Eagle Pharmaceuticals Inc. v. Slayback Pharma LLC
Docket No. 2019-1924
O’MALLEY, REYNA, CHEN
May 8, 2020
Brief Summary: DC finding of no infringement under DOE based on disclosure-dedication doctrine affirmed.
Summary: Eagle appealed DC judgment of non-infringement of US Pat. Nos. 9,265,831; 9,572,796; 9,572,797; and 10,010,533 (four of six Orange Book patents for Eagle’s BELRAPZO® (bendamustine for CLL and indolent B-cell non-Hodgkin lymphoma; NDA N205580). The FC panel opinion explains that all four patents “share the same specification and all independent claims recite essentially the same limitations.” Claim 1 of the ‘796 patent claims “[a] non-aqueous liquid composition comprising…bendamustine…a pharmaceutically acceptable fluid comprising a mixture of polyethylene glycol and propylene glycol…and a stabilizing amount of an antioxidant….” Slayback admitted its generic product did not literally infringe the “pharmaceutical acceptable fluid” limitation which Eagle alleged was infringed under the doctrine of equivalents (e.g., “insubstantially different from the propylene glycol (‘PG’) in the claimed composition”). Slayback argued DOE was inapplicable because “the disclosure-dedication doctrine barred Eagle’s claim…because the asserted patents disclose but do not claim, ethanol as an alternative solvent to PG.” The DC agreed with Slayback since, as explained in this opinion, expert opinion was unconvincing and “[t]he specification expressly and repeatedly identifies ‘ethanol’ as an alternative ‘pharmaceutically acceptable fluid’ to PG” (e.g., in the “Summary of the Invention” and the specification). The FC panel explained that “[t]he disclosure-dedication doctrine bars application of the [DOE]” and “reinforces ‘the primacy of the claims in defining the scope of the patentee’s exclusive right’” (Johnson & Johnston, FC 2002 (“when a patent drafter discloses but declines to claim subject matter…this action dedicates the unclaimed subject matter to the public”); PSC Comput., FC 2004 (“ask whether the specification discloses unclaimed subject matter with ‘such specificity that one of ordinary skill in the art could identify the subject matter that had been disclosed and not claimed’”); Maxwell, FC 1996). Eagle argued the doctrine does not apply to its claims because “a ‘skilled artisan would not understand that ethanol…is an alternative to PG in the separate, claimed ‘PEG/PG/antioxidant’ category of formulations” disclosed in the specification. But the FC panel explained that the doctrine does not require disclosure of “an embodiment that exactly matches the claimed embodiment”, and only needs to “disclosure the unclaimed subject matter ‘as an alternative to the relevant claim limitation’” (Pfizer, FC 2005 (microcrystalline cellulose not identified “as an alternative to ‘saccharide’ that prevents hydrolysis”)). Eagle’s specification, the FC panel found, “repeatedly identifies-without qualification-ethanol as an alternative” and does not “suggest that these disclosures of ethanol are limited to certain formulations, or that they do not extend to the claimed formulations.” The DC decision on this point was therefore affirmed, as was its decision as a judgment as a matter of law (“the only reasonable inference”).