Two cases being argued at the Federal Circuit in May attracted amicus briefs. One of these cases is Wyeth LLC v. AstraZeneca Pharmaceuticals LP, a patent case. In it, 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. This is our argument preview.
In its opening brief, Wyeth spends most of its time arguing the lower court erred by adopting a new claim construction after the jury returned its verdict of infringement, no invalidity, and damages. Throughout the litigation, Wyeth claims, the lower court defined the key claim term, “unit dosage,” as “calculated to produce the desired therapeutic effect.” The lower court, Wyeth says, repeatedly held this term “does not require clinical efficacy.” Wyeth says, however, that after the jury verdict, the lower court sua sponte adopted a new construction. New safety considerations were added, Wyeth contends, because the court held, if it was necessary that a “person of ordinary skill in the art” must “undertake undue experimentation to find a ‘unit dosage’ that would not fatally poison a patient,” then the patents-in-suit “do not enable” the claims. In Wyeth’s view, this post-verdict shift in construction was procedurally impermissible because “judgment as a matter of law is too late for such a change.” Wyeth also relies on case law it says hold that, “[a]bsent incorporation of safety and efficacy requirements in the claims,” such questions are instead “the purview of the Food and Drug Administration.” As for the second question presented, Wyeth claims the lower court “failed to read the statute as a whole and to credit its purpose to protect patentees from pre-issuance infringement, regardless of type.”
In its response brief, AstraZeneca argues there was no change in claim construction and that the lower court “reaffirmed its claim constructions and prior orders.” AstraZeneca contends, moreover, that the patents are invalid because “Wyeth filed an incomplete patent application that taught the wrong solution”–a specification that “describes an unfinished project, not a completed invention.” AstraZeneca points to admissions by Wyeth’s inventors stating “the concentrations in the test tube are higher than those you can give to patients” and were “five times higher than the maximum dose.” AstraZeneca asserts that, by the claims’ own terms, a “unit dosage” must be administrable to a patient, and that as a result “it was undisputed that a toxic dose is not a ‘unit dosage.'” Under existing case law, AstraZeneca argues, “the patent must provide some guidance that will reliably enable” a person of ordinary skill in the art “to make and use all of what is claimed, not merely a subset.” Furthermore, AstraZeneca suggests, the statute provides no basis for induced-infringement damages for provisional applications because the statute does not incorporate the relevant section of the patent statute.
In its reply brief, Wyeth argues AstraZeneca “offers no meaningful defense” of the lower court’s lethality-based analysis. According to Wyeth, “[t]here is zero evidence that avoiding fatal doses took too much work.” Wyeth contends AstraZeneca “never specified any meaning of ‘toxicity,'” which Wyeth says would require answering questions such as: “What type or severity of side effects is too much? Measured by what metric, and by whom?” On the question of side effects, Wyeth notes they are “common and manageable,” and that patients with “deadly cancers” regularly “accept treatments that are ‘quite toxic’ with only ‘modest benefit.'” Wyeth, moreover, argues AstraZeneca concedes “the specification need not enable a ‘unit dosage’ with particular safety or efficacy requirements.” Yet, in Wyeth’s view, AstraZeneca defends judgment as a matter of law based on a toxicity limitation, which Wyeth calls “the exact sort” of safety requirement AstraZeneca purports to disclaim.
The case attracted an amicus brief by Regeneron Pharmaceuticals, Inc. and Sanofi-Aventis U.S. LLC in support of affirmance. The amici argue Wyeth’s claims are “broad, functionally-defined” claims that “purport to cover a category of molecule with an enormous number of members defined only by what they do.” They contend the relevant specification provides “only three exemplary compounds,” all sharing the same structural scaffold; yet, they say, Wyeth takes the position that “none of these structural elements were necessary to or limitations on the scope” of the patent. The amici urge the court to affirm on the ground that the patents lack both written description and enablement support. According to amici, the patents “send a scientist not just on one hunting expedition, but on an extended series of nested trial-and-error experiments.”
Oral argument is scheduled to be heard on Thursday, May 7 at 10:00 a.m. in Courtroom 402.