ABBOTT LABORATORIES et al v. ACTAVIS ELIZABETH LLC et al
Filing
77
OPINION. Signed by Judge Dennis M. Cavanaugh on 2/23/12. (dc, )
NOT FOR PUBLICATION
UNITED STATES DISTRICT COURT
DISTRICT OF NEW JERSEY
ABBOTT LABORATORIES and
FOURNIER LABORATORIES
iRELAND LTD.,
Plaintiffs,
Hon. Dennis M. Cavanaugh
OPINION
Civil Action No. 10-1578 (DMC-JAD)
LUPIN LTD. et al.,
Defendants.
ABBOTT LABORATORIES and
FOURNIER LABORATORIES
IRELAND LTD.,
Plaintiffs,
Civil Action No, 10-2073 (DMC-JAD)
V.
MYLAN PHARMACEUTICALS, et al.,
Defendants.
ABBOTT LABORATORIES and
FOURNIER LABORATORIES
IRELAND LTD.,
Plaintiffs,
Civil Action No, 10-2139 (DMC-JAD)
V.
WATSON LABORATORIES, INC.
FLORIDA, et al.,
Defendants.
ABBOTT LABORATORIES and
FOURNIER LABORATORIES
IRELAND LTD.,
Plaintiffs,
Civil Action No. 10-2352 (DMC-JAD)
V.
ACTAVIS ELIZABETH LLC., et al.,
Defendants.
ABBOTT LABORATORIES and
FOURNIER LABORATORIES
IRELAND LTD.,
Plaintiffs,
Civil Action No. 10-3015 (DMC-JAD)
V.
ANCHEN PHARMACEUTICALS, INC.,:
Defendants.
DENNIS M. CAVANAUGH, U.S.D.J.
This matter comes before the Court upon the Motions for Summary Judgment filed by
Defendants Lupin Ltd., et al,, Mylan Pharmaceuticals, Inc., et al., Watson Labs, Inc,-Florida, et al.,
Actavis Elizableth LLC, et al., and Anchem Pharmaceuticals, Inc. (collectively, ‘Defendants”). ECF
No. 61 in Docket 10-1578; ECF No. 61 in Docket 10-2073; ECF No. 74 in Docket 10-2139; ECF
No. 57 in Docket 10-2352; and ECF No. 59 in Docket 10-3015.’ Pursuant to FED. R. Cw. P. 78, no
oral argument was heard, After carefully considering the submissions of the parties, and based upon
the following, it is the finding of this Court that Defendants’ Motions are denied.
b
BACKGROUND
This case concerns a pharmaceutical patent infringement suit. Plaintiffs jointly own the
rights to U.S. Patent No. 7.259,186 (the
“
186 Patent”), which currently expires on Jan. 7, 2025, and
claims novel salts of and formulations of fenofibric acid. Compi.
¶ 15, ECF No. 1. These salts and
formulations of fenofibric acid are useful as lipid and cholesterol lowering agents for treatment of
adults with increased triglyceride levels. Compi. ¶ 17. Plaintiffs market choline fenofibrate delayed
release capsules under the name TRILIPIX. Compi. ¶ 18. Defendants submitted Abbreviated New
Drug Applications (“ANDAs”) to the U.S. Food and Drug Administration (‘FDA”), seeking
approval to manufacture, use, and sell choline fenofibrate delayed release capsules as generic
versions of TRILIPIX.
Compi.
¶
21.
Plaintiffs thereafter filed the present suit for patent
infringement. Compl. ¶j 25-31.
Defendants filed the present Motion for Summary Judgment on October 24, 2011, arguing
that Claims One and Two of the ‘186 Patent are invalid as obvious. Plaintiffs filed their Opposition
‘The Motion filed in each docket is identical, as are the parties’ related filings. The
Court will therefore refer to filings in the Lupin action, Civ. Action No. 10-1578, for the sake of
ease.
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papers on November 22, 2011. ECF No. 65, 66. Plaintiffs also filed related Motions to Seal
Materials on November 23, 201 1, Redacted versions of the documents at issue are currently
available on the Court’s electronic docket, and un-redacted versions of those documents are currently
sealed. Defendants filed their Reply papers in support of their Motion for Summary Judgment on
December 6. 2011. ECF No. 71. The matter is now before this Court.
