HORIZON PHARMA, INC. et al v. DR. REDDY'S LABORATORIES INC. et al

Filing 252

OPINION. Signed by Judge Stanley R. Chesler on 12/18/2019. (dam, )

NOT FOR PUBLICATION
UNITED STATES DISTRICT COURT
DISTRICT OF NEW JERSEY
_______________________________________
:
HORIZON MEDICINES LLC and NUVO
:
Civil Action No. 15-3324 (SRC)
PHARMACEUTICAL (IRELAND)
:
DESIGNATED ACTIVITY COMPANY,
:
:
OPINION
Plaintiffs,
:
:
v.
:
(consolidated for discovery
:
purposes with Civil Action
DR. REDDY’S LABORATORIES, INC.
:
Nos. 16-4918, 15-3327,
and DR. REDDY’S LABORATORIES,
:
16-4921, 15-3326,
:
and 16-4920)
Defendants.
:
_______________________________________:

CHESLER, U.S.D.J.
This matter comes before this Court on the motion for a preliminary injunction by
Plaintiffs Horizon Medicines LLC and Nuvo Pharmaceutical (Ireland) Designated Activity
Company (collectively, “Plaintiffs”). Defendants Dr. Reddy’s Laboratories, Inc. and Dr.
Reddy’s Laboratories, Ltd. (collectively, “DRL”) oppose the motion. The Court held a hearing
on this motion on December 11, 2019. For the reasons that follow, the motion will be denied.
These cases arise from Hatch-Waxman litigation regarding patents related to the drug
Vimovo®. Plaintiff Nuvo owns the patents, Plaintiff Horizon is a licensee, and Defendants are
pharmaceutical companies which have filed ANDA applications to produce generic versions.1
The first round of litigation involved U.S. Patent Nos. 6,926,907 and 8,557,285.2 Those patents

1

DRL has filed ANDA No. 202461 (“ANDA I”) and ANDA No. 204206 (“ANDA II.”) The
parties have stipulated that this preliminary injunction motion shall be briefed and argued as to
ANDA I only, but that the outcome shall apply to both ANDA I and ANDA II.
2
This round of litigation involved Civil Action Nos. 11-2317, 11-4275, 13-91, and 13-4022.

have been found to be invalid for failure to satisfy the written description requirement. Nuvo
Pharm. (Ir.) Designated Activity Co. v. Dr. Reddy's Labs. Inc., 923 F.3d 1368, 1371 (Fed. Cir.
2019).
During the first round of litigation, nine additional patents related to Vimovo® issued and
were listed in the Orange Book, and the instant cases arose. The two patents presently at issue
descend from U.S. Patent No. 6,926,907: U.S. Patent Nos. 8,858,996 (the “’996 patent”) and
9,161,920 (the “’920 patent”).
APPLICABLE LEGAL STANDARDS
I.

Preliminary Injunction
“The grant of a preliminary injunction under 35 U.S.C. § 283 is within the discretion of

the district court.” Curtiss-Wright Flow Control Corp. v. Velan, Inc., 438 F.3d 1374, 1378 (Fed.
Cir. 2006). “A plaintiff seeking a preliminary injunction must establish that he is likely to
succeed on the merits, that he is likely to suffer irreparable harm in the absence of preliminary
relief, that the balance of equities tips in his favor, and that an injunction is in the public
interest.” Winter v. NRDC, Inc., 129 S. Ct. 365, 374 (2008). The Supreme Court has held that
injunctive relief is “an extraordinary remedy that may only be awarded upon a clear showing that
the plaintiff is entitled to such relief.” Id. at 376.
As to the requirement that the movant establish that he is likely to succeed on the merits,
the Federal Circuit has held:
[T]he patentee seeking a preliminary injunction in a patent infringement suit must
show that it will likely prove infringement, and that it will likely withstand
challenges, if any, to the validity of the patent. In assessing whether the patentee
is entitled to the injunction, the court views the matter in light of the burdens and
presumptions that will inhere at trial. . . .
Titan Tire Corp. v. Case New Holland, Inc., 566 F.3d 1372, 1376 (Fed. Cir. 2009) (citation
2

