DC findings of obviousness of certain claims affirmed and others vacated based on secondary considerations

Arius Two, Inc., Biodelivery Sci. Int., Inc. v. Alvogen PB Res. & Develop. LLC, et al.

Docket No. 2022-1394, -1449 (https://cafc.uscourts.gov/opinions-orders/22-1394.OPINION.12-21-2022_2051391.pdf) (Non-Precedential)


December 21, 2022

Brief Summary:   DC obviousness findings for two patents affirmed; obviousness of certain claims vacated as DC applied “clear and convincing” to secondary considerations while only “preponderance of the evidence” standard required.

Summary:  This Hatch-Waxman case involves US 8,147,866; 9,655,843; and 9,901,539 regarding a bi-layer film containing a bioerodable mucoadhesive (BEMA) layer comprising  buprenorphine and a backing layer between the BEMA layer and the oral cavity.  BDSI sued Alvogen with respect to Alvogen’s ANDA for a generic version of BDMI’s Belbuca® product.  Alvogen appealed the DC’s evidentiary and procedural findings against it for the asserted claims found not to be invalid, while BDMI/Arius appealed with respect to the burden of proof of long-felt needs and unexpected results.  The disputed claims include 4 and 5 of the ‘866 patent that claim pharmacokinetic properties (“PK” claims); claims 9 and 20 of the ‘539 patent claiming a certain pH of the BEMA and backing layers (“Backing Layer” claims); and claims 3 and 10 of the ‘866 patent and claims 8, 9 and 20 of the ‘843 patent that claim a certain pH of the BEMA layer (“BEMA layer” claims). 

The DC held the PK claims “not invalid because Alvogen failed to show a skilled artisan would have been motivated to combine the prior art references and waived its inherency argument by failing to raise the argument in the pre-trial order.”  The FC panel found no error with the DC’s conclusions, citing Stryker (FC 1996 (no motivation to combine)).

The DC held the Backing Layer claims not invalid “because Alvogen failed to show the pH of the backing layer was inherently present in the prior art and because secondary considerations supported a finding of nonobviousness.”  Alvogen’s expert testified that the backing layer pH of BDMI’s product is the same as that of the prior art (“‘identical ingredients present in materially identical amounts,’ and because the formulations are nearly the same, one would expect both formulations to have the same pH”) and it also pointed to an inventor declaration submitted during prosecution, but the DC found it showed that on average that the prior art pH was different.  The FC panel found no clear error in the DC’s decision of no invalidity (e.g., “incompatible representations in the record”).

The DC held the BEMA layer claims “invalid as obvious because a skilled artisan would have been motivated to combine certain prior art references with a reasonable expectation of success to arrive at the claimed invention” (“BDSI had not: (1) “clearly and convincingly” shown evidence of a long-felt need, (2) shown the prior art taught away, or (3) shown unexpected results.”)  The FC panel remanded this part of the DC’s decision as it applied a “clear and convincing standard” while “[s]econdary considerations must be established by a preponderance of the evidence” (Apple, FC 2016).

This entry was posted in Generics / ANDA, Obviousness, Obviousness (Secondary Considerations), Prosecution History Estoppel. Bookmark the permalink.

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