United States Court of Appeals for the Federal Circuit
2007-1059
FOREST LABORATORIES, INC.,
FOREST LABORATORIES HOLDING, LTD.,
and H. LUNDBECK A/S,
Plaintiffs-Appellees,
v.
IVAX PHARMACEUTICALS, INC.
and CIPLA, LTD.,
Defendants-Appellants.
John M. Desmarais, Kirkland & Ellis LLP, of New York, New York, argued for
plaintiffs-appellees. With him on the brief were Peter J. Armenio, Gerald J. Flattmann,
Jr., Ellen A. Scordino, and Anne S. Toker.
Henry C. Dinger, Goodwin Proctor LLP, of Boston, Massachusetts, argued for
defendants-appellants. With him on the brief was Francis C. Lynch. Of counsel on the
brief were Jeffrey S. Ward, and Thomas P. Heneghan, Michael Best & Friedrich LLP, of
Madison, Wisconsin.
Appealed from: United States District Court for the District of Delaware
Judge Joseph J. Farnan, Jr.
United States Court of Appeals for the Federal Circuit
2007-1059
FOREST LABORATORIES, INC., FOREST LABORATORIES HOLDING, LTD.,
and H. LUNDBECK A/S,
Plaintiffs-Appellees,
v.
IVAX PHARMACEUTICALS, INC. and CIPLA, LTD.,
Defendants-Appellants.
_______________________
DECIDED: September 5, 2007
_______________________
Before LOURIE, Circuit Judge, FRIEDMAN, Senior Circuit Judge, and SCHALL, Circuit
Judge.
Opinion for the court filed by Circuit Judge LOURIE. Opinion concurring as to parts I
through IV.A and dissenting as to part IV.B filed by Circuit Judge SCHALL.
LOURIE, Circuit Judge.
Ivax Pharmaceuticals, Inc. (“Ivax”) and Cipla, Ltd. (“Cipla”) appeal from the order
of the United States District Court for the District of Delaware entering judgment
upholding the validity of United States Reissue Patent 34,712 (“the ’712 patent”) in favor
of Forest Laboratories, Inc., Forest Laboratories Holding, Ltd., and H. Lundbeck A/S
(collectively “Forest”) and enjoining Ivax and Cipla from infringing the ’712 patent. We
affirm the district court’s entry of judgment on validity and its entry of an injunction as to
both Ivax and Cipla, but we modify the injunction to apply only to escitalopram oxalate.
BACKGROUND
Ivax filed Abbreviated New Drug Application 76-765 (“the ANDA”) at the Food
and Drug Administration, pursuant to 21 U.S.C. § 355(j) (§ 505(j) of the Federal Food,
Drug, and Cosmetic Act), for approval to market generic tablets containing 5, 10, or 20
milligrams of escitalopram oxalate (“EO”). The ANDA certified, pursuant to 21 U.S.C.
§ 355(j)(2)(A)(vii)(IV), that the claims of the ’712 patent are invalid and/or not infringed
by the manufacture, use, or sale of the products for which approval was sought. Cipla
is the intended supplier of EO for Ivax and contributed information for the filing of the
ANDA. Forest filed suit on September 22, 2003, alleging that Ivax’s filing of the ANDA
infringed the ’712 patent under 35 U.S.C. § 271(e)(2)(A). 1 Ivax filed its answer on
October 15, 2003, denying infringement and counterclaiming for invalidity of the ’712
patent. Forest later amended its complaint to add Cipla as a defendant on May 27,
2004.
The ’712 patent issued on August 30, 1994 and relates, inter alia, to a
substantially pure (+)-enantiomer of citalopram (also referred to as “escitalopram”) and
nontoxic acid additional salts thereof. Stereoisomers are compounds that contain the
1
35 U.S.C. § 271(e)(2)(A) provides:
It shall be an act of infringement to submit an application under section
505(j) of the Federal Food, Drug, and Cosmetic Act or described in section
505(b)(2) of such Act for a drug claimed in a patent or the use of which is
claimed in a patent if the purpose of such submission is to obtain approval
under such Act to engage in the commercial manufacture, use, or sale of
a drug or veterinary biological product claimed in a patent or the use of
which is claimed in a patent before the expiration of such patent.
