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Eli Lilly & Co. v. Hospira, Inc.

“Tangential Exception” to Prosecution History Estoppel is Context-Sensitive

Eli Lilly & Co. v. Hospira, Inc., __ F.3d __, 2019 WL ___ (Fed. Cir. Aug. 9, 2019) (LOURIE, Moore, Taranto) (S.D. Ind.: Pratt) (3 of 5 stars)

In appeals from two Hatch-Waxman cases concerning the same Lilly patent, Fed Cir reverses finding of literal infringement in one case, while affirming the finding of infringement under the doctrine of equivalents in both cases. Lilly’s patent related to an improved method of treating certain cancers and mesothelioma with pemetrexed (marketed by Lilly as Alimta). The district court clearly erred in determining that Hospira literally practiced a step of “administration of pemetrexed disodium [i.e., a disodium salt of pemetrexed],” because in Hospira’s product, the pemetrexed is dissolved in saline prior to administration, and any “pemetrexed disodium no longer exists once dissolved in solution.” Op. at 13.

The district court correctly applied the doctrine of equivalents and its findings of infringement by equivalence were not clearly erroneous. Prosecution history estoppel did not bar Lilly’s equivalence argument, and the opinion describes how Lilly rebutted the presumption of estoppel by showing that a narrowing amendment made during prosecution was only tangentially related to the equivalent in question, as per Festo VIII, 535 U.S. 722 (2002), and Integrated Technology, 734 F.3d 1352 (Fed. Cir. 2013). It rejects the accused infringers’ argument that Lilly had an obligation to show why it did not pursue an even narrower amendment in the circumstances. It also rejects one accused infringer’s (Dr. Reddy) argument that this was a case where Lilly was trying to avoid the consequences of ceding more claim scope during prosecution than necessary. “[T]he tangential exception only exists because applicants over-narrow their claims during prosecution.” Op. at 19. In context, the reason for Lilly’s amendment was tangential to the equivalent here. It rejects the accused infringers’ argument that Lilly had an obligation to prove that it could not have drafted a claim that literally reached the equivalent here. “We do not demand perfection from patent prosecutors, and neither does the Supreme Court.” Op. at 19. The opinion also distinguishes Felix, 562 F.3d 1167 (Fed. Cir. 2009), on the facts, and notes that per Intervet, 617 F.3d 1282 (Fed. Cir. 2010), “there is no hard-and-fast test for what is and what is not a tangential relation.” Op. at 21. It declines to enter a bright-line rule that “where the reason for the amendment and the equivalent in question both relate to the same claim element, the tangential exception does not apply.” Id. (quoting DRL brief). In the context of this case, the record “show[s] that it is implausible that the reason for Lilly’s amendment was to surrender other pemetrexed salts [such as the accused product].” Op. at 22.

The disclosure-dedication rule also did not bar Lilly’s assertion of the doctrine of equivalents. The opinion notes that Lilly’s patent did not disclose the accused equivalent, and so could not have dedicated it to the public. Finally, there was no clear error in the district court’s determination that the accused products here were insubstantially different from Lilly’s claims.

KEYWORDS: INFRINGEMENT (NO); INFRINGEMENT (YES); DOCTRINE OF EQUIVALENTS; TANGENTIAL EXCEPTION; DISCLOSURE-DEDICATION RULE