Astrazeneca Pharms. LP v. Apotex Corp., Nos. 2011–1182

• Court: United States Courts of Appeals. United States Court of Appeals for the Federal Circuit
• Writing for the Court: LOURIE
• Citation: 101 U.S.P.Q.2d 1675,669 F.3d 1370
• Parties: ASTRAZENECA PHARMACEUTICALS LP, AstraZeneca AB, IPR Pharmaceuticals Inc., and the Brigham and Women's Hospital, Inc., Plaintiffs–Appellants, v. APOTEX CORP., Defendant–Appellee,andAurobindo Pharma Limited, Defendant–Appellee,andCobalt Pharmaceuticals Inc. and Cobalt Laboratories Inc., Defendants–Appellees,andGlenmark Generics Inc. USA, Defendant–Appellee,andMylan Pharmaceuticals Inc., Defendant–Appellee,andPar Pharmaceuticals, Inc., Defendant–Appellee,andSun Pharmaceutical Industries, Ltd., Defendant–Appellee,andTeva Pharmaceuticals USA, Inc., Defendant–Appellee,andTorrent Pharma Inc. and Torrent Pharmaceuticals Ltd., Defendants.
• Decision Date: 09 February 2012
• Docket Number: 2011–1187,2011–1190.,2011–1186,2011–1189,2011–1184,2011–1185,Nos. 2011–1182,2011–1183,2011–1188

101 U.S.P.Q.2d 1675
669 F.3d 1370

ASTRAZENECA PHARMACEUTICALS LP, AstraZeneca AB, IPR Pharmaceuticals Inc., and the Brigham and Women's Hospital, Inc., Plaintiffs–Appellants,
v.
APOTEX CORP., Defendant–Appellee,andAurobindo Pharma Limited, Defendant–Appellee,andCobalt Pharmaceuticals Inc. and Cobalt Laboratories Inc., Defendants–Appellees,andGlenmark Generics Inc. USA, Defendant–Appellee,andMylan Pharmaceuticals Inc., Defendant–Appellee,andPar Pharmaceuticals, Inc., Defendant–Appellee,andSun Pharmaceutical Industries, Ltd., Defendant–Appellee,andTeva Pharmaceuticals USA, Inc., Defendant–Appellee,andTorrent Pharma Inc. and Torrent Pharmaceuticals Ltd., Defendants.

Nos. 2011–1182

2011–1183

2011–1184

2011–1185

2011–1186

2011–1187

2011–1188

2011–1189

2011–1190.

United States Court of Appeals, Federal Circuit.

Feb. 9, 2012.

[669 F.3d 1372]

Mary W. Bourke, Connolly, Bove, Lodge & Hutz, LLP, of Wilmington, DE, argued for plaintiffs-appellants. With her on the brief was Dana K. Severance. Of counsel on the brief were Ford F. Farabow, Jr., Finnegan, Henderson, Farabow, Garrett & Dunner, LLP, of Washington, DC; and Charles E. Lipsey, Kenneth M. Frankel and York M. Faulkner, of Reston, VA; and Mary K. Ferguson, of Cambridge, MA.

Shane A. Brunner, Mechant & Gould, P.C. of Madison, WI, argued for defendants-appellees Aurobindo Pharma Limited and Glenmark Generics Inc. USA. With him on the brief were Jeffrey S. Ward and Edward J. Pardon. Of counsel on the brief was Rachel C. Hughey, of Minneapolis, MN.

