AbbVie Inc. et al v. The Kennedy Trust Rheumatology Research

Filing 63

OPINION & ORDER re: 27 MOTION for Summary Judgment filed by AbbVie Inc.: For the foregoing reasons, the Court GRANTS Plaintiffs' motion for summary judgment. The Clerk of Court is directed to enter judgment declaring that claims 1-2, 6-8, 12-14, and 18-19 of U.S. Patent No. 8,383,120 are invalid and to close this case. (Signed by Judge Paul A. Crotty on 7/9/2014) (tn)

UNITED STATES DISTRICT COURT
SOUTHERN DISTRICT OF NEW YORK
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:
ABBVIE INC. and ABBVIE
:
BIOTECHNOLOGY LIMITED,
:
:
Plaintiffs,
:
:
-against:
:
THE KENNEDY TRUST FOR
:
RHEUMATOLOGY RESEARCH,
:
:
Defendant.
:
:
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USDC SDNY
DOCUMENT
ELECTRONICALLY FILED
DOC #: _________________
DATE FILED: July 9, 2014

13 Civ. 1358 (PAC)

OPINION & ORDER

HONORABLE PAUL A. CROTTY, United States District Judge:
This is a patent validity dispute regarding a method for treating rheumatoid arthritis
(“RA”). The validity of a similar patent was the subject of a related case between the same
parties in this Court (the “Prior Action”). Following a four-day bench trial, the Court found that
certain claims of U.S. Patent No. 7,846,442 (“the ‘442 Patent”) were invalid for obviousnesstype double patenting (“ODP”) over certain claims of U.S. Patent No. 6,270,766 (“the ’766
Patent”). Abbvie Inc. v. Mathilda & Terence Kennedy Inst. of Rheumatology Trust, 956 F. Supp.
2d 429, 493 (S.D.N.Y. 2013) (the “Prior Decision”). Plaintiffs now move for summary judgment
declaring claims of a similar patent, U.S. Patent No. 8,383,120 (“the ‘120 Patent”), invalid on the
grounds of collateral estoppel. For the reasons set forth below, the motion is granted.
BACKGROUND
The RA treatment at issue involves co-administering anti– tumor necrosis factor alpha
(“TNFα”) antibodies with the well-known drug methotrexate. Defendant The Kennedy Trust for
Rheumatology Research (“Kennedy”) holds a patent for certain methods of this treatment—the
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’766 Patent—which expired on October 8, 2012. Plaintiffs Abbvie Inc. and Abbvie
Biotechnology Limited (collectively, “Abbvie”) have paid more than $100 million in royalties to
license the use of the ‘766 Patent in Abbvie’s prescription drug marketed as Humira®. See Prior
Decision, 956 F. Supp. 2d 429, ¶¶ 266–69. The ‘442 Patent at issue in the Prior Action had a
later expiration date due to its later effective filing date, 1 and Kennedy demanded continued
royalty payments from Abbvie on the basis of the ‘442 Patent. See id. ¶ 270.
In the Prior Decision, the Court found that Abbvie had proven by clear and convincing
evidence that the disputed claims in the ‘442 Patent 2 were obvious variants of claims in the ’766
Patent and therefore invalid under the ODP doctrine. See 956 F. Supp. 2d at 493. The Court
presumes familiarity with its Prior Decision, including its findings regarding the prior art, the
person of ordinary skill in the art (“POSA”), and its construction of the claims of the ‘766 and
‘442 Patents. See generally id.
After trial, but before the Court issued its decision, Kennedy obtained a third patent for a
similar RA treatment—the ‘120 Patent—which contains the claims in dispute here. 3 In this
motion, Abbvie contends that the ‘120 Patent is likewise invalid as a matter of collateral estoppel
because the differences between the ‘442 and ‘120 Patents do not vary the issues bearing on the
ODP analysis.

1

The ‘442 Patent would have expired on “August 21, 2018, which is twenty years from the effective filing date of
August 1, 1996, plus an additional 750 days the PTO added under 35 U.S.C. § 154(b).” Prior Decision, 956 F.
Supp. 2d 429, ¶ 251.

2

In the Prior Action, the parties stipulated that only certain claims of the ‘442 Patent were in dispute: claims 1–7,
13–14, and 17–20. (See Shehigian Decl. Ex. 10.) Unless otherwise noted, references to the ‘442 Patent are only to
those claims.

