Allergan, Inc. v. Sandoz, Inc. et al

Filing 241

MEMORANDUM OPINION AND ORDER. Signed by Judge Rodney Gilstrap on 3/29/2016. (ch, )

IN THE UNITED STATES DISTRICT COURT
FOR THE EASTERN DISTRICT OF TEXAS
MARSHALL DIVISION
ALLERGAN SALES, LLC,

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Plaintiff,
v.
SANDOZ INC., ET AL.,
Defendants.

Case No. 2:12-cv-207-JRG
(Lead Case)

MEMORANDUM OPINION AND ORDER
Before the Court are Plaintiff Allergan Sales, LLC’s (“Allergan”) Opening Claim
Construction Brief (Dkt. No. 232), Sandoz, Inc., Alcon Laboratories, Inc., Alcon Research, Ltd.,
and Falcon Pharmaceuticals, Ltd.’s (collectively, “Sandoz”) Responsive Claim Construction
Brief (Dkt. No. 235), and Allergan’s Reply Claim Construction Brief (Dkt. No. 238). The Court
held a hearing on March 2, 2016, to determine the proper construction of the disputed terms in
this case. Having considered the parties’ arguments and the claim construction briefing, the
Court issues this Memorandum Opinion and Order construing the disputed terms.
I.

BACKGROUND

This is a case brought by Plaintiff Allergan under the provisions of the Hatch-Waxman
Act, alleging that Defendants’ application for approval to market a generic version of Allergan’s
Combigan® product, and Defendants’ proposed product, infringes United States Patent Nos.
7,030,149 (“the ’149 patent”); 7,320,976 (“the ’976 patent”); 7,642,258 (“the ’258 patent”); and
8,748,425 (“the ’425 patent”). The ’149 patent, titled “Combination of Brimonidine Timolol for
Topical Ophthalmic Use,” issued on April 18, 2006.

The ’976 patent is similarly titled,

“Combination of Brimonidine and Timolol for Topical Ophthalmic Use,” and issued on January
1

22, 2008. The ’258 and ’425 patents bear the same title and issued on January 5, 2010, and June
10, 2014, respectively. In general, the patents-in-suit concern compositions comprising both
brimonidine and timolol and methods of treating a patient exhibiting elevated intraocular
pressure (“IOP”) associated with diseases such as glaucoma or ocular hypertension with a
composition comprising both brimonidine and timolol.
The ’149, ’976, and ’258 patents were previously construed by Judge T. John Ward of
this Court in a claim construction order involving the same parties to this litigation. Allergan,
Inc. v. Sandoz, Inc., et al., No. 2:09-cv-97, 2011 WL 1599049 (E.D. Tex. April 27, 2011) (Dkt.
No. 151, “Allergan I Markman”). That prior litigation involving the ’149, ’976, and ’258 patents
is referred to below as Allergan I. The Court issued its findings of fact and conclusions of law
on August 22, 2011, finding that Defendants’ generic versions of Combigan® infringed the
asserted claims of those patents, and that those patents are not invalid. Allergan, Inc. v. Sandoz,
Inc., et al., 818 F. Supp. 2d 974 (E.D. Tex. 2011). Defendants appealed the Court’s decision that
the patents in that case were not invalid, and Plaintiff appealed a portion of the Court’s claim
construction. On May 1, 2013, the Court of Appeals for the Federal Circuit reversed a portion of
this Court’s validity decision, finding that the asserted claims of U.S. Patent No. 7,323,463 were
invalid as obvious. However, the Federal Circuit upheld the validity of claim 4 of U.S. Patent
No. 7,030,149. 1
In separate litigation before this Court, Allergan also asserted two additional patents from
the same family against Sandoz: U.S. Patent Nos. 8,133,890 (“the ’890 patent”) and 8,354,409
(“the ’409 patent”). Allergan Sales, LLC v. Sandoz, Inc., et al., No. 2:12-cv-207 (E.D. Tex. April

1

Because the ’149 Patent expires on the same day as two other patents at issue in that case (and this one)—the ’976
and ’258 patents—and because as a result of the Federal Circuit’s affirmance of claim 4 of the ’149 patent,
Defendants would be unable to market their generic versions of Combigan® until April 19, 2022, the Federal Circuit
did not address the validity of the claims of the ’976 and ’258 patents.

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13, 2012). That litigation is referred to below as Allergan II. On September 5, 2013, this Court
construed certain terms of the ’890 and ’409 patents following briefing and a hearing. Allergan
Sales, LLC v. Sandoz, Inc., et al., No. 2:12-cv-207 (E.D. Tex. Sept. 5, 2013) (Dkt. No. 171,
“Allergan II Markman”). In so doing, the Court considered the claim construction in Allergan I,
but reached a different construction as to the terms “brimonidine” and “timolol.” Allergan II was
stayed pending the appeal in Allergan I.
On January 23, 2015, Allergan received notice that Sandoz had filed an amendment to its
ANDA No. 91-087. Allergan subsequently filed suit against Sandoz, alleging infringement of
the ’149, ’976, ’258 and ’425 patents. Allergan Sales, LLC v. Sandoz Inc., No. 2:15-cv-347
(E.D. Tex.). Following initiation of the instant litigation, the Court consolidated it with Allergan
II.
II.

LEGAL PRINCIPLES

It is understood that “[a] claim in a patent provides the metes and bounds of the right
which the patent confers on the patentee to exclude others from making, using or selling the
protected invention.” Burke, Inc. v. Bruno Indep. Living Aids, Inc., 183 F.3d 1334, 1340 (Fed.
Cir. 1999). Claim construction is clearly an issue of law for the court to decide. Markman v.
Westview Instruments, Inc., 52 F.3d 967, 970–71 (Fed. Cir. 1995) (en banc), aff’d, 517 U.S. 370
(1996).
To ascertain the meaning of claims, courts look to three primary sources: the claims, the
specification, and the prosecution history. Markman, 52 F.3d at 979. The specification must
contain a written description of the invention that enables one of ordinary skill in the art to make
and use the invention. Id. A patent’s claims must be read in view of the specification, of which
they are a part. Id. For claim construction purposes, the description may act as a sort of
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dictionary, which explains the invention and may define terms used in the claims. Id. “One
purpose for examining the specification is to determine if the patentee has limited the scope of
the claims.” Watts v. XL Sys., Inc., 232 F.3d 877, 882 (Fed. Cir. 2000).
Nonetheless, it is the function of the claims, not the specification, to set forth the limits of
the patentee’s invention. Otherwise, there would be no need for claims. SRI Int’l v. Matsushita
Elec. Corp., 775 F.2d 1107, 1121 (Fed. Cir. 1985) (en banc). The patentee is free to be his own
lexicographer, but any special definition given to a word must be clearly set forth in the
specification. Intellicall, Inc. v. Phonometrics, Inc., 952 F.2d 1384, 1388 (Fed. Cir. 1992).
Although the specification may indicate that certain embodiments are preferred, particular
embodiments appearing in the specification will not be read into the claims when the claim
language is broader than the embodiments. Electro Med. Sys., S.A. v. Cooper Life Sciences, Inc.,
34 F.3d 1048, 1054 (Fed. Cir. 1994).
This Court’s claim construction analysis is substantially guided by the Federal Circuit’s
decision in Phillips v. AWH Corporation, 415 F.3d 1303 (Fed. Cir. 2005) (en banc). In Phillips,
the court set forth several guideposts that courts should follow when construing claims. In
particular, the court reiterated that “the claims of a patent define the invention to which the
patentee is entitled the right to exclude.” 415 F.3d at 1312 (quoting Innova/Pure Water, Inc. v.
Safari Water Filtration Sys., Inc., 381 F.3d 1111, 1115 (Fed. Cir. 2004)). To that end, the words
used in a claim are generally given their ordinary and customary meaning. Id. The ordinary and
customary meaning of a claim term “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 1313. This principle of patent law flows naturally from the

