Novartis Pharm. Corp. et al. v. Breckenridge Pharm. Inc.

Docket Nos. 2017-2173, -2175-6, -2178-80, -2182-84

December 7, 2018

Brief summary: DC decision finding that Novartis’s “earlier-filed, but later expiring, patents’s statutorily-granted 17-year term” was invalid for double-patenting in view of its “later-filed, but earlier-expiring patent” reversed (“a change in patent term law should not truncate the term statutorily assigned to” a pre-URAA patent).

Summary: The question considered here is whether an “earlier-filed, but later expiring, patents’s statutorily-granted 17-year term so that it expires at the same time as the later-filed, but earlier-expiring patent, whose patent term is governed under an intervening statutory scheme of 20 years from that patent’s earliest effective filing date.” In this case, the “earlier-filed, but later expiring” patent is Novartis’s US 5,665,772 which claims everolimus (Zortress®, Afinitor®) (filed before the 20-year term went into effect (pre-URAA) and was set to expire 17 years from issuance, on Sept. 9, 2014) and “the later-filed, but earlier-expiring patent” is Novartis’s US 6,440,990 directed to methods of treatment using everolimus (filed after the 20-year term went into effect (post-URAA) and expiring on Sept. 23, 2013 which is 20 years from its earliest effective filing date). The ‘772 patent was extended for five years under 35 USC § 156 and therefore was set to expire on September 9, 2019. The DC held, however, under Gilead Sciences (FC 2014 (holding that a later-filed but earlier-expiring patent can serve as a double-patenting reference for an earlier-filed but later-expiring patent)), that the ‘990 patent is “a proper double patenting reference for the ‘772 patent” which was therefore held to be invalid. The FC panel explained that its Gilead opinion “was limited to the context of when both patents in question are post-URAA patents” and “thus does not control the present situation.” “Instead,” the FC panel wrote, “the correct framework here is to apply the traditional obviousness-type double patenting practices extant in the pre-URAA era to the pre-URAA ‘772 patent and look to the ‘772 patent’s issuance date as the reference point for obviousness-type double patenting”. The FC panel found that “[u]nder this framework, and because a change in patent term law should not truncate the term statutorily assigned to the pre-URAA ‘772 patent…the ‘990 patent is not a proper double patenting reference for the ‘772 patent.” It explained that “unlike Gilead” (or Abbvie, FC 2014, explained separately and relating to post-URAA patents), “Novartis here did not structure the priority claim of its ‘990 patent’s term to capture additional patent term beyond the term it was granted for its ‘772 patent.” The FC panel noted that as it “recognized in Gilead, looking to patent issuance dates pre-URAA serves as a reliable guide for assessing whether a patent may serve as a double patenting reference against another patent” but that, in this case, “[w]hen the ‘772 patent issued, the ‘990 patent had not yet issued and thus did not exist as a double-patenting reference against the ‘772 patent” (“consistent with the URAA transition statute, which ensures that patent owners, like Novartis with its pre-URAA ‘772 patent, enjoy the greater of a 20-year from earliest effective filing date or 17-year from issuance of patent term…The statute reads…‘The term…shall be the greater of”…its ‘990 patent’s term was truncated by the intervening change in law. To find that obviousness-type double patenting applies here because a post-URAA patent expires earlier would abrogate Novartis’s right to enjoy one full patent term on its invention.”) The DC decision was therefore reversed.

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