Robert B. Breisblatt and Jeremy C. Daniel, Katten Muchin Rosenman LLP, of Chicago, IL, were on the brief for defendant-appellee Apotex Corp.Steven A. Maddox, Knobbe, Martens, Olson & Bear, LLP, of Washington, DC; and Payson Lemeilleur and Jared C. Bunker, of Irvine, CA, were on the brief for defendants-appellees Cobalt Pharmaceuticals Inc., et al.H. Ketto Sabharwal, Daniel E. Yonan and Dennies Varughese, Sterne, Kessler, Goldstein & Fox, PLLC, of Washington, DC, were on the brief for defendant-appellee Glenmark Generic Inc. USA.William A. Rakoczy, Deanne M. Mazzochi, Joseph T. Jaros and Eric R. Hunt, Rakoczy Molino Mazzochi Siwik, LLP, of Chicago, IL, were on the brief for defendant-appellee Mylan Pharmaceuticals Inc.Nicole W. Stafford, Wilson, Sonsini, Goodrich & Roisati, of Austin, TX; and Daniel G. Brown, of New York, NY, were on the brief for defendant-appellee Par Pharmaceutical, Inc.James F. Hurst, Winston & Strawn LLP, of Chicago, IL, and Charles B. Klein and John K. Hsu, of Washington, DC, were on the brief for defendant-appellee Sun Pharmaceutical Industries, Ltd.Ralph J. Gabric, Jeffrey M. Nichols and Jason W. Schigelone, Brinks Hofer Gilson & Lione, of Chicago, IL, were on the brief for defendant-appellee Teva Pharmaceuticals USA, Inc.

Before RADER, Chief Judge, and LOURIE and MOORE, Circuit Judges.

LOURIE, Circuit Judge.

AstraZeneca Pharmaceuticals LP, AstraZeneca AB, IPR Pharmaceuticals, Inc., and The Brigham and Women's Hospital, Inc. (collectively, “AstraZeneca”) appeal from the consolidated final orders of the United States District Court for the District of Delaware dismissing their

[669 F.3d 1373]

§ 271(e)(2) patent infringement claims against Apotex Corp., Aurobindo Pharma Ltd., Cobalt Pharmaceuticals Inc., Cobalt Laboratories Inc., Glenmark Generics Inc. USA, Mylan Pharmaceuticals Inc., Par Pharmaceuticals Inc., Sun Pharmaceutical Industries Ltd., Teva Pharmaceuticals USA Inc., Torrent Pharma Inc., and Torrent Pharmaceuticals Ltd. (collectively, “Appellees”). Astrazeneca Pharms. LP v. Apotex Corp., Nos. 10–338 to –346 and 10–584, 2010 U.S. Dist. LEXIS 132727, 2010 WL 5376310 (D.Del. Dec. 22, 2010). For the reasons indicated below, we affirm.

Background

The dispute before us involves patented methods for using the cholesterol-lowering drug rosuvastatin calcium. Rosuvastatin calcium is one member of a widely prescribed class of drugs known as statins, which serve to reduce circulating cholesterol by competitively inhibiting 3–hydroxy–3–methylglutaryl–CoA reductase, or HMG–CoA reductase, a key enzyme in the cholesterol biosynthesis pathway. AstraZeneca markets rosuvastatin calcium under the brand name CRESTOR® and holds the rights to three related patents relevant to this appeal. U.S. Patent RE37,314 (“the '314 patent”) claims rosuvastatin compounds and pharmaceutical compositions containing such compounds. U.S. Patent 6,858,618 (“the '618 patent”) claims methods of using rosuvastatin compounds to treat heterozygous familial hypercholesterolemia (“HeFH”), a genetic condition characterized by impaired cholesterol metabolism and clinically elevated blood cholesterol, and U.S. Patent 7,030,152 (“the '152 patent”) claims methods of using rosuvastatin compounds to lower the cardiovascular disease risk for individuals who have normal cholesterol levels but demonstrate elevated circulating C-reactive protein (“CRP”), another risk factor associated with various cardiovascular disorders. The '314 composition patent expires in 2016, while the '618 and '152 method of use patents expire in 2021 and 2018, respectively.¹

AstraZeneca filed a New Drug Application (“NDA”) to market rosuvastatin calcium and obtained approval from the U.S. Food and Drug Administration (“FDA”) on August 12, 2003. As required by the Drug Price Competition and Patent Term Restoration Act of 1984 (popularly known as the Hatch–Waxman Act, hereinafter “the Act”), AstraZeneca notified the FDA of all patents that it believed could be infringed by the unlicensed manufacture, use, or sale of rosuvastatin calcium to be published in the FDA's Approved Drug Products with Therapeutic Equivalence Evaluations (known as “the Orange Book”). See 21 U.S.C. § 355(b)(1). Among those patents, AstraZeneca listed the '314, '618, and '152 patents. The approved NDA and AstraZeneca's corresponding CRESTOR® labeling cover several indications for using rosuvastatin calcium, including treatment of HeFH in pediatric patients and preventative use in high-risk patients with elevated CRP. J.A. 152. While these indications may fall under AstraZeneca's method patents, the FDA also approved rosuvastatin calcium for treating homozygous familial hypercholesterolemia (“HoFH”) and hypertriglyceridemia—uses not claimed by either of the '618 or '152 patents. Thus, the FDA approved rosuvastatin calcium for a number of different treatment indications, some of which may be protected by AstraZeneca's '618 and '152 patents, i.e., the HeFH and elevated CRP indications, as well as others not subject to any such