2007-1059 -2-
same constituent atoms and the same bonding between those atoms but have different
spatial arrangements. Enantiomers are stereoisomers that are nonsuperimposable
mirror images of one another. Enantiomers accordingly exhibit different optical activity;
the enantiomer that rotates a plane of polarized light in the clockwise direction is the (+)-
enantiomer; the enantiomer that rotates a plane of polarized light in the
counterclockwise direction is the (-)-enantiomer. Enantiomers may also be designated
as the S-enantiomer and the R-enantiomer according to a different criterion relating to
the location of the chiral centers. In the case of citalopram, the (+)-enantiomer is also
the S-enantiomer. A mixture of equal amounts of two enantiomers is called a racemic
mixture or a racemate, and separating the two enantiomers from a racemate is referred
to as resolving the compound. Forest also owned the now expired U.S. Patent
4,136,193 on the racemic form of citalopram and U.S. Patent 4,650,884 that claims a
method for making racemic citalopram using an intermediate racemic 1,4-diol.
EO, which is the oxalate salt form of escitalopram, is one of the compounds
encompassed by the claims of the ’712 patent. It is an antidepressant by virtue of being
a selective serotonin reuptake inhibitor and is the active ingredient in Forest’s Lexapro®
branded drug. Forest has alleged that Ivax and Cipla infringed claims 1, 3, 5, 7, 9 and
11 of the ’712 patent by filing the ANDA. Independent claim 1 of the ’712 patent reads
as follows:
A compound selected from substantially pure (+)-1-(3-
Dimethylaminopropyl)-1-(4’-fluorophenyl)-1,3-dihydroisobenzofuran-5-
carbonitrile and non-toxic acid addition salts thereof.
’712 patent col.10 ll.31-34. Dependent claim 11 recites a method of preparing the
compound of claim 1 by cyclizing an intermediate diol.
2007-1059 -3-
The parties stipulated to a specific claim construction for the primary disputed
term in the ’712 patent, and, based on that agreement, the parties further stipulated that
the proposed products included in the ANDA infringe claims 1, 3, 5, 7, and 9 of the ’712
patent and that the proposed process for making those products infringes claim 11.
Thus, the district court was only required to reach a determination with respect to the
counterclaims, including those asserting that the claims are invalid for anticipation and
obviousness, and that they were improperly broadened through reissue.
After a bench trial, the district court issued its decision on July 13, 2006,
concluding that Ivax and Cipla had failed to prove that the ’712 patent is invalid as
anticipated. Specifically, the court found that an article by Donald F. Smith (“Smith”)
entitled The Stereoselectivity of Serotonin Uptake in Brain Tissue and Blood Platelets:
The Topography of the Serotonin Uptake Area (“Smith reference”) did not anticipate
claim 1 of the ’712 patent because it did not disclose “substantially pure” escitalopram
as claimed in claim 1 and it did not enable a person having ordinary skill in the art to
obtain that compound. The court found that chiral High Performance Liquid
Chromatography (“HPLC”) was a relatively new and unpredictable technique at the time
of the invention and that Smith had worked with the founder of the field of chiral HPLC
to separate the enantiomers of citalopram near the time of the invention, but had failed
in his efforts. The court also found that a team of chemists at Lundbeck had
unsuccessfully attempted to use chiral HPLC to resolve citalopram for two years and
that Dr. Danishefsky, Forest’s medicinal chemistry expert, had unsuccessfully tried to
resolve compounds with HPLC in the mid-1980’s. The court also found that an inventor
of the ’712 patent, Dr. Bogeso, had conducted numerous experiments attempting to
2007-1059 -4-
resolve racemic citalopram through the method of diasteriomeric salt formation, but had
also failed. Finally, the court found that Dr. Bogeso only attempted to resolve
citalopram using a diol intermediate, as recited in claim 11 of the ’712 patent, as a last
resort and that others of skill in the art would have similarly hesitated because there was
a real possibility that the resolved intermediate would re-racemize during the attempt to
convert it from the diol intermediate enantiomer to the desired citalopram enantiomer.
