First published in LES Insights

Abstract

Relying on the recent U.S. Supreme Court decision in Akamai, and the subsequent en banc Federal Circuit ruling, an Indiana court recently concluded that the entire performance of a patented method covering drug administration is attributable solely to a single entity, the physician or other health care provider of the patient. In particular, although patients on their own need to obtain one of three claimed components of the patented dosing regimen, the court found that physicians and other health care providers direct the manner and timing of ingesting that component and that patient compliance with those instructions is necessary to receive the full benefit of treatment. Thus, there would be no defense of divided infringement because through this attribution, physicians would directly infringe the patent claims, and the generic drug manufacturer defendants would induce such infringement because their drug labeling instructs physicians to follow the patented regimen.

Any person who actively induces infringement of a patent is liable as an infringer under 35 U.S.C. § 271(b). This form of indirect infringement is commonly at issue in Hatch-Waxman infringement actions because generic drug manufacturers always provide drug-package inserts containing instructions for healthcare providers and patients, and these package inserts typically correspond to a patented method of treatment.

A finding of induced infringement is predicated on a finding of direct infringement. Direct infringement occurs where all the steps of a claimed method are performed by or attributable to a single entity. Recently, in Eli Lilly and Co. v. Teva Parenteral Medicines, Inc.1 et al the parties disputed whether a patented method of administering a drug would be directly infringed where a physician would administer two of the claimed components, but the patient was required to obtain and take another of the claimed components. The U.S. District Court for the Southern District of Indiana concluded that the entire performance of the patented administration is attributable to physicians and, thus, physicians would directly infringe the patented method. Because the defendants' proposed generic drug-labeling instructs physicians to follow the patented administration, the court found they would be liable for inducing the physicians' infringement.

Background

Eli Lilly owns U.S. Patent No. 7,772,209 (the '209 patent) covering a method of administering a chemotherapy drug, pemetrexed disodium, marketed by Lilly under the trade name ALITMA®. The method of administration requires co-administration of the drug with folic acid and vitamin B12 in order to reduce incidences of patient toxicity caused by pemetrexed disodium.

Several generic drug manufacturers (Defendants) filed Abbreviated New Drug Applications seeking Federal Drug Administration (FDA) approval to market generic forms of pemetrexed disodium. The Defendants sought to sell their generic pemetrex disodium products with drug labeling that instructs physicians to follow the patented administration.

Eli Lilly brought a Hatch-Waxman infringement action against the Defendants, asserting infringement of the '209 patent. The asserted claims required treatment with specified amounts of folic acid and vitamin B12 prior to administering the pemetrexed disodium. During a first trial, only patent validity was at issue because the parties jointly stipulated to induced infringement, but the Defendants reserved the right to litigate the induced infringement issue if the U.S. Supreme Court granted a then-pending petition for writ of certiorari in Limelight Networks, Inc. v. Akamai Technologies, Inc., and either reversed or vacated the Federal Circuit's decision. The Supreme Court did so, and the parties moved to litigate the issue of induced infringement.

The parties' dispute centered on whether the '209 patent would be directly infringed, which is a prerequisite for induced infringement. The experts for both sides agreed that in following the Defendants' proposed drug labeling, a physician will administer the vitamin B12 by injection and the pemetrexed disodium by infusion and that the patient, at the instruction of the physician, must obtain and take the folic acid.

The Eli Lilly Decision

Looking to the U.S. Supreme Court's holding in Akamai, the court observed that for direct infringement to occur, "performance of all of the claimed steps [must] be attributed to a single person." The court then looked to a subsequent en banc decision of the Federal Circuit in which the Court unanimously set forth the present law on divided infringement. Specifically, if more than one actor practices the steps of an asserted claim, a court must decide if the acts of one are attributable to the other such that a single entity is responsible for infringement. The Federal Circuit explained that a court will hold a single entity responsible for others' performance 1) where the entity directs or controls others' performance or 2) where the actors form a joint enterprise. The Federal Circuit found that the first circumstance may be satisfied if an entity conditions others' participation in an activity or receipt of a benefit on performance of a step or steps of a patented method, and also establishes the manner or timing of the performance.

Applying this reasoning to the present case, the court expressed the relevant question as whether the physician sufficiently directs or controls the patient's acts so as to condition treatment with pemetrexed disodium in the manner that reduces toxicities upon the performance of a patented step and establishes the manner and timing of the performance. The court answered this question affirmatively. Although patients on their own obtain and take folic acid, the court found that taking folic acid prior to the administration of pemetrexed disodium—as claimed in the patent and explained in the drug prescribing information and patient information—was critical to lower the chances of harmful side effects. According to the court, therefore, taking the folic acid in the manner specified was a condition of the patient's participation in the pemetrexed disodium treatment to receive the full benefit of treatment. Physicians, the court continued, based upon the patented method, direct the manner and timing of patients' ingestion of folic acid.

Based on these findings, the court determined that the physicians, in accordance with the Defendants' proposed drug-labeling, direct, or control-patients' administration of folic acid "such that the performance of all the claimed steps, including administration of folic acid, can be attributed to a single person, i.e., the physician." Accordingly, the physicians, the Court concluded, would directly infringe the patent, and the defendants would induce such infringement through the instructions in their drug labeling.

Strategy and Conclusion

This decision provides an example of a divided infringement analysis post Akamai within the context of Hatch-Waxman patent-infringement litigation. Generic drug manufacturers will be liable for induced infringement if physicians or other healthcare providers direct or control the performance of patients based upon the manufacturer's proposed drug package insert.