omitted). “To establish a likelihood of success on the merits, a patentee must show that it will
likely prove infringement of the asserted claims and that its infringement claim will likely
withstand the alleged infringer's challenges to patent validity and enforceability.” Mylan
Institutional LLC v. Aurobindo Pharma Ltd., 857 F.3d 858, 866 (Fed. Cir. 2017). “An accused
infringer can defeat a showing of likelihood of success on the merits by demonstrating a
substantial question of validity or infringement.” Trebro Mfg. v. FireFly Equip., LLC, 748 F.3d
1159, 1165 (Fed. Cir. 2014); Tinnus Enters., LLC v. Telebrands Corp., 846 F.3d 1190, 1202
(Fed. Cir. 2017).
ANALYSIS
I.

Plaintiffs have not demonstrated that they are likely to succeed on the merits.
Plaintiffs move for injunctive relief on the ground that they expect that DRL will soon

launch at risk a generic product that will infringe claims in the ‘996 and ‘920 patents. At the
hearing, DRL confirmed that it plans to launch its generic product at risk as soon as it receives
final FDA approval to do so, which could occur at any time. Plaintiffs assert claims 1-19 of the
‘996 patent and claims 1-5, 7-9, and 11-14 of the ‘920 patent. DRL does not dispute
infringement on this motion. Plaintiffs argue that injunctive relief should be granted because: 1)
DRL’s proposed generic product will infringe, and DRL’s validity defenses will fail, and thus
Plaintiffs are likely to succeed on the merits; 2) Plaintiffs will suffer irreparable harm absent an
injunction; 3) the balance of hardships supports injunctive relief; and 4) the public interest favors
a grant of injunctive relief to maintain the status quo.
DRL opposes the preliminary injunction motion by challenging the validity of the ‘996
and ‘920 patents. Specifically, inter alia, DRL argues that the asserted claims lack adequate
written description.
3

As noted, in May of 2019, the Federal Circuit decided Nuvo and invalidated the ‘907 and
‘285 patents for failure to meet the written description requirement. 923 F.3d 1368. The ‘907
patent states an application number of 10/158,216. In the “Related U.S. Application Data”
section of the ‘285 patent, it states that the ‘285 patent is descended from that same application,
10/158,216. In the “Related U.S. Application Data” section of the ‘920 patent, it states that the
‘920 patent is descended from that same application, 10/158,216. In the “Related U.S.
Application Data” section of the ‘996 patent, it states that the ‘996 patent is descended from that
same application, 10/158,216. Thus, the application that resulted in the ‘907 patent is a parent
application that the ‘285, ‘996, and ‘920 patents all descended from.
In August of 2019, DRL moved for summary judgment, and this Court decided that
motion in the Opinion and Order entered November 8, 2019. In brief, DRL moved for summary
judgment of invalidity of the ‘996 and ‘920 patents, as well as other patents which Plaintiffs have
since withdrawn from this litigation, on the grounds of issue preclusion and claim preclusion, in
view of the Nuvo decision. This Court denied the motion, stating, inter alia, that the Federal
Circuit’s decision in Nuvo had relied on the fact that the plain language of the claims at issue in
that case required effectiveness of an uncoated proton pump inhibitor (“PPI”), but that the plain
language of the asserted claims in this case did not.3 (Opinion and Order of November 8, 2019
at 3-4.) This important difference, among others, prevented finding that the same issue had

3

In Nuvo, the Federal Circuit stated:
At trial, the parties and the district court understood that the plain words of the
patents claim effectiveness of uncoated PPI. Beyond the plain language of the
claims, the district court was not asked to define further the effectiveness
limitation.

