thereof.
' 237 patent, claims 10-12. Plaintiffs have taken the position that propylene glycol is the "base"
in Glenrnark's ANDA products. (D.I. 84 at 67, 69). Therefore, since claims 10 and 11 imply
that propylene glycol is an "emollient," Glenrnark argues construction is necessary to determine
whether "emollient" has "a different and non-overlapping definition than ' base. "' (Id.) .

8

I disagree. The material dispute is whether propylene glycol is a "base." That is a factual
question that can be addressed at trial in light of my construction of "base." It would be
superfluous to construe "emollient," especially when the term does not appear in any of the
asserted claims. I think I would be rendering an advisory opinion. See Vivid Techs., Inc. v. Am.
Sci. & Eng'g, Inc., 200 F.3d 795 , 803 (Fed. Cir. 1999) ("[O]nly those terms need be construed
that are in controversy, and only to the extent necessary to resolve the controversy."). Therefore,
I do not construe "emollient."

IT IS SO ORDERED this

1.L day of October 2018.
United States Di

9