Allergan, Inc. v. Sandoz Inc
Filing
261
MEMORANDUM OPINION and ORDER - the Court GRANTS Defendant's motion for summary judgment that none of the Defendants are seeking FDA approval for the uses claimed in claims 1-3 of the '149 patent and that the uses claimed in claims 1-3 of the '149 patent are not FDA approved.. Signed by Judge T. John Ward on 8/5/11. (ehs, )
IN THE UNITED STATES DISTRICT COURT
FOR THE EASTERN DISTRICT OF TEXAS
MARSHALL DIVISION
ALLERGAN, INC.,
v.
SANDOZ INC.,
ALLERGAN, INC.,
v.
HI-TECH PHARMACAL CO., INC.,
ALLERGAN, INC.,
v.
ALCON LABORATORIES, INC., et al.,
ALLERGAN, INC.,
v.
APOTEX INC. and APOTEX CORP.
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CIVIL ACTION NO. 2:09-cv-97
CIVIL ACTION NO. 2:09-cv-182
CIVIL ACTION NO. 2:09-cv-348
CIVIL ACTION NO. 2:10-cv-200
MEMORANDUM OPINION AND ORDER
Pending before the court is Defendants Sandoz Inc.‟s (”Sandoz”); Alcon Laboratories,
Inc.‟s, Alcon Research Ltd.‟s, Alcon Research, Inc.‟s, and Falcon Pharmaceuticals, Ltd.‟s
(“Alcon”); Apotex Inc.‟s and Apotex Corp.‟s (“Apotex”); and Watson Laboratories, Inc.‟s
(“Watson”) (collectively, “Defendants”) motion for summary judgment of non-infringement of
claims 1-3 of Allergan Inc.‟s (“Allergan”) U.S. Patent No. 7,030,149 (“the „149 patent”). (D.I.
196.) Defendants contend the Court should decide as a matter of law that Allergan cannot assert
infringement of claims 1-3 of the „149 Patent under 35 U.S.C. § 271(e)(2); and/or there is no
evidence that each of the Defendants infringe claims 1-3 of the „149 patent. Having carefully
considered the parties‟ arguments, the court GRANTS Defendants‟ motion for summary
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judgment that none of the Defendants are seeking FDA approval for the uses claimed in claims
1-3 of the „149 patent and that the uses claimed in claims 1-3 of the „149 patent are not FDA
approved. In addition, Plaintiff‟s request for reconsideration of the Court‟s claim construction is
DENIED.
I.
Factual Background
Allergan is the holder of a New Drug Application (“NDA”) for a 0.2% brimonidine
tartrate/0.5% timolol fixed combination ophthalmic drug called Combigan®. See, e.g., D.I. 1 at ¶
12. Under the Hatch-Waxman Act, Allergan is required to disclose to the United States Food
and Drug Administration (“FDA”) the patent numbers and expiration dates of those patents that
Allergan believes claim the “drug” for which its NDA is submitted, or patents covering a
“method of using such drug.” See 21 U.S.C. §§ 355(b)(1) and (c)(2). Pursuant to 21 U.S.C. §
355(b)(1)(G), Allergan caused the FDA to publish the „149 patent, along with U.S. Patent Nos.
7,320,976; 7,323,463; and 7,642,258, in the FDA “Orange Book” in connection with its NDA for
Combigan®. See, e.g., D.I. 1 at ¶ 13.
Each of Sandoz, Alcon, Apotex and Watson submitted an ANDA to the FDA seeking
approval to manufacture and market a 0.2% brimonidine tartrate/0.5% timolol fixed combination
ophthalmic drug. See, e.g., D.I. 1 at ¶ 15. Each of the Defendants included a certification
pursuant to 21 U.S.C. § 355(j)(2)(A)(vii)(IV) (a “Paragraph IV certification”) that the „149, „976,
„463 and „258 patents are invalid and/or will not be infringed by the manufacture, importation,
use or sale of the drug product described in their ANDAs. See, e.g., D.I. 1 at ¶¶ 16-17.
Furthermore, pursuant to 21 U.S.C. § 355(j)(2)(B) and 21 C.F.R. § 314.95, each of the
Defendants sent a Confidential Notice Letter to Allergan informing Allergan of the filing of their
ANDA and providing the detailed basis for their Paragraph IV certifications. Allergan filed
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lawsuits against each of the Defendants, alleging that each of their ANDA products infringe the
„149, „976, „463 and „258 patents (“patents-in-suit”). See, e.g., D.I. 1.
