Docket No. 2016-2475
MOORE, REYNA, TARANTO
May 11, 2018
Brief summary: DC dismissal of AHF’s request for DJ for not relating to a current “substantial controversy” affirmed.
Summary: AHF appealed DC dismissal of its request for a declaratory judgment (DJ) against Gilead. AHF provides antiviral drugs such as Gilead’s tenofovir alafenamide fumarate (TAF (Genvoya®, Descovy®, Odefesey®)). AHF sought DJ of “five patents purportedly covering TAG and various combination products…in order to ‘clear out the invalid patents’ so that it” could “‘purchase generic TAF as soon as it would become available’ on expiration of the five-year” NCE exclusivity (21 USC § 355(j)(5)(F)(ii)). AHF filed the DJ action “two months after the FDA approved Genvoya®” and “other TAF products were still undergoing clinical trials and FDA approval procedures”. The FC panel noted it was “undisputed that no unlicensed source was offering a TAF product or preparing to do so when this [DJ] was filed.” AHF argued for its request because it “is an indirect infringer”, Gilead did not response to its request for a covenant not to sue, and “public policy favors invalidation of invalid patents”. The DC concluded that AHF’s role as a consumer (“encouraging others to produce TAF products”, its “interest in purchasing such products”) “did not create a case of actual controversy in terms of the [DJ] Act.” The FC panel explained that “[a] plaintiff seeking a [DJ] judgment bears the burden of demonstrating that a case of actual controversy existed at the time the declaratory action was filed” (Matthews, FC 2012; Steel Co., US 1998 (must show an “injury-in-fact, connection between the challenged conduct and the injury, and redressability by the requested remedy”)), and that “[t]he existence of a patent, without more, does not create a case of actual controversy” (Prasco, FC 2008). The FC panel further explained that “[t]he foundation of a declaratory action is that…there is a substantial controversy…of sufficient immediacy and reality to warrant the issuance of” DJ (MedImmune, US 2007 (considering “all the circumstances”); Sandoz, FC 2014 (“whether there is an immediate impact on the plaintiff and whether the lapse of time creates uncertainty”)). The FC panel found AHF’s arguments to relate only to a “speculative future controversy” and not a current “substantial controversy” (e.g., since AHF did not take “significant, concrete steps to conduct infringing activity, the dispute is neither ‘immediate’ nor ‘real’” (Cat Tech, FC 2008; Teva, FC 2007); no ANDA filed (Acorda Ther., FC 2016 (ANDA “is an explicit statutory basis for litigation before actual infringement occurs”)). AHF’s argument “that it is incurring present liability for inducing infringement” by others was also rejected as it is not a direct infringer (Power Integrations, FC 2016; Fina Res., FC 1998; AHF’s “role as a purchaser of TAF drugs…cannot form the basis of an ‘actual controversy” (Creative Cmpds., FC 2011); Caraco, FC 2008; Allergan, FC 2003). AHF’s arguments regarding the absence of a covenant not to sue was also rejected as “there was no affirmative act by the patentee to assert rights against it” (BP Chems., FC 1993; Prasco, FC 2008). And finally, the FC panel rejected AHF’s patent policy arguments since “a change in policy to facilitate challenge to drug patents would warrant legislative consideration” (SAS Inst., US 2018). The DC decision was therefore affirmed.