Astrazeneca Lp v. Apotex Inc.

• Decision Date: 31 January 2011
• Docket Number: Nos. 2009–1381,2009–1424.,s. 2009–1381
• Citation: 633 F.3d 1042
• Parties: ASTRAZENECA LP and AstraZeneca AB, Plaintiffs–Cross Appellants,v.APOTEX, INC. and Apotex Corp., Defendants–Appellants.
• Court: U.S. Court of Appeals — Federal Circuit

633 F.3d 1042

97 U.S.P.Q.2d 1029

ASTRAZENECA LP and AstraZeneca AB, Plaintiffs–Cross Appellants,

v.APOTEX, INC. and Apotex Corp., Defendants–Appellants.

Nos. 2009–1381

2009–1424.

United States Court of Appeals, Federal Circuit.

Nov. 1, 2010.Rehearing En Banc Denied Jan. 31, 2011.

Denise L. Loring, Ropes & Gray LLP, of New York, NY, argued for plaintiffs-appellees. With her on the brief were Christopher J. Harnett, Pablo D. Hendler and Derek M. Kato.Richard J. Basile, St. Onge Steward Johnston & Reens LLC, of Stamford, CT, argued for defendants-appellants. With him on the brief were David W. Aldrich and Roy D. Gross. Of counsel on the brief was Shashank Upadhye, Intellectual Property Law Apotex, Inc., of Toronto, Ontario, CA.William A. Rakoczy, Rakoczy Molino Mazzochi Siwik LLP, of Chicago, IL, for amicus curiae Breath Limited. With him on the brief were Deanne M. Mazzochi and Amy D. Brody.Richard T. Ruzich, Duane Morris LLP, of Chicago, IL, for amicus curiae Xttrium Laboratories, Inc. With him on the brief were Joseph M. Bennett–Paris, of Atlanta, GA; Anthony J. Fitzpatrick and Christopher S. Kroon, of Boston, MA; Matthew C. Mousley, of Philadelphia, PA; and Kerry B. McTigue, of Washington, DC.Before RADER, Chief Judge,^* BRYSON and LINN, Circuit Judges.Opinion for the court filed by Circuit Judge LINN. Opinion concurring-in-part and dissenting-in-part filed by Circuit Judge BRYSON.LINN, Circuit Judge.

Apotex, Inc. and Apotex Corp. (collectively “Apotex”) appeal from the grant by the United States District Court for the District of New Jersey of a preliminary injunction barring Apotex from launching a generic version of a budesonide drug made and distributed under the approval of the United States Food and Drug Administration (“FDA”) by AstraZeneca LP and AstraZeneca AB (collectively “AstraZeneca”) and covered under method and kit claims in AstraZeneca's U.S. Patents No. 6,598,603 (“the '603 Patent”) and No. 6,899,099 (“the '099 Patent”). AstraZeneca cross-appeals the district court's ruling that the asserted kit claims in both patents are invalid. Because the district court did not abuse its discretion by granting the preliminary injunction and did not err in determining that the kit claims are invalid, this court affirms.

Background

I. The Drug Approval Process

In part, this appeal concerns the procedures for obtaining permission to sell either a “new” or generic drug under the Federal Food, Drug, and Cosmetic Act, ch. 675, 52 Stat. 1040 (1938) (codified as amended in scattered sections of 21 U.S.C.). Under the Act, the FDA must approve all new drugs before such drugs may be distributed in interstate commerce. 21 U.S.C. § 355(a). To obtain approval for a new drug, an applicant may file a New Drug Application (“NDA”) that includes examples of the proposed label for the drug and clinical data demonstrating that the drug is safe and effective for use. Id. § 355(b)(1)(A), (b)(1)(F). The NDA must contain the patent number and expiration date of any patent that claims either the drug or a method of using the drug if “a claim of patent infringement could reasonably be asserted.” Id. § 355(b)(1). The FDA publishes the names of approved drugs and their associated patent information in the Approved Drug Products with Therapeutic Equivalence Evaluations list, commonly referred to as the “Orange Book.”

An applicant seeking approval to market a generic version of a drug may file either an Abbreviated New Drug Application (“ANDA”) or a “505(b)(2) application,” which is also known as a “paper NDA.” Id. § 355(b)(2), (j). An ANDA allows an applicant to rely on the safety and efficacy information for the listed drug if the applicant can show that the generic drug is “bioequivalent” to the listed drug.

An ANDA has three requirements that are particularly relevant here. First, the applicant must demonstrate that “the route of administration, the dosage form, and the strength of the new drug are the same as those of the listed drug,” unless the FDA has approved a “suitability petition” requesting permission to file an ANDA that differs from the listed drug in one or more of these respects. Id. § 355(j)(2)(A)(iii), (j)(2)(C). Second, subject to changes required by FDA regulations or a successful suitability petition, the applicant must also show that “the labeling proposed for the new drug is the same as the labeling approved for the listed drug.” Id. § 355(j)(2)(A)(v). Third, for each patent listed in the Orange Book that claims either the listed drug or a use of the listed drug for which the applicant is requesting approval, an ANDA must include either one of four certifications or a “section viii statement.”