Thus, the court found that attempting to separate the enantiomers of citalopram based
on the knowledge of one of ordinary skill in the art would have required undue
experimentation and that the Smith reference was therefore not enabled.
Next, the district court concluded that Ivax and Cipla had failed to prove by clear
and convincing evidence that any of the asserted claims of the ’712 patent were
obvious. The court found that one of ordinary skill in the art at the time of the invention
would generally have been motivated to develop new compounds rather than undertake
the difficult and unpredictable task of resolving a known racemate. The court further
found that a person of ordinary skill attempting to resolve racemic citalopram would
have had no reasonable expectation of success for reasons similar to those discussed
with respect to enablement of the Smith reference. With respect to the method of claim
11 of the ’712 patent, the court found that none of the articles relied upon by Ivax and
Cipla described the particular types of reactions claimed (viz., “a Mosher ester serving
as a leaving group for a ring closure of a Diol Intermediate,” “an enantioconserving ring
closure of a diol containing a tertiary amine to form a tetrahydrofuran,” or “an
enantioconserving cyclization reaction of the type needed to convert a tertiary amine
like any enantiomerically pure Diol Intermediate into substantially pure (+)-citalopram”).
2007-1059 -5-
The court also found that secondary considerations of commercial success, unexpected
results, and copying by others supported the validity of the claims.
In addition, the district court found that claim 11 of the ’712 patent was not invalid
for impermissible broadening during reissue. During the reissue proceeding that
resulted in the ’712 patent, claim 11 was corrected to claim a method of converting a
(-)-diol intermediate to (+)-citalopram, rather than using a (+)-diol intermediate as shown
in the original patent claim. The court found that, given the specific description of the
process in the specification, this change amounted to correction of a typographical
error. In other words, the court found that the mistake would have been clear to one of
ordinary skill in the art reviewing the patent, and therefore that it did not constitute a
change in scope from the original claim.
The court entered judgment in accordance with its opinion on November 3, 2006
and at the same time enjoined both Ivax and Cipla “from commercially making, using,
offering to sell or selling within the United States, or importing into the United States any
products that infringe the ’712 patent, including the escitalopram oxalate products
referred to in the Abbreviated New Drug Application No. 76-765 until such time as the
’712 patent expires.” Ivax and Cipla timely appealed. We have jurisdiction pursuant to
28 U.S.C. § 1295(a)(1).
DISCUSSION
I. Anticipation
On appeal, Ivax and Cipla argue that the Smith reference clearly anticipates
claim 1 of the ’712 patent because it discusses and analyzes the efficacy of various
drug enantiomers and predicts that one citalopram enantiomer will be more potent as a
2007-1059 -6-
serotonin reuptake inhibitor than the other. Ivax and Cipla further argue that one of
ordinary skill in the art would have known at the time of the invention to use
diasteriomeric salt formation to resolve citalopram. Specifically, a person of skill in the
art would have used the method described in the Wilen reference to resolve the racemic
intermediate diol into its enantiomers and the method in the Jacobus reference
(Williamson ether synthesis) to convert the diol enantiomer (by cyclizing the ether ring)
to (+)-citalopram. Ivax and Cipla add that Dr. Borgeso’s ability to resolve citalopram on
his first try after starting with the diol intermediate is further compelling evidence that
only routine experimentation was required to separate the enantiomers.
In response, Forest argues that the Smith reference does not disclose
“substantially pure” (+)-citalopram. Forest also argues that the testimony of the experts
and the repeated failures of Dr. Borgeso and others to resolve citalopram into its
enantiomers support the district court’s determination that the Smith reference was not
enabled for (+)-citalopram. Forest also states that the court was correct to conclude
that a person of ordinary skill would have viewed the difficulty in resolving the diol
intermediate rather than citalopram itself as significant and a deterrent. In addition,
Forest argues that even if a person of skill in the art were to consider using the diol, the
Wilen and Jacobus references do not involve compounds with structures similar enough
to the citalopram diol intermediate so that a person of ordinary skill would rely upon
them to predict the results of a reaction with that compound. More specifically, Forest
argues that neither reference discloses a cyclizing reaction involving a compound, like
the citalopram diol, that has a resident tertiary amine or a benzylic alcohol.
