Everolimus - USA

On Dec 07, 2018, Federal Circuit reversed district court’s decision regarding post-URAA patent as double patenting reference for pre-URAA patent.

Novartis appealed the district court’s decision to invalidate U.S. Patent No. 5,665,772 (claims everolimus compound) based on obviousness-type double patenting over Novartis’s U.S. Patent No. 6,440,990 (claims MoU & composition), which was filed after, and issued after, but expired before the ’772 patent. Both patents claimed the same priority date. The ’990 patent expired before the ’772 patent because the ’990 patent was filed after the June 8, 1995 effective date of the Uruguay Round Agreements Act of 1994 (URAA) and thus expired on September 23, 2013 (20 years from its earliest effective filing date). The ’772 patent, on the other hand, was filed before the effective date of the URAA and— pursuant to the URAA transition statute 35 U.S.C. § 154(c)(1)—expired 17 years from its issuance, on September 9, 2014. Due to a five-year patent term extension (PTE) under 35 U.S.C. § 156, the ’772 patent’s term expires on September 9, 2019.

Applying decision of Gilead Sciences, Inc. v. Natco Pharma Ltd., 753 F.3d 1208, 1212 (Fed. Cir. 2014), which held that a later-filed but earlier-expiring patent can serve as a double patenting reference for an earlier-filed but later-expiring patent, the district court found the ’990 patent to be a proper double patenting reference for the ’772 patent &thus invalidated the US’772 patent. The only issue on appeal was whether US’990 (post-URAA) patent is a double patenting reference for US’772 (pre-URAA) patent.

On appeal federal circuit said that Gilead addressed a different question that is not applicable here. In Gilead, both patents were post-URAA and court concluded that a patent that issues after but expires before another patent can qualify as a double patenting reference against the earlier-issuing, but later-expiring patent. Here, however, Novartis owns one pre-URAA patent (the ’772 patent) and one post-URAA patent (the ’990 patent), and the 17-year term granted to the ’772 patent does not pose the unjustified time extension problem that was the case for the invalidated patent in Gilead.

Specifically, there are shortcomings while relying on Gilead & issuance dates for patents in the post-URAA context. One such shortcoming is that patent terms could be subject to significant gamesmanship during prosecution. Another shortcoming of using the issuance date for post-URAA patents is that a mere day’s difference in the issuance of multiple patents could result in a significant difference in an inventor’s period of exclusivity. Gilead had “crafted a separate ‘chain’ of applications, having a later priority date than the first patent family” such that the later-filed but earlier-issued patent expired second, thus unduly increased the life of patent. Here, the present facts do not give rise to similar patent prosecution gamesmanship because the ’772 patent expires after the ’990 patent only due to happenstance of an intervening change in patent term law. Both the ’772 and the ’990 patents share the same effective filing date of September 24, 1993. If they had been both pre-URAA patents, the ’990 patent would have expired on the same day as the ’772 patent by operation of the terminal disclaimer Novartis filed on the ’990 patent, tying its expiration date to that of the ’772 patent. And if they had been both post-URAA patents, then they would have also both expired on the same day. Thus, the current situation does not raise any of the problems identified in our prior obviousness-type double patenting cases. Also at the time the ’772 patent issued, it cannot be said that Novartis improperly captured unjustified patent term. The ’990 patent had not yet issued, and the ’772 patent, as a pre-URAA patent, was confined to a 17-year patent term. Moreover, federal circuit applied traditional, pre-URAA obviousness-type double patenting practice because looking to the 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. Under this analysis, the ’990 patent is not a proper obviousness-type double patenting reference for the ’772 patent. When 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. This approach is most 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 patent term.      

    

The district court thus erred in finding that the post-URAA ’990 patent is a proper obviousness-type double patenting reference for the pre-URAA ’772 patent. Therefore, federal circuit reversed the district court’s decision.