923 F.3d at 1377. In the ‘996 and ‘920 patents, the plain language of the claims at issue does
4

already been litigated. (Id.)
DRL opposes the instant preliminary injunction motion principally on the ground that the
asserted claims are invalid for lack of written description, as in Nuvo. Now, however, DRL
argues that this Court should construe the asserted claims to require effective uncoated
esomeprazole, and that the asserted claims, thus construed, fail to meet the written description
requirement, for reasons similar to the Federal Circuit’s reasoning in Nuvo. Plaintiffs, in their
reply brief, contend that all claim language should have its ordinary meaning.
As to the likelihood of success on the merits, then, the present dispute turns on the
question of whether the asserted claims should be construed to require effective uncoated
esomeprazole. At this juncture, in the context of a preliminary injunction motion, this Court
need not reach a conclusive resolution of this issue. The Federal Circuit has held:
[T]he trial court has no obligation to interpret claim 1 conclusively and finally
during a preliminary injunction proceeding. Under Markman, claim interpretation
is a matter of law. However, Markman does not obligate the trial judge to
conclusively interpret claims at an early stage in a case. A trial court may
exercise its discretion to interpret the claims at a time when the parties have
presented a full picture of the claimed invention and prior art. Illinois Tool
Works, Inc. v. Grip-Pak, Inc., 906 F.2d 679, 681 (Fed. Cir. 1990)(referring to a
preliminary injunction “hearing in which neither party was required to prove his
case in full and in light of findings and conclusions not binding at trial.”
(emphasis added); Atari Games Corp. v. Nintendo of Am., Inc., 897 F.2d 1572,
1575 (Fed. Cir. 1990)(“The district court need not make binding findings of fact,
but at the very least, must find probabilities that the necessary facts can be
proved.”)

Sofamor Danek Grp., Inc. v. DePuy-Motech, Inc., 74 F.3d 1216, 1221 (Fed. Cir. 1996) (citations
omitted). The Federal Circuit has called this “rolling claim construction.” Conoco, Inc. v.
Energy & Envtl. Int'l, L.C., 460 F.3d 1349, 1359 (Fed. Cir. 2006). This Court now considers

not require the effectiveness of uncoated PPI.
5

the parties’ claim construction arguments not to conclusively construe all the claims, but to
assess Plaintiffs’ likelihood of success on the merits in view of the arguments and the record
presently before the Court.
DRL proposes that this Court should construe the claims at issue to require effective
uncoated esomeprazole, and thus to import a limitation from the specification. The ‘996 patent
has two independent claims:
1.

A pharmaceutical composition in unit dosage form in the form of a tablet,
said composition comprising: naproxen in an amount of 200-600 mg per
unit dosage form; and esomeprazole in an amount of from 5 to 100 mg per
unit dosage form, wherein upon introduction of said unit dosage form into
a medium, at least a portion of said esomeprazole is released regardless of
the pH of the medium, and release of at least a portion of said naproxen is
inhibited unless the pH of said medium is 3.5 or higher.

12.

A pharmaceutical composition in unit dosage form in the form of a tablet,
said composition comprising: a core layer comprising naproxen, wherein
said core layer has a coating that inhibits release of said naproxen from
said core layer unless said dosage form is in a medium with a pH of 3.5 or
higher; and a layer comprising esomeprazole, wherein said layer is has a
non-enteric film coating that, upon ingestion by a patient, releases said
esomeprazole into the stomach of said patient.

The ‘920 patent has two independent claims:
1.

A method of reducing the incidence of NSAID-associated gastric ulcers in
a patient requiring chronic NSAID treatment and who is at risk of
developing an NSAID-associated ulcer, wherein the method comprises
administering to said patient in need thereof a pharmaceutical composition
in unit dose form in the form of a tablet, said composition comprising:
naproxen in an amount of 200-600 mg per unit dosage form; and
esomeprazole in an amount of from 5 to 100 mg per unit dosage form,
wherein upon introduction of said unit dosage form into a medium, at least
a portion of said esomeprazole is released regardless of the pH of the
medium, and release of at least a portion of said naproxen is inhibited
unless the pH of said medium is 3.5 or higher.

11.