2007-1059 -7-
Anticipation is a question of fact that we review for clear error following a bench
trial. Amgen Inc. v. Hoechst Marion Roussel, Inc., 457 F.3d 1293, 1304 (Fed. Cir.
2006). “Under the clear error standard, the court’s findings will not be overturned in the
absence of a definite and firm conviction that a mistake has been made.” Impax Labs.,
Inc. v. Aventis Pharm. Inc., 468 F.3d 1366, 1375 (Fed. Cir. 2006) (quotation omitted).
“Whether a prior art reference is enabling is a question of law based upon underlying
factual findings.” Id. at 1382 (quoting Minn. Mining & Mfg. Co. v. Chemque, Inc., 303
F.3d 1294, 1301 (Fed. Cir. 2002)).
We agree with Forest that the district court’s factual findings relating to
enablement of the Smith reference are not clearly erroneous, and, based upon those
findings, we find no error in the district court’s conclusion that the Smith reference is not
enabled with respect to (+)-citalopram. The Smith reference is a pharmacology paper,
not a chemical paper. It describes the effects of various enantiomers of particular drugs
(not including (+)-citalopram) on the uptake of serotonin in brain tissue and/or platelets.
It mentions racemic citalopram (“also of interest”) and shows its structure, but predicts,
incorrectly, that the R-enantiomer (the (-)-enantiomer for citalopram, not the one
claimed in the ’712 patent) should be far more potent as a serotonin reuptake inhibitor.
Because a racemate does encompass its two enantiomers, it in effect does state that
there is a (+)-enantiomer of citalopram, but it does not tell how to obtain it. A reference
that is not enabling is not anticipating. Elan Pharm., Inc. v. Mayo Found. For Med.
Educ. & Research, 346 F.3d 1051, 1054 (Fed. Cir. 2003). The Smith reference, as a
pharmacology paper, thus does not enable the preparation of the (+)-enantiomer of
citalopram.
2007-1059 -8-
Ivax and Cipla acknowledge that the Smith reference itself does not teach one of
ordinary skill how to make (+)-citalopram, but their arguments that it is enabled by other
references are largely a recounting of the testimony favorable to their theory of the case
without explanation as to why we should have a definite and firm conviction that
mistakes were made by the district court in its fact-finding. In other words, they do not
inform us why the district court was not entitled to rely on the evidence favorable to
Forest or demonstrate that the evidence favorable to them heavily outweighed the
evidence favorable to Forest. Such evidence includes the failures of various scientists
to resolve citalopram as recited above. Given Ivax and Cipla’s failure to disturb the
detailed and thorough factual findings underlying the district court’s decision, we see no
error in the finding that the Smith reference does not enable one of ordinary skill to
make (+)-citalopram and hence that the Smith reference does not anticipate claims to
(+)-citalopram.
II. Obviousness
Ivax and Cipla argue that (+)-citalopram was obvious in light of racemic
citalopram and descriptions of techniques available to separate enantiomers from their
racemates. Further, they argue that the general expectation in the art that one
enantiomer would be more potent than the other provided reason for a person of
ordinary skill in the art to isolate the enantiomers. For reasons similar to those
discussed with respect to their argument that the Smith reference was enabled, Ivax
and Cipla contend that a person of ordinary skill in the art would have had a reasonable
expectation that one could separate the enantiomers of citalopram. Ivax and Cipla also
argue that Lexapro’s® commercial success was due to aggressive marketing rather
2007-1059 -9-
than any alleged superiority of the drug to alternatives and that it did not possess
unexpectedly superior properties. Ivax and Cipla also argue that claims 3, 5, 7, and 9
represent only obvious variations on claim 1 with no elements that are not standard in
medicinal chemistry and that claim 11 represents the obvious way of resolving
citalopram in light of the teaching of the Wilen and Jacobus references.
In response, Forest argues that any prima facie obviousness based on racemic
citalopram was rebutted by the evidence demonstrating the difficulty of separating the
enantiomers and the unexpected properties of (+)-citalopram. Forest argues that it was
unexpected that all of the therapeutic benefit of citalopram would reside in the (+)-
enantiomer, resulting in escitalopram having twice the potency of racemic citalopram.
