Nalpropion’s naltrexone/bupropion claims found by FC panel not to lack written description (affirming DC) but invalid for obviousness (reversing DC)

Nalpropion Pharmaceuticals, Inc. v. Actavis Laboratories FL, Inc.

Docket No. 2018-1221
August 15, 2019

Brief Summary: DC decision of no invalidity for lack of WD affirmed, but decision of no obviousness reversed.

Summary: Actavis appealed DC judgment that is proposed ANDA naltrexone/bupropion extended release product (ANDA 208043) would infringe certain claims of Nalpropion’s US 7,375,111; 7,462,626; and 8,915,195; that those claims are not invalid for lack of written description (WD) or obviousness; the effective date of Actavis’ ANDA can be no earlier than the expiration dates of the patents; and permanently enjoining Actavis from manufacturing, using, or selling its ANDA product before expiration of the patents. The ‘626 and ‘195 patents are directed to methods for treating obesity using bupropion and naltrexone. The ‘111 patent is directed to a composition of sustained-release bupropion and naltrexone “for affecting weight loss”. The FC panel reviewed the DC’s decisions that claim 11 of the ‘195 patent was not invalid for lacking WD (Ariad, FC 2010) and that claims 26 and 31 of the ‘626 patent are not invalid for obviousness (Tokai, FC 2011) for clear error. The method of ‘195 claim 11 requires orally administering about 16 mg of naltrexone and about 180 mg of bupropion, sustained release, twice a day, with a particular in vitro dissolution profile which the DC found to be exemplified in the ‘195 patent examples, relying in part on expert testimony. The FC panel found no clear error with this decision, explaining that “[i]t is not necessary that the exact terms be used in haec verba in the specification, and equivalent language may be sufficient” (“so-called equivalent disclosure, in this case, buttressed by the [DC’s] fact-finding, and where the so-called equivalence relates only to resultant dissolution parameters rather than operative claim steps” (here, the administration steps)). The DC’s WD decision was therefore affirmed. Judge Prost dissented from the FC panel’s rationale on WD (“appears to me to be a new rule”).

The DC’s non-obviousness findings for ‘111 claim 1 and ‘626 claims 26 and 31 were based on its conclusions that the prior art “did not teach a person of ordinary skill that the combination was effective for weight loss”, “the synergistic effect of the combination was an unexpected result”, and “secondary considerations supported a finding of nonobviousness.” The FC panel disagreed with the DC and concluded the claims would have been obvious because “[t]he prior art…discloses the claimed components of the composition claims” (‘111 patent) “and the steps of the method claims including the use claimed by the method” (‘626 patent) (e.g., “[t]he references teach that bupropion causes weight loss” confirmed by an inventor, “the record indicates that naltrexone can cause weight loss”, that the combination could “minimize weight gain”, and the motivation to combine “cannot be limited to those reasons the FDA sees fit to consider in approving drug applications” (Allergan, FC 2013; Arctic Cat, FC 2017 (“the court should consider a range of real-world facts”)). The FC panel also concluded that “combining” the drugs “for [the] known purpose” of “affect[ing] weight loss” “yields no unpredictable result” (KSR, US 2007) and “failure of others…alone cannot overcome the clear record in this case”. Thus, the DC’s nonobviousness decisions were reversed.

This entry was posted in Generics / ANDA, Obviousness, Uncategorized, Written description. Bookmark the permalink.

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