A method of reducing the incidence of NSAID-associated gastric ulcers in
a patient requiring chronic NSAID treatment and who is at risk of
developing an NSAID-associated ulcer, wherein the method comprises
6

administering to said patient in need thereof a pharmaceutical composition
in unit dose form in the form of a tablet, said composition comprising: a
core layer comprising naproxen, wherein said core layer has a coating that
inhibits release of said naproxen from said core layer unless said dosage
form is in a medium with a pH of 3.5 or higher; and a layer comprising
esomeprazole, wherein said layer is has a non-enteric film coating that,
upon ingestion by a patient, releases said esomeprazole into the stomach
of said patient.
Crucially, at oral argument, the parties agreed that the ‘920, ‘996, ‘907, and ‘285 patents share a
common specification.
DRL begins its claim construction analysis by pointing to the statements in the
specification which describe “the present invention” as having an effective acid inhibitor. The
Abstract for both the ‘920 and ‘996 patents states:
The present invention is directed to drug dosage forms that release an agent that
raises the pH of a patient's gastrointestinal tract, followed by a non-steroidal
anti-inflammatory drug. The dosage form is designed so that the NSAID is not
released until the intragastric pH has been raised to a safe level.
The specification for both the ‘920 and ‘996 patents states:


The present invention is directed to pharmaceutical compositions that provide for
the coordinated release of an acid inhibitor and a non-steroidal anti-inflammatory
drug (NSAID). ‘996 patent, col.1 ll.25-28.



The present invention is based upon the discovery of a new method for reducing
the risk of gastrointestinal side effects in people taking NSAIDs for pain relief
and for other conditions, particularly during chronic treatment. The method
involves the administration of a single, coordinated, unit-dose product that
combines: a) an agent that actively raises intragastric pH to levels associated with
less risk of NSAID-induced ulcers; and b) an NSAID that is specially formulated
to be released in a coordinated way that minimizes the adverse effects of the
NSAID on the gastroduodenal mucosa. ‘996 patent, col.3 ll.15-24.



The present invention is based upon the discovery of improved pharmaceutical
compositions for administering NSAIDs to patients. In addition to containing one
or more NSAIDs, the compositions include acid inhibitors that are capable of
raising the pH of the GI tract of patients. ‘996 patent, col.6 ll.23-27.

7

These statements support DRL’s assertion that the specification repeatedly describes “the present
invention” as containing an acid inhibitor that raises the pH of the GI tract prior to the release of
the NSAID. DRL contends that, under Federal Circuit law, “such language bounds invention
scope,” which is overstatement: under Federal Circuit law, such language may bind claim scope.
(Defs.’ Opp. Br. 10.) In support, DRL cites Netcraft Corp. v. eBay, Inc., 549 F.3d 1394, 1398
(Fed. Cir. 2008), in which the Federal Circuit held:
We agree with Netcraft that use of the phrase “the present invention” does not
“automatically” limit the meaning of claim terms in all circumstances, and that
such language must be read in the context of the entire specification and
prosecution history. For the reasons below, however, we agree with the district
court that the common specification’s repeated use of the phrase “the present
invention” describes the invention as a whole, and, as will be discussed further
below, that the prosecution history does not warrant a contrary result.
Id. (citation omitted). DRL’s second citation offers firmer support for Defendants’
characterization of Federal Circuit law: “When a patent thus describes the features of the ‘present
invention’ as a whole, this description limits the scope of the invention.” Verizon Servs. Corp.
v. Vonage Holdings Corp., 503 F.3d 1295, 1308 (Fed. Cir. 2007); see also Honeywell Int'l, Inc.
v. ITT Indus., 452 F.3d 1312, 1318 (Fed. Cir. 2006) (finding that repeated use of “the present
invention” in the specification characterized the invention as a whole and limited a key claim
term); Sony Corp. v. Iancu, 924 F.3d 1235, 1241 (Fed. Cir. 2019) (quoting Verizon.)
The specification also states: “In a more general sense, the invention includes methods of
treating pain, inflammation and/or other conditions by orally administering an acid inhibitor at a
dose effective to raise a patient's gastric pH to at least 3.5, preferably to at least 4 or and more
preferably to at least 5.” ‘996 patent, col.5 ll.36-40. This statement makes clear that the
invention, in general, contains an acid inhibitor at a dose effective to raise a patient’s gastric pH
to at least 3.5.
8