Forest also argues that the district court was entitled to credit evidence that a person of
ordinary skill in the art would not easily have turned to the diol intermediate to attempt
resolution of racemic citalopram both because of the uncertainty involved and because
Wilen and Jacobus describe compounds less complex than those necessary here to
resolve the diol intermediate and then convert the (-)-diol enantiomer to escitalopram.
“Obviousness is a question of law, reviewed de novo, based upon underlying
factual questions which are reviewed for clear error following a bench trial.” Leapfrog
Enter., Inc. v. Fisher-Price, Inc., 485 F.3d 1157, 1160 (Fed. Cir. 2007) (quoting Alza
Corp. v. Mylan Labs., Inc., 464 F.3d 1286, 1289 (Fed. Cir. 2006)).
We agree with Forest that the district court’s key factual findings underlying its
conclusions on obviousness are not clearly erroneous, and, based upon those findings,
we find no error in the court’s conclusion that the asserted claims of the ’712 patent are
not invalid for obviousness. As with their arguments on anticipation, Ivax and Cipla
2007-1059 -10-
mainly emphasize the evidence that is favorable to their desired outcome without
addressing the evidence favorable to Forest. The latter includes the failure of the
inventors and others to resolve citalopram without undue experimentation and the
testimony of Forest’s experts. The district court applied the Graham factors to conduct
a thorough analysis of the evidence, and we find no clear error on facts and no error of
law. See Graham v. John Deere Co., 383 U.S. 1 (1966). These findings fully support
the conclusion that the claimed subject matter would not have been obvious to one of
ordinary skill in the art.
III. Broadening Reissue
Ivax and Cipla argue that claim 11 of the ’712 patent is invalid because it
represents a broadening of original claim 11. They argue that the change in the optical
rotation sign of the diol intermediate in claim 11 during reissue was clearly a broadening
of the claim because the claim now covers a process beginning with a different
enantiomer. Ivax and Cipla also argue that a typographical error may nonetheless be
broadening and that a typographical error must be evident to the general public in order
to serve the public notice function of patents. In response, Forest argues that the
district court correctly determined that the reissue application corrected a typographical
error that was readily apparent to one of ordinary skill in the art reviewing the patent and
therefore did not result in any change in the scope of the patent.
The reissue statute reads as follows:
Whenever any patent is, through error without any deceptive intention,
deemed wholly or partly inoperative or invalid, by reason of . . . the
patentee claiming more or less than he had a right to claim in the patent,
the Director shall . . . reissue the patent for the invention disclosed in the
original patent . . . for the unexpired part of the term of the original patent. .
. . No reissued patent shall be granted enlarging the scope of the claims of
2007-1059 -11-
the original patent unless applied for within two years from the grant of the
original patent.
35 U.S.C. § 251.
The ’712 reissue patent resulted from an application filed more than two years
after the grant of the original patent, and the claims of a reissue patent filed after that
date are invalid if they enlarge the scope of the original claims. See 35 U.S.C. § 282;
Quantum Corp. v. Rodime PLC, 65 F.3d 1577, 1583 (Fed. Cir. 1995). However, a
change in a reissue application that is only clerical does not necessarily broaden the
scope of the claims and so does not render the patent invalid. The question before us
is whether the change effected in the reissue application here broadened the scope of
claim 11 or merely clarified or corrected the original claim.
Comparison of the scope of the reissue claims with the claims of the original
patent is a matter of claim construction, and it is performed from the perspective of one
having ordinary skill in the art. See Pannu v. Storz Instruments, Inc., 258 F.3d 1366,
1370 (Fed. Cir. 2001); Phillips v. AWH Corp., 415 F.3d 1303, 1313 (Fed. Cir. 2005) (en
banc). Whether the claims of a reissue patent violate 35 U.S.C. § 251 is a question of
law that we review de novo based on underlying facts reviewed for clear error.
Medtronic, Inc. v. Guidant Corp., 465 F.3d 1360, 1373 (Fed. Cir. 2006).
We agree with Forest that the change in the optical rotation sign for the diol
intermediate in claim 11 of the ’712 patent did not broaden the scope of the claim. The
patent specification supports, even compels, this conclusion. In Reaction Scheme I, the
process begins with a racemic mixture of the diol intermediate. See ’712 patent col.5
ll.41-42. The diagram of Reaction Scheme I reinforces that conclusion because it
includes a notation next to the diagram of the diol intermediate that reads “(+) and (-).”