Allergan served its infringement contentions on Sandoz and Alcon on March 22, 2010,
Apotex on August 16, 2010, and Watson on March 7, 2011. See, e.g., Exh. F. Sandoz and Alcon
served their invalidity contentions on Allergan on May 24, 2010, while Apotex and Watson
served their invalidity contentions on Allergan on September 15, 2010 and March 21, 2011,
respectively. The Court conducted a Markman hearing on January 28, 2011 and issued a
Memorandum Opinion and Order on claim construction on April 27, 2011. D.I. 151. Fact
discovery closed on May 2, 2011. On May 11, 2011, Defendants submitted a letter brief
requesting permission to file for summary judgment of noninfringement of claims 1-3 of the „149
patent. D.I. 160. Allergan submitted its responsive brief on May 25, 2011 and Defendants
submitted their reply brief on June 3, 2011. D.I. 169 and 177.
Allergan served its opening expert report on infringement of the patents-in-suit to each of
the Defendants on May 27, 2011. Each of the Defendants submitted their opening expert reports
on invalidity of the claims of the patents-in-suit on May 27, 2011. Defendants and Allergan
served rebuttal reports on June 17, 2011. Allergan amended its infringement contentions on May
27, 2011 and Defendants amended their invalidity contentions on June 15, 2011. The Court
granted Defendants‟ request to file for summary judgment of non-infringement of claims 1-3 of
the „149 patent on June 23, 2011. D.I. 186.
II.
Legal Standard
Summary judgment is proper if the pleadings and evidence show that “there is no genuine
issue as to any material fact and the moving party is entitled to judgment as a matter of law.”
FED. R. CIV. P. 56(c); Celotex Corp. v. Catrett, 477 U.S. 317, 322-23 (1986); Anderson v. Liberty
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Lobby, Inc., 477 U.S. 242, 248-55 (1986). “Summary judgment is as appropriate in a patent case
as it is in any other case.” C.R. Bard, Inc. v. Advanced Cardiovascular Sys., Inc., 911 F.2d 670,
672 (Fed. Cir. 1990). When the summary judgment movants demonstrate the absence of a
genuine dispute over any material fact, the burden shifts to the non-movant to show there is a
genuine factual issue for trial. Celotex, 477 U.S. at 323-24. The court must draw all reasonable
inferences in favor of the non-moving party. BMC Res., Inc. v. Paymentech, L.P., 498 F.3d
1373, 1378 (Fed. Cir. 2007).
An infringement analysis requires comparison of the construed patent claims to the
accused devices. Carroll Touch, Inc. v. Electro Mech. Sys., Inc., 15 F.3d 1573, 1577 (Fed. Cir.
1993). This determination of infringement is a question of fact. Wright Med. Tech., Inc. v.
Osteonics Corp., 122 F.3d 1440, 1443 (Fed. Cir. 1997). In the absence of a genuine dispute
regarding the structure or function of the accused product, the question of infringement may
collapse into one of claim construction and thus is well suited for summary judgment. Wang
Labs., Inc. v. Am. Online, Inc., 197 F.3d 1377, 1381 (Fed. Cir. 1999); Laitram Corp. v.
Morehouse Indus., Inc., 143 F.3d 1456, 1461-62 (Fed. Cir. 1998). Literal infringement requires
the accused device to contain each claim limitation exactly. Telemac Cellular Corp. v. Topp
Telecom, Inc., 247 F.3d 1316, 1330 (Fed. Cir. 2001); Litton Sys., Inc. v. Honeywell, Inc., 140
F.3d 1449, 1454 (Fed. Cir. 1998). As a matter of law, the absence of a single claim limitation
from the accused product precludes literal infringement. Wolverine World Wide Inc. v. Nike, Inc.,
38 F.3d 1192, 1196 (Fed. Cir. 1994). A dependent claim cannot be infringed unless the claim
from which it depends is infringed. Wahpeton Canvas Co. v. Frontier, Inc., 870 F.2d 1546, 1552
n.9 (Fed. Cir. 1989).
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The Court’s Claim Construction Ruling
III.
In its April 27, 2011 Memorandum Opinion and Order, the Court construed several terms
that are present in claim 1 of the „149 patent. See D.I. 151. Claim 1 of the „149 patent is as
follows:
A method of treating glaucoma or ocular hypertension by
topical administration of about 0.2% brimonidine by weight to an
eye of a person in need thereof, said improvement comprising
topically administering to said eye, in a single composition, about
0.2% brimonidine by weight and about 0.5% timolol by weight
twice a day; as the sole active agents; wherein said method is as
effective as administration of 0.5% timolol twice a day and 0.2%
brimonidine three times a day to said eye, wherein the two
compounds are administered in separate compositions.
