Recent jurisprudence on the issue of divided infringement has arisen in the context of computer-related technologies, where a user or customer performs one or more steps of a patented method. Now the issue has arisen in the pharmaceutical context, where a patient self-administers a drug. In Eli Lilly and Company v. Teva Parenteral Medicines, Inc., et. al., 1-10-cv-01376 (INSD), the U.S. District Court for the Southern District of Indiana found that generic drug manufacturers can be liable for induced infringement when a doctor and patient perform different steps of the method.

The Patent At Issue

The patent at issue was Eli Lilly’s U.S. Patent No. 7,772,209, directed to combination therapies using folic acid, a methylmalonic acid lowering agent such a vitamin B12, and pemetrexed:

12. An improved method for administering pemetrexed disodium to a patient in need of chemotherapeutic treatment, wherein the improvement comprises:

a) administration of between about 350 μg and about 1000 μg of folic acid prior to the first administration of pemetrexed disodium;

b) administration of about 500 μg to about 1500 μg of vitamin B12, prior to the first administration of pemetrexed disodium; and

c) administration of pemetrexed disodium.

The ‘209 patent is listed in the Orange Book for Lilly’s ALIMTA® (pemetrexed) product for treatment of specific types of lung cancer and mesothelioma. The defendants (Teva, APP Pharmaceuticals, Barr Laboratories, and Pliva Hrvatska D.O.O.) filed Abbreviated New Drug Applications (ANDAs) seeking FDA approval to market generic forms of pemetrexed with prescribing information and patient information that provides instructions to both doctors and patients to use pemetrexed in methods claimed in the ‘209 patent.

Lilly asserted claims 9, 10, 12, 15, 18, 19, and 21 of the ‘209 patent. The parties agreed that a doctor or other medical professional will administer the vitamin B₁₂ to the patient by injection and will administer pemetrexed to the patient by infusion, while the patient will obtain and self-administer the folic acid. The defendants challenged Lilly’s position that the doctor (or other medical professional) would be liable for direct infringement under such circumstances.

Divided Infringement

In its recent en banc decision in Akamai Technologies, Inc. v. Limelight Networks, Inc., the Federal Circuit broadened the circumstances under which direct infringement of a method patent can be found when more than one actor carries out the claimed method steps. According to previous Federal Circuit precedent, the actions of one entity can be attributed to another if (1) the accused entity directs or controls the other’s performance, or (2) the accused entity and the other are part of a joint enterprise. Under Akamai, it “can also be found when an alleged infringer conditions participation in an activity or receipt of a benefit upon performance of a step or steps of a patented method and establishes the manner or timing of that performance.”

Does A Doctor Control A Patient’s Conduct? 

The district court framed the issue presented as follows:

What is relevant is whether the physician sufficiently directs or controls the acts of the patients in such a manner as to condition participation in an activity or receipt of a benefit—in this case, treatment with pemetrexed in the manner that reduces toxicities—upon the performance of a step of the patented method and establishes the manner and timing of the performance.

The defendants argued that a physician lacks “control or direction” over the patient’s performance, because “there is no way of knowing whether the patient will or will not actually take the folic acid.” However, the district court reasoned that, in the ANDA context, it “cannot base a finding of non-infringement upon the mere possibility that some patients might not follow their physician’s instructions and instead must look to the ANDA Products’ labeling to determine, if all the patented steps are followed, whether it would infringe the Asserted Claims.” Thus, “the only relevant question is whether the actions of the patient in taking folic acid as instructed may be attributable to the physician as a single actor.”

The court noted that “[o]ne of the key steps set forth in the ‘209 patent is the administration of folic acid … prior to the administration of pemetrexed.” As characterized by the court, “[t]his is not merely a suggestion or recommendation, but a critical step in the patented method that has a specific purpose and direct impact on the outcome of the patented method.” The court found that this critical aspect of the claimed methods was reflected in the ANDA:

The prescribing information requires physicians to “[i]nstruct patients to initiate folic acid 400 mcg to 1000 mcg orally once daily beginning 7 days before the first dose of ALITMA®.” …. Additionally, the patient information states “[i]t is very important to take folic acid . . . during your treatment with ALITMA to lower your chances of harmful side effects. You must start taking 400-1000 micrograms of folic acid every day for at least 5 days out of the 7 days before your first dose of ALITMA.” ….

The court therefore concluded:

It is clear from the patent, the prescribing information, and the patient information that taking folic acid in the manner specified is a condition of the patient’s participation in pemetrexed treatment as described by the patent, and is necessary in order to receive the benefit of such treatment. …. The physician, based upon the patented method, directs the manner and timing of the patient’s ingestion of folic acid … and the patient is required to do so to receive the full benefit of the treatment.

Thus, the court held that when the defendants ANDA Products are used in accordance with the proposed labeling, a physician would directly infringe the ’209 patent, such that the defendants can be liable for induced infringement under § 271(b).

A Precedent For Other Therapeutic Methods?

As a district court decision, this case is not binding on other courts facing similar issues, unless and until it is reviewed and affirmed by the Federal Circuit. Nevertheless, it illustrates how Akamai can be applied to therapeutic methods to find direct infringement when a doctor and patient perform different steps of a claimed method.