Pioneer pharmaceutical firms are sure to welcome the boost to their patent portfolios resulting from a recent opinion by the Court of Appeals for the Federal Circuit. In the wake of Eli Lilly v. Teva, infringement may now be found even where the defendant follows none of the steps in a patented method of treatment and no single actor performs all the steps of that method of treatment. Depending on the wording of the patent claims and the content of the prescribing information provided with their products, generic pharmaceutical manufacturers might not escape liability even if some steps of the method are performed by physicians and others by patients.
The claims of Eli Lilly’s patent are directed to methods of administering the chemotherapy drug pemetrexed after pretreating a patient with two common vitamins –folic acid and vitamin B12. The pretreatment is designed to reduce the toxicity of pemetrexed. Eli Lilly markets pemetrexed under the brand name ALIMTA®, and the drug is used to treat certain types of lung cancer and mesothelioma.
The patent owner sued a number of generic pharmaceutical manufacturers, including Teva, to prevent their launch of a generic version of ALIMTA® with accompanying product literature that would allegedly infringe methods of treatment claimed by the patent. The district court found that no single actor performed all the steps of the asserted claims because the actions of both physicians and patients were required. Nonetheless, by applying the theory of divided infringement, the court attributed direct infringement to physicians and held the generic manufacturers liable for inducing that infringement.
As for the pretreatment of patients with folic acid and vitamin B12, physicians administered the vitamin B12 (and the pemetrexed), while patients self-administered folic acid with guidance from physicians. The judicial analysis therefore weighed liability under a theory of divided infringement, an area of law which has recently undergone important developments.
Specifically, the Akamai V decision (2015) has broadened the circumstances in which others’ acts may be attributed to a single actor to support direct-infringement liability. The Federal Circuit held that one person can be deemed accountable for directing or controlling another person’s performance if the first person (1) conditions participation in an activity or receipt of a benefit upon the performance of one or more steps of a patented method, and (2) establishes the manner or timing of that performance. The question in Eli Lilly v. Teva thus became: Did physicians direct or control patients to self-administer folic acid within the meaning of this two-part test?
In addressing this question, the Federal Circuit noted that Teva’s proposed product labeling was much the same as Eli Lilly’s ALTIMA labelling, which consists of two documents: the Physician Prescribing Information and the Patient Information. The former explained that folic acid is a “[r]equirement for premedication” in order “to reduce the severity of hematologic and gastrointestinal toxicity of [pemetrexed].” The product labeling stressed that physicians should “[i]nstruct patients” to take folic acid and included information about dosage ranges and schedules. The Patient Information reinforced the message by cautioning that physicians may withhold pemetrexed until the patient has initiated or resumed folic acid treatment.
These instructions, said the court, showed that physicians were not merely guiding or instructing patients to take folic acid, but were conditioning pemetrexed treatment on their self-administration of folic acid.
With regard to part (2) -establishing the manner or timing of the performance- the product labeling was again decisive. The Physician Prescription Information instructed physicians not only to tell patients to take folic acid, but specified a daily dosage of 400 to 1000 micrograms beginning seven days before the first dose of pemetrexed.
The court’s analysis required one further step, since the generic manufacturers, not the doctors, were charged with infringement. This involved inquiring whether the manufacturers were inducing the doctors to infringe. Liability for inducement requires proof that the alleged inducer intended to cause infringement. The defendants resisted the inducement claim by arguing that the proposed drug labelling was advisory and that the doctors could decide how and whether to follow the labelling.
The Federal Circuit responded by noting that the proposed labelling was sufficiently clear to be seen as encouraging, recommending and promoting the infringing activity. This clarity was enough to infer an intent to cause the doctors to infringe. Had the instructions been vaguer, the court suggested, induced infringement might not have been found.
The Eli Lilly decision holds valuable guidance for practitioners. Now that generic pharmaceutical producers may be held liable under Akamai V’s theory of induced infringement, patent applicants should expand their claiming strategy to cover instances of divided infringement where steps of treatment methods are performed by parties other than the physician. By tailoring one’s claims to cover concerted activity by multiple parties, valuable scope may be added to pharmaceutical patents.