2007-1059 -12-
’712 patent (emphasis added). The patent then describes a reaction sequence that
results in production of “the ester as a diastereomeric mixture.” Id. at col.5 ll.47-48. It is
the diastereomeric mixture of an ester (of a monoalcohol) that is then subjected to
HPLC to produce an enantiomerically pure compound that can be converted into the
desired (+)-citalopram end product. Id. at col.5 ll.47-59. Further, as found by the district
court, because Reaction Scheme I begins with the racemate of the diol intermediate,
the patent is ambiguous as to which enantiomer of the diol intermediate is actually
converted to (+)-citalopram.
In contrast, while the description of Reaction Scheme II also begins with the
racemate of the diol intermediate, it is the diol intermediate itself that is resolved to
produce an enantiomerically pure product compound. Id. at col.6 ll.8-33. The
description also specifically describes using the (-)-diol intermediate to produce (+)-
citalopram. Id. at col.6 ll.29-42. Further support is again provided by the diagram of
Reaction Scheme II, which includes a notation that reads “(-) or (+)” next to the
structural diagram of citalopram. ’712 patent (emphasis added). Thus, the
enantiomeric labeling for the end product is reversed from that of the starting
compound. Given this plain reading and the additional supporting expert testimony also
relied upon by the district court, we see no error in the district court’s finding that a
person of ordinary skill in the art reviewing the patent would find the error in claim 11
relating to the optical sign of the diol intermediately apparent. The diagram of Reaction
Scheme II makes clear that it is the (-)-diol that is converted to (+)-citalopram and that
the correction in the claim corresponds to the disclosure in the specification. We
therefore agree that the change in the optical sign during reissue does not represent a
2007-1059 -13-
change of claim scope, but merely a correction of the claim to be consistent with the
disclosure of the specification.
IV. The Scope of the Injunction
Ivax and Cipla argue that the language of the injunction is overly broad in
extending to “any products that infringe the ’712 patent.” Also, they argue that the
artificial act of infringement created by 35 U.S.C. § 271(e)(2)(A) is narrow and that
Cipla’s provision of information to Ivax for its filing of the ANDA is not an act of
infringement. Ivax and Cipla further argue that the injunction granted by the district
court violates our holding in International Rectifier Corp. v. IXYS Corp., 383 F.3d 1312,
1316 (Fed. Cir. 2004). Forest responds that the injunction is sufficiently narrowly
defined because of the infringement stipulation of the parties and the detailed record.
Forest also argues that because Cipla will manufacture and import the EO products
described in the ANDA if it is approved, Cipla may properly be enjoined for inducement
of infringement.
A. Scope of Products
We do not agree with the scope of the district court’s injunction that includes
products other than escitalopram oxalate. “Although the standard of review for the
issuance and scope of an injunction is abuse of discretion, whether the terms of the
injunction fulfill the mandates of Federal Rule of Civil Procedure 65(d) is a question of
law that this court reviews de novo.” Signtech USA, Ltd. v. Vutek, Inc., 174 F.3d 1352,
1356 (Fed. Cir. 1999). In International Rectifier, we held that “the only acts [an]
injunction may prohibit are infringement of the patent by the adjudicated [products] and
infringement by [products] not more than colorably different from the adjudicated
2007-1059 -14-
[products]. 383 F.3d at 1316. In order to comply with Rule 65(d), the injunction should
explicitly proscribe only those specific acts.”
Here, the ’712 patent covers a range of products beyond those described in the
ANDA. The statute, 35 U.S.C. § 271(e)(4)(B), provides that “injunctive relief may be
granted against an infringer to prevent the commercial manufacture, use, offer to sell, or
sale within the United States or importation into the United States of an approved drug.”
Thus, while the injunction may properly extend to the “approved drug,” it should not
extend to the remainder of the products covered by the patent. The injunction is
therefore modified to delete the language “any products that infringe the ’712 patent,
including.”
