Last week the Federal Circuit issued its opinion in Wyeth LLC v. AstraZeneca Pharmaceuticals LP, a patent case we have been following because it attracted an amicus brief. In this case, Wyeth appealed a lower court’s grant of judgment as a matter of law of invalidity for lack of enablement. The case presented questions related to claim construction as well as whether pre-issuance provisional rights under the Patent Act extend to induced infringement. In an opinion authored by Judge Lourie and joined by Judges Linn and Hughes, the court affirmed the judgment of invalidity. This is our summary of the opinion.
Judge Lourie began by outlining the factual and procedural background:
Wyeth’s ’314 and ’162 patents generally relate to methods of cancer treatment. Specifically, the asserted patents claim methods of using irreversible inhibitors to treat ‘gefitinib and/or erlotinib resistant’ non-small cell lung cancer (‘NSCLC’). NSCLC is associated with overactivity of the epidermal growth factor receptor (‘EGFR’), a receptor tyrosine kinase that regulates cell growth and division. Drugs used to treat NSCLC—known as EGFR tyrosine kinase inhibitors (‘TKIs’)—bind to specific regions of EGFR and inhibit signaling that would otherwise promote cancer cell growth. . . .
The specification also discloses that ‘[t]he therapeutic compositions of this invention, e.g. irreversible EGFR inhibitors, are conventionally administered intravenously, as by injection of a unit dose, for example.’ It further states that the claimed ‘unit dosage’ refers to ‘physically discrete units suitable as unitary dosage for the subject, each unit containing a predetermined quantity of active material calculated to produce the desired therapeutic effect in association with the required diluents; i.e., carrier, or vehicle.’ . . .
[T]he specification states that the ‘[p]recise amounts of active ingredient . . . depend on the judgment of the practitioner and are peculiar to each individual.’ In terms of any additional guidance, the specification explains that a ‘skilled artisan is aware of the effective dose for each patient,’ and offering that, ‘in general, satisfactory results are obtained when the compounds of the invention are administered at a daily dosage of from about 0.5 to about 1000 mg/kg of body weight,’ and that the ‘total daily dosage is projected to be from about 1 to 1000 mg, preferably from about 2 to 500 mg.’
In September 2021, Wyeth filed a complaint in the district court asserting that AstraZeneca induced infringement of the ’314 and ’162 patents based on marketing, distribution, and sales of its irreversible EGFR inhibitor Tagrisso (osimertinib). The district court construed several terms, including the term ‘unit dosage.’ The court explained that the ‘claimed methods involve administering daily a “unit dosage” of an irreversible EGFR inhibitor that covalently binds to a specific part of the enzyme.’ The court identified that the specification ‘expressly define[d]’ a ‘unit dos[age],’ and ultimately adopted that definition: ‘physically discrete units suitable as unitary dosage for the subject, each unit containing a predetermined quantity of active material calculated to produce the desired therapeutic effect in association with the required diluents; i.e., carrier, or vehicle.’ . . .
AstraZeneca renewed its motion for JMOL post-verdict and argued, in part, that no reasonable jury could have found the asserted patents not invalid. As relevant on appeal, AstraZeneca argued that the asserted claims were invalid for lack of enablement. Specifically, it argued that ‘the patents claim but do not enable treatment via a ‘unit dosage—i.e., a predetermined quantity of active material calculated to produce the desired therapeutic effect.’ . . .
The district court granted JMOL of invalidity for lack of enablement of the asserted claims determining that no reasonable jury could have found the asserted claims not invalid. . . .
The district court next turned to the evidence presented at trial. It concluded that AstraZeneca presented clear and convincing evidence that no reasonable jury could have found that the asserted patents enabled a skilled artisan to administer the claimed ‘unit dosage’ of the claimed irreversible EGFR inhibitor to a patient without undue experimentation. The court emphasized that (1) the specification disclosed no working examples of unit dosages administered to patients, and (2) AstraZeneca presented unrebutted evidence that some disclosed dosage levels would be toxic, including doses required to achieve a therapeutic effect in patients. . . .
In view of that evidence, the district court concluded that the asserted patents ‘provide[d] “only a starting point, a direction for future research” that place[d] the burden on a [skilled artisan] to conduct “an iterative, trial-and-error approach to practice the claimed invention.”‘ . . . In sum, the district court held ‘the asserted claims of the ’314 and ’162 patents [ ] invalid for failure to meet the enablement requirement of 35 U.S.C. § 112(a)’ and granted AstraZeneca’s motion for JMOL of invalidity.
Reaching the dispute, Judge Lourie first addressed Wyeth’s contention “that the district court improperly imported clinical safety and efficacy requirements into the claims.” Judge Lourie explained that, “[w]hile Wyeth is correct that the claims do not require FDA-type clinical safety or efficacy standards, it fails to appreciate and give meaning to other relevant claim terms—namely, that the claimed ‘unit dosage’ must be ‘administer[ed] daily’ to a human ‘patient.'” Judge Lourie then found that, because the specific definitions of these terms were “unchallenged,” the district court’s “interpretation does not import any FDA-type safety or efficacy requirements into the claims as Wyeth contends.” Additionally, he explained, “the district court did not improperly amend its construction post-verdict” because the “district court’s ‘elaboration’ on its construction of ‘unit dosage’ post-verdict was permissible to ‘clarif[y] what was inherent in the construction.'”
Judge Lourie next addressed Wyeth’s argument “that the district court erred in granting JMOL because . . . a reasonable jury could have concluded that AstraZeneca failed to prove . . . that the asserted claims require undue experimentation.” Judge Lourie found that Wyeth’s argument “mischaracterizes the district court’s analysis, and, regardless, the specification fails to enable the claims as properly construed.” Judge Lourie explained that “the specification describes in vitro experimentation without any further description of (1) how to extrapolate in vivo dosing from those in vitro results or (2) any other teachings sufficient to allow a skilled artisan to calculate a ‘unit dosage’ as claimed.” Additionally, he found, “the specification itself demonstrates that determining the claimed ‘unit dosage’ is a complex and highly individualized task, while at the same time failing to provide the information and guidance necessary for a skilled artisan to perform that task without undue experimentation.” Judge Lourie concluded that these patents and their claims “disclosed only a broad range of doses some of which were shown to be toxic, and they disclosed no actual dosages for any compound within the scope of the claims, thereby leaving it to a practitioner of the claims to perform undue experimentation.”
As a result of Judge Lourie’s analysis, the panel affirmed the district court’s grant of JMOL of invalidity.
In a footnote, Judge Lourie noted the panel would not reach a second issue raising in the briefing, “pre-patent-issuance damages and provisional rights under 35 U.S.C. § 154(d).” He explained the court would not do so because it affirmed the grant of JMOL of invalidity.