By Dennis Crouch

Astrazeneca v. Apotex, et. al (Fed. Cir. 2012)

Next year, I will be teaching the required first year course here at Mizzou titled Civil Procedure II. It would not be too difficult to almost fill an entire civil procedure casebook with patent cases.  In this decision, the court focused on the difference between dismissal for lack of subject matter jurisdiction and dismissal for failure to state a claim.

Here, the defendant generic pharmaceutical manufacturers filed an abbreviated new drug application (ANDA) with the Food & Drug Administration (FDA) requesting permission to begin selling a generic version of Astrazeneca's CRESTOR statin drug. The ANDA requested approval only for a limited set of drug uses. And, as it turns out, none of the applied-for uses are covered by the method patents listed in the Orange Book. (Astrazeneca has a composition patent that is being litigated in a separate lawsuit).

A generic ANDA must provide some indication as to why the generic application should be approved despite any patent rights held by the branded manufacturer. This explanation is typically identified as a Paragraph I, II, III, or IV certification.

  • Paragraph I Certification indicates that the Orange Book lists no patents relevant to the ANDA.
  • Paragraph II Certification indicates that the listed patents have expired.
  • Paragraph III Certification indicates that the generic manufacturer will stay off market until the patents expire.
  • Paragraph IV Certification indicates that the generic manufacturer believes that the listed patents are either invalid or would not be infringed by the generic compositions.

21 U.S.C. § 355(j)(2)(A)(vii)(I-IV). The generic ANDA may alternatively include a statement that excludes all uses claimed in any listed patents. 21 U.S.C. § 355(j)(2)(A)(viii). Here, the generic filers followed this alternative approach and explicitly excluded any and all uses of the compounds claimed in AZ's listed patents.

The patent statute creates a quirky cause of action for generic drug patent litigation. Rather than requiring a patentee to wait for infringement by manufacture or sale under 35 U.S.C. § 271(a), the law includes a shortcut under Section 271(e)(2) that creates a cause of action based simply on filing an ANDA for the purpose of gaining approval to manufacture or sell a generic version of a drug before the associated patent expires.

It shall be an act of infringement to submit—(A) an [ANDA] under [section 355(j)] for a drug claimed in a patent or the use of which is claimed in a patent … if the purpose of such submission is to obtain approval … to engage in the commercial manufacture, use, or sale of a drug … claimed in a patent or the use of which is claimed in a patent before the expiration of such patent.

35 U.S.C. § 271(e)(2). AZ seemingly agreed that the generic filing, by its terms did not seek approval for any use that would infringe AZ's patent claims. However, Astrazeneca sued the generic filers for infringement anyway. AZ's argument was – once approved – the drug would certainly be sold and used for infringing purposes and that the FDA will eventually require the generic filers to amend their ANDA to cover all approved uses of the drug. The district court rejected these claims and dismissed the case for lack of subject matter jurisdiction under Federal Rule of Civil Procedure 12(b)(1).

On appeal, the federal circuit rejected that conclusion – holding instead that the court's subject matter jurisdiction persists because the complaint alleged infringement under the patent act. The court wrote "the requirements for jurisdiction in the district courts are met once a patent owner alleges that another's filing of an ANDA infringes its patents under §271(e)(2), and this threshold jurisdictional determination does not depend on the ultimate merits of the claims."

Although the court rejected the dismissal on Rule 12(b)(1), the court went on to affirm the judgment based on Rule 12(b)(6) – dismissal on the pleading for failure to state a viable claim. The rules of adjudging 12(b)(6) issues allow the court to consider whether it would be possible for the plaintiff to win based upon facts alleged in the pleadings. Here, the appellate panel held that the complaint failed because "an ANDA seeking to market a drug not covered by a composition patent for unpatented methods of treatment cannot infringe under § 271(e)(2)."

Dismissal Affirmed.

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