Endo Pharmaceuticals Inc. et al v. Teva Pharmaceuticals USA, Inc. et al
OPINION: For the reasons given above, defendants' motions for summary judgment are granted with regard to United States Patent Number 8,114,383. Summary judgment is denied with regard to United States patent numbers 8,309,060 and 8,192,722. SO ORDERED. (Signed by Judge Thomas P. Griesa on 3/17/2015) (kl)
UNITED STATES DISTRICT COURT
SOUTHERN DISTRICT OF NEW YORK
ENDO PHARMACEUTICALS INC., and
– against –
TEVA PHARMACEUTICALS USA, INC., and
BARR LABORATORIES, INC.
ENDO PHARMACEUTICALS INC., et al.
– against –
IMPAX LABORATORIES, INC. et al.,
ENDO PHARMACEUTICALS INC., et al.,
– against –
IMPAX LABORATORIES, INC.,
on the following page)
ENDO PHARMACEUTICALS INC., et al.
– against –
ACTAVIS INC., et al.,
On February 18, 2015, defendants in these patent infringement
actions moved for summary judgment with regard to three of the six
patents in suit, U.S. Patent Numbers 8,114,383 (“the ’383 Patent”),
8,309,060 (“the ’060 Patent”), and 8,192,722 (“the ’722 Patent”).
Defendants argue that plaintiffs are collaterally estopped from litigating
those patents here because they were invalidated in a case presided over
by Judge Stein of this court. For the following reasons, the court grants
summary judgment with regard to the ’383 Patent, but denies summary
judgment with regard to the ’060 Patent and the ’722 Patent.
The three patents at issue on this motion relate to co-plaintiff
Grünenthal GmbH’s “thermoforming” technology. The technology uses
heat and pressure to make pills difficult to crush and snort. Grünenthal
licensed a version of the technology, named INTAC®, to co-plaintiff Endo
Pharmaceuticals Inc. Endo then used the technology to develop a crush-
resistant version of its oxymorphone painkiller OPANA®ER. The crushresistant formulation of the drug is named OPANA®ER CRF.
From September through December of 2012, defendants filed
applications with the Food and Drug Administration to market generic
oxymorphone hydrochloride pills in extended release form. Plaintiffs
responded by filing the instant lawsuits for patent infringement. Among
other things, plaintiffs allege that defendants, in applying to make a
generic oxymorphone hydrochloride product, infringe on several of the
claims contained in the ’383, ’060, and ’722 patents.
In September of 2013, Judge Stein of this court held a bench trial
in a case titled In re Oxycontin Antitrust Litigation. 994 F. Supp. 2d 367
(S.D.N.Y. 2014). In that case, the plaintiff Purdue Pharmaceuticals alleged
that the defendant, Teva Pharmaceuticals USA, Inc., would infringe on
several of its patents if allowed to market a generic version of the drug
OxyContin. Id. at 376. One of the patents asserted in that case was United
States Patent Number 8,114,383. Id. That patent, the ’383 Patent, is also
asserted in this case.
Five claims of the ’383 Patent were invalidated in In re Oxycontin.
These were claim 1; claim 2; claim 5; claim 7; and claim 8. Judge Stein
found that these claims were invalid because they were anticipated by the
prior art, specifically by a publication known as the “McGinity
Application.” See id. at 421. Moreover, Judge Stein determined that even
if not anticipated by the prior art, these claims were invalid for
obviousness, meaning that a “person of ordinary skill in the art would have
had sufficient knowledge and motivation to make the invention claimed by
the ′383 Patent.” Id. at 426.
Plaintiffs in the instant case assert four of the exact same claims of
the ’383 Patent invalidated in the OxyContin case. These are claim 1; claim
2, claim 5, and claim 7. Plaintiffs also assert claim 9 of the ’383 Patent,
which was not at issue in the OxyContin case. Claim 9 reads: “The dosage
form according to claim 1, wherein the active ingredient with abuse
potential (A) is oxymorphone or a physiologically acceptable salt thereof.”
This language is identical to claim 8, which was asserted in the OxyContin
case, except that the word “oxymorphone” is substituted for the word
“oxycodone.” Compare Claim 9, U.S. Patent No. 8,114,383 B2 with Claim
8, U.S. Patent No. 8,114,383 B2.
Plaintiffs also assert two patents, the ’060 Patent and the ’722
Patent, which were not asserted in the OxyContin case.
The standard governing motions for summary judgment is wellsettled. A court may grant summary judgment only when the moving party
shows that “there is no genuine issue as to any material fact and that the
moving party is entitled to judgment as a matter of law.” Fed. R. Civ. P.
56(c); see also Celotex Corp. v. Cartrett, 477 U.S. 317, 322 (1986). “When
considering a motion for summary judgment, a court must construe the
evidence in the light most favorable to the nonmoving party, drawing all
inferences in that party's favor.” Jeffreys v. City of New York, 426 F.3d 549,
553 (2d Cir. 2005).
Collateral estoppel prohibits a party from relitigating an issue that
has already been decided in a previous proceeding. Collateral estoppel will
apply where “(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.” Ball v. A.O. Smith Corp., 451 F.3d 66, 69 (2d Cir.