[669 F.3d 1374]

patent rights, e.g., treatment of HoFH and hypertriglyceridemia.

Appellees are generic pharmaceutical manufacturers that filed Abbreviated New Drug Applications (“ANDAs”) with the FDA seeking to market generic rosuvastatin calcium. As set forth at 21 U.S.C. § 355(j)(2)(A)(i), the Act only allows ANDA filers to obtain approval for marketing drugs for uses that have been approved under a preexisting NDA. In this case, Appellees further restricted their ANDAs, requesting approval to offer their generic rosuvastatin formulations for treating only HoFH and hypertriglyceridemia while omitting or “carving out” patented indications directed toward HeFH and elevated CRP. Mylan's proposed labeling is representative:

INDICATIONS AND USAGE

Rosuvastatin calcium tablets are an HMG–CoA reductase inhibitor indicated for:

• patients with hypertriglyeridemia as an adjunct to diet (1.2)

• patients with homozygous familial hypercholesterolemia (HoFH) to reduce LDL–C, total-C, and ApoB (1.4)

J.A. 284. It appears undisputed that none of Appellees' ANDAs sought approval to market rosuvastatin calcium specifically for the HeFH or high-CRP indications disclosed in the '618 and '152 patents.

Appellees' ANDAs also addressed each rosuvastatin-related patent listed in the Orange Book. The Act requires each ANDA applicant to certify that (1) the Orange Book contains no patent information relevant to their ANDA (“Paragraph I certification”), (2) the listed patents have expired (“Paragraph II certification”), (3) the applicant will not enter the market until the listed patents expire (“Paragraph III certification”), or (4) the applicant believes that the listed patents are invalid or will not be infringed by the applicant's generic compositions (“Paragraph IV certification”). 21 U.S.C. § 355(j)(2)(A)(vii)(I)-(IV) (2006). The Act specifies that filing an ANDA containing a Paragraph IV certification constitutes an act of infringement. 35 U.S.C. § 271(e)(2) (2006); Glaxo, Inc. v. Novopharm, Ltd., 110 F.3d 1562, 1568–69 (Fed.Cir.1997). Where the Orange Book lists a method of use patent that “does not claim a use for which the applicant is seeking approval,” an applicant may instead submit a statement under 21 U.S.C. § 355(j)(2)(A)(viii) averring that the ANDA excludes all uses claimed in the patent (“Section viii statement”). Warner–Lambert Co. v. Apotex Corp., 316 F.3d 1348, 1360–61 (Fed.Cir.2003).

Accordingly, Appellees filed Paragraph IV certifications with regard to the ' 314 composition patent, but, having only sought approval for unpatented methods of using generic rosuvastatin calcium for treating HoFH and hypertriglyeridemia, they submitted Section viii statements regarding the '618 and '152 method of use patents.² Appellees notified AstraZeneca of their ANDA filings in late 2007 as required under 21 U.S.C. § 355(j)(2)(B)(ii).

In December 2007, AstraZeneca responded by suing Appellees for infringement of the '314 composition patent under § 271(e)(2). After a bench trial, the district court ruled on June 29, 2010, in favor of AstraZeneca on infringement, validity, and enforceability of the '314 patent, enjoining Appellees from making, using, or selling rosuvastatin calcium until the '314

[669 F.3d 1375]

patent expires in 2016. Appellees have separately appealed that decision. In re Rosuvastatin Calcium Patent Litig., 719 F.Supp.2d 388 (D.Del.2010), appeal docketed, Nos. 10–1460 to –1473 (Fed.Cir....