The specification statement just mentioned is the clearest statement which ties together:
1) a broad view of the invention as a whole; and 2) the use of an acid inhibitor “at a dose
effective to raise a patient’s gastric pH to at least 3.5.” ‘996 patent, col.5 ll.38-39 (italics added).
Also already quoted is this statement: “the compositions include acid inhibitors that are capable
of raising the pH of the GI tract of patients.” ‘996 patent, col.6 ll.26-27 (italics added).
Including the sentence that preceded it, that statement ties together: 1) a broad view of the
invention as a whole; and 2) the use of an acid inhibitor that is capable of raising the pH of the
GI tract of patients. While the words “effective” and “capable” are different words, in these
contexts, they have a common meaning: they refer to the ability to produce a desired result, and
the result is raising the pH of the GI tract of patients. In the context of the patent as a whole, it
is clear that the desired result is not simply raising the pH of the GI tract of patients in any
amount, but raising the pH of the GI tract of patients to at least 3.5.
This inference is supported by these statements in the “Summary of the Invention”
section of the specification:
In its first aspect, the invention is directed to a pharmaceutical composition in unit
dosage form suitable for oral administration to a patient. The composition
contains an acid inhibitor present in an amount effective to raise the gastric pH of
a patient to at least 3.5, preferably to at least 4, and more preferably to at least 5,
when one or more unit dosage forms are administered.
‘996 patent, col.3 ll.31-37 (italics added). This quote expressly refers to an aspect of the
invention, and not to the invention as a whole, but again we see the assertion that the
composition contains an acid inhibitor in an amount effective to raise the gastric pH to at least
3.5. This supports the inference that the inventors understood that it was necessary that the acid
inhibitor be present in amount that would have the ability to produce the result of raising the pH
to at least 3.5. Although, in this instance, the statements do not refer to the invention as a
9

whole, other statements quoted make clear that this is a characteristic of the invention as a whole.
This Court agrees with DRL that these statements in the common specification of the
‘920 and ‘996 patents support the inference that the invention, as a whole, comprises an acid
inhibitor in an amount effective to raise the pH of the GI tract, prior to the release of the NSAID,
to at least 3.5.
DRL also points to the prosecution history of a parent patent, the ‘907 patent. The ‘920
and ‘996 patents descended from the application that produced the ‘907 patent, application
number 10/158,216.4 On April 22, 2004, in a non-final office action, all claims were rejected as
either anticipated by the Goldman reference, or as anticipated by the Depui references, or as
obvious over Depui in view of other references. (Office action of April 22, 2004, application
number 10/158,216.) In response to these rejections, the applicants filed traversing arguments,
including the following:
All of Applicant’s claims have requirements not only with respect to the type of
active ingredients present in compositions or methods, but also with respect to the
way in which active ingredients are delivered in relation to one another.
Specifically, claim 1 requires that there be a single unit dosage form containing
both an acid inhibitor and an NSAID and that, upon administration to a patient,
the dosage form deliver these drugs in a coordinated fashion such that the acid
inhibitor is released first and the NSAID is not released until after the gastric pH
of the patient is 3.5 or higher. Applicant submits that these characteristics are not
disclosed or suggested Goldman. [sic]
(Applicant Remarks filed 7/22/2004, application number 10/158,216.)
In the Final Office Action filed October 20, 2004, the examiner allowed certain claims
and rejected others, for the reasons stated in the previous rejection, including anticipation by the

4

DRL submitted exhibits with its opposition brief that included some, but not all, of the relevant
documents from the file wrapper for the prosecution of the ‘907 patent. The entire file wrapper
is publicly available on the PTO’s website, and this Court has taken judicial notice of certain
relevant documents from the file wrapper that DRL did not include as exhibits.
10