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recognition that inventors are usually persons who are skilled in the field of the invention and
that patents are addressed to, and intended to be read by, others skilled in the particular art. Id.
Despite the importance of claim terms, Phillips made clear that “the person of ordinary
skill in the art is deemed to read the claim term not only in the context of the particular claim in
which the disputed term appears, but in the context of the entire patent, including the
specification.” Id. Although the claims themselves may provide guidance as to the meaning of
particular terms, those terms are part of “a fully integrated written instrument.” Id. at 1315
(quoting Markman, 52 F.3d at 978). Thus, the Phillips court emphasized the specification as the
primary basis for construing the claims. Id. at 1314–17. As the Supreme Court stated long ago,
“in case of doubt or ambiguity it is proper in all cases to refer back to the descriptive portions of
the specification to aid in solving the doubt or in ascertaining the true intent and meaning of the
language employed in the claims.” Bates v. Coe, 98 U.S. 31, 38 (1878). In addressing the role
of the specification, the Phillips court quoted with approval its earlier observations from
Renishaw PLC v. Marposs Societa’ per Azioni, 158 F.3d 1243, 1250 (Fed. Cir. 1998):
Ultimately, the interpretation to be given a term can only be determined and
confirmed with a full understanding of what the inventors actually invented and
intended to envelop with the claim. The 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.
Phillips, 415 F.3d at 1316.

Consequently, Phillips emphasized the important role the

specification plays in the claim construction process.
The prosecution history also continues to play an important role in claim interpretation.
Like the specification, the prosecution history helps to demonstrate how the inventor and the
Patent and Trademark Office (“PTO”) understood the patent. Id. at 1317. Because the file
history, however, “represents an ongoing negotiation between the PTO and the applicant,” it may
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lack the clarity of the specification and thus be less useful in claim construction proceedings. Id.
Nevertheless, the prosecution history is intrinsic evidence that is relevant to the determination of
how the inventor understood the invention and whether the inventor limited the invention during
prosecution by narrowing the scope of the claims. Id.; see Microsoft Corp. v. Multi-Tech Sys.,
Inc., 357 F.3d 1340, 1350 (Fed. Cir. 2004) (noting that “a patentee’s statements during
prosecution, whether relied on by the examiner or not, are relevant to claim interpretation”).
Phillips rejected any claim construction approach that sacrificed the intrinsic record in
favor of extrinsic evidence, such as dictionary definitions or expert testimony. The en banc court
condemned the suggestion made by Texas Digital Systems, Inc. v. Telegenix, Inc., 308 F.3d 1193
(Fed. Cir. 2002), that a court should discern the ordinary meaning of the claim terms (through
dictionaries or otherwise) before resorting to the specification for certain limited purposes.
Phillips, 415 F.3d at 1319–24. According to Phillips, reliance on dictionary definitions at the
expense of the specification had the effect of “focus[ing] the inquiry on the abstract meaning of
words rather than on the meaning of claim terms within the context of the patent.” Id. at 1321.
Phillips emphasized that the patent system is based on the proposition that the claims cover only
the invented subject matter. Id.
Phillips does not preclude all uses of dictionaries in claim construction proceedings.
Instead, the court assigned dictionaries a role subordinate to the intrinsic record. In doing so, the
court emphasized that claim construction issues are not resolved by any magic formula. The
court did not impose any particular sequence of steps for a court to follow when it considers
disputed claim language. Id. at 1323–25. Rather, Phillips held that a court must attach the
appropriate weight to the intrinsic sources offered in support of a proposed claim construction,
bearing in mind the general rule that the claims measure the scope of the patent grant.
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III.

CONSTRUCTION OF AGREED TERMS

The Court hereby adopts the following agreed to constructions:
Term

Patent Claims

Agreed Construction

“% … by weight”;
“% by weight”;
“% … (w/v),”
“%”

’149 patent claim 4
’976 patent claim 1
’258 patent claims 1–3, 7–9
’425 patent claim 1

“ratio of the weight of the ingredient in
question divided by the total volume of the
solution, with this ratio expressed as a
percentage”

“a single
composition”
“about”

’149 patent claim 4

plain and ordinary meaning

’976 patent claim 1

“approximately”

“brimonidine
tartrate”
“timolol maleate”

’258 patent claim 4
’425 patent claim 1
’258 patent claim 4

plain and ordinary meaning

“timolol free base”

’425 patent claim 1

plain and ordinary meaning

“as compared to
the administration
of”
“the affected eye”

’425 patent claim 1

plain and ordinary meaning

’976 patent claim 1
’425 patent claim 1

“an eye exhibiting elevated intraocular
pressure”

plain and ordinary meaning

(Dkt. No. 229 at 1, “Joint Claim Construction and Prehearing Statement,” Dec. 9, 2015.)
IV.

CONSTRUCTION OF DISPUTED TERMS

a. “brimonidine”
Plaintiff’s Proposed Construction
“brimonidine tartrate”

Defendants’ Proposed Construction
“the chemical compound brimonidine,
including its free base and tartrate salt forms”

(Joint Claim Construction and Prehearing Statement, Ex. A.) The term appears in claim 4 of the
’149 patent, claim 1 of the ’976 patent, and claims 1, 4 and 7 of the ’258 patent. 2

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Because the patents share a common specification, reference is made herein to the ’149 patent specification.

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i. The Parties’ Positions
Allergan submits that the term “brimonidine” should be construed to mean “brimonidine
tartrate,” as it was for the same patents in Allergan I. See (Allergan I Markman). Allergan
argues that issue preclusion bars Sandoz from now seeking a different construction of this term
(and others) because Sandoz previously litigated the construction of “brimonidine” (and other
terms) in these same patents and received final judgment. Allergan also argues that the patent
specification expressly defines “brimonidine” as “brimonidine tartrate,” providing the full
chemical name for brimonidine tartrate and a chemical drawing of the compound. ’149 Patent at
1:39–53. Allergan further argues that brimonidine tartrate is the form of brimonidine used in
Examples 1 and 2 of the ’149 patent.
Sandoz responds that issue preclusion does not bar it from now seeking a different
construction of brimonidine (and other terms) because the factors required for issue preclusion
are not met here. Sandoz further argues that the Court, in its discretion, should decline to find
issue preclusion even if each of the required factors is found. Sandoz also argues that the Court’s
construction of “brimonidine” in Allergan II for the ’890 and ’409 patents as “the chemical
compound brimonidine, including its free base and tartrate salt forms” should be applied here.
In support, Sandoz also points to claim 4 of the ’258 patent, dependent from claim 1,
which further defines the brimonidine in claim 4 as “brimonidine tartrate.” Sandoz argues that
under the doctrine of claim differentiation, brimonidine in claim 1 of the ’258 patent (and the
other independent claims) must include more than just brimonidine tartrate. Am. Med. Sys., Inc.
v. Biolitec, Inc., 618 F.3d 1354, 1360 (Fed. Cir. 2010). Sandoz also points to patents cited in the
“Background” section of the patent specification, arguing that these prior art patents describe

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brimonidine as including salt or free base forms. Finally, Sandoz argues that the prosecution
history of the subsequently issued ’890 patent supports its position.
ii. Analysis
1. Issue Preclusion
Under Fifth Circuit law, 3 issue preclusion applies where (1) the identical issue was
previously adjudicated; (2) the issue was actually litigated; and (3) the previous determination
was necessary to the decision. Pace v. Bogalusa City Sch. Bd., 403 F.3d 272, 290 (5th Cir.
2005); see also In re Freeman, 30 F.3d 1459, 1465 (Fed. Cir. 1994). 4
Sandoz specifically argues that issue preclusion is not appropriate in this instance because
(1) the identical issue was not previously adjudicated due to the fact that the prosecution history
and the accused product have changed from Allergan I, making this a different issue from that
which was previously adjudicated; (2) the term “brimonidine” was not actually litigated due to
the fact that the construction of “brimonidine” was the subject of a stipulation by the parties in
Allergan I; and (3) the construction was not “necessary to the decision” due to the fact that the
construction was not explicitly used to determine issues of validity.
Regarding the first factor, Sandoz argues that the facts before this Court are not identical
to those presented during the Allergan I Markman, and, thus, issue preclusion would be
inappropriate here. See In re Freeman, 30 F.3d at 1465. Specifically, Sandoz argues that
changes in the prosecution history (by virtue of subsequently issued patents) and changes to its
product have resulted in issues that are not identical to those in Allergan I.
3

Because issue preclusion is a procedural matter, Fifth Circuit law applies here. See Bayer AG v. Biovail Corp., 279
F.3d 1340, 1345 (Fed. Cir. 2002).
4
Under Federal Circuit law, the same three factors apply. A fourth factor, that there was a full and fair opportunity
to litigate the issue in the previous action, is also relevant under Federal Circuit law. Freeman, 30 F.3d at 1465.
Under that law, the Court finds that there was, in Allergan I, a full and fair opportunity to litigate construction of
each of the four disputed terms as to which issue preclusion is alleged by Allergan.