2006). In a patent infringement action, it is not necessary that the claims
asserted be identical to the previously adjudicated claims in order for
collateral estoppel to apply. Ohio Willow Wood Co. v. Alps S., LLC, 735 F.3d
1333, 1342 (Fed. Cir. 2013). Rather, “If the differences between the
unadjudicated patent claims and adjudicated patent claims do not
materially alter the question of invalidity, collateral estoppel applies.” Id.
The factors listed above indisputably apply to the four claims of the
’383 Patent asserted in the trial before Judge Stein. The issue in OxyContin
was whether claims 1, 2, 5, 7, and 8 of the ’383 Patent were invalid. In re
OxyContin, 994 F. Supp. 2d at 421. Judge Stein held that those claims
were invalid because two scientists at the University of Texas had
developed a “hot-melt extrusion process” for manufacturing extendedrelease pills years earlier, and that a publication relating to this process
(the “McGinity Application”) disclosed every required limitation of the
claims asserted. Id. at 425. Thus, those claims were invalid as anticipated
by the McGinity Application. Id.
Judge Stein did not adjudicate the validity of claim 9 of the ’383
Patent because that claim was not before him. However, he did adjudicate
the validity of claim 8 of that patent. Claim 8 of the patent reads “The
dosage form according to claim 1, wherein the active ingredient with abuse
potential (A) is oxycodone or a physiologically acceptable salt thereof.”
Judge Stein ruled that this claim was invalid because the McGinity
Application disclosed to a person of ordinary skill in the art that the
invention could be used with oxycodone. Id. at 425. Notably, claims 8 and
9 of the ’383 patent are identical, except that they refer to different opioids:
oxycodone and oxymorphone.
Although Judge Stein did not consider claim 9 of the ’383 Patent,
resolving the validity of that claim would involve questions, and answers
to those questions, identical to those relevant to claim 8 of the ’383 Patent.
The McGinity application describes using the hot-melt extrusion of a highdensity polymer and therapeutic compound to create controlled-release
drugs. See International Application Published Under the Patent
Cooperation Treaty (PCT) (“McGinity Application”) at 2, 8. This process was
expressly intended, among other things, to create analgesics in the form
of “tablets, pills . . . and the like.” Id. at 8, 11. Oxymorphone, like
oxycodone, is an opioid analgesic. See Remington’s Pharmaceutical
Sciences 17 (Ex. G) at 1103–05 (describing oxymorphone hydrochloride as
one of several semisynthetic opiate analgesics). Consequently, a person of
ordinary skill in the art would interpret the McGinity Application as
disclosing the invention’s use in creating controlled release tablets of
oxycodone, In re OxyContin, 994 F. Supp. 2d at 425, and oxymorphone.
Because there is no material difference between the questions of validity
with regard to claim 8 and claim 9 of the ’383 Patent, collateral estoppel
applies. See Ohio Willow, 735 F.3d at 1342.
Defendants have satisfied their burden for obtaining summary
judgment with regard to the ’383 Patent. There is no dispute that claims
1, 2, 5 and 7 of the ’383 Patent were litigated to final judgment in the
OxyContin case, and that collateral estoppel applies to those claims. As
discussed, collateral estoppel applies with equal force to claim 9 of the ’383
Patent because trial on that patent would implicate questions of validity
identical to those presented in the earlier case.
Defendants have also highlighted intriguing similarities between the
other two patents at issue on this motion, the ’060 and ’722 patents, and
the patent litigated to final judgment in the OxyContin case. See Defs.
Mem. L. Supp. Mot. Summary J. at 9–11. However, unlike the ’383 Patent,
defendants have not shown that the claims asserted from the ’060 and
’722 patents are similar enough to (and raise materially identical questions
as to validity) as the claims adjudicated in the OxyContin litigation. Indeed,
the claims of the ’060 and ’722 patents recite limitations that were not
considered or adjudicated by Judge Stein. See, e.g., Claim 1 of U.S. Patent
Number 8,309,060 (referring to an “abuse-proofed” thermoformed dosage
form). Because the ’060 and ’722 patents were not adjudicated in the
OxyContin case, and because their claims recite different limitations,
collateral estoppel does not preclude litigation of those claims here.
Of course, summary judgment does not require collateral estoppel.
A party may also obtain summary judgment by showing that there is no
genuine issue as to any material fact and that the party is entitled to
judgment as a matter of law. But defendants, in their briefing in support
of summary judgment, did not invoke summary judgment on the merits
(validity/invalidity) of the ’060 and ’722 patents, but simply as a matter of
collateral estoppel. See Mot. Summ. J. at 1 (“defendants will move the
Court . . . for partial summary judgment of collateral estoppel as to [the
three patents at issue].”) Thus, absent collateral estoppel, there is
insufficient evidence before the court to warrant summary judgment on
the ’060 and ’722 patents.
For the reasons given above, defendants’ motions for summary
judgment are granted with regard to United States Patent Number
8,114,383. Summary judgment is denied with regard to United States
patent numbers 8,309,060 and 8,192,722.
Dated: New York ' NewYork
March 17, 2015
Thomas p. Gnesa
U.S. District Judge
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