IL
LEGAL STANDARD
Summary judgment is granted only if all probative materials of record, viewed with all
inferences in favor of the non-moving party, demonstrate that there is no genuine issue of material
fact and that the movant is entitled to judgment as a matter of law. $.g FED. R. Civ. P. 56(c);
Celotex Corp. v. Catrett, 477 U.S. 317, 330 (1986). The moving party bears the burden of showing
that there is no genuine issue of fact.
jj “The burden has two distinct components: an initial
burden of production, which shifts to the nonmoving party if satisfied by the moving party: and an
ultimate burden of persuasion, which always remains on the moving party.” Id. The non-moving
party “may not rest upon the mere allegations or denials of his pleading” to satisfy this burden, but
must produce sufficient evidence to support a jury verdict in his favor.
FED. R, Civ. p. 56(e);
see g Matsushita Elec. Indus. Co. v. Zenith Radio Corp., 475 U.S. 574. 586 (1986).
“[U]nsupported allegations in [a] memorandum and pleadings are insufficient to repel summary
judgment.” Schoch v. First Fid. Bancorporation, 912 F.2d 654,657 (3d Cir. 1990). “In determining
whether there are any issues of material fact, the Court must resolve all doubts as to the existence
of a material fact against the moving party and draw all reasonable inferences including issues of
-
credibility in favor of the nonmoving party.” Newsome v. Admin. Office of the Courts of the State
-
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of N.J., 103 F. Supp.2d 807, 815 (D.N.J. 2000), afid, 51 Fed. Appx. 76 (3d Cir. 2002) (citing Watts
v. Univ. of Del., 622 F.2d 47, 50 (D.N.J. 1980)).
ffl,
DISCUSSION
Defendants seek to have Claims One and Two of the ‘186 Patent declared invalid. Claim
One of the 186 Patent claims “[a] salt of fenofibric acid selected from the group consisting of
choline, ethanolamine, diethanolamine, piperazine, calcium and tromethamine.” Claim Two of the
‘186 Patent claims “[t]he salt of claim 1 wherein said salt is choline,” Defendants assert that
summary judgment is warranted on the grounds of obviousness, stating that “the asserted claims arc
directed to salts of a known compound, fenofibric acid, and the prior art teaches the advantages of
salts selected from a limited class that are known to be pharmaceutically acceptable.” Defs,’ Mot,
Br. 1.
To prevail on a defense of invalidity for obviousness, Defendants must demonstrate by clear
and convincing evidence that:
the ditTerences between the subject matter sought to be patented and the prior art are
such that the subject matter as a whole would have been obvious at the time the
invention was made to a person having ordinary skill in the art to which said subject
matter pertains.
35 U.S.C.
§
103(a). “A party seeking to invalidate a patent based on obviousness must demonstrate
by clear and convincing evidence that a skilled artisan would have been motivated to combine the
teachings of the prior art references to achieve the claimed invention, and that the skilled artisan
would have had a reasonable expectation of success in doing so.” j.j (citing Pfizer, Inc. v. Apotex.
Inc., 480 F.3d 1348, 1361 (Fed. Cir. 2007)).
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The Supreme Court has enumerated four factors to be considered by courts to assess whether
an invention is obvious. Takedav. Alphapharm Pty., Ltd., 492 F.3d 1350, 1356-57 (Fed. Cir. 2007)
(citing Graham v. John Deere Co., 383 U.S. 1, 17-18 (1966)). The four factors are: (1) the scope and
content of the prior art; (2) the level of ordinary skill in the art; (3) the differences between the
claimed subject matter and the prior art; and (4) secondary considerations, or “objective indicia of
non-obviousness.” Id.
This Court finds that genuine issues of material fact exist in this case, including but not
necessarily limited to whether the prior art motivated one of skill in the art to consider making the
choline salt of fenofibric acid, and whether the prior art demonstrated that the use of the choline salt
of fenofibric acid was a predictable way to improve solubility and bioavailabilit’v of fenofibrate.
Accordingly, these factual disputes preclude a finding at the summary judgment stage. These
disputes present exceptionally complicated questions of fact, and based on this Court’s experience,
are the type of disputes best resolved at trial. Defendants’ Motion is therefore denied.
Y.
CONCLUSION
For the foregoing reasons, Defendants’ Motion for Summary Judgment is denied, Plaintiffs’
Motion to Seal is granted. An appropriate Order accompanies this Opinion.
M. Cavanaugh,
Date:
Orig,:
cc:
February 2012
Clerk
All Counsel of Record
Hon. Joseph A. Dickson, U.S.M.J.
File
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