B. Inclusion of Cipla
However, we find that it was not inappropriate for the district court to include
Cipla within the scope of the injunction. Section 271(e)(2) may support an action for
induced infringement. Allergan, Inc. v. Alcon Labs., Inc., 324 F.3d 1322, 1331 (Fed. Cir.
2003). “The only difference in the analysis of a traditional infringement claim and a
claim of infringement under section 271(e)(2) is the timeframe under which the elements
of infringement are considered.” Id. An inquiry into induced infringement focuses on
the party accused of inducement as the prime mover in the chain of events leading to
infringement. Here, we do not know if Cipla first approached Ivax or vice versa, but the
plan to manufacture, import, market, and sell the EO products described in the ANDA
was undoubtedly a cooperative venture, and Cipla was to manufacture and sell
infringing EO products to Ivax for resale in the United States. Under the standards for
inducement which we apply to 35 U.S.C. § 271(b), Cipla has therefore actively induced
2007-1059 -15-
the acts of Ivax that will constitute direct infringement upon approval of the ANDA, and it
was thus not inappropriate for the district court to include Cipla within the scope of the
injunction.
The dissent asserts that § 271(e)(1) exempts Cipla from being enjoined with Ivax.
We disagree. Cipla is providing information, and will provide material, that Ivax will use
to obtain FDA approval. Up to that point, there is indeed no infringement. And, in fact,
Ivax is not currently liable for infringement, as long as it is only pursuing FDA approval,
not commercially manufacturing or selling the infringing product. However, just as Ivax
will be liable for, and hence is being enjoined from, the commercial exploitation of
escitalopram when it is approved by the FDA and during the life of the patent, so should
Cipla be enjoined. They are partners. Cipla would be contributing to the infringement
by Ivax, so the injunction should cover both partners. It is true that, as the dissent
states, § 271(e)(2) defines Ivax’s filing of its ANDA as an infringement, and Cipla did not
file the ANDA; however, when the question of an injunction against commercial activity
arises, Cipla is as culpable, and hence entitled to be enjoined, as Ivax.
CONCLUSION
For the reasons stated, we affirm the district court’s grant of judgment of no
invalidity of the ’712 patent and the entry of injunction, as modified herein, as to both
Ivax and Cipla pursuant to the stipulation of infringement.
AFFIRMED
2007-1059 -16-
United States Court of Appeals for the Federal Circuit
2007-1059
FOREST LABORATORIES, INC.,
FOREST LABORATORIES HOLDING, LTD.,
and H. LUNDBECK A/S,
Plaintiffs-Appellees,
v.
IVAX PHARMACEUTICALS, INC.
and CIPLA, LTD.,
Defendants-Appellants.
SCHALL, Circuit Judge, dissenting-in-part.
I join the court’s opinion insofar as it (i) affirms the judgment of non-invalidity of
the ’712 patent and (ii) modifies the scope of the injunction issued by the district court.
However, I respectfully dissent from the court’s opinion insofar as it affirms the district
court’s entry of an injunction as to Cipla.
Ivax filed its ANDA seeking approval to market generic tablets containing
escitalopram oxalate. See Forest Labs., Inc. v. Ivax Pharms., Inc., 438 F. Supp. 2d
479, 484 (D. Del. 2006). Under the statutory framework set forth by Congress:
It shall be an act of infringement to submit⎯
(A) an application under section 505(j) of the Federal Food, Drug,
and Cosmetic Act or described in section 505(b)(2) of such Act for
a drug claimed in a patent or the use of which is claimed in a
patent, or
(B) an application under section 512 of such Act or under the Act of
March 4, 1913 (21 U.S.C. 151-158) for a drug or veterinary
biological product which is not primarily manufactured using
recombinant DNA, recombinant RNA, hybridoma technology, or
other processes involving site specific genetic manipulation
techniques and which is claimed in a patent or the use of which is
claimed in a patent,
if the purpose of such submission is to obtain approval under such
Act to engage in the commercial manufacture, use, or sale of a
drug or veterinary biological product claimed in a patent or the use
of which is claimed in a patent before the expiration of such patent.
