October 15, 2015

Case Name: Eli Lilly & Co. v. Teva Parenteral Medicines, Inc., Civ. No. 10-cv-1376-TWP, 2015 U.S. Dist. LEXIS 112221 (S.D. Ind. Aug. 25, 2015) (Pratt, J.) 

Drug Product and Patents-in-Suit: Alimta^® (pemetrexed disodium); U.S. Patent No. 7,772,209 ("the '209 patent")

Nature of the Case and Issue(s) Presented: This case presented the issue of when indirect infringement can be established in light of the new case law from the Federal Circuit. Alimta is a chemotherapy drug that is prescribed to be used with vitamins. The ‘209 patent claims several methods of using Alimta in various combinations with vitamins.

Eli Lilly argued that Teva indirectly infringed the claims because the patient and prescribing information directed the patient to take Alimta with various dosage levels of vitamins. The patent states that using Alimta with vitamins allows the patient to obtain the benefit of the claimed method to reduce potentially life-threatening toxicities.

Teva argued that indirect infringement cannot be found because there was no evidence that patients actually took the vitamin with Alimta. Further, Teva argued that it does not direct or control the patient or that such actions are attributable to the physician.

The district court ruled that Eli Lilly had shown, by the preponderance of the evidence, that Teva indirectly infringed the '209 patent.

Why Eli Lilly Prevailed: The district court determined that, based on the recent Federal Circuit authority, the question before the court was whether the physicians directs or controls the acts of the patient in such manner as to participate in an activity or receipt of a benefit. The court found that the evidence presented was that physicians controlled the actions of the patients to utilize Alimta with the requisite level of vitamins as claimed in the patent in order for the patient to receive the benefit of reducing toxicities associated with Alimta.

The district court rejected Teva’s argument that there was no evidence that patients actually took the requisite level of vitamins because the patient and prescribing information made it clear that taking the vitamins was important to receive the full benefits of Alimta. Further, the court determined that non-infringement cannot be established by the mere possibility that one of the claimed steps may not be performed.