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Sandoz is correct that prosecution history plays an important role in claim interpretation.
The prosecution history is intrinsic evidence relevant to determining how the inventor
understood the invention and whether the inventor limited the invention during prosecution by
narrowing the scope of the claims. See Microsoft Corp. v. Multi-Tech Sys., Inc., 357 F.3d at
1350 (noting that “a patentee’s statements during prosecution, whether relied on by the examiner
or not, are relevant to claim interpretation”).

In support of its argument that subsequent

prosecution history is relevant to issue preclusion, Sandoz cites Golden Bridge Tech., Inc. v.
Apple Inc., 937 F. Supp. 2d 490, 496 (D. Del. 2013). In Golden Bridge Tech, however, the
patents in suit underwent reexamination, canceling new claims and adding others, which
occurred after the conclusion of the original litigation. Id. at 493, 496. Here, by contrast, the
prosecution history of the ’149, ’258, and ’976 patents did not change. Rather, Sandoz cites to
the prosecution of the subsequently issued ’890 patent. But, as Allergan correctly notes, the
relevant portions of the ’890 patent’s prosecution history were available more than a year prior to
the briefing and issuance of the Allergan I claim constructions. Therefore, with respect to
the ’890 patent’s prosecution history, the relevant portions that were available to the parties and
the Court in Allergan I are the same as those available to it now. In other words, the prosecution
history did not change.
Furthermore, Sandoz does not provide any specific information from the prosecution
history of the ’409 or ’425 patents that would provide a different construction of any of the
disputed terms. The only evidence offered by Sandoz of the effects of the new and allegedly
differing prosecution history is that this Court previously found, when construing the ’890
and ’409 patents, that the prosecution history of the ’425 patent (which was pending at the time)

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provided “some evidence regarding the patentee’s understanding of the term ‘brimonidine.’” 5
That evidence, cited in a footnote in the Allergan II Markman, was not central to that decision,
and, in any event, is cumulative of the evidence from the ‘890 patent prosecution history.
Therefore, the Court finds this argument unpersuasive.
Sandoz next argues that because its product has changed since Allergan I, claim
construction is now a different issue than that previously decided. The change in its product is
apparently to omit the word “glaucoma” from the approved uses in its proposed product label.
Other than this amendment, Sandoz’s product has not changed.

The active ingredients,

formulation and other aspects remain identical to those at issue in Allergan I.
The Court also finds this argument unpersuasive.

Regardless of whether Sandoz’s

product has changed, the Federal Circuit has made clear that “[a] claim is construed in the light
of the claim language, the other claims, the prior art, the prosecution history, and the
specification, not in light of the accused device . . . claims are not construed ‘to cover’ or ‘not to
cover’ the accused device. That procedure would make infringement a matter of judicial whim.
It is only after the claims have been construed without reference to the accused device that the
claims, as so construed are applied to the accused device to determine infringement.” SRI Int’l.,
775 F.2d at 1118 (emphasis in original).
The status and contours of Sandoz’s product may be “kept in mind” during claim
construction but only because “it is efficient to focus on the construction of only the disputed
elements or limitations of the claims. However, the construction of claims is simply a way of
elaborating the normally terse claim language in order to understand and explain, but not to
change, the scope of the claims.” Scripps Clinic & Research Found. v. Genentech, Inc., 927
5

The Court declined to rule in the Allergan II Markman whether the prosecution history of the ’425 patent was
intrinsic or extrinsic evidence to the construction of the ’409 and ’890 patents.

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F.2d 1565, 1580 (Fed. Cir. 1991). Thus, the Court rejects Sandoz’s argument that the change to
its label makes claim construction a different issue than that decided in the Allergan I Markman.
That this label change might provide grounds for Sandoz to dispute infringement is also
irrelevant to claim construction.

Claims are construed the same way for validity and

infringement. See, e.g., Source Search Techs., LLC v. LendingTree, LLC, 588 F.3d 1063, 1075
(Fed. Cir. 2009); C.R. Bard, Inc. v. M3 Sys., Inc., 157 F.3d 1340, 1363 (Fed. Cir. 1998). For
these reasons, the first prong of issue preclusion is met here.
Sandoz next argues that because the term “brimonidine” was stipulated to by the parties
in Allergan I, the term was not litigated as required for issue preclusion. See In re Freeman, 30
F.3d at 1465. Allergan argues that no “stipulation” was filed, although it admits that the parties
did agree to a construction. Allergan further argues that despite that agreement, issue preclusion
applies because in the Allergan I Markman the Court independently analyzed the evidence, and
therefore, the term was litigated.
A review of the Allergan I record reveals that Allergan and Sandoz expressly “agreed” on
the construction of the term “brimonidine.” (Dkt. No. 112 in Allergan I at 2, “Allergan I Joint
Claim Construction Chart,” Oct. 27, 2010.) In the Allergan I Markman, the Court noted the
parties’ agreement and found the parties’ proposed construction to be consistent with the
intrinsic evidence. (Allergan I Markman at 8.) Nowhere did Sandoz argue a term contrary to
Allergan’s proposal, and thus there was not full briefing of this issue, nor a full hearing.
Allergan incorrectly focuses on that fact that the Court independently confirmed the
construction of the term “brimonidine” in the Allergan I Markman. Allergan argues that this
shows that the issue was actually litigated. Allergan is wrong. This requirement of issue
preclusion is satisfied where “the parties to the original action disputed the issue and the trier of
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fact decided it.” In re Freeman at 1466 (emphasis added). In Allergan I, Sandoz and Allergan
did not dispute the construction of the term “brimonidine,” and, accordingly, there was no
dispute that the Court decided. For this reason, the Court finds that the second prong of the
doctrine of issue preclusion has not been met here. Regarding the term “brimonidine,” issue
preclusion is not appropriate.
As to the third prong of the test, Sandoz argues that the construction of the term
“brimonidine” was not essential to judgment because the only issue tried to this court was
validity. The Court, however, entered judgments on both infringement and validity. (Dkt. No.
262 in Allergan I, “Allergan I Final Judgment and Injunction,” Aug. 25, 2011.) Even if validity
was the only issue tried, Sandoz has not provided any evidence that the disputed terms were not
relied upon and at least implicitly essential to the validity decision. Sandoz provides only the
Federal Circuit’s decision and alleges non-reliance on the disputed terms. This Court, however,
in finding both infringement and invalidity, did not expressly state that such terms were
irrelevant or non-essential. Rather, this court expressly found infringement of claims which
included the term “brimonidine” and determined validity based on prior art that included
teachings regarding brimonidine. Id.
Further, as the Federal Circuit has stated “it is important to note that the requirement that
a finding be ‘necessary’ to a judgment does not mean that the finding must be so crucial that,
without it, the judgment could not stand. Rather, the purpose of the requirement is to prevent the
incidental or collateral determination of a nonessential issue from precluding reconsideration of
that issue in later litigation.” Mother’s Rest., Inc. v. Mama’s Pizza, Inc., 723 F.2d 1566, 1571
(Fed. Cir. 1983). Claim construction is not incidental or non-essential to issues of validity and
infringement. Indeed, it is the first step in the process of deciding those issues. The Court,
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therefore, finds that the construction of the term “brimonidine” was at least implicitly essential to
the judgment in Allergan I.
For the reasons previously stated, as to the term “brimonidine,” the identical issue was
previously litigated, and that term was essential to the judgment in Allergan I. However,
because the term “brimonidine” was not actually litigated in Allergan I, Sandoz is not precluded
from now contesting construction of that term. The Court is aware of no additional authority that
requires it to apply issue preclusion to this term. See also Tex. Instruments, Inc. v. Linear Techs.
Corp., 182 F. Supp. 2d 580, 589 (E.D. Tex. 2002); Blue Calypso, Inc. v. Groupon, Inc., 93 F.
Supp. 3d 575, 583 (E.D. Tex. 2015).
2.

