Bayer Schering Pharma AG v. Lupin, Ltd.

• Decision Date: 16 April 2012
• Docket Number: Nos. 2011–1143,2011–1228.,s. 2011–1143
• Citation: 102 U.S.P.Q.2d 1583,676 F.3d 1316
• Parties: BAYER SCHERING PHARMA AG and Bayer Healthcare Pharmaceuticals, Inc., Plaintiffs–Appellants, v. LUPIN, LTD., and Lupin Pharmaceuticals, Inc., Defendants–Appellees.Bayer Schering Pharma AG and Bayer Healthcare Pharmaceuticals, Inc., Plaintiffs–Appellants, v. Sandoz, Inc., Defendant–Appellee,andWatson Pharmaceuticals, Inc., and Watson Laboratories, Inc., Defendants–Appellees.
• Court: U.S. Court of Appeals — Federal Circuit

102 U.S.P.Q.2d 1583

676 F.3d 1316

BAYER SCHERING PHARMA AG and Bayer Healthcare Pharmaceuticals, Inc., Plaintiffs–Appellants,

v.LUPIN, LTD., and Lupin Pharmaceuticals, Inc., Defendants–Appellees.Bayer Schering Pharma AG and Bayer Healthcare Pharmaceuticals, Inc., Plaintiffs–Appellants,

v.Sandoz, Inc., Defendant–Appellee,andWatson Pharmaceuticals, Inc., and Watson Laboratories, Inc., Defendants–Appellees.

Nos. 2011–1143

2011–1228.

United States Court of Appeals, Federal Circuit.

April 16, 2012.

Peter B. Bensinger, Jr., Bartlit, Beck Herman Palenchar & Scott, LLP, of Chicago, IL, argued for plaintiffs-appellants. With him on the brief were Adam K. Mortara, Paul J. Skiermont, Sundeep K. Addy and Matthew R. Ford. Of counsel on the brief was Lawrence D. Rosenberg, Jones Day, of Washington, DC.

Mark T. Jansen, Kilpatrick Townsend and Stockton, LLP, of San Francisco, CA, argued for all defendants-appellees. With him on the brief were Gia L. Cincone; and Cedric C.Y. Tan and Kristin M. Cooklin, of Washington, DC, for defendant-appellees Watson Pharmaceuticals, Inc., et al. Also on the brief were Joseph A. Hynds and Steven Lieberman, Rothwell, Figg, Ernst & Manbeck, P.C., of Washington, DC, for defendant-appellee Sandoz Inc.; and Robert F. Green and Christopher T. Griffith, Leydig, Voit & Mayer, Ltd., of Chicago, IL, and Jamaica P. Szeliga, of Washington, DC, for defendants-appellees Lupin Ltd., et al.

Christopher N. Sipes, Covington & Burling LLP, of Washington, DC, for amicus curiae Pharmaceutical Research and Manufacturers of America. With him on the brief were Erika F. Lietzan and Roger A. Ford.

Before NEWMAN, PLAGER, and BRYSON, Circuit Judges.

Opinion for the court filed by Circuit Judge BRYSON.

Dissenting opinion filed by Circuit Judge NEWMAN.

BRYSON, Circuit Judge.

Bayer Schering Pharma AG and Bayer HealthCare Pharmaceuticals, Inc., (collectively, “Bayer”) appeal from two judgments of the United States District Court for the Southern District of New York. In the first case, the court dismissed Bayer's patent infringement claims against Watson Pharmaceuticals, Inc., and Watson Laboratories, Inc., (collectively, “Watson”) and Sandoz, Inc. In the second case, the court dismissed similar patent infringement claims against Lupin Ltd. and Lupin Pharmaceuticals, Inc., (collectively, “Lupin”). We affirm.

I

The Drug Price Competition and Patent Term Restoration Act of 1984 (“the Hatch–Waxman Act”), Pub. L. No. 98–417, 98 Stat. 1585, creates a procedure by which a drug manufacturer can obtain permission from the Food and Drug Administration (“FDA”) to market a generic version of a previously approved drug. A manufacturer seeking to market a generic drug is entitled to submit an Abbreviated New Drug Application (“ANDA”), rather than submitting a full New Drug Application (“NDA”). Eli Lilly & Co. v. Teva Pharm. USA, Inc., 557 F.3d 1346, 1348 (Fed.Cir.2009). The ANDA process streamlines FDA approval by allowing the generic manufacturer to rely on the safety and efficacy studies of a drug that has previously been approved upon a showing that the generic version and the relevant listed drug share the same active ingredients and are bioequivalent. Caraco Pharm. Labs., Ltd. v. Forest Labs., Inc., 527 F.3d 1278, 1282 (Fed.Cir.2008).

In the case of drugs that enjoy patent protection, the Hatch–Waxman Act creates a mechanism that allows for prompt judicial determination of whether the ANDA applicant's drug or method of using the drug infringes a valid patent. The Act makes it an act of infringement to file an ANDA for a drug or for a use of the drug that is claimed in a patent. 35 U.S.C. § 271(e)(2)(A). That “artificial” act of infringement creates jurisdiction for a court to entertain an action by the patentee against the ANDA applicant in which issues of patent infringement and validity can be resolved. Warner–Lambert Co. v. Apotex Corp., 316 F.3d 1348, 1365 (Fed.Cir.2003).

