Allergan Sales, LLC v. Sandoz, Inc.

211 F. Supp. 3d 907, 2016 U.S. Dist. LEXIS 135088, 2016 WL 5661638
CourtDistrict Court, E.D. Texas
DecidedSeptember 30, 2016
DocketCASE NO. 2:12-CV-207-JRG, CASE NO. 2:15-CV-347-JRG
StatusPublished
Cited by1 cases

This text of 211 F. Supp. 3d 907 (Allergan Sales, LLC v. Sandoz, Inc.) is published on Counsel Stack Legal Research, covering District Court, E.D. Texas primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
Allergan Sales, LLC v. Sandoz, Inc., 211 F. Supp. 3d 907, 2016 U.S. Dist. LEXIS 135088, 2016 WL 5661638 (E.D. Tex. 2016).

Opinion

MEMORANDUM OPINION AND ORDER

RODNEY GILSTRAP, UNITED STATES DISTRICT JUDGE

Before the Court are the competing motions for summary judgment by Plaintiff Allergan Sales, LLC (“Allergan”) and Defendants Sandoz, Inc., Aleon Laboratories, Inc., Alcon Research, Ltd., and Falcon Pharmaceuticals, Ltd. (collectively “San-doz”) (Dkt. No. 277; Dkt. No. 280; Dkt. No. 281). Allergan’s motion sought summary judgment that Sandoz was precluded from challenging the validity of claim 4 of U.S. Patent No. 7,030,149 (“the ’149 patent”) under the doctrines of issue preclusion and claim preclusion and that Sandoz’s proposed ANDA product infringes claim 4 of the ’149 patent (Dkt. No. 277). Sandoz filed two motions for summary judgment. San-doz’s first motion sought summary judg[912]*912ment that claim 4 of the ’149 patent was invalid (Dkt. No. 280). Sandoz’s second motion sought summary judgment of non-infringement of claim 4 of the ’149 patent (Dkt. No. 281). The Court held a hearing on August 25, 2016 and heard oral argument on the motions. After considering the briefing and evidence, the Court finds that Allergan’s Motion for Summary Judgment (Dkt. No. 277) and Sandoz’s Motion for Summary Judgment of Invalidity of Claim 4 of the ’149 Patent (Dkt. No. 280) should be DENIED; however, the Court finds that Sandoz’s Motion for Summary Judgment of Non-Infringement as to Claim 4 of the ’149 Patent (Dkt. No. 281) should be GRANTED-IN-PART and DENIED-IN-PART.

I. BACKGROUND

A. Procedural History: Allergan I, Aller-gan II, and Allergan III

In 2007, the FDA approved Allergan’s New Drug Application for the drug Combi-gan, which is described as a “fixed combination” product designed to lower intrao-cular pressure in patients with glaucoma and ocular hypertension. (Dkt. No. 277 p. 3). Allergan has six patents alleged to cover Combigan and its administration: the ’149 patent, and U.S. Patent Nos. 7,320,976 (“the ’976 patent”), 7,642,258 (“the ’258 patent”), 8,133,890 (“the ’890 patent”), 8,354,409 (“the ’409 patent”), and 8,748,425 (“the ’425 patent”). (Id. at 3-4). Each of these patents is listed in the FDA-Approved Drug Products with Therapeutic Equivalence Evaluations database, commonly referred to as the “Orange Book.” (Id. at 4).

1. Allergan I

In 2008, Sandoz submitted an Abbreviated New Drug Application (“ANDA”) to the FDA seeking approval to make a generic version of Combigan (“the proposed ANDA product”). (Dkt. No. 287 p. 5). After submitting its ANDA, Sandoz sent a Paragraph IV letter to Allergan indicating that it had submitted its ANDA to the FDA. (Dkt. No. 277 p. 4). In response to San-doz’s Paragraph IV letter, Allergan filed suit against Sandoz for infringement of the T49, ’463, ’976, and ’258 patents. See Allergan, Inc. v. Sandoz Inc., 818 F.Supp.2d 974 (E.D.Tex.2011) (“the Aller-gan I case”). In its Answer to Allergan’s Complaint in Allergan I, Sandoz raised affirmative defenses and counterclaims of invalidity of the asserted patents. (Dkt. No. 277 at 4; Dkt. No. 287 at 6). Sandoz also moved for summary judgment of non-infringement of claims 1 through 3 of the ’149 patent, which the Court granted. Allergan, 818 F.Supp.2d at 982. Shortly before trial, Sandoz filed a stipulation of infringement that its ANDA met all of the limitations of claim 4 of the ’149 patent, claim 1 of the ’976 patent, claims 1-6 of the ’463 patent, and claims 1-9 of the ’258 patent. (2:09-cv-97, Dkt. No. 234). The case proceeded to a bench trial on the issue of invalidity of the remaining asserted claims (including claim 4 of the ’149 patent), and the Court found the claims to be infringed, based on the stipulations, and not invalid. Allergan, 818 F.Supp.2d at 1031. The Court enjoined Sandoz from making, using, offering to sell, or selling the products described in the ANDA within the United States until after the latest of the expiration dates of the ’149, ’976, ’463, and ’258 patents. (2:09-cv-97, Dkt. No. 260).