Construction

Turning to the construction of the term “brimonidine,” the ’149 patent states that
“[b]rimonidine is an alpha adrenergic agonist represented by the following formula,” and it then
provides a chemical structure for brimonidine tartrate. ’149 patent at col. 1, ll. 39–50. The
patent specification goes on to state that the “chemical name for brimonidine is 5-Bromo-6-(2imidazolidinylideneamino) quinoxaline L-tartrate.” ’149 patent at col. 1, ll. 52–53. To act as its
own lexicographer, a patentee must “clearly set forth a definition of the disputed claim term”
other than its plain and ordinary meaning. CCS Fitness, Inc. v. Brunswick Corp., 288 F.3d 1359,
1366 (Fed. Cir. 2002). It is not enough for a patentee to simply disclose a single embodiment or
use a word in the same manner in all embodiments; instead, the patentee must “clearly express
an intent” to redefine the term. Helmsderfer v. Bobrick Washroom Equip., Inc., 527 F.3d 1379,
1381 (Fed. Cir. 2008). The Federal Circuit has described the standard for determining whether
an inventor has provided such clear intent as “exacting.” Thorner v. Sony Comput. Entm’t Am.,
LLC, 669 F.3d 1362, 1366 (Fed. Cir. 2012).
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Allergan argues that the description set forth above is such an express definition.
However, in Allergan II, this Court found that such language in the counterpart ’890 patent 6 did
not clearly rise to the level of lexicography and declined to find that the cited language meets this
“exacting” standard and thus limits the understanding of one skilled in the art of the term
“brimonidine” only to “brimonidine tartrate.” (Allergan II Markman at 7–13.) In addition, the
prosecution history of the ’890 patent demonstrated that Allergan itself did not view this as a
clear definition rising to the level of lexicography.

Rather, that prosecution history “at a

minimum, strongly suggests that the patentees clearly understood the term ‘brimonidine’ to
encompass at least brimonidine tartrate and brimonidine free base.” (Id. at 11.) The Court also
relied on the fact that the specification demonstrated that Allergan “knew how to write the words
“brimonidine tartrate” when it wanted to use that term. (Allergan II Markman at 10, n.3.) It did
not do so in the claims at issue here. The specification and prosecution history of the related
’890 patent are strongly suggestive that the term brimonidine encompasses more than simply
brimonidine tartrate.
Similarly, in the Allergan II Markman, the Court addressed and rejected Plaintiff’s
argument that, because brimonidine tartrate is the form of brimonidine used in examples 1 and 2
of the ’890 patent, the claims are so limited. It did so in part because particular embodiments
appearing in the specification are generally not read into the claims.

See, e.g., Specialty

Composites v. Cabot Corp., 845 F.2d 981, 987 (Fed. Cir. 1988) (refusing to limit the term
“plasticizer” to external plasticizers).

It also rejected that argument because the patent

specification, through citation to prior art patents, demonstrated that “brimonidine” has an
accepted scientific meaning that included its salt and free base forms. (Allergan II Markman at
6

The ’890 patent issued from a continuation application from the patents in suit. They share the same specification
and common parentage.

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10–11 (citing Glaxo Wellcome, Inc. v. Andrx Pharms., Inc., 344 F.3d 1226, 1233 (Fed. Cir.
2003) (“When a claim term has an accepted scientific meaning, that meaning is generally not
subject to restriction to the specific examples in the specification.”)).) Finally, the Court found
that Allergan had offered no compelling reason why one chemical compound, brimonidine,
should be interpreted as limited to a particular brimonidine salt, while another chemical
compound, timolol, should be interpreted as “timolol free base.” The description of both
compounds in the specification and usage in the claims was substantially similar, and the Court
could discern no clear reason why the two compounds should be construed in such different
manners. (Allergan II Markman at 11, n.4.) These reasons are equally applicable here.
Sandoz also argues that the doctrine of claim differentiation further supports its
construction here, citing to claim 4 of the ’258 patent, which depends from claim 1. Claim 1
defines a “composition comprising 0.2% brimonidine (w/v) and 0.5% timolol (w/v) in a single
composition.” Claim 4 recites the “composition of claim 1 wherein brimonidine is brimonidine
tartrate and timolol is timolol maleate.” Under that doctrine, a dependent claim is presumed to
have different scope than the claim from which it depends. Kraft Foods, Inc. v. Int’l Trading
Co., 203 F.3d 1362, 1366 (Fed. Cir. 2000). The doctrine is based on “the common sense notion
that different words or phrases used in separate claims are presumed to indicate that the claims
have different meanings and scope.” Karlin Tech. Inc. v. Surgical Dynamics, Inc., 177 F.3d 968,
971–72 (Fed. Cir. 1999). “To the extent that the absence of such difference in meaning and scope
would make a claim superfluous, the doctrine of claim differentiation states the presumption that
the difference between claims is significant.” Tandon Corp. v. U.S. Int’l Trade Comm’n, 831
F.2d 1017, 1023 (Fed. Cir. 1987). Here the doctrine of claim differentiation clearly raises the
presumption that the term “brimonidine” as used in claim 1 of the ’258 patent must have a
16

separate meaning than simply brimonidine tartrate. See also Phillips, 415 F.3d at 1314 (claims
referring to steel baffles strongly implies that the term “baffles” does not inherently mean objects
made of steel).
Thus, as in the Allergan II Markman, the Court construes the term “brimonidine”
according to its plain and ordinary meaning, the chemical compound brimonidine, including both
its free base and salt forms.
b. “timolol”
Plaintiff’s Proposed Construction
“timolol free base”

Defendants’ Proposed Construction
“timolol free base, timolol tartrate, or timolol
maleate”

(Joint Claim Construction and Prehearing Statement, Ex. A at 6.) The term appears in claim 4 of
the ’149 patent, claim 1 of the ’976 patent, and claims 1, 4 and 7 of the ’258 patent.
i. The Parties’ Positions
Allergan submits that the term “timolol” should be construed to mean “timolol free base,”
as it was for the same patents in Allergan I. See (Allergan I Markman at 13–16.) Allergan again
argues that issue preclusion bars Sandoz from now seeking a different construction of this term.
Allergan also argues that the patent specification explains that to formulate the claimed solution,
timolol maleate 0.68% (w/v) is used to achieve a concentration of 0.5% timolol in the final
solution, because 0.68% timolol maleate is “equivalent to 0.5% (w/v) Timolol, free base,” citing
to, e.g., the ’149 patent at Example I. Allergan further argues that using 0.5% timolol maleate
would result in a final solution of less than 0.5% timolol. Accordingly, Allergan explains, the
0.5% timolol used in the claims must refer to timolol free base.
Sandoz again responds that issue preclusion does not bar it from now seeking a different
construction of timolol because the factors required for issue preclusion are not met here.
17

