Relying on Gilead, the district court found that the post-URAA ’990 patent is a proper ODP reference against the pre-URAA ’772 patent, and held the ’772 patent claims invalid as not being patentably distinct over the claims of the ’990 patent.28 The Federal Circuit, however, reversed the district court by holding that it was improper to apply Gilead to the pre-URAA ’772 patent, because Gilead applied only to circumstances where the later-expiring patent is governed by post-URAA law, which was not the case in Breckenridge.29 Under pre-URAA ODP law, “courts looked at the issuance dates of the respective patents, because, under the law pre-URAA, the expiration date of the patent was inextricably intertwined with the issuance date, and used the earlier-issued patent to limit the patent term(s) of the later issued patent(s).”30 Thus, “regardless of whether Novartis obtained the ’990 patent, the ’772 patent would have expired on September 9, 2014 (September 9, 2019 with the patent term extension)” and by filing the ’990 patent after the change in law, Novartis was likely deprived term in the ’990 patent.31
ODP Issues to Consider in Managing a Patent Portfolio
Ezra and Breckenridge clarified that if a patent remains valid within its original term, without PTE extension, then that patent will remain valid during its PTE-extended term. Ezra also clarified that PTE cannot rescue a patent that is already invalid for ODP.32 This means that a PTE-extended patent can be invalidated for ODP if its original expiration, before adding a PTE, is unjustifiably later than that of the reference patent.
In many instances, ODP can be overcome by filing of a terminal disclaimer, which causes the term of the later-expiring patent to be truncated and expire when the earlier-expiring reference patent expires. Preconditions to a terminal disclaimer require that the patents are commonly owned33 and the reference patent is pending when the terminal disclaimer is filed.34 Provided the preconditions to filing a terminal disclaimer are met, a terminal disclaimer can even be filed after a finding of ODP during litