Judge Stark today dismissed an ANDA claim after the defendant converted their ANDA in such a way that it simply did not infringe, and plaintiff was left with no claim and no remedy.
What Is an ANDA? (The Short Short Version)
ANDA cases make up a fair portion of the Court's docket. If you're not already familiar, ANDA cases are brought by patent holders after a drug manufacturer files an ANDA seeking approval to manufacture a generic version of a drug.
As part of the ANDA, if there are unexpired patents listed with the FDA as covering the drug, the manufacturer may certify either that the patents are invalid, unenforceable, or won't be infringed (paragraph IV), or that the generic will stay off the market until the relevant patents expire (paragraph III).
After a paragraph IV ANDA is filed, the patent holder can bring an infringement action against the filer.
Judge Stark's Opinion
In his opinion today, Judge Stark explored what happens when an ANDA filer converts their application from paragraph III to paragraph IV mid-stream and moves to dismiss a pending action.
The answer? The Court found that it could not dismiss for lack of subject matter jurisdiction, but could dismiss on the basis that, by delaying its launch until after the patents expire, the defendant just will not infringe:
Sandoz seeks authorization to market its ANDA product only after the polymorph patents expire. At that point, Sandoz will not be committing “an act of infringement” under § 271(e)(2).
Judge Stark rejected plaintiff's reliance on the idea that the defendant might reconvert back to paragraph IV:
Plaintiffs’ suggestion that Sandoz might reconvert to Paragraph IV and, therefore might infringe during the term of the polymorph patents, does not give rise to a claim under § 271(e)(2).
Thus, any injunction would be "utterly speculative":
Plaintiffs suggest that relief the Court could still provide (upon a post-trial finding that Sandoz’s ANDA product infringes a valid claim of a polymorph patent) is an injunction against Sandoz to prevent it from reconverting from Paragraph III to Paragraph IV. (See Tr. at 80-81) In the Court’s view, such relief would be inappropriate – given the utterly speculative nature of the claim on which it would be based, as Sandoz has no present intent to seek FDA approval prior to the expiration of the polymorph patents – and, accordingly, is not truly available.
In short, no infringement = no case. The Court dismissed the claim.
P.S.—Along the way, and following our recent theme, Judge Stark rejected plaintiff's argument that defendant's DJ counterclaims should be dismissed with prejudice, because plaintiff failed to raise the point before the hearing.
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