Sandoz also argues that the Court’s construction of “timolol” in the Allergan II Markman for the
’890 and ’409 patents as “the chemical compound timolol, including its free base, maleate salt,
and tartrate salt forms” should be applied here.
In support, Sandoz again argues the doctrine of claim differentiation, and again points to
claim 4 of the ’258 patent, which recites that for that dependent claim, “timolol” is “timolol
maleate.” Sandoz points as well to the patent specification, which it says uses “timolol” to refer
to both timolol maleate and free base. And, as above with the term “brimonidine,” Sandoz
argues that the prosecution history of the subsequent ’890 patent supports it interpretation.
ii. Analysis
1. Issue Preclusion
The parties’ arguments regarding issue preclusion are substantially similar to those for
the term brimonidine, and the Court reaches the same conclusions here. Construction of the term
“timolol” is an identical issue to that raised in Allergan I. The subsequent prosecution history of
the ’890, ’409, and ’425 patents does not alter that conclusion. Likewise, Sandoz’s argument
regarding the change to its product is unavailing with respect to the term “timolol.” While in
Allergan I the parties initially disputed construction of “timolol” as used in the claims of
the ’149, ’976, and ’463 patents (Allergan I Joint Claim Construction Chart at 2), Sandoz stated
in its briefing that it agreed “with Allergan that the term ‘timolol’ as used in the ’258 patent
should be construed to mean ‘timolol free base.’” (Dkt. No. 123 in Allergan I at 14, “Sandoz’s
Allergan I Claim Construction Brief,” Dec. 22, 2010.) Although a separate defendant did dispute
that construction and lose, making this a closer case, there was no dispute between Sandoz and
Allergan that was ultimately litigated and decided. Finally, the Court finds that the construction
of “timolol” was essential to the final judgment on validity and infringement, at least implicitly.
18

Because all of the factors required for issue preclusion are not met here, Sandoz is not precluded
from seeking an alternative construction of the term “timolol.”
2. Construction
The ’149 patent states that “[t]imolol is a beta adrenergic agent represented by the
following formula,” then presenting the chemical structure of timolol maleate. ’149 patent at
col.1, l. 54 to col. 2, l. 5.

While Allergan argues that similar language used to describe

brimonidine means that brimonidine must mean “brimonidine tartrate,” it does not argue that the
chemical structure provided for timolol maleate also defines the term “timolol.” As the Court
found in the Allergan II Markman, this inconsistency undermines Allergan’s positions regarding
the construction of both “timolol” and “brimonidine.”
Allergan further argues that timolol free base is the correct interpretation of “timolol”
because the 0.5% w/v limitation in the claims corresponds to the amount of timolol free base
used in the combination of the claimed methods.

Again, as explained in the Allergan II

Markman, while this may be the case, it does not explain the inconsistency between Allergan’s
constructions of brimonidine and timolol. There is no compelling reason why the two terms
should be interpreted in the different manners Allergan suggests.
Moreover, as discussed above, claim 4 of the ’258 patent further defines the timolol of
claim 1 as including “timolol maleate.” Thus, under the doctrine of claim differentiation, claim 1
of the ’258 patent must be interpreted in a way that is different than, but encompasses, timolol
maleate. Limiting the term “timolol” to the “free base” in claim 1 of the ’258 patent would
seemingly exclude salt forms, such as timolol maleate.

As explained in the Allergan II

Markman, the breadth of the term timolol is also shown by the prosecution history of the ’890
patent. There Allergan presented a claim (28) reading: “A method according to claim 26,
19

wherein the timolol is selected from the group consisting of timolol tartrate, timolol maleate, and
timolol free base.” 7 This prosecution history certainly suggests that the patentees understood the
term “timolol” to encompass each of these forms. See e.g., Phillips, 415 F.3d at 1314 (use of
term “steel baffles” strongly implies that “baffles” does not inherently mean objects made of
steel).
Accordingly, the Court construes the term “timolol” according to its plain and ordinary
meaning, the chemical compound timolol, including both its free base and salt forms.
c. “reducing the number of daily topical ophthalmic doses”
Plaintiff’s Proposed Construction
The term should be construed as it was in
Allergan I, to have its plain and ordinary
meaning.

Defendants’ Proposed Construction
“adjusting downward the number of daily
topical ophthalmic doses”

(Joint Claim Construction and Prehearing Statement, Ex. A at 11.) The term appears in claim 4
of the ’149 patent.
i. The Parties’ Positions
Allergan again argues that this term was construed in Allergan I to be given its plain and
ordinary meaning, and accordingly, Sandoz is precluded from now seeking a different
construction. More specifically, according to Allergan, in Allergan I Sandoz argued that the
term meant “reducing the number of daily ophthalmic doses from 3 to 2 times a day,” that the
Court rejected that argument, (Allergan I Markman at 2011 WL 1599049, at *17), and therefore,
that issue preclusion applies.
Sandoz asserts that it is not precluded, and that consistent with the Court’s prior plain
meaning construction, claim 4 requires an actual reduction in the number of daily doses from
7

As explained in Allergan II, that Allergan disclaimed the ultimately issued claim with the same language does not
erase this prosecution history. Allergan II at 12, 16. As further pointed out by Sandoz, Allergan did not disclaim
claim 4 of the ’258 patent.

20

three to two times a day. In other words, Sandoz argues that the claim requires that “a person
would need to administer the recited fixed composition twice daily to a patient who previously
received brimonidine three times daily.” Thus, according to Sandoz, claim 4 has two steps: first,
a reducing step, and second, an administering step.
ii. Analysis
1. Issue Preclusion
For the same reasons articulated more fully above the issue here is identical to that
presented in Allergan I. The same claim term was the subject of construction. Sandoz points to
no specific prosecution history from the subsequently issued patents that is relevant to this issue.
In addition, as discussed above in more detail, that Sandoz has amended its proposed label has no
bearing on the issue of claim construction. While in Allergan I the ultimate dispute between the
parties at trial and on appeal focused on validity, rather than infringement, it is “axiomatic that
claims are construed the same way for both invalidity and infringement.” Source Search Techs.,
588 F.3d at 1075. That Sandoz has amended its proposed product label does not make the
construction of this term a different issue than that decided in Allergan I.
Unlike the terms “brimonidine” and “timolol,” it is clear that Sandoz disputed, briefed,
and argued construction of the term “reducing the number of daily topical ophthalmic doses.”
Specifically, Sandoz argued that the term should be construed to mean “reducing the number of
daily ophthalmic doses from 3 to 2 times a day.” The Court rejected that construction. See
(Allergan I Markman at 20–24.) Therefore, the term was actually litigated for purposes of the
second prong of the doctrine of issue preclusion. That Sandoz now proposes a slightly different
construction from that it previously proffered is irrelevant.