3

As in the Prior Action, the parties have stipulated that only certain claims of the ’120 Patent are in dispute: claims
1–2, 6–8, 12–14, 18, and 19 (“insofar as it depends from” any of the other disputed claims). (See Dkt. 26.) Unless
otherwise noted, references to the ‘120 Patent are only to those claims.

2

There is no dispute that (1) the ‘442 Patent and the ’120 Patent share the same effective
filing date (August 1, 1996); (2) the specifications of the two patents are identical (aside from the
claim language); (3) Kennedy offers no new studies or data to support the nonobviousness of the
’120 Patent; and (4) the ‘120 Patent claims a narrowed species of the broader genus claimed in
the ‘442 Patent. Kennedy argues that although the newly worded claims may be logically
“encompassed by” the previously invalidated claims, they nonetheless raise new questions about
obviousness that are not precluded by collateral estoppel.
DISCUSSION
I.

Legal Standards
A. Summary Judgment
“Summary judgment is appropriate when, construing the evidence in the light most

favorable to the non-moving party, ‘there is no genuine dispute as to any material fact and the
movant is entitled to judgment as a matter of law.’” Rojas v. Roman Catholic Diocese of
Rochester, 660 F.3d 98, 104 (2d Cir. 2011) (quoting Fed. R. Civ. P. 56(a)). A fact is material
only if it “might affect the outcome of the suit under the governing law,” and a factual dispute is
genuine only if “the evidence is such that a reasonable jury could return a verdict for the
nonmoving party.” Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 248 (1986). The moving
party bears the initial burden of producing evidence on each material element of its claim or
defense demonstrating that it is entitled to relief as a matter of law. See Celotex Corp. v. Catrett,
477 U.S. 317, 323 (1986). The Court resolves all ambiguities and draws all factual inferences in
favor of the nonmovant, but “only if there is a ‘genuine’ dispute as to those facts.” Scott v.
Harris, 550 U.S. 372, 380 (2007).

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B. Obviousness-Type Double Patenting (“ODP”)
The Prior Decision set forth the legal standards for the ODP doctrine, which remain
applicable here:
Under 35 U.S.C. § 101, an inventor may obtain “a patent,” but only one patent for
a single invention. The doctrine of non-statutory, or “obviousness-type,” double
patenting prevents the extension of the term of a patent via the patenting of an
obvious variation of the original patent.
Obviousness-type double patenting is a judicially-created doctrine designed to
prevent claims in separate applications or patents that do not recite the same
invention, but nonetheless claim inventions so alike that granting both exclusive
rights would effectively extend the life of patent protection. . . .
The doctrine of obviousness-type double patenting prohibits claims in a second
patent that are “not patentably distinct from” claims in an earlier patent. Two
claims are not “patentably distinct” if the later claim would have been obvious to a
person of ordinary skill in the art based on the earlier claim, in light of the prior art.
...
In determining whether the claims at issue are patentably distinct, the Court does
not consider the differences in the claims in isolation, but must consider the claims
“as a whole.”
956 F. Supp. 2d at 473–74 (citations and quotation marks omitted).
C. Collateral Estoppel
“Collateral estoppel, or issue preclusion, prevents parties or their privies from relitigating
in a subsequent action an issue of fact or law that was fully and fairly litigated in a prior
proceeding.” Marvel Characters, Inc. v. Simon, 310 F.3d 280, 288 (2d Cir. 2002). To succeed
on a motion for summary judgment based on collateral estoppel, the movant must demonstrate
that “(1) the identical issue was raised in a previous proceeding; (2) the issue was actually
litigated and decided in the previous proceeding; (3) the party had a full and fair opportunity to
litigate the issue; and (4) the resolution of the issue was necessary to support a valid and final
judgment on the merits.” Id. at 288–89 (internal quotations omitted). While Second Circuit