The Hatch–Waxman Act requires an NDA applicant seeking FDA approval for a drug that enjoys patent protection to identify every patent that claims the drug or a use of the drug that could reasonably be asserted in an infringement action. 21 U.S.C. § 355(b)(1). The FDA lists the patents identified by the NDA applicant in a publication entitled Approved Drug Products With Therapeutic Equivalence Evaluations, which is universally referred to in the industry as the “Orange Book.” In the case of patents claiming methods of use, FDA regulations provide that only patents claiming “indications or other conditions of use” that either have been approved by the FDA or are in a pending NDA are to be submitted for listing in the Orange Book. 21 C.F.R. § 314.53(b).

When an applicant files an ANDA seeking FDA permission to market a generic drug, it is required to address each patent in the Orange Book that relates to that drug. Eli Lilly & Co., 557 F.3d at 1348. For method-of-use patents that will not expire prior to the proposed marketing of the generic drug, the ANDA applicant has two options.

First, the ANDA applicant can include a statement, known as a “section viii statement,” that the applicant is not seeking approval for the method of use that is claimed in the patent. 21 U.S.C. § 355(j)(2)(A)(viii). When submitting a section viii statement, the ANDA applicant must include a proposed label that removes or “carves out” the claimed method of use. See AstraZeneca LP v. Apotex, Inc., 633 F.3d 1042, 1046 (Fed.Cir.2010). The FDA will approve an ANDA with a section viii statement only if (1) there is no overlap between the proposed label submitted by the ANDA applicant and the use described in the Orange Book, and (2) removing the information about the claimed method of use from the label does not render the drug less safe or effective. See 21 C.F.R. § 314.127(a)(7); see also Applications for FDA Approval to Market a New Drug, 68 Fed. Reg. 36,676, 36,682 (June 18, 2003) (“A section viii statement would not be appropriate [when] the ANDA applicant is seeking approval for exactly the same labeling as that in the NDA for which the patent was submitted.”).

Second, the ANDA applicant can file a “paragraph IV certification,” which states that the patent “is invalid or will not be infringed by the manufacture, use, or sale” of the generic drug. 21 U.S.C. § 355(j)(2)(A)(vii)(IV); see Novo Nordisk A/S v. Caraco Pharmaceutical Laboratories, Ltd., 601 F.3d 1359, 1361 (Fed.Cir.2010). If the ANDA applicant files a paragraph IV certification, it must also send a notice letter so advising the holder of the original NDA and the patent owner. 21 U.S.C. § 355(j)(2)(B).

For method-of-use patents, the “artificial” infringement claim provided by section 271(e)(2)(A) lies only against a patented use that has been approved by the FDA. Warner–Lambert, 316 F.3d at 1356. As this court explained in the Warner–Lambert case, “because an ANDA may not seek approval for an unapproved or off-label use of a drug under 21 U.S.C. § 355(j)(2)(A)(i), it necessarily follows that 35 U.S.C. § 271(e)(2)(A) does not apply to a use patent claiming only such a use.” Id.; see also AstraZeneca Pharm. LP v. Apotex Corp., 669 F.3d 1370, 1377–78 (Fed.Cir.2012); Allergan, Inc. v. Alcon Labs., Inc., 324 F.3d 1322, 1334 (Fed.Cir.2003).

II

Bayer produces and markets Yasmin, an oral contraceptive. In 2001, the FDA approved the new drug application for Yasmin that was filed by Bayer's predecessor, Berlex Laboratories, Inc. That application sought FDA approval for the use of Yasmin “for oral contraception.” The FDA approved the application, noting that it had “concluded that adequate information has been presented to demonstrate that the drug product is safe and effective for use as recommended in the agreed upon enclosed labeling text.”

The defendants in the two cases before us have all filed ANDAs with the FDA to market generic versions of Yasmin. The ANDAs, which track the original NDA as required, seek FDA approval for the use of the generic versions of Yasmin for oral contraception. In their respective ANDAs, the defendants have certified that the three patents that Bayer had listed in the Orange Book in connection with Yasmin are either invalid or would not be infringed by the manufacture, use, or sale of their generic version of Yasmin. See 21 U.S.C. § 355(j)(2)(A)(vii)(IV). In March 2008, Watson and Sandoz sent notice letters to Bayer regarding their ANDA filings. In response, Bayer filed a complaint against Watson and Sandoz in April 2008, alleging infringement under section 271(e)(2)(A) of one of the three listed patents, U.S. Patent No. 5,569,652 (“the '652 patent”). Lupin sent Bayer a notice letter in June 2010 regarding its ANDA filing. Bayer filed a complaint against Lupin in July 2010 alleging infringement of the same patent.

The '652 patent is a method-of-use patent with two independent claims:

1. A method of simultaneously achieving, during premenopause or menopause a gestagenic effect, antiandrogenic effect, and an antialdosterone effect in a female patient in need thereof comprising administering an amount of dihydrospirorenone to said female patient, wherein said amount of dihydrospirorenone is effective to simultaneously achieve a gestagenic effect, antiandrogenic effect and antialdosterone effect in said patient.

11. A method of simultaneously achieving, during premenopause or menopause, a contraceptive effect, an anti-androgenic effect, and an antialdosterone effect in a female patient in need thereof comprising administering an effective amount of dihydrospirorenone and an effective amount of an estrogenic compound, wherein said effective amount of dihydrospirorenone is effective to simultaneously achieve a gestagenic effect, anti-androgenic effect, and an anti-aldosterone effect in said female patient.

Those claims recite that the claimed method achieves three effects simultaneously: a contraceptive (or gestagenic) effect, an anti-androgenic effect (which reduces the activity of male...