„149 patent 9:14-10:4. The Court construed the bolded terms above of claim 1 of the „149 patent
as follows:
Claim Phrase in Claim 1 of the ‘149 patent
Court’s Construction
“treating glaucoma or ocular hypertension”
“as effective as”
“treating glaucoma or ocular hypertension”
“equal or greater at lowering intraocular
pressure (IOP)”
“serially administered to the eye in separate
compositions as brimonidine three times a day
and timolol twice a day”
“administered in separate compositions”
See D.I. 151 at 14-18, 20-24, and 27-30. Based on this construction, claim 1 can be summarized
as a method of treating glaucoma or ocular hypertension of about 0.2% brimonidine and about
0.5% timolol in a single composition dosed twice a day that is equal or greater at lowering
intraocular pressure as compared to a serial administration to the eye in separate compositions of
brimonidine three times a day and timolol twice a day.
IV.
Discussion and Analysis
In the context of Hatch-Waxman cases, the Federal Circuit has held that a party cannot
assert infringement for uses not approved by the FDA. Allergan, Inc. v. Alcon Labs., Inc., 324
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F.3d 1322, 1332-1333 (Fed. Cir. 2003). Defendants contend that they are not seeking FDA
approval for the uses claimed in claims 1-3 of the „149 patent because the proposed products
included in Defendants‟ ANDA are not equal or greater at lowering intraocular pressure as
compared to a serial administration of the active agents. Instead, Defendants argue that their
proposed ANDA products state that the lowering of intraocular pressure by their ANDA
products is slightly less (not “equal or greater”) than a concomitant regimen of brimonidine
tartrate dosed three times a day and timolol dosed twice a day. Additionally, Defendants contend
that the FDA approved use stated in Allergan‟s Combigan® label is not the same use claimed in
claim 1 of the „149 patent.
Allergan responds that Defendants have each identified the indication of their products in
their ANDAs, and that none of the ANDAs identify the indications as being anything other than
the lowering of IOP. Accordingly, Allergan argues that Defendants‟ “off-label” arguments are
contrary to their ANDAs, and should be rejected. Allergan argues that the FDA approved use is
simply a method of lowering IOP. That is, Allergan contends that the language that Defendants
rely on—that the IOP lowering of the fixed combination formulation is “slightly less” than that
of serial administration of brimonidine TID and timolol BID—is not part of the approved
indication.
Allergan argues that while this information may be relevant to the ultimate
infringement inquiry, it does not transform everything on the label into the “approved indication”
for purposes of whether a Hatch-Waxman suit is “off-label” under Section 271(e)(2). Allergan
concludes that the approved use for Combigan®, and for Defendants‟ products, is “the reduction
of elevated intraocular pressure (IOP) in patients with glaucoma or ocular hypertension who
require adjunction or replacement therapy due to inadequately controlled IOP.”
The Court disagrees with Allergan and finds that its “„hypothetical [infringement
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analysis] is properly grounded in the ANDA application and the extensive materials typically
submitted in its support.‟ Therefore, it is proper for the court to consider the ANDA itself,
materials submitted by the ANDA applicant in support of the ANDA, and any other relevant
evidence submitted by the applicant or patent holder.” Bayer AG v. Elan Pharm. Research Corp.,
212 F.3d 1241, 1248-1249 (Fed. Cir. 2000) (quoting Glaxo, Inc. v. Novopharm, Ltd., 110 F.3d
1562, 1569 (Fed. Cir. 1997).
The Court concludes that Defendants are not seeking FDA approval for the uses claimed
in claims 1-3 of the „149 patent because Defendants‟ ANDA products are not equal or greater at
lowering intraocular pressure as compared to a serial administration of the active agents. See
„149 patent 9:14-10:4; D.I. 151 at 20-24; 27-30; D.I. 196-3, Sandoz draft label at SAN-BRI000079; D.I. 196-4, Alcon‟s draft label at ALCON(BRIM) 003254; D.I. 196-5, Apotex‟s draft
label at ANDA0000018; D.I. 196-6, Watson‟s draft label at WAT0000093. Like Allergan,
Defendants‟ proposed ANDA products state that the lowering of intraocular pressure by their
ANDA products is slightly less (not “equal or greater”) than a concomitant regimen of
brimonidine tartrate dosed three times a day and timolol dosed twice a day. Id. and D.I. 196-7,
Combigan® Prescribing Information at AGN_COMBI0080429, AGN_COMBI0080430 and
AGN-COMBI0080437. Additionally, the FDA approved use stated in Allergan‟s Combigan®
label is not the same use claimed in claim 1 of the „149 patent.
