Endo Pharms. Inc. v. Teva Pharms. USA, Inc.

The Federal Circuit affirms the district court’s judgment that the asserted patents were not invalid and were infringed.

May 16, 2018

GENERICally Speaking: A Hatch Waxman Litigation Bulletin

Case Name: Eli Lilly & Co. v. Hospira, Inc., Civ. No. 12-3460-TWP-MPB, 2018 U.S. Dist. LEXIS 100550 (S.D. Ind. June 15, 2018) (Pratt, J.)

Drug Product and Patent(s)-in-Suit: Alimta® (pemetrexed disodium); U.S. Patent No. 7,772,209 (“the ’209 patent”)

Nature of the Case and Issue(s) Presented: Lilly marketed Alimta, having the active ingredient pemetrexed disodium, as a chemotherapy drug taken in conjunction with a vitamin B12 and folic acid pretreatment. The ’209 patent taught a method for using pemetrexed disodium for chemotherapeutic treatment.

During the prosecution of the ’209 patent, Lilly narrowed the scope of its claims to only include pemetrexed disodium to avoid the prior art. Hospira made a similar chemotherapy drug, using pemetrexed ditromethamine. Hospira’s prescribing information stated that the product could be reconstituted in a saline solution. The issue before the court, and the subject of the parties’ cross motions for summary judgment, was whether this reconstituted saline solution were within the scope of the ’209 patent in light of the prosecution history. The court found in favor of Lilly and against Hospira.

Why Lilly Prevailed: Supporting its summary judgment motion, Lilly submitted expert testimony that, when mixed with a saline solution, pemetrexed ditromethamine formed pemetrexed disodium. This was because the chemical serving as the chemotherapeutic agent was pemetrexed. Because pemetrexed disassociated its ionic bond after administration, it was irrelevant whether it was initially ionically bonded to disodium or ditromethamine. Accordingly, Hospira’s product literally infringed the claims of the ’209 patent.

The court also found that Hospira induced infringement of the ’209 patent. Hospira’s product label instructed its user to administer the product in accordance with the method steps claimed by the ’209 patent. Due to this labeling, Hospira conceded that, as a matter of law, if the Court were to find its product would infringe, Hospira would induce infringement.

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