21

Sandoz offers no unique arguments as to why the term “reducing the number of topical
ophthalmic doses” was not at least implicitly essential to this Court’s prior judgments on validity
and infringement, or to the Federal Circuit’s decision. Indeed, a review of this Court’s opinion
in Allergan I shows that reduction in daily dosing was an important factor distinguishing the
claimed invention from the prior art. Allergan I, 818 F. Supp. 2d at 1005 (the prior art “fails to
disclose a method of reducing brimonidine treatment from three times a day to twice a day by
using a fixed combination”); see also id. at 1008 (“Specific to claim 4 of the ‘149 patent, nothing
in DeSantis discloses that reducing the dose of brimonidine from three times a day to two times a
day through a fixed composition of brimonidine and timolol can maintain the efficacy of the
brimonidine treatment.”), 1009 (“DeSantis does not disclose a method of reducing the dose of
brimonidine from three times a day to two times a day without losing efficacy in the treatment of
glaucoma.”). Likewise, the Federal Circuit’s opinion demonstrates that the reduction in daily
dosing without loss of efficacy to be a key factor distinguishing claim 4 over the prior art.
Allergan, 726 F.3d at 1293–94. Therefore, for the reasons stated previously, the Court finds this
argument unpersuasive and views the construction of the term “reducing the number of topical
ophthalmic doses” to be essential to the prior judgment.
Accordingly, the Court determines that as to this claim term, the issue is 1) identical to
that previously adjudicated; 2) was actually litigated; and 3) was necessary to final judgment in
Allergan I. Sandoz is therefore precluded from seeking a different construction than that set
forth by the Court in Allergan I. See Parklane Hosiery Co. v. Shore, 439 U.S. 322, 330–31
(1979) (acknowledging the broad discretion awarded to courts when applying issue preclusion).
However, even if the Court had found that Sandoz was not so precluded, the Court would reach
the same conclusion as in Allergan I.
22

2. Construction
In general, prior claim construction proceedings involving the same patents-in-suit are
“entitled to reasoned deference under the broad principals of stare decisis and the goals
articulated by the Supreme Court in Markman, even though stare decisis may not be applicable
per se.” Maurice Mitchell Innovations, LP v. Intel Corp., No. 2:04–cv–450, 2006 WL 1751779,
at *4 (E.D. Tex. June 21, 2006) (Davis, J.); see TQP Development, LLC v. Intuit Inc., No. 2:12–
CV–180, 2014 WL 2810016, at *6 (E.D. Tex. June 20, 2014) (Bryson, J.) (“[P]revious claim
constructions in cases involving the same patent are entitled to substantial weight, and the Court
has determined that it will not depart from those constructions absent a strong reason for doing
so.”); see also Teva Pharm. USA, Inc. v. Sandoz, Inc., 135 S.Ct. 831, 839–40 (2015) (“prior
cases will sometimes be binding because of issue preclusion and sometimes will serve as
persuasive authority”) (citation omitted).

The Court nonetheless conducts an independent

evaluation during claim construction proceedings. See, e.g., Texas Instruments, Inc. v. Linear
Techs. Corp., 182 F. Supp. 2d at 589–90; Burns, Morris & Stewart Ltd. P’ship v. Masonite Int’l
Corp., 401 F. Supp. 2d 692, 697 (E.D. Tex. 2005); Negotiated Data Sols, Inc. v. Apple, Inc., No.
2:11–cv–390, 2012 WL 6494240, at *5 (E.D. Tex. Dec. 13, 2012).
In the Allergan I Markman, the Court rejected a similar argument to the one that Sandoz
now makes. Even if Sandoz was not precluded from re-litigating this issue, the Court would
accord its prior decision on the same disputed claim term substantial weight. In addition,
nothing in the claims themselves, the patent specification, or the prosecution history requires, as
Sandoz argues, “an actual reduction in the number of daily topical ophthalmic doses of 0.2%
brimonidine from three to two times a day.” (Dkt. No. 235 at 19, “Sandoz Responsive Claim
Construction Brief,” Feb. 3, 2016.) Sandoz’s construction would require, in its own words, that
23

to practice the claimed method, “a person would need to administer the recited fixed
composition twice daily to a patient who previously received brimonidine three times daily.” Id.
(emphasis in original). Nothing in the intrinsic evidence requires such a step or such an actual
reduction. 8
Both parties agree that the preamble to claim 4 is an actual limitation on the claim.
Sandoz argues that the claim requires two steps: first, a reducing step, and second, an
administering step. Allergan, on the other hand, argues that the claim requires only the single
step of administering a single composition comprising brimonidine and timolol at the claimed
concentrations. The claim language itself states that “said method comprises administering said
0.2% brimonidine by weight and 0.5% timolol by weight in a single composition.” Nothing in
the claim preamble requires more than that. Rather, the preamble provides context for the claim.
As explained by Allergan, the preamble indicates that the claimed method permits a reduction in
the number of daily topical ophthalmic doses of brimonidine as compared to prior art treatments.
Put another way, the preamble describes the outcome of the claimed method—that the number of
daily doses of brimonidine can be reduced.

It thus informs the claimed method—actual

reduction in doses is not a separate requirement of the claimed method.
The patent specification supports that interpretation. The specification describes the
results of a clinical trial comparing the efficacy of different treatments in different patient
populations. One group of patients was dosed three times a day with 0.2% brimonidine, and
another twice a day with the claimed combination. Patients in the clinical trial were not first
dosed with brimonidine three times a day and then switched to the combination twice daily. The
combination treatment dosed twice a day is reported as being “superior” to brimonidine three

8

Neither party cites to any portion of the prosecution history to support its interpretation of this term.

24

times a day “in lowering the elevated IOP of patients with glaucoma or ocular
hypertension.” ’149 patent at col. 8, l. 65–col. 9, l. 3. The combination is also reported as
having a more favorable safety profile than brimonidine dosed three times a day. ’149 patent at
col. 9, ll. 4–8. The claim preamble, which reads “[a] method of reducing the number of daily
topical ophthalmic doses of brimonidine administered topically to an eye of a person in need
thereof for the treatment of glaucoma or ocular hypertension from 3 to 2 times a day without loss
of efficacy, wherein the concentration of brimonidine is 0.2% by weight” is consistent with the
clinical trial and results reported in the specification. Reading an actual “reducing” step into
claim 4 is inconsistent with the patent specification.
Accordingly, the Court finds that one skilled in the art would understand the term and
that no construction is necessary for “reducing the number of daily topical ophthalmic doses.”
d. “without loss of efficacy”
Plaintiff’s Proposed Construction
“without decrease in lowering
intraocular pressure”

Defendants’ Proposed Construction
“without decrease in lowering
intraocular pressure in the person for whom the
number of administered daily doses has been
reduced.”

(Joint Claim Construction and Prehearing Statement, Ex. A at 12.) The term appears in claim 4
of the ’149 patent.
i. The Parties’ Positions
According to Allergan, this term was construed in Allergan I Markman and given the
meaning that Sandoz articulated. Allergan states that the Federal Circuit relied heavily on this
limitation in finding claim 4 not invalid as obvious. Allergan, 726 F.3d at 1294. Thus, Allergan
submits that Sandoz is now precluded from seeking a different construction. Allergan further
argues that Sandoz’s interpretation reads an erroneous and improper limitation into the claim.
25

Sandoz argues that it is not precluded, offering the same arguments discussed above.
Sandoz further argues that the claim requires a comparison in the decrease in lowering
intraocular pressure on a patient by patient basis.
ii. Analysis
1. Issue preclusion
As above, the issue here is identical to that presented in Allergan I. The same claim term
was the subject of construction. Sandoz points to no specific prosecution history from the
subsequently issued patents that is relevant to this issue. As discussed above, any change to
Sandoz’s proposed label does not make claim construction a different issue than previously
decided.
In Allergan I, Sandoz fully disputed, briefed, and argued the construction of the term
“reducing the number of daily topical ophthalmic doses.” Indeed, Sandoz argued (against a
different interpretation by Allergan) that the term should be construed to mean “without decrease
in lowering intraocular pressure.” Sandoz’s litigated construction was adopted by the Court. See
(Allergan I Markman at 20–24.) It is therefore clear that the term was actually litigated and
decided, meeting the second prong of issue preclusion.
Finally, as before, Sandoz does not adequately explain why the term was not at least
implicitly essential to the court’s prior judgments on validity and infringement. Moreover, both
this Court and the Federal Circuit expressly relied on this limitation in finding that Sandoz failed
to prove that claim 4 is invalid. See, e.g., Allergan, 726 F.3d at 1293–94. Therefore, the
construction of the term “without loss of efficacy” was essential to the prior judgment.
Accordingly, the Court determines that as to this claim term, the issue is 1) identical to
that previously adjudicated; 2) was actually litigated; and 3) was necessary to final judgment in
26