35 U.S.C. § 271(e)(2). By its terms, the statute limits the act of infringement to the filing
of an ANDA application. At the same time, 35 U.S.C. § 271(e)(4)(B) provides that
“injunctive relief may be granted against an infringer to prevent the commercial
manufacture, use, offer to sell, or sale within the United States or importation into the
United States of an approved drug or veterinary biological product.” (Emphasis added).
In interpreting a statute, we presume that Congress intended to give words their
ordinary meanings. Asgrow Seed Co. v. Winterboer, 513 U.S. 179, 187 (1995). In
§ 271(e)(2), Congress chose to employ the clause “[i]t shall be an act of infringement to
submit.” The plain language of § 271(e)(2) thus compels the conclusion that an action
for infringement may lie based upon the filing of an ANDA. By filing its ANDA, Ivax
committed an act constituting infringement under § 271(e)(2) and, as an infringer, was
properly enjoined under § 271(e)(4)(B).
Cipla provided information to Ivax that was included in the ANDA, and if the
ANDA were approved, Cipla would manufacture the escitalopram oxalate used in the
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proposed generic drugs. Forest, 438 F. Supp. 2d at 484. In contrast to what IVAX did
in this case, Cipla’s involvement—limited to providing information to IVAX that was
included in the submission of the ANDA—seems akin to the activity protected by
paragraph (e)(1) of the statute, which provides that:
It shall not be an act of infringement to make, use, offer to sell, or
sell within the United States or import into the United States a
patented invention . . . solely for uses reasonably related to the
development and submission of information under a Federal law
which regulates the manufacture, use, or sale of drugs or veterinary
biological products.
35 U.S.C. § 271(e)(1). The Supreme Court has stated that “§ 271(e)(1)’s exemption
from infringement extends to all uses of patented inventions that are reasonably related
to the development and submission of any information under the [Federal Food, Drug,
and Cosmetic Act].” Merck KGaA v. Integra Lifesciences I, Ltd., 545 U.S. 193, 202
(2005). In short, Congress made it an act of infringement to file an ANDA, but
exempted from infringement acts reasonably related to the development and filing of an
ANDA, such as those of Cipla here.
In holding that it was not inappropriate for the district court to include Cipla within
the scope of the injunction, the court relies on Allergan, Inc. v. Alcon Labs, Inc., 324
F.3d 1322 (Fed. Cir. 2003), for the proposition that § 271(e)(2) may support an action
for induced infringement. Maj. op. at 15. I think Allergan is distinguishable on its facts.
In Allergan, we held as a general matter that § 271(e)(2) may support an action for
induced infringement. 1 However, in Allergan the defendant was the party that submitted
1
In Allergan, a drug manufacturer, Allergan, who held a patent for a method
of using a specified drug for a particular purpose brought an infringement action against
two competitors, Alcon and Bausch & Lomb, who filed ANDAs seeking approval for the
production of a generic version of the drug for a use different from the method of use of
the drug claimed in the patent. Allergan brought its suit under 35 U.S.C. § 271(e)(2),
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the ANDA. 324 F.3d at 1332 (“[S]ummary judgment of non-infringement under section
271(e)(2)[] is inappropriate where the plaintiff can demonstrate the existence of a
genuine issue of material fact with respect to the claim that the ANDA filer will induce
infringement of its patent upon approval of the ANDA.” (emphasis added)). In other
words, the court was presented with the question of whether § 271(e)(2) may support
an action where the ANDA filer would induce infringement if the ANDA were approved.
I am unable to agree that Allergan supports the proposition that, standing alone,
what Cipla did here (providing information used in the filing of an ANDA) can form the
basis for a cause of action under § 271(e)(2). In my view, that proposition goes beyond
the language of § 271(e)(2). Accordingly, I respectfully dissent from that part of the
court’s opinion that affirms the district court’s action enjoining Cipla.
alleging that if the FDA approved Alcon’s and Bausch & Lomb’s ANDAs, Alcon and
Bausch & Lomb would induce doctors to infringe Allergan’s patents by prescribing the
drug for the patented method of use and would induce patients to infringe by using the
drug for the patented method of use.
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Forest Laboratories, Inc. v. Ivax Pharmaceuticals, Inc.
Court: Court of Appeals for the Federal Circuit
Date filed: 2007-09-05
Citations: 501 F.3d 1263
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