Allergan and Sandoz both appealed the Court’s ruling to the Federal Circuit. See Allergan, Inc. v. Sandoz Inc., 726 F.3d 1286 (Fed.Cir.2013). On appeal, the Federal Circuit reversed-in-part, finding that the asserted claims of the ’463 patent were invalid as obvious. Id. at 1288. However, the Federal Circuit affirmed this Court’s holding that claim 4 of the ’149 patent was not invalid, reasoning that Sandoz failed to present clear and convincing evidence that [913]*913claim 4 of the 149 patent would have been obvious. Id. at 1288. The Federal Circuit declined to address the claims of the ’258 and ’976 patents, explaining that ‘[t]he ’258, ’976, and 149 patents each expire on April 19, 2022. Because we conclude that claim 4 of the 149 patent is not invalid, the Appellants will be unable to enter the market until that date. Accordingly, we find it unnecessary to address the claims of the ’258 and ’976 patents.” Id. at 1294 n.2.1

2. Allergan II

In March of 2012, while Allergan I was still pending in this Court, the ’890 patent issued. (Dkt. No. 1 ¶ 23). Shortly thereafter, Allergan filed suit against Sandoz alleging that Sandoz’s ANDA infringed the ’890 patent. (Dkt. No. 1) (“the Allergan II case”). On March 15, 2013, Sandoz amended its answers to add counterclaims for non-infringement and invalidity of the later-issued ’409 patent, as well as non-infringement and invalidity of the ’890 patent. (Dkt. No. 311 p. 6-7). Allergan II was ultimately consolidated with Allergan III to form the present action. (Dkt. No. 220).

3. Allergan III

While Allergan I was on appeal, Sandoz modified its ANDA in an effort to design around Allergan’s patents. (Dkt. No. 287 p. 6). Sandoz’s modifications came in the form of a label change, rather than alterations to the chemical composition of its product. (Id. at 7; Dkt. No. 303 p. 56). The label of the proposed ANDA product at issue in Allergan I indicated use of the product “in patients with glaucoma or ocular hypertension.” However, Sandoz later modified its ANDA to remove the indicated use of glaucoma. (Dkt. No. 287 p. 7). As a result, Sandoz now only seeks approval for the indicated use of its product in patients with ocular hypertension. (Id.). After San-doz modified its ANDA, it filed a Rule 60(b)(5) motion to modify the injunction the Court issued in Allergan I to permit Sandoz to make its proposed ANDA product. (2:09-ev-97, Dkt. 280). This Court denied Sandoz’s Rule 60(b)(5) motion, (2:09-ev-97, Dkt. No. 308), and the Federal Circuit affirmed. Allergan, Inc. v. Sandoz, Inc., 587 Fed.Appx. 657 (Fed.Cir.2014).

On January 23, 2015, Sandoz sent a second Paragraph IV letter to Allergan, which notified Allergan of Sandoz’s modified ANDA. (2:15-cv-347, Dkt. No. 1 ¶ 33-34). Following receipt of the Paragraph IV letter, Allergan again filed suit against Sandoz, this time for infringement of the ’149, ’976, ’258, ’425 patents. (2:15-cv-347, Dkt. No. 1) (“the Allergan III case”). As noted above, the Court then consolidated Allergan II and Allergan III. (Dkt. No. 220).

The motions presently before the Court focus solely on claim 4 of the T49 patent, and claim 4 currently lies at the heart of the dispute between the parties.

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211 F. Supp. 3d 907, 2016 U.S. Dist. LEXIS 135088, 2016 WL 5661638, Counsel Stack Legal Research, https://law.counselstack.com/opinion/allergan-sales-llc-v-sandoz-inc-txed-2016.