To prove infringement of a method of treatment claim under section 271(e), a patent owner must prove that the ANDA filer will induce infringement by another, typically a physician, who will directly infringe the asserted patent by carrying out the method according to instructions in the ANDA label.  But what happens when the label instructs a physician to carry out some of the method steps and a patient to practice others?  Is there a single direct infringer whose actions support an inducing claim? That was the issue before the court in Eli Lilly and Co. v. Teva Parenteral Medicines, Inc., 2015 U.S. Dist. LEXIS 112221 (S.D. Ind. Aug. 25, 2015).  The court in that case was asked to answer this question in the wake of the Supreme Court’s decision in Limelight Networks, Inc. v. Akamai Tech., Inc., 1134 S.Ct. 2111 (2014), which held that “for direct infringement to occur – a requirement for finding inducement of infringement under § 271(b) – performance of all of the claimed steps must be attributed to a single person.”

The patent-in-suit in Eli Lilly required that a physician co-administer pemetrexed with folic acid and vitamin B12.  The ANDA label, however, directed the physician to “instruct patients to initiate folic acid” before the first dose of pemetrexed.  Teva argued there was no direct infringement under Limelight because no single person practiced all steps of the patented method.

The court rejected Teva’s argument and held that the physician was a direct infringer because he or she would specify the manner and timing of treatment in detail, including prescribing an exact dose of folic acid and directing that it be ingested daily. Thus, all claimed steps of the patent were attributed to the physician. In reaching this conclusion, the court applied the Federal Circuit’s reasoning on remand from Limelight Networks, in which the court said that an entity was responsible for another’s performance of method steps where the entity directs or controls the others performance.  Akamai Tech. v. Limelight Networks, Inc., 2015 WL 4760450 (Fed. Cir. Aug. 13, 2015).