Last month, the Federal Circuit heard oral argument in Wyeth LLC v. AstraZeneca Pharmaceuticals LP, a patent case we have been tracking because it attracted an amicus brief. In this case, Wyeth appeals a lower court’s grant of judgment as a matter of law of invalidity. The case presents questions related to claim construction as well as whether pre-issuance provisional rights under the Patent Act extend to induced infringement. Judges Lourie, Linn, and Hughes heard the oral argument. This is our argument recap.
Jennifer Swize argued on behalf of Wyeth. She began by claiming that the “district court’s fatal dose theory for granting JMOL had no evidentiary support . . . and AstraZeneca does not even defend that on appeal.” Swize reiterated that “there is a complete absence of proof.”
Judge Lourie pressed Swize on the validity of the patent, suggesting there was “essentially a constructive reduction to practice” with “no examples of actual doses and treatment.” He questioned if there was a failure of enablement too because, he said, the evidence showed the stated doses being “five times the toxic dose.” In response, Swize argued “toxicity is not part of the claims and that is clear in the district court’s claim construction, which is not being challenged by AstraZeneca.” Judge Lourie, however, pressed further, saying “the claim reads treatment to patients and that presumes enablement.” Swize pointed to the dosage range included in the patent, but judge Hughes found them to not be sufficient because the patent “indisputably includes ranges that are ineffective and that are toxic.” In response, Swize highlighted AstraZeneca “carries both the burden of clear and convincing evidence” and the burden to grant JMOL, and so AstraZeneca must prove “that anything in this range doesn’t work.”
Judge Hughes reasserted the enablement issue by asking how Wyeth could “claim a range if it requires undue experimentation to come up with actual dosages that will fall within that range.” In response, Swize argued the “fine-tuning of exactly what range [is] what doctors do.” She said “[t]hat’s standard in the art.” She explained the dosage language was only added during prosecution “because the examiner was mistaken in using a reference as anticipatory that had extremely high . . . , unconventional dosing.”
Christopher Sipes argued on behalf of AstraZeneca Pharmaceuticals. He began by expanding on Wyeth’s explanation for “why unit dose was added” and “whether dosing was a point of novelty.” He claimed the dosage language “was added to distinguish . . . treating resistant cancer with what the applicants here disparaged as overdosing and, specifically, with dosing that was not well tolerated.”
Sipes continued by arguing that constructive reduction to practice was hot shown because “there was no working example, . . . no identification, no reduction to practice of daily unit dose for any particular embodiment.” Moreover, he said, there was “not even a teaching of how to do it.”
Judge Hughes pointed to the “argument that [Wyeth] identified some of the inhibitors . . . and there were animal studies and in vitro studies that showed this worked.” In response, Sipes suggested this was not enough to show constructive reduction because “there has to be a teaching of how to carry out the invention, particularly with regard to its novel aspects.” But, he said, “here, among other things, the novel aspect was figuring out the dosing.”
Sipes further argued that there is a gap in Wyeth’s patent between “the dose to actually make it effective and reduce cancer . . . [and] the dose a patient can tolerate.” He reiterated “it was undisputed, and the district court below found, that there’s no working examples in the patent.”
In rebuttal, Swize argued “[m]aximum tolerated dose, dose limiting toxicity, and therapeutic window are not relevant.” She said “[t]hose are FDA standards” and the “district court ruled those are out multiple times.” Swize then reaffirmed her claim that Wyeth does not “have to actually reduce to practice” because its patent does “enable an artisan who’s already in this field, already familiar with other cancers, [and] dosing at conventional ranges.”
We will continue monitoring this case and report on developments.