Depui reference. (Office action of October 20, 2004, application number 10/158,216.) In
response, the applicants submitted amendments and remarks on November 22, 2004. In the
remarks, the applicants distinguished Depui as follows:
It should also be recognized that Depui’s compositions would act in a very
different way than those claimed by Applicant. Specifically, release of acid
inhibitor in Depui’s compositions would be delayed whereas acid inhibitor release
from Applicant’s compositions is immediate and only the release of NSAID is
delayed. The basic concept of coating NSAIDs in a way that will prevent them
from being released until the surrounding pH rises to at least 3.5 is entirely
missing from the Depui reference.
(Amendment and Response under 37 C.F.R. § 1.116, filed November 22, 2004, Pollack Dec. Ex.
5.) On March 29, 2005, a notice of allowance was issued for all but two out of fifty-seven
claims.
The prosecution history of a parent application, application number 10/158,216, shows
that the applicants overcame a rejection in part by distinguishing the Depui reference as not
having taught the following features of the inventive composition: immediate release of an acid
inhibitor and delayed release of an NSAID until the gastric pH rises to at least 3.5. This does
not appear to meaningfully differ from characterizing the invention as having an immediate
release acid inhibitor effective to raise gastric pH to at least 3.5. The applicants overcame a
rejection over the Depui reference by describing the invention as having an immediate release
acid inhibitor and an NSAID that does not release until the gastric pH rises to at least 3.5. This
constitutes further evidence supporting the inference that the applicants so understood the
invention of the ‘920 and ‘996 patents as a whole.
The intrinsic evidence just reviewed supports the inference that what the inventors

11

actually invented5 was a composition, as well as a treatment method using that composition,
comprising naproxen and esomeprazole, which worked because uncoated esomeprazole was first
released in the stomach, and then raised the pH of the stomach to at least 3.5, at which point the
naproxen was released. The intrinsic evidence supporting this inference is quite strong.
DRL also points to statements made by the then-owners of the ‘996 patent, Horizon and
Pozen, in the preliminary response they submitted in IPR2015-1344. In this response, the
then-owners attempted to rebut an invalidity challenge involving a reference by Gimet with an
argument that included this statement: “Gimet does not disclose a dosage form comprising an
acid inhibitor in an amount effective to raise the gastric pH of a patient to at least 3.5.” (Pollack
Dec. Ex. 9 at 19.) This is not intrinsic evidence, but it is consistent with DRL’s contention that
the invention of the ‘996 patent, as a whole, comprises an acid inhibitor effective to raise the
gastric pH to at least 3.5.
This Court finds that the evidence of record supports DRL’s contention about the
invention as a whole. Next, this Court considers the question of whether such evidence may,
under Federal Circuit law, support the construction that DRL proposes, which imports a
limitation from the specification.

At oral argument, Plaintiffs argued principally that DRL’s

proposed construction did not comport with Federal Circuit law because the claim language
contains no “hook.” This Court understood this to refer to a case cited in Plaintiffs’ reply brief,
NTP, Inc. v. Research In Motion, Ltd., 418 F.3d 1282, 1310 (Fed. Cir. 2005), which states:
Our case law requires a textual “hook” in the claim language for a limitation of
this nature to be imposed. Generally, “a party wishing to use statements in the
5

See 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.”)
12

written description to confine or otherwise affect a patent’s scope must, at the
very least, point to a term or terms in the claim with which to draw in those
statements. Without any claim term that is susceptible of clarification by the
written description, there is no legitimate way to narrow the property right.”
Renishaw PLC v. Marposs Societa' per Azioni, 158 F.3d 1243, 1248 (Fed. Cir.
1998). In other words, there must be a textual reference in the actual language of
the claim with which to associate a proffered claim construction.
Plaintiffs’ opening brief does not mention the hook argument. Plaintiffs’ reply brief cites NTP
only in support of its argument that the word “effective” does not appear in the specification
quotes in DRL’s opposition brief. (Pls.’ Reply Br. 3.) The argument that Plaintiffs made at
oral argument was that there was no hook for DRL’s proposed construction in the claims, not the
specification. The point is that the hook argument, as made at oral argument, was entirely new.
Furthermore, the hook argument, as presented at oral argument, was little more than the assertion
that there was no hook in the claims, without supporting explanation of the law or analysis of the
claim language. This leaves this Court in the position of considering an argument that was not
made in the briefs nor developed at oral argument.
Thus, while Plaintiffs argued at the hearing that the claims have no hook, they did not
offer a definition of a hook, within the meaning of NTP and the Federal Circuit law of claim
construction. Nor does NTP offer a definition of a hook, nor articulate how a court should
decide whether or not a hook is present in claim language, beyond the statement that “there must
be a textual reference in the actual language of the claim with which to associate a proffered
claim construction.” NTP, 418 F.3d at 1310. These statements appear in the context of the
Federal Circuit’s review of the district court’s claim construction decision which declined to
impose a “separate and distinct” limitation on certain claims. Id. The Federal Circuit affirmed
the district court’s decision that a limitation should not be imported, and so NTP does not offer
an example of a textual reference in claim language with sufficient association with a proffered
13