Allergan I. See In re Freeman, 30 F.3d at 1465. Thus, Sandoz is precluded from seeking a
different construction than that set forth by the Court in Allergan I. But even if the Court had
found that Sandoz was not so precluded, the Court would still reach the same conclusion as in
Allergan I.
2. Construction
As an initial matter, both parties agree that the term, at a minimum, means “without
decrease in lowering intraocular pressure.” Sandoz, however, further argues that claim 4 also
requires that the IOP lowering effects are maintained in one or more individual patients treated
twice daily with the brimonidine/timolol combination, as compared to IOP lowering effects in
the same patient with the prior thrice daily brimonidine treatment. While Sandoz argues that this
issue—whether the efficacy comparison is done on a patient by patient basis—was not addressed
during claim construction in Allergan I, Sandoz also points to no sound reason why it did not or
could not raise this argument previously. In any event, the Court’s prior construction of this term
is, at a minimum, entitled to substantial weight in construing the term “without loss of efficacy.”
The Court also finds nothing in the patent claims, specification, or prosecution history 9 that
supports Sandoz’s position.
The Court has already rejected Sandoz’s argument that claim 4 requires a two-step
process of first reducing the number of daily doses a patient actually receives, followed by a
separate administration step. The Court similarly rejects the argument that claim 4 requires an
actual comparison of IOP lowering on a patient by patient basis. Sandoz points to no intrinsic or
extrinsic evidence requiring such a construction.

9

Neither party cites to the prosecution history as relevant to the interpretation of this term.

27

As explained above, the Court finds that the claim preamble sets forth the outcome of
performing the claimed single step method—that brimonidine can be dosed twice daily (as
opposed to thrice) without losing efficacy. It thus informs the method, but requires no specific
additional steps to be performed. The patent specification, reporting on the results of a clinical
trial, is consistent with this interpretation. The specification does not compare results on an
individual by individual basis. Rather, it reports on results of different treatments in different
patient populations. It would be inconsistent with the intrinsic evidence to interpret claim 4 as
requiring a patient-by-patient comparison of IOP lowering results.
Accordingly, the Court construes the term “without loss of efficacy” to mean “without
decrease in lowering intraocular pressure.”
e.

“a person in need thereof”

Plaintiff’s Proposed Construction
Defendants’ Proposed Construction
“general class of persons to whom the
“a person in need of the reduction in the
patented compositions are directed, i.e., a
number of daily doses”
patient population”
(Joint Claim Construction and Prehearing Statement, Ex. A at 14.) The term appears in claim 4
of the ’149 patent.
i. The Parties’ Positions
Allergan argues that “a person in need thereof” is directed to the general class of patients
in need of treatment—in other words, patients with glaucoma or ocular hypertension. Allergan
argues that the description in the specification of clinical trial results, as well as arguments made
during prosecution, support its construction.
Sandoz argues that “[c]laim 4 requires that IOP lowering effects are maintained in one or
more individual patients as compared to the IOP lowering effect in each of the patients with the
prior three-times-daily brimonidine regimen.” (Sandoz Responsive Claim Construction Brief at
28

20.) Thus, according to Sandoz, the “person” is one needing a reduction in the number of daily
doses. As above, Sandoz argues that the claim requires a person-by-person analysis.
ii. Analysis
The Court has already rejected Sandoz’s argument that the claim preamble requires a
patient by patient analysis for the terms “reducing the number of daily ophthalmic doses” and
“without loss of efficacy.” For the same reasons, the Court rejects Sandoz’s construction here.
The patent specification does not speak of comparisons on a patient by patient basis, and does
not provide clinical results on a patient by patient basis. Rather, it reports on and provides
analysis for separate treatment groups.
Moreover, the plain claim language does not support Sandoz’s argument that the “person
in need thereof” is one in need of a reduction in the number of daily doses of brimonidine.
Rather, it more naturally supports a reading that “a person in need thereof” refers to patients in
need of treatment for glaucoma or ocular hypertension. The claim specifies that brimonidine is
administered topically to a “person in need thereof for the treatment of glaucoma or ocular
hypertension.” Allergan’s proposed definition is thus far more consistent with the specification
and the plain claim language. As Allergan argues, “a person in need thereof for the treatment of
glaucoma or ocular hypertension” is “directed to the general class of patients with glaucoma or
ocular hypertension.”
As a general rule, “a” means “one or more.” Baldwin Graphic Sys., Inc. v. Siebert, Inc.,
512 F.3d 1338, 1342–43 (Fed. Cir. 2008). “That ‘a’ or ‘an’ can mean ‘one or more’ is best
described as a rule, rather than merely as a presumption or even a convention. . . . An exception
to the general rule that ‘a’ or ‘an’ means more than one only arises where the language of the
claims themselves, the specification, or the prosecution history necessitate a departure from the
29

rule.” Id. Thus, according to that rule, “a person in need thereof” reads as “one or more persons
in need thereof.” That is also consistent with Allergan’s proposed definition.
Allergan also cites Braintree Labs., Inc. v. Novel Labs., Inc., 749 F.3d 1349 (Fed. Cir.
2014) and Wyeth v. Sandoz, 703 F. Supp. 2d 508 (E.D.N.C. 2010) as case law that should control
here. The Court disagrees that they control. Braintree does not establish a rule that the term “a
patient” (or “a person”) always refers to “a general class of persons to whom the patented
compositions are directed, i.e., a patient population.” Braintree, 749 F.3d at 1357. Rather, it
simply stands for the proposition that this was the appropriate construction based on the facts in
that case. Wyeth, and its statement that “[i]n Markman opinions, all but one of the courts that
have addressed the issue agree that the appropriate comparison should be based on an average
taken from a group of patients” refers only to a set of cases all of which relate to the same patent,
and again, was based on the unique facts of that case. The Court therefore sees no controlling
case law requiring the use of the particular language used in Braintree.
However, the Court finds that one skilled in the art would, in this instance, understand the
term “a person in need thereof” to refer to those persons in need of brimonidine for the treatment
of glaucoma or ocular hypertension. Accordingly, the Court adopts the plain and ordinary
meaning of “a person in need thereof” and holds that such plain and ordinary meaning would be
understood by a person of ordinary skill in the art to be a “general class of persons to whom the
patented compositions are directed.”
f. “reduces the incidence of”
Plaintiff’s Proposed Construction
The term does not require construction,
but if it does, the Court should apply its plain
and ordinary meaning

Defendants’ Proposed Construction
“reduces the numerical instances of”

30

(Joint Claim Construction and Prehearing Statement, Ex. A at 17.) The term appears in claim 1
of the ’425 patent.
i. The Parties’ Positions
Allergan argues that no construction is necessary, but that if construction is necessary, the
Court should apply the term’s plain and ordinary meaning. According to Allergan, one of
ordinary skill would understand the term without any further definition. Allergan further argues
that a numerical limitation such as that proposed by Sandoz is improper because side effects may
be reduced in either numerical occurrence or severity.
Sandoz argues that construction is necessary, and that while the words “numerical
reduction” do not appear in the patent specification, the specification does set forth numerical
reductions in adverse events. According to Sandoz, because the specification provides data in
the form of numbers, therefore, so should the claim.
ii. Analysis
As a starting point, the claim in question reads:
A method of treating a patient with glaucoma or ocular hypertension comprising administering
twice daily to an affected eye a single composition comprising 0.2% w/v brimonidine tartrate
and 0.5% w/v timolol free base, wherein said method reduces the incidence or one or more
adverse events, as compared to the administration of 0.2% w/v brimonidine tartrate monotherapy
three times per day wherein the adverse event is selected from the group consisting of
conjunctival hyperemia, oral dryness, eye pruritis, allergic conjunctivitis, foreign body sensation,
conjunctival folliculolis, and somnolence.
According to the claim, the “method reduces the incidence of one or more adverse
events.” No numerical limitation is set forth in the claim language itself. Sandoz argues that this
is irrelevant because the patent specification does provide numerical reduction numbers (some of
which are statistically significant, some of which are not) for adverse events. However, the
Court is mindful that it is improper to read limitations from the specification into the claims.
31

