Novartis Pharm. Corp. et al. v. Ezra Ventures LLC

Docket Nos. 2017-2284

December 7, 2018

Brief summary: FC panel agreed with DC that § 156 PTE was proper even if it might otherwise be invalid for obviousness-type double patenting.

Summary: Ezra appealed DC conclusion that the § 156 Patent Term Extension (PTE) for Novartis’s US 5,604,229 (regarding Novartis’s multiple sclerosis drug Gilenya® (fingolimod)) is not invalidated by obviousness-type double patenting (Merck & Co. v. Hi-Tech Pharmacal Co., FC 2007). The ‘229 patent was filed before the effective date of the URAA and would therefore expire 17 years from issuance (original expiration date: Feb. 18, 2014). Novartis obtained a five-year PTE for the ‘229 patent, moving the expiration date to Feb. 18, 2019. As explained in the FC panel’s opinion, “Novartis owned at least two patents covering Gilenya® that could qualify for PTE under § 156(a): the ‘229 patent and U.S. Patent No. 6,004,565” (a post-URAA patent having a patent term of 20 years from filing (i.e., Sept. 23, 2017), “which claims a method of administering fingolimod”, but selected the ‘229 patent for the PTE (“Congress…chose a flexible approach to give the patentee the choice”, limiting “a PTE grant…to only one of its patents” (Merck, FC 2007)). With the five-year PTE in place, therefore, the pre-URAA ‘229 patent expired after the post-URAA ‘565 patent. Ezra argued that the PTE should not extend the ‘229 term beyond that of the ‘565 patent because of obviousness-type double patenting (e.g., “should be ruled invalid, or otherwise terminally disclaimed”). The DC disagreed and “concluded that the ‘229 patent’s term extension was permissible under § 156” (e.g., under Merck, “a terminally disclaimed patent could still have its term extended with a PTE”). The FC panel reviewed the DC’s decision, a “question[] of statutory interpretation” and its “ultimate conclusion on obviousness-type double patenting”, “de novo, without reference to the [DC’s] interpretation” (Glaxo, FC 1990), and “any predicate findings of fact for clear error” (Eli Lilly, FC 2012). The FC panel disagreed with Ezra, based on its reading of § 156(c)(4), that “two patents were extended here: the extension of the ‘229 patent’s term ‘effectively’ extended the ‘565 patent’s term as well, because the ‘229 patent covers a compound necessary to practice the methods claimed by the ‘565 patent.” The FC panel agreed with the DC that Ezra’s reading of § 156(c)(4) was incorrect (e.g., “there is no reason to read ‘effectively’ as a modifier to ‘extend’”). Thus, the FC panel concluded, “[t]hat the method of the ‘565 patent cannot be practices during the ‘229 patent’s extended term is a permissible consequence of the legal status conferred upon the ‘229 patent by § 156.” The FC panel also concluded “that obviousness-type double patenting does not invalidate a validly obtained PTE” and that the conclusion reached here is “a logical extension of our holding in Merck” (“if a patent, under its pre-PTE expiration date, is valid under all other provisions of the law, then it is entitled to the full term of its PTE”; Proctor & Gamble, FC 2009; Gliead, FC 2014 (“no potential gamesmanship issue through structuring of priority claims”; Abbvie, FC 2014 (“no concern that Novartis, once the ‘229 patent issued, sought to subsequently ‘secur[e] a second, later expiring patent for the same invention”); “agreeing with Ezra would mean that a judge-made doctrine would cut off a statutorily-authorized time extension” (In re Berg, FC 1998). Accordingly, the DC decision was affirmed.

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