Docket No. 2014-1416
LOURIE, DYK, REYNA
August 22, 2014
Brief Summary: DC decision that Ferring’s claims were not obvious affirmed because “critical dissolution limitations” not taught or suggested by prior art. And infringement by “final, coated commercial…tablets” was not shown.
Summary: Watson appealed DC decision that Ferring’s US 7,947,739; 8,022,106; and 8,273,795 claims encompassing modified release formulations of tranexamic acid (marketed as Lysteda® for treatment of menorrhagia) would not have been obvious, Watson’s generic tranexamic acid product infringed the claims, and ordering the FDA to reset Watson’s ANDA approval date and permanently enjoining it from manufacturing, using, selling or offering the generic product for sale. Ferring’s claims require “each tablet of the formulation [to provide] a dose of about 650 mg of tranexamic acid”. Watson argued that Ferring’s claims would have been obvious from the prior art. Ferring argued the prior art did not teach or suggest 650 mg formulations containing the modified release materials and dissolution limitations of the claims and “actually taught away from using such a high dose.” It also argued that secondary considerations support its position. The FC panel agreed with the DC and Ferring, concluding that “the cited prior art references neither set forth the limitations required by the asserted claims, nor provided any reason or motivation to combine those teachings to derive the claimed formulations with specific dissolution profiles” (references only disclose 500 mg, that higher doses may case GI side effects, do not disclose the claimed amounts of modified release polymers (“merely recites hydroxypropylcellulose…among a list of a dozen other excipients” and “tranexamic acid as one of more than eight orally dosable medicinal ingredients”), and none of the “critical dissolution limitations”). The panel also agreed “there was a long-felt and unmet need for a treatment of menorrhagia that avoided adverse events, as the FDA recognized in granting ‘fast track’ status”. The opinion also explained that the DC erred by concluding the filing of an ANDA by Watson “established infringement sufficient to preclude consideration of the ANDA specification and any amendments” (“only a technical act of infringement for jurisdictional purposes”, Warner-Lambert, FC 2003). The FC panel also wrote that “[t]he infringement evaluation is only concerned with the final, coated commercial…tablets for which Watson sought and was granted FDA approval to market as a generic” (“Watson cannot sell the cores alone”). And since “[t]he dissolution data collected by both parties during discovery showed that, in an overwhelming majority of the samples tested by the claimed USP method” (a preponderance of the evidence (In re Omeprazole, FC 2003)) did not meet the “critical dissolution limitations” and no testing was presented to show the claimed “modified release material[s]…modifie[d] the release” (“just because a certain material can modify release…does necessarily mean that it actually does”), there was no infringement. The DC’s resetting of the FDA approval data and grant of a permanent injunction were therefore vacated.