claim construction to justify importing a claim limitation. As already stated, Plaintiffs did not
give the Court an analysis of the NTP decision that might elucidate how this Court should apply
NTP to the facts of this case.
DRL, on the other hand, relies on the Federal Circuit’s decision in Alloc, Inc. v. ITC, 342
F.3d 1361, 1371 (Fed. Cir. 2003), and argued in its opposition brief that the facts of the instant
case are analogous to those in Alloc. In short, in Alloc, the Federal Circuit held that certain
claims should be construed to have a “play” limitation, based on the specification, despite the
fact that the word “play” did not appear in the claims. Id. at 1368-73. The word “hook” does
not appear in the Alloc decision, and so this Court examines the Federal Circuit’s reasoning to
see what relationship “play” had with the language of the relevant claims.
The Federal Circuit began its discussion as follows:
Turning to the Commission’s finding that the claims include a “play” limitation,
none of the asserted patent claims recites the term play. Even so, the claims recite
floor system features, which are emphasized in the claim language above, in
which play is necessarily present. These features, and their associated claim
terms, relate to “displacement” and “disassembly.”
Id. at 1368. The Federal Circuit then examined the specification and explained the basis for the
conclusions that “play between components of the locking joint permits displacement” and “play
in the joint also permits ‘disassembly.’” Id. at 1369. The Federal Circuit considered the
prosecution history, including the prosecution history of a parent application, and stated: “the
applicant represented to the USPTO examiner that play facilitated its novel system set forth in
the revised claims.” Id. at 1372. The Federal Circuit found that “play facilitates displacement
and disassembly,” and concluded: “the patent applicant tethered the displacement and
disassembly features of the claims to the play feature.” Id. at 1372-73. The Federal Circuit
held that the claims at issue should be construed to require play. Id. at 1373.
14

Thus, in Alloc, the Federal Circuit examined the language of the claims and the intrinsic
record and found that a product feature disclosed in the specification, but not in the claims,
facilitated and permitted product features that were expressly claimed. This Court now inquires
into whether the instant case presents analogous facts. DRL argues that the intrinsic evidence
demonstrates that the invention, in general, requires that the uncoated esomeprazole be effective
to raise the gastric pH to at least 3.5; this would be the product feature disclosed in the
specification. Two of the four independent claims include the phrase, “release of at least a
portion of said naproxen is inhibited unless the pH of said medium is 3.5 or higher,” while the
other two independent claims include the phrase, “a core layer comprising naproxen, wherein
said core layer has a coating that inhibits release of said naproxen from said core layer unless
said dosage form is in a medium with a pH of 3.5 or higher.” The product property disclosed in
the specification – the uncoated esomeprazole is effective to raise the gastric pH to at least 3.5 –
facilitates or permits the product property disclosed in the claims: the naproxen is not released
until the pH of the medium is 3.5 or higher. On the present record, it appears that the patentee
tethered the naproxen release feature disclosed in the claims to the effectiveness of the
esomeprazole to raise gastric pH disclosed in the intrinsic record. DRL has persuaded this
Court that Alloc is analogous, and that there is “a textual reference in the actual language of the
claim with which to associate [the] proffered claim construction.” NTP, 418 F.3d at 1310.
The intrinsic evidence strongly supports the inference that the applicants for the ‘996 and
‘920 patents understood the invention, as a whole, to comprise immediate release esomeprazole
which is effective to raise gastric pH to at least 3.5. Applying Alloc, this Court tentatively finds
that the applicants tethered the naproxen release feature disclosed in the claims to the
effectiveness of the esomeprazole to raise gastric pH disclosed in the intrinsic record, and
15