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precedent governs this Court’s general application of collateral estoppel, Federal Circuit
precedent governs “those aspects of such a determination that involve substantive issues of
patent law.” Ohio Willow Wood Co. v. Alps S., LLC, 735 F.3d 1333, 1342 (Fed. Cir. 2013).
In patent validity cases, the “first consideration” in the collateral estoppel analysis is
“whether the issue of invalidity common to each action is substantially identical.” Bourns, Inc.
v. United States, 537 F.2d 486, 491 (Ct. Cl. 1976) (quotations omitted). 4 “To assess the identity
of th[e] issues, it is convenient to compare the adjudicated and unadjudicated claims.” Id. at 493.
A prior obviousness determination is preclusive “[w]here the differences revealed by a
comparison of the claims do not vary the relevant issues bearing on obviousness.” Id. The
relevant issues are “the art pertinent to the nonlitigated claims,” “the scope and content of that
art,” “the differences between the prior art and the nonlitigated claims,” and “the level of
ordinary skill in that art.” Westwood Chem., Inc. v. U. S., 525 F.2d 1367, 1375 (Ct. Cl. 1975).
Importantly, “[i]t is the issues litigated, not the specific claims around which the issues
were framed, that is determinative.” Id. at 1367. “[M]erely because the invention, the patentee’s
contribution to the art, is presented in varying language or varying combinations of elements
does not necessarily mean that the issues bearing on the nonobviousness of that concept or
contribution vary from one claim to the next.” Bourns, 537 F.2d at 492. Accordingly, “each of
several differently worded claims may present identical issues.” Id.
The analysis does not turn, however, solely on a comparison of (a) the prior art with (b)
the differences between a previously adjudicated claim and the one at issue. Doing so would

4

The Federal Circuit has adopted as precedent the decisions of the Court of Claims. S. Corp. v. United States, 690
F.2d 1368, 1370 (Fed. Cir. 1982) (en banc). In particular, the Federal Circuit has cited with approval the Court of
Claims’ “pragmatic approach” for applying collateral estoppel in patent cases. E.g., Interconnect Planning Corp. v.
Feil, 774 F.2d 1132, 1136 (Fed. Cir. 1985).

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erroneously treat the adjudicated claims as prior art. Bourns, 537 F.2d at 492–93 (“A domino
approach in which each successively narrower claim is compared with the one before it, not with
the prior art, is inappropriate since it improperly gives prior-art effect to the subject matter of an
invalid claim.”). Rather, “it is still necessary to assess the importance of the difference to the
combination as a whole since it is from that standpoint that the obviousness determination must
be made.” Westwood, 525 F.2d at 1375. Thus, the question is whether “the additional elements
recited in the unadjudicated claims . . . distinguish the claimed combination as a whole from the
prior art.” Bourns, 537 F.2d at 493. “[I]n the end, application of [collateral] estoppel ‘will
necessarily rest on the trial courts’ sense of justice and equity.’” Id. at 497 (quoting BlonderTongue Labs., Inc. v. Univ. of Ill. Found., 402 U.S. 313, 334 (1971)).
II.

Collateral Estoppel Analysis
In the Prior Decision, the Court determined that the‘442 Patent was not made patentably

distinct from the ‘766 Patent by narrowing the scope of its claims regarding patient population,
methods of treatment, antibody types, dosing frequency, mechanism of action, and efficacy. See
956 F. Supp. 2d 429, ¶¶ 347–410. Here again with the ‘120 Patent, Kennedy has narrowed the
scope of its claims in these categories but has done so with greater specificity. Since the ‘442
and ’120 Patents share the same effective filing date, the scope of the prior art is identical, and
there is no need to revisit the Court’s determination regarding the POSA.
Although a patent may issue for a narrower subset of a broader prior claim (i.e., “a
species of a genus”), the narrowed claim must not be an obvious variant of the prior claim. See,
e.g., Eli Lilly & Co. v. Barr Labs., Inc., 222 F.3d 973, 987 (Fed. Cir. 2000) (“With the [prior]
patent now expired, [the patentee] cannot hide behind its once-advantageous broad coverage [of
a patent on a genus] . . . and argue that [practicing the species] would not have been obvious.”);

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Prior Decision, 956 F. Supp. 2d at 476 (invalidating patent of a species of a genus for
obviousness-type double patenting); cf. In re Gleave, 560 F.3d 1331, 1338 (Fed. Cir. 2009)
(genus anticipates a species when “the genus is so limited that a person of ordinary skill in the art
can ‘at once envisage each member of this limited class.’”). Therefore, the Court must determine
whether the further-refined claim language varies the issues bearing on ODP that were
adjudicated in the Prior Decision.
The language of the ’120 Patent varies from the ‘442 Patent in all of the respects listed
above (i.e., patient population, methods of treatment, antibody types, etc.), but Kennedy defends
the ’120 Patent’s validity on three grounds in particular. First, the ’120 Patent defines the
“disease activity element” in a manner that is “substantially more specific and fundamentally
differs from the Court’s construction of ‘active disease’ in the Prior Litigation.” (Kennedy Br. at
12.) Second, the ‘120 Patent “require[s] a specific level of therapeutic benefit[,] . . . . whereas
the litigated ‘442 claims require reduction of the signs and symptoms of RA.” (Id.) Third, “the
’120 claims explicitly recite the biological mechanism by which the claimed antibody must act,
whereas the ’442 claims were not so explicit.” (Id. at 12–13.) The following table sets forth the
relevant claim language with respect to these three issues for each of the ‘766, ‘442, and ’120
Patents:

7

Issue

‘766 Patent

‘442 Patent

‘120 Patent

Level of
Disease in
Patient
Population

Claim 8:

Claim 1:

Claim 1:

“A method of
treating
rheumatoid
arthritis in an
individual in need
thereof . . . .”

“A method of treating an individual
suffering from rheumatoid arthritis
whose active disease is incompletely
controlled despite already receiving
methotrexate . . . .”

“A method of treating an individual
suffering from rheumatoid arthritis
who, despite prior treatment with
methotrexate, still has active disease,
defined as the presence of six or
more swollen joints plus at least
three of the following four secondary
criteria: duration of morning stiffness
≥45 minutes; ≥6 tender or painful
joints; erythrocyte sedimentation rate
(ESR) ≥28 mm/hour; and C-reactive
protein (CRP) ≥20 mg/l . . . .”

Efficacy

Claim 8:

Claim 1:

Claim 1:

“. . . in
therapeutically
effective
amounts.”

“. . . wherein such administration
reduces or eliminates signs and
symptoms associated with rheumatoid
arthritis.”

“. . . wherein the treatment reduces
the individual’s signs and symptoms
by greater than fifty percent (50%)
according to the Paulus criteria for a
significant duration of time.”
Claim 19:
“The method of any of claims 1-18,
wherein the method further results in
the individual’s rheumatoid arthritis
going into remission or near
remission.”

Mechanism
of Action

Claim 8:

Claim 1:

Claim 1:

“. . . an anti-tumor
necrosis factor
alpha antibody or
an antigenbinding fragment
thereof . . . .”

“. . . wherein the anti-human tumor
necrosis factor-α antibody or fragment
thereof (a) binds to an epitope on
human tumor necrosis factor-α, (b)
inhibits binding of human tumor
necrosis factor-α to human tumor
necrosis factor-α cell surface receptors
. . . .”

“. . . which antibody (a) binds
specifically to human tumor necrosis
factor-α and (b) inhibits binding of
human tumor necrosis factor-α to
both p55 and p75 cell surface
receptors . . . .”

Claim 19:
“. . . wherein the anti-human tumor
necrosis factor-α antibody binds
specifically to human tumor necrosis
factor-α . . . .”

A. Level of Disease in Patient Population
In the Prior Action, the Court found that “a person of ordinary skill in the art would not
consider there to be a substantial difference” between (1) “an individual in need of” treatment for
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RA (‘766 Patent) and (2) “an individual suffering from rheumatoid arthritis whose active disease
is incompletely controlled despite already receiving methotrexate” (‘442 Patent). See Prior
Decision, 956 F. Supp. 2d 429, ¶ 354. In reaching this conclusion, the Court construed “patients
with ‘active disease’” to mean “patients with continuing signs and symptoms of rheumatoid
arthritis despite their ongoing methotrexate treatment.” Id. ¶ 345. The Court held that “a person
of ordinary skill in the art would not be limited to the definition of ‘active disease’” urged by
Kennedy, which was “the presence of six or more swollen joints plus at least three of four
secondary criteria.” Id. ¶¶ 342–44. Although this definition had been used in clinical trials, the
Court determined that a POSA would not be limited to this particular definition. Id.
As Abbvie correctly observes, the Prior Decision rejected Kennedy’s contention that it
would be nonobvious to treat a “sicker subset of patients.” (Reply at 3.) Although the Court
held that the definition of “active disease” was not “limited to” the one Kennedy now spells out
in its claims, Kennedy does not refer to any evidence to raise a genuine dispute that such a
circumscribed definition yields a patentably distinct invention. Instead, Kennedy merely refers
to evidence that “the treatment regimen for a patient would depend considerably on the signs and
symptoms of the patient being treated, and that a POSA would have different treatment plans and
different expectations of success depending on the signs and symptoms present.” (Opp’n at 15.)
Of course, every patient is different, but this does not suggest that treating patients with this
particular level of disease requires a different ODP analysis than treating patients whose RA is
“incompletely controlled.”
B. Efficacy
In the Prior Action, the Court found that narrowing the ‘766 Patent’s claim for a
treatment in a “therapeutically effective amount” to the ‘442 Patent’s claim for a treatment that

