In a post-trial Hatch-Waxman opinion issued this week, Chief Judge Connolly sided with the defendant regarding the sole infringement dispute: whether the defendant's ANDA product had an infringing pH. The plaintiffs' patents required that the claimed compositions have a pH of between 3.7 and 3.9. The defendant's ANDA undisputedly required that the defendant's generic product have a pH between 3.4 and 3.6. Importantly, the ANDA required that the product fall within the 3.4-3.6 range both upon release and during the stability testing period (24 months).
Given that the ANDA's requirements are binding on the manufacturer of the generic product, and given that the ANDA is the operative document for the purposes of the infringement inquiry in Hatch-Waxman cases, you might think that would be the end of the inquiry. Indeed, Judge Connolly noted that in these circumstances, a judgment of noninfringement "must necessarily ensue."
However, the plaintiffs challenged this conclusion, arguing that two "undisputed facts" required a judgment of infringement.
First, the plaintiffs asserted that the generic product's stability testing data showed "drift" in the pH, such that pH would rise during storage.
Second, the plaintiffs asserted that defendant sought approval to release a generic product with a pH of up to 3.64 (which would be rounded down to 3.6), such that if the pH were to "drift" upward just 0.01 unit, it would be infringing.
Judge Connolly found that the drift was not decidedly directional (i.e., some samples drifted up and some drifted down). He also found that the optimized manufacturing process resulted in much tighter pH control around a value of 3.5, which made any drift less likely to cause infringement. He also noted that the generic product was required to comply with the release and stability specifications in the ANDA, both of which required a pH between 3.4 and 3.6, which meant that by definition it could not drift into infringing territory:
[Plaintiff] Par wants me to assume that [defendant] Eagle will comply with the ANDA's release pH specification but not comply with its stability pH specification. It insists that "the stability specification is not a legal bar to finding infringement." . . . But unequivocal binding precedent holds otherwise. As the Federal Circuit held in In re Brimonidine, courts "cannot assume that [an ANDA filer] will not act in full compliance with its representations to the FDA." 643 F.3d at 1378 (emphasis added).
Ultimately, Judge Connolly "reject[ed]" plaintiffs' "attempt to use testing data to support a finding that Eagle would violate the binding representations it made to the FDA in its ANDA." He summed up:
At most, Par proved at trial that if Eagle were not bound by its stability pH specification and its representation to use its optimized manufacturing process then Eagle could use a different manufacturing process that could result in a drug product with a pH that meets the pH limitation in the asserted claims. Proof of that possibility is insufficient to sustain a finding of infringement under§ 271(e)(2).