Intellectual Property for Life Sciences, Chemistry and Biotechnology
In Eli Lilly & Co. v. Teva Parenteral Medicines, Inc., the Federal Circuit affirmed the district court’s finding of infringement where two actors perform individual steps of a claimed method. This case demonstrates the impact of the Akamai decision, which makes it considerably more difficult to escape infringement through a divided infringement defense. The weakening of the divided infringement defense is welcome news for pharmaceutical patent holders.
The patent at issue is Eli Lilly’s U.S. Patent No. 7,772,209 (“the ‘209 patent”). The claims of the ‘209 patent are directed to methods for administering a chemotherapy drug, pemetrexed disodium (“pemetrexed”) (sold by Eli Lilly as ALIMTA®), after pretreatment with folic acid and vitamin B12. The purpose of the vitamin pretreatments is to reduce the toxicity of pemetrexed in patients.
The patient practices the first step of the claim involving administering folic acid, which is typically administered orally. A physician performs the next step of the claim involving administering the vitamin B12 and pemetrexed by injection. Therefore, there are two separate actors performing individual steps of the claimed method.
Around 2008-2009, Teva Pharmaceuticals (“Teva”) submitted Abbreviated New Drug Applications (ANDAs) seeking approval by the Food and Drug Administration (“FDA”) to market generic versions of ALIMTA®. Eli Lilly subsequently filed a consolidated action against Teva for induced infringement alleging that Teva’s generic drug and product labeling would infringe methods of treatment claimed by the ‘209 patent. Specifically, Eli Lilly alleged that Teva’s generic drugs are administered with folic acid and vitamin B12 pretreatments, per instructions in the product labeling, and infringe the ‘209 patent.
The district court held that Teva induced infringement of the ‘209 patent. Teva’s proposed product labeling, which was based on Eli Lilly’s labeling for ALIMTA®, was relied on as evidence of infringement. The parties agreed that Teva’s product labeling was materially the same as the ALIMTA® product labeling, which consists of two documents: the Physician Prescribing Information and the Patient Information. Both documents include instructions regarding the administration of folic acid by the patient.
Teva appealed the district court’s finding of induced infringement, arguing that there was no direct infringement, which is a requisite to finding induced infringement. Where no single actor performs all steps of a method claim, as in this case, direct infringement only occurs if “the acts of one are attributable to the other such that a single entity is responsible for the infringement.” Therefore, the deciding factor in this case was whether the actions of the patient were attributable to the physician.
The Akamai Test
In Akamai Technologies, Inc. v. Limelight Networks, Inc., the Federal Circuit created a two-prong test for assessing when the actions of more than a single actor amount to direct infringement sufficient to support a determination of inducement. The test asks whether a single actor (1) conditions participating in an activity or receipt of a benefit upon another’s performance of one or more steps of a patented method; and (2) establishes the manner or timing of that performance.
The Federal Circuit applied the Akamai test to determine if there was direct infringement in the instant case. With regards to the first prong, the Federal Circuit agreed with the district court that physicians conditioned pemetrexed treatment on the patient taking the folic acid. To reach this conclusion, the Federal Circuit looked at the Physician Prescribing Information, which explains that folic acid is a requirement for premedication in order to “reduce the treatment-related hematologic and gastrointestinal toxicity” of pemetrexed. Further, the documented repeatedly instructs physicians to direct their patients to take folic acid and to inform them about folic acid dosage ranges and schedules.
The Federal Circuit also relied on evidence that the Patient Information states that “[y]ou will have regular blood tests before and during your treatment with pemetrexed. Your doctors may adjust your dose of pemetrexed or delay treatment based on the results of your blood test and on your general condition.” The Federal Circuit found that this informs patients that physicians may withhold pemetrexed treatment if they do not take folic acid as directed.
The Federal Circuit rejected Teva’s arguments that the product labeling was a “mere guidance or instruction” insufficient to show conditioning. In rejecting this argument, the Federal Circuit noted the critical nature of the folic acid pretreatment and the physicians conditioning pemetrexed treatment on their administration of folic acid. Thus, the Federal Circuit found that the first prong was satisfied.
With regards to the second prong, the Federal Circuit noted that the product labeling instructs physicians to tell patients to take folic acid orally and when to take it, accompanied with warnings about the consequences of non-compliance. The court noted that the dosage range and schedule in the Physician Prescribing Information overlaps with all of the asserted claims’ dosage ranges and schedules. In light of this information, the Federal Circuit found that the second prong was met.
The court rejected Teva’s arguments that prescribing physicians did not control the manner or timing of the folic acid treatment because patients could technically seek outside guidance on folic acid administration. The Federal Circuit explicated that it was not creating a rule that “patient action is attributable to a prescribing physician solely because they have a physician-patient relationship.”
Benefits For Pharmaceutical Patent Holders
This case may be advantageous for pharmaceutical companies having “method of treatment” patent claims. In many cases, every step of the patent claims can be performed by a patient or by a physician. However, there are method claims, such as in the instant case, where some steps must be performed by the patient and some by the physician. After Akamai, the defense of divided infringement was weakened, as demonstrated in the Eli Lilly case. Therefore, infringers are no longer shielded from liability merely because multiple actors perform individual steps of the claimed method.
This will be beneficial for emerging technologies, such as personalized medicine. In general, personalized medicine utilizes tests for biomarkers present in a particular patient and then uses those tests to create a specific treatment. Patent claims that include both biomarker testing and the treatment of patients involve multiple actors, thereby opening the claims up to divided infringement defenses. However, after Akamai and Eli Lilly, it is likely that a physician who draws the patient’s blood, sends the sample to the lab to be tested for specific biomarkers, and uses those results to create an individualized treatment, would be considered a direct infringer, rendering the divided infringement defense moot.