9

“reduces or eliminates signs or symptoms associated with rheumatoid arthritis” did not render
the latter patentably distinct. See Prior Decision, 956 F. Supp. 2d 429, ¶ 366. The Court
observed that the former “clearly encompasses” the latter. Id.
Here again, Kennedy has narrowed the language regarding efficacy, this time in two
separate claims. Claim 1 of the ‘120 Patent recites a treatment that “reduces the individual’s
signs and symptoms by greater than fifty percent (50%) according to the Paulus criteria for a
significant duration of time.” Claim 19 recites a treatment that “results in the individual’s
rheumatoid arthritis going into remission or near remission.” These claims rely on the same data
considered in the Prior Action. In support of these claims’ nonobviousness, Kennedy cites Dr.
Michael Weinblatt’s deposition testimony that, as of August 1, 1995, achieving remission was
“generally not doable with most of the therapies we had” and is “generally not doable now.”
(Maldonado Decl. Ex. 14 at 69.)
The claims of increased efficacy, however, do not vary the issues bearing on obviousness
for two reasons. First, the Court already determined—on the basis of the same clinical data
presented here—that the methods claimed in the ‘442 Patent did not yield “unexpected results”
when compared to those of the ‘766 Patent. See Prior Decision, 956 F. Supp. 2d 429, ¶¶ 370–74.
Indeed, the Court heard testimony regarding purportedly surprising results as measured by the
Paulus criteria at issue here. (Shehigian Decl. Ex. 7 at 691–92.)
Second, the Prior Decision’s observation that the ‘442 Patent’s efficacy claims were
“encompassed by” those of the ‘766 Patent are equally applicable to the ‘120 Patent. The ‘442
Patent claimed a treatment that “reduces or eliminates signs or symptoms” of RA, and the ’120
Patent merely measures the reduction in terms of the Paulus criteria and uses the word

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“remission” in lieu of “eliminates.” Even if there were a possible semantic difference, 5 there is
not a substantial legal one for purposes of the ODP analysis. “[M]erely discovering and claiming
a new benefit of an old process cannot render the process again patentable.” King Pharm., Inc. v.
Eon Labs, Inc., 616 F.3d 1267, 1275 (Fed. Cir. 2010). That is true even where there are “[n]ewly
discovered results of known processes directed to the same purpose . . . because such results are
inherent.” Bristol-Myers Squibb Co. v. Ben Venue Labs., Inc., 246 F.3d 1368, 1376 (Fed. Cir.
2001). Accordingly, the ‘120 Patent raises no new ODP issues with respect to the treatment’s
efficacy.
C. Mechanism of Action
The Prior Decision found that reciting the anti–TNFα antibodies’ mechanism of action
did not render the ‘442 claims patentably distinct from the ‘766 claims. See 956 F. Supp. 2d 429,
¶¶ 359–61. While the ‘766 Patent does not recite a mechanism of action, the ‘442 Patent did so
as follows: the anti–TNFα antibody “(a) binds to an epitope on human [TNFα], [and] (b) inhibits
binding of human [TNFα] to human [TNFα] cell surface receptors.” The Court found that “[a]
person of ordinary skill in the art would expect these mechanisms of action by the antibody as
they had been known in the prior art by August 1, 1995.” Id. at ¶ 361. Here, the ‘120 Patent
adds a recitation that the anti–TNFα antibody “inhibits binding of human [TNFα] to both p55
and p75 cell surface receptors.”
Abbvie contends that this mechanism is “an inherent part of the antibody’s binding
mechanism,” and thus does not raise any new issue here. (Opening Br. at 17.) Indeed,
Kennedy’s expert, Dr. Peter Lipsky, testified at trial that this particular mechanism was “within

5

See generally Webster’s Third New International Dictionary 1920 (2002) (defining “remission” as “a temporary
abatement of the symptoms of a disease”).

