Lilly’s Orange Book ‘209 patent regarding administration of pemetrexed not literally infringed, but infringed under DOE

Eli Lilly and Company v. Hospira, Inc., Dr. Reddy’s Laboratories

Docket No. 2018-2126, -2127, -2128
August 9, 2019

Brief Summary: DC literal infringement decision reversed, but infringement under DOE affirmed.

Summary: Hospira and Dr. Reddy’s (DRL) appealed two DC judgments of infringement of Lilly’s US 7,772,209 regarding antifolate pemetrexed product Alimta® (a disodium salt; NDA 021462 for which the ‘209 patent is the only OB-listed patent). Hospira and DRL sought to market pemetrexed ditromethamine, “represent[ing] to the FDA that their choice of the tromethamine cation was immaterial because pemetrexed dissociates from its counterion in solution…and tromethamine was known to be safe for pharmaceutical use.” FN3 points out that this is the fourth appeal regarding Alimta® and the third appeal regarding the ‘209 patent (vs. Neptune and Teva; FN4 notes that Lilly also sued Actavis but that the parties agreed to be bound by the DRL decision). Hospira was found to infringe literally, and both Hospira and DRL were found to infringe under the doctrine of equivalents (DOE). The ‘209 patent claims “[a]n improved method for administering pemetrexed disodium to a patient in need of chemotherapy” by pre-administering “between about” 350-1000 micrograms and “about” 500-1500 micrograms vitamin B12, and then administering the pemetrexed disodium. Hospira argued the DC incorrectly found literal infringement since “administration of pemetrexed ditromethamine dissolved in saline-a solution which contains pemetrexed and chloride ions alongside sodium and tromethamine cations-is not ‘administration of pememtrexed disodium’”, and the FC panel agreed with Hospira (e.g., “to literally practice the ‘administration of pemetrexed sodium’ step under the [DC’s] claim construction,” it “must itself be administered”; Tex. Inst., FC 1996). Regarding the DOE, the FC panel explained that “[t]he main dispute in these appeals is whether Lilly rebutted the presumption of prosecution history estoppel [PHE] that attached to its amendment” to the disodium salt during prosecution of the ‘209 patent. PHE “arises when a patent applicant narrows the scope of his claims during prosecution for a reason ‘substantial[ly] relating to patentability’” (Festo X, FC 2003), which “Lilly does not dispute”. However, Lilly relied on the “tangential exception” to PHE, arguing “that the rationale of its amendment ‘[bore] no more than a tangential relation to the equivalent in question’”, namely, “to distinguish pemetrexed from antifolates generally and that the different salt type of a merely tangential change with no consequence for pemetrexed’s administration” (Festo VIII, US 2002; Int. Tech., FC 2013). The FC panel agreed with Lilly and the DC, finding that Lilly’s amendment was made “to avoid Arsenyan, which only discloses treatment using methotrexate, a different antifolate” (e.g., “the particular type of salt to which pemetrexed is complexed relates only tenuously to the reason for the narrowing amendment”, “[h]ere, it is unlikely that a competitor would have been ‘justified in assuming that if he [made an equivalent pemetrexed salt], he would not infringe”, “must be decided in the context of the invention disclosed in the patent and the” PH (Kinzenbaw, FC 1984; Intervet, FC 2010 (“There is no hard and fast rule…”)). The FC panel also concluded that the “disclosure-dedication rule” did not apply since “the ‘209 patent does not disclose…ditromethamine, and, as a result, Lilly could not have dedicated such a method to the public” (Abbott, FC 2009). The FC panel also agreed with the DC on the merits of infringement under DOE since, e.g., “DRL’s product will accomplish an identical aim…in exactly the same way” (“DRL’s product is functionally identical” (UCB, FC 2019)). Thus, the DC decision was affirmed-in-part and reversed-in-part.

This entry was posted in Claim Construction, Doctrine of equivalents, Generics / ANDA, Infringement, Method claims, Prosecution History Estoppel, Uncategorized. Bookmark the permalink.

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