In Allergan, the Federal Circuit precluded Allergan from suing Alcon and B & L under
section 271(e)(2) for inducing infringement of two patents, because Alcon and B & L were not
seeking FDA approval for the uses claimed in the patents and because the uses claimed in the
patent were not FDA-approved. 324 F.3d at 1332-1333; see also Warner-Lambert Co. v. Apotex
Corp., 316 F.3d 1348 (Fed. Cir. 2003) (“[I]t is not an act of infringement to submit an ANDA for
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approval to market a drug for a use when neither the drug nor that use is covered by an existing
patent, and the patent at issue is for a use not approved under the NDA.”). In its May 25, 2011
responsive letter brief, Allergan‟s attempt to distinguish these cases on the basis that the methods
in dispute in those cases are more distinct than the methods in this case. The Court disagrees
and finds that the Federal Circuit‟s reasoning in Allergan and Warner-Lambert did not apply a
level of distinctness between the methods claimed and the methods approved by the FDA.
Moreover, as discussed above, it is proper for the court to consider the ANDA itself, materials
submitted by the ANDA applicant in support of the ANDA, and any other relevant evidence
submitted by the applicant or patent holder when conducting an infringement analysis under §
271(e)(2)(A). Thus, Allergan‟s attempt to distinguish these cases is misguided.
The uses for which Defendants are seeking FDA approval here are stated in each of the
labels of their ANDA products. The “Indications and Usage” section of each of Defendants‟
proposed labels contain the following language:
[T]he IOP-lowering of brimonidine tartrate and timolol maleate
ophthalmic solution dosed twice a day was slightly less than that
seen with the concomitant administration of 0.5% timolol maleate
ophthalmic solution dosed twice a day and 0.2% brimonidine
tartrate ophthalmic solution dosed three times a day.
See D.I. 196-3, Sandoz draft label at SAN-BRI-000079; D.I. 196-4, Alcon‟s draft label at
ALCON(BRIM) 003254; D.I. 196-5, Apotex‟s draft label at ANDA0000018; D.I. 196-6,
Watson‟s draft label at WAT0000093. As the excerpted labels demonstrate, Defendants are not
seeking FDA approval for a method of treating glaucoma or ocular hypertension of about 0.2%
brimonidine and about 0.5% timolol in a single composition dosed twice a day that is equal or
greater at lowering intraocular pressure as compared to a serial administration to the eye in
separate compositions of brimonidine three times a day and timolol twice a day, the use claimed
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in claim 1 of the „149 patent. Additionally, as admitted in its label, Allergan‟s Combigan®
product has less intraocular pressure lowering than a concomitant administration of 0.2%
brimonidine tartrate dosed three times a day and 0.5% timolol dosed twice a day:
[T]he IOP-lowering of COMBIGAN® dosed twice a day was
slightly less than that seen with the concomitant administration of
timolol maleate ophthalmic solution, 0.5% dosed twice a day and
brimonidine tartrate ophthalmic solution, 0.2% dosed three times
per day.
***
However, the IOP lowering of COMBIGANTM BID was less
(approximately 1-2 mm Hg) than that seen with the concomitant
administration of 0.5% timolol BID and 0.2% brimonidine tartrate
TID.
See D.I. 196-7 at AGN_COMBI0080429, AGN_COMBI0080430 and AGN-COMBI0080437
(emphasis added). Thus, the FDA approved use stated in Allergan‟s Combigan® label is not the
same use claimed in claim 1 of the „149 patent.
In its May 25, 2011 responsive letter brief, Allergan asks the Court to rely on the first
section of the “Indications and Usage” section of the FDA-approved Combigan® label and
ignore the last two-thirds of this section entirely.
However, the last two-thirds of the
“Indications and Usage” section is not merely superfluous or irrelevant information. Rather, the
FDA specifically required Allergan to include this material in its label because it defines the
indications and use of Combigan® in its entirety. Indeed, Allergan gives the Court no basis for
ignoring the “Indications and Usage” section of the Combigan® label in its entirety. In addition,
the FDA‟s Summary Review for NDA Application No. 21-398 for Combigan® states “[t]he
combination is slightly inferior to brimonidine and timolol being given concomitantly
(approximately
0.19-1.69
mmHg).”
See
D.I.
196-27,
FDA
Summary
Review
at
AGN_COMBI0673031 (emphasis added). For these reasons, the Federal Circuit‟s reasoning in
Allergan is equally applicable here and the Court finds that none of the Defendants are seeking
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FDA approval for the uses claimed in claims 1-3 of the „149 patent and that the uses claimed in
claims 1-3 of the „149 patent are not FDA approved.
VII. Conclusion
For the foregoing reasons, the Court GRANTS Defendant's motion for summary
judgment that none of the Defendants are seeking FDA approval for the uses claimed in claims
1-3 of the „149 patent and that the uses claimed in claims 1-3 of the „149 patent are not FDA
approved.
It is so ORDERED.
SIGNED this 25th day of August, 2011.
__________________________________________
T. JOHN WARD
UNITED STATES DISTRICT JUDGE
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