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the scope of” the ‘442 Patent. (Maldonado Decl. Ex. 7 at 632.) Moreover, his deposition
testimony from the Prior Action demonstrates his understanding that the ‘442 Patent’s language
concerning “cell surface receptors” refers to the p55 and p75 receptors. He explained that since
“[t]here are only two” cell surface receptors, he “assume[d] that means p55 and p75.” (See
Shehigian Decl. Ex. 14 at 250– 251.) He stated that he drew that conclusion based on “the
literature of that time” relevant to the ‘442 Patent (id. at 251), whose prior art is coextensive with
that of the ‘120 Patent.
Kennedy does not directly dispute that this binding mechanism is inherent, 6 but rather
asserts that it was “unknown as of 1993.” (Opp’n at 18.) Yet the study Kennedy cites does not
state that the mechanism was unknown, but rather that it “was not established in this study.”
(Maldonado Decl. Ex. 12 at 1688.) Therefore, Kennedy has not raised a genuine dispute of fact
regarding whether the claimed mechanism was known.
Moreover, even if there were a genuine dispute about whether the mechanism was
known, it would be immaterial because there is also no dispute that the mechanism is an inherent
feature of the invention. Merely describing an inherent property or mechanism of the prior art,
without more, does not render a claim patentably distinct. See, e.g., Alcon Research, Ltd. v.
Apotex Inc., 687 F.3d 1362, 1369 (Fed. Cir. 2012) (claimed limitation was obvious where it was
an “inherent property”), cert. denied, 133 S. Ct. 1736 (2013); In re Huai-Hung Kao, 639 F.3d
1057, 1070 (Fed. Cir. 2011) (concluding that even where the claimed limitation was a

6

Kennedy disputes only that the Court considered the inherency issue in the Prior Action. (See Def.’s R. 56.1 Stmt.
¶ 78.) Here, Kennedy contends that “AbbVie has not cited any admissible evidence” on the issue. (Id.) On the
contrary, Abbvie has cited the prior testimony of Kennedy’s expert, which could be “presented in a form that would
be admissible in evidence,” Fed. R. Civ. P. 56(c)(2), namely his live testimony at trial. See Donovan v. Diplomat
Envelope Corp., 587 F. Supp. 1417, 1426 (E.D.N.Y. 1984) (“All that is required is that the affiant or deponent make
statements which would be admissible in evidence if given as testimony.”), aff’d, 760 F.2d 253 (2d Cir. 1985).

12

“previously-unknown, yet inherent” property, it “add[ed] nothing of patentable consequence”);
In re Kubin, 561 F.3d 1351, 1357 (Fed. Cir. 2009) (“Even if no prior art of record explicitly
discusses the [binding mechanism], the [applicant’s] application itself instructs that [such]
binding is not an additional requirement imposed by the claims on the [molecule], but rather a
property necessarily present in [the molecule].”); CollaGenex Pharm., Inc. v. IVAX Corp, 375 F.
Supp. 2d 120, 137 (E.D.N.Y. 2005) (“When a process described in a later patent is inherent,
although not specifically described, in the claims of an earlier patent owned by the same person,
the later patent is likely invalid under the judicially created doctrine of obviousness-type double
patenting.”). Accordingly, there is no new ODP issue raised by the ‘120 Patent’s additional
language concerning the mechanism of action.
D. Comparison of Claims “As a Whole” With Prior Art
Taking the differences between the ‘120 Patent and the ‘442 Patent in the context of their
importance to the invention as a whole, it is clear that they raise no new issue bearing on the
ODP analysis. Not only does the ‘120 Patent merely limit its claims to those that were already
clearly covered by the prior two patents, it has done so in ways that the Court actually considered
in the Prior Action. A patentee like Kennedy may seek to adjust its claims in response to actions
by a patent examiner or by a court, but Kennedy has failed to do so here in any way that would
materially affect the Court’s prior ODP analysis. In essence, Kennedy has claimed the same
treatment as a new invention—but with limitations to treat sicker patients, for a specific
outcome, and by a specific mechanism that was inherent in the prior art. As with the narrowed
claims of the ‘442 Patent, this is precisely the kind of insubstantial tinkering on a previous patent
that the ODP doctrine renders unpatentable.

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Accordingly, the Court determines that the interests of "justice and equity" weigh
strongly against relitigating issues that are "substantially identical" to those adjudicated in the
Prior Action. See Bourns, 537 F.2d at 491, 497- 98 (applying collateral estoppel "despite verbal
differences in the claims" because plaintiffs had already "had their one day in court on those
issues").
CONCLUSION
For the foregoing reasons, the Court GRANTS Plaintiffs' motion for summary judgment.
The Clerk of Court is directed to enter judgment declaring that claims 1-2, 6-8, 12-14, and 1819 of U.S. Patent No. 8,383,120 are invalid and to close this case.

Dated: New York, New York
July 9, 2014

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