Matching Claim Language with Label Language Ensnares Infringers
Written by Caleb A. Bates, Ph.D. and Agnes Juang, Ph.D.
On January 12, 2017, the U.S. Court of Appeals for the Federal Circuit issued an opinion affirming the judgement that Eli Lilly’s U.S. Patent No. 7,772,209 (“the ’209 Patent”) was valid and infringed under the doctrine of induced infringement. Specifically, the Court relied upon product labeling, which instructs doctors and patients on the dosage ranges and schedules recited in the asserted claims of the ’209 Patent.
The District Court
The ’209 Patent recites methods of administering the drug Pemetrexed to a patient comprising “administering an effective amount of folic acid . . . followed by administering an effective amount of pemetrexed . . . .” Thus, each claim requires pre-treatment with folic acid. Lilly’s prescribing information and labeling also emphasizes the importance of this pre-treatment by stating “instruct patients to initiate folic acid . . . before the first dose of [pemetrexed].” Defendants’ proposed prescribing information would have mimicked Lilly’s labeling. Accordingly, the District Court found that Defendants induced infringement of the ’209 Patent based on the similarity between the claim language and the language in the proposed product labeling, which “induced” physicians and patients to infringe the claimed method. Under 35 U.S.C. § 271(b), “[w]hoever actively induces infringement of a patent shall be liable as an infringer.”
The Federal Circuit
The Federal Circuit agreed with the District Court, under the en banc decision in Akamai Techs., Inc. v. Limelight Networks, Inc., 797 f. 3d 1020 (Fed. Cir. 2015)(en banc)(per curiam) cert. denied, 136 S. Ct. 1661 (2016) (“Akamai V”). Akamai V addressed infringement of method claims reciting multiple steps, when a single actor does not perform each step of the claimed method (known as “divided infringement”). Under Akamai V, multiple parties performing the claimed steps may constitute infringement by a “single actor” when a single entity “directs or controls” the others’ performance. The Court applied a two-prong test to determine whether Defendants, together with physicians and patients, constituted a “single actor.” The alleged single actor must (1) condition participation in an activity (or receipt of a benefit) upon others’ performance of one or more steps of the claimed method, and (2) establish the manner or timing of the others’ performance. See Akamai V at 1023.
First, the Federal Circuit determined that the labeling language amounted to more than mere instructions or guidance and was a requirement. Accordingly, treatment with Pemetrexed was a benefit to the patients that was conditioned on pre-administration of folic acid. Second, the Federal Circuit found that Defendants controlled the timing and manner of the other actors’ performance of the claimed method steps. The prescribing information instructs physicians to administer a specific amount of folic acid orally, once per day, beginning seven days prior to the first dose of Pemetrexed, and provides express warnings about the consequences of noncompliance. The folic acid dosage ranges and the dosing schedule overlaps with the ranges and schedules recited in the asserted claims of the ’209 Patent. The Federal Circuit thus found that physicians prescribing Defendants’ generic Pemetrexed would directly infringe the ’209 Patent.
The Federal Circuit also explained that the product instructions here were not vague, and did not require a physician to look for additional guidance outside the label. Accordingly, by intending physicians to administer Pemetrexed consistent with the proposed labeling (and therefore, consistent with the asserted claims), Defendants had intent to induce infringement. Thus, because the proposed product labeling would inevitably lead some physicians to infringe the ’209 Patent, the Federal Circuit found the requisite intent to induce infringement, affirming the District Court’s ruling.
Practical Considerations
This case highlights the importance of considering possible product labeling language while drafting a patent application and throughout prosecution. Specifically, the Court focused on the repeated express directions in the Prescribing Information and product labeling. These directions were mirrored by the asserted claims of the ’209 Patent, both with respect to the amounts of Pemetrexed and folic acid administered and the dosing schedules. Thus, Applicants may find it advantageous to consider potential label language early in the product development timeline. Claims directed to specific dosage amounts and dosing schedules, particularly to avoid side-effects, may prevent generic competition via induced infringement.