construes the claims at issue to include this limitation.
With this foundation, this Court considers the impact of the Federal Circuit’s decision in
Nuvo. In Nuvo, the Federal Circuit held: “we hold that the ‘907 and ‘285 patents are invalid for
lack of an adequate written description given that the shared specification does not adequately
describe the claimed effectiveness of uncoated PPI.” Nuvo, 923 F.3d at 1384. At oral
argument on this motion, the parties agreed that the ‘920, ‘996, ‘907, and ‘285 patents share a
common specification. No one has argued that esomeprazole is not a PPI. This Court has
tentatively construed the asserted claims to include a limitation requiring immediate release
esomeprazole which is effective to raise gastric pH to at least 3.5. The Federal Circuit has held
that the common specification does not adequately describe uncoated PPI which is effective to
raise the gastric pH to at least 3.5.
On this basis, this Court finds that DRL has raised a substantial question of patent
validity, which Plaintiffs have not shown lacks substantial merit. The Court makes this finding
not based on the application of any preclusion doctrine; the parties have not raised a preclusion
argument on this motion. Instead, the Court considers Nuvo as relevant to estimating the
likelihood of success of the parties, in view of the burdens and presumptions that will inhere at
trial. The reported decision shows that the parties before the Federal Circuit in Nuvo were the
same parties now before this Court. 923 F.3d at 1368. The Federal Circuit concluded: “we
hold that the ‘907 and ‘285 patents are invalid for lack of an adequate written description given
that the shared specification does not adequately describe the claimed effectiveness of uncoated
PPI.” Id. at 1384. It is a common-sense proposition that, if Plaintiffs-Cross-Appellants Nuvo
and Horizon were unable to persuade the Federal Circuit that the shared specification – shared
with the ‘996 and ‘920 patents, the parties agreed – provides adequate written description
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support for a claim limitation of effective uncoated PPI, they are unlikely to succeed in defeating
the same validity challenge in this case.
Neither Plaintiffs’ reply brief nor their arguments to this Court at the hearing suggest
otherwise. The reply brief restates Plaintiffs’ position that the words of all claims should have
their ordinary meaning, and does not seriously challenge DRL’s argument that the intrinsic
evidence, under Alloc, supports construing the claims to require effective uncoated
esomeprazole. Plaintiffs’ approach to the Nuvo decision is to ignore it: it is not even cited in the
reply brief. Plaintiffs assert that DRL cannot meet its burden of proof, but Plaintiffs bear the
burden of proof on this motion. As the parties know, pursuant to 35 U.S.C. § 282(a), a patent
shall be presumed valid, and, at trial, the challenger bears the burden of proof of invalidity.
While the presumption of validity applies in the context of deciding a preliminary injunction
motion, the burdens of proof differ somewhat from those at trial. As the Federal Circuit has
explained:
A patent holder seeking a preliminary injunction bears the ultimate burden of
establishing a likelihood of success on the merits with respect to the patent's
validity. If the alleged infringer raises a “substantial question” of invalidity, the
preliminary injunction should not issue. The burden on the accused infringer to
show a substantial question of invalidity at this stage is lower than what is
required to prove invalidity at trial. “Vulnerability is the issue at the preliminary
injunction stage, while validity is the issue at trial.” Amazon.com, 239 F.3d at
1359 (“In resisting a preliminary injunction . . . one need not make out a case of
actual invalidity. . . . The showing of a substantial question as to invalidity thus
requires less proof than the clear and convincing showing necessary to establish
invalidity itself.”). Once the accused infringer satisfies this requirement, the
burden shifts to the patentee to show that the defense lacks substantial merit.
Altana Pharma AG v. Teva Pharm. USA, Inc., 566 F.3d 999, 1005-06 (Fed. Cir. 2009) (citations
omitted). At this juncture, DRL does not bear the burden of proof of invalidity by clear and
convincing evidence. It need only show the vulnerability of the patents at issue to a validity

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challenge, and it has done so. The burden then shifted back to Plaintiffs to show that the
defense lacks substantial merit, and Plaintiffs have not met this burden.
Plaintiffs have failed to demonstrate that their “infringement claim will likely withstand
the alleged infringer’s challenges to patent validity and enforceability.” Mylan, 857 F.3d at 866.
Plaintiffs have therefore failed to show a likelihood of success on the merits. The motion for a
preliminary injunction is denied.

s/ Stanley R. Chesler
STANLEY R. CHESLER, U.S.D.J.

Dated: December 18, 2019

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