Expanding the Reach of Pharmaceutical Patents: Generic Manufacturer Held Liable For Inducing Infringement By Physicians and Patients

By W. John Keyes, Ph.D.. A member of our Patent Practice Group

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? More...