December 7, 2018

Normal Double Patenting Rules Don’t Apply When the Patents Straddle the URAA

By Bryan K. Wheelock, Principal

In Novaritis Pharmaceuticals Corporation v. Breckenridge Pharmaceutical Inc., [2017-2173, 2017-2175, 2017-2176, 2017-2178, 2017-2179, 2017-2180, 2017-2182, 2017-2183, 2017-2184] (December 7, 2018), the Federal Circuit reversed the district court, determining that the law of obviousness-type double patenting does not require a patent owner to cut down the earlier-filed, but later expiring, patent’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.

Applying Gilead Sciences, Inc. v. Natco Pharma Ltd., 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 U.S. Patent No. 6,440,990 to be a proper double patenting reference for the earlier filed U.S. Patent No. 5,665,772, which had a longer term because of a change in the statutory term.

The Federal Circuit said that Gilead addressed a question that was not applicable in the present case. In Gilead, the Federal Circuit concluded that, where both patents are post-Uruguay Round Agreements Act (URAA), 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. In contrast, in the present case, 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.

[T]he 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. 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.

The Federal Circuit concluded that in this particular situation where we have an earlier filed, earlier-issued, pre-URAA patent that expires after the later-filed, later-issued, post-URAA patent due to a change in statutory patent term law, it would not invalidate the challenged pre-URAA patent by finding the post-URAA patent to be a proper obviousness-type double patenting reference.