If an applicant chooses to submit a certification, the applicant must certify “(I) that ... patent information has not been filed, (II) that such patent has expired, (III) ... the date on which such patent will expire, or (IV) that such patent is invalid or will not be infringed by the manufacture, use, or sale of the new drug.” Id. § 355(j)(2)(A)(vii)(I)-(IV). These certifications are referred to as Paragraph I, II, III, and IV certifications, respectively.

Assuming all regulatory requirements are satisfied, the FDA may immediately make effective the approval of an ANDA that includes either a Paragraph I or II certification. Id. § 355(j)(5)(B)(i). By contrast, the filing of a Paragraph III or IV certification may delay the effective date of an ANDA approval, and, in the case of a Paragraph IV certification, invite a patent infringement suit. See 35 U.S.C. § 271(e)(2), 21 U.S.C. § 355(j)(5)(B)(ii)-(iii).

If, however, an applicant is seeking approval for a method of use not claimed in a “method of use patent” associated with the listed drug, the applicant must submit a section viii statement declaring that the patent does not claim such a use. 21 U.S.C. § 355(j)(2)(A)(viii). The applicant must also remove or “carve out” any mention of the patented method of use from the proposed label for the generic drug. See 21 C.F.R. § 314.92(a)(1); Novo Nordisk A/S v. Caraco Pharm. Labs., Ltd., 601 F.3d 1359, 1361 (Fed.Cir.2010) (“Along with the section viii statement, the generic manufacturer must submit a proposed label to the FDA that does not contain the patented method of using the listed drug.”). Unlike a Paragraph III or IV certification, the filing of a section viii statement will not by itself delay approval of an ANDA.

Finally, in contrast to an ANDA, a paper NDA must include safety and effectiveness data. 21 U.S.C. § 355(b)(2). However, a paper NDA may rely on safety and effectiveness data not developed by the applicant. Id. As with an ANDA, a paper NDA requires the applicant to submit either a patent certification or a statement declaring that the patent does not claim the method of use for which the applicant is seeking approval. Id. § 355(b)(2)(A)-(B).

II. AstraZeneca's Budesonide Drug and Patents

In 2000, the FDA approved AstraZeneca's NDA for a budesonide inhalation suspension that AstraZeneca now markets under the name “PULMICORT RESPULES®.” Each “respule” is a plastic vial containing a single dose of budesonide, an anti-inflammatory corticosteroid, suspended in a sterile liquid. The drug is administered by squeezing the entire contents of a vial into a jet nebulizer and inhaling the resulting mist through a mask attached to the nebulizer.

The Orange Book entry for AstraZeneca's budesonide product includes the ' 099 Patent and its parent, the '603 Patent. Both patents are owned by AstraZeneca and have specifications that are nearly identical in all relevant respects. The patents explain that “[t]he invention provides a new method of treating respiratory diseases such as asthma that involves administering a budesonide composition with a nebulizer not more than once per day.” ' 603 Patent col.1 ll.20–23; '099 Patent col.1 ll.26–29. “The invention also features a kit for treating respiratory diseases, the kit including a budesonide composition in a sealed container ... and a label indicating administration by nebulization in a continuing regimen at a frequency of not more than once per day.” '603 Patent col.2 ll.1–6; ' 099 Patent col.2 ll.7–12. Both patents include method claims directed to administering a budesonide composition once daily and product claims directed to the described kit containing either a budesonide composition or suspension and a label indicating once-daily administration by nebulization.

While AstraZeneca's patents are directed to once-daily treatment, the label that accompanies AstraZeneca's budesonide product indicates that the drug may be administered once or twice daily. The label states that the drug is available in three strengths—0.25 mg, 0.5 mg, and 1.0 mg per 2 mL vial—and provides a table of recommended starting doses based on a patient's history of therapy. The label repeatedly warns that patients should “titrate down” to the lowest effective dose of the medication to avoid any adverse effects from excessive use of the medication. For example, in its DOSAGE AND ADMINISTRATION section, the label states that “[i]n all patients, it is desirable to downward-titrate to the lowest effective dose once asthma stability is achieved” and “[o]nce the desired clinical effect is achieved, consideration should be given to tapering to the lowest effective dose.” The PRECAUTIONS section also warns that “suppression of HPA function may be associated ... when the dose is not titrated to the lowest effective dose” and “[t]o minimize the systemic effects of orally inhaled corticosteroids ... each patient should be titrated to his/her lowest effective dose.” It is undisputed that the FDA requires all manufacturers of inhaled corticosteroids such as budesonide to include this downward titration language in the labels of their inhaled corticosteroid products.

III. Apotex's ANDA

Apotex submitted an ANDA seeking FDA approval to manufacture and sell a generic version of budesonide for...