Phillips, 415 F.3d at 1323. While the specification does provide a comparison of the numerical

instances and percentages of the adverse events identified in the claims between treatment
groups, there is no clear indication in the specification that the patentee intended to so limit the
term “reduces the incidence of” only to numerical reductions.
Allergan offers that the plain meaning of the term encompasses both a reduction in
severity of an adverse event, as well as numerical occurrence of such an event. Allergan also
argues that the patent specification does present reductions in severity of adverse events, pointing
to the ’425 patent at col. 7, ll. 39–53. That paragraph discusses “serious adverse events.” While
these “serious adverse events” are reportedly reduced as compared to the three times a day
group, it is not clear that this language relates to the severity of a particular incidence of a side
effect, as opposed to the seriousness of the side effect itself. The specification at this point
appears to discuss the latter, not the former. “Two patients receiving Timolol had 4 serious
adverse events (emphysema in one patient; nausea, sweating and tachycardia in another) which
were considered possibly related to the study drug.” ’425 patent, col. 7, ll. 46–49. None of these
“serious adverse events” are those listed in the claim, or in the table of adverse events reported in
the patent. ’425 patent at col. 7, ll. 24–38. They thus appear to, regardless of their magnitude,
constitute a separate class of “serious adverse events.”
The specification does, however, discuss “[i]ncreases from baseline in the severity of
conjunctival erythema and conjunctival follicles” and that these were statistically significantly
lower with the combination as compared to the brimonidine only group. ’425 patent at col. 7, l.
66–col. 8, l. 5. Thus, there is support in the specification for the fact that one skilled in the art
would understand that adverse events may be reduced in both number of occurrences, as well as
in the degree of the adverse event.
32

Sandoz also cites to an extrinsic evidence dictionary definition of “incidence” from
Stedman’s Medical Dictionary as supporting its position.
Construction Brief, Ex. 29.)

(Sandoz Responsive Claim

That dictionary defines “incidence” as: “The extent or rate of

occurrence, especially the number of new cases of a disease in a population over a period of
time.” Sandoz particularly points to the language in the definition regarding “number of new
cases” as supporting its position that a numerical qualifier should be added. However, this
extrinsic evidence actually supports a broader interpretation of “incidence” that encompasses
both severity or degree (extent) and numerical (rate) occurrence, and demonstrates that one
skilled in the art would so understand the term. Such an interpretation is consonant with
common sense and experience as well—for example, a headache can be mild or incapacitating.
Accordingly, the Court construes the term “reduces the incidence of” as “reduces the
severity and/or rate of occurrence of.”
g. “a patient”
Plaintiff’s Proposed Construction
“general class of persons to whom the
patented compositions are directed, i.e., a
patient population”

Defendants’ Proposed Construction
“one or more particular patients”

(Joint Claim Construction and Prehearing Statement, Ex. A at 15.) The term appears in claim 1
of the ’425 patent.
i. The parties’ positions
Allergan again argues, as it did regarding the term “a person in need thereof,” that the
term should be construed as covering a patient population. In support, Allergan points to the
specification and particularly to the clinical trial extensively discussed therein. Allergan argues
that this discussion highlights that the adverse events recited in the claims of the ’425 patent are
among those that were analyzed during those clinical trials, and that the claimed combination of
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brimonidine and timolol resulted in a lower percentage of patients experiencing these adverse
events.
Sandoz agrees that a patient population is required, because the claim requires a
comparison step. According to Sandoz, if the claims require a comparison step, they also require
that a doctor generate comparative data for the brimonidine tartrate monotherapy.
Allergan responds that the claims do not require any actual comparison step and explains
that, for certain adverse events, such a comparison would be impossible because once a patient
develops an allergy to brimonidine, that compound can no longer be used to treat the patient.
ii. Analysis
As an initial matter, the Court rejects the proposition that the ’425 patent claims require a
separate comparison step, as suggested by Sandoz. Nothing in the claim itself, or the patent
specification, requires a separate comparison step. The claim recites:
A method of treating a patient with glaucoma or ocular hypertension comprising administering
twice daily to an affected eye a single composition comprising 0.2% w/v brimonidine tartrate
and 0.5% w/v timolol free base, wherein said method reduces the incidence or one or more
adverse events, as compared to the administration of 0.2% w/v brimonidine tartrate monotherapy
three times per day wherein the adverse event is selected from the group consisting of
conjunctival hyperemia, oral dryness, eye pruritis, allergic conjunctivitis, foreign body sensation,
conjunctival folliculolis, and somnolence.
The “wherein” clause begins after the method is fully defined by the claim. While both
parties appear to agree that this clause defines an actual limitation on the claim, the claim does
not define a multi-step process. Rather, the claimed method has a single step: administering the
claimed composition twice daily to an affected eye. The “wherein” clause, much like the claim
preamble discussed above, describes the outcome of the claimed method—that there are lower
incidences of certain defined adverse events when the method is practiced. It thus informs the
claimed method, but does not require a separate measurement step. The outcome is understood
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based on the clinical data presented in the patent. As Allergan explains, the results of that
clinical data show that a lower percentage of patients taking the combination brimonidine/timolol
treatment twice daily experienced adverse events than those taking brimonidine monotherapy
three times a day.
Turning to Sandoz’s contention that the term “patient” should be interpreted as “one or
more particular patients,” the Court rejects that argument as well. First, Sandoz does not explain
what is meant by “particular patients” and how the “one or more particular patients” are selected.
Second, as this Court previously found, it is well understood that brimonidine 0.2% causes a high
rate of ocular allergy and that once a patient develops such an allergy, brimonidine is no longer
available as a treatment for the patient. Allergan I, 818 F. Supp. 2d at 979. The adverse events
recited in claim 1 of the ’425 patent include at least two associated with brimonidine allergy,
allergic conjunctivitis and conjunctival folliculosis. These facts are undisputed by Sandoz.
Thus, a particular patient developing one of these conditions could not be used to compare the
adverse events associated with thrice daily brimonidine monotherapy and twice daily
combination therapy. In view of these facts, the only comparison that makes sense is as between
patient populations taking different therapies. And as explained above, claim 1 itself requires no
separate comparison step.
For the reasons set forth above regarding the term “a person in need thereof,” the Court
finds that one skilled in the art would understand the term “a patient” to refer to those persons
with glaucoma or ocular hypertension. Accordingly, the Court adopts the plain and ordinary
meaning of “a patient” and holds that such plain and ordinary meaning would be understood by a
person of ordinary skill in the art to be a “general class of persons to whom the patented
compositions are directed.”
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h. Indefiniteness
Sandoz argues that claims 1–8 of the ’425 patent are indefinite because they fail to
inform one skilled in the art about the scope of the invention with reasonable certainty. Sandoz’s
argument consists of one page of attorney argument with no supporting expert testimony or other
factual evidence and is insufficient to carry its burden of proving invalidity by clear and
convincing evidence.
V.

CONCLUSION

The Court adopts the constructions set forth in this opinion for the disputed terms of the
’149, ’976, ’258 and ’425 patents. Within thirty (30) days of the issuance of this Memorandum
Opinion and Order, the parties are hereby ORDERED, in good faith, to mediate this case with
the. mediator agreed upon by the parties. As a part of such mediation, each party shall appear by
counsel and by at least one corporate officer possessing sufficient authority and control to
unilaterally make binding decisions for the corporation adequate to address any good faith offer
or counteroffer of settlement that might arise during such mediation. Failure to do so shall be
deemed by the Court as a failure to mediate in good faith and may subject that party to such
sanctions as the Court deems appropriate.

SIGNED this 19th day of December, 2011.
So ORDERED and SIGNED this 29th day of March, 2016.

____________________________________
RODNEY GILSTRAP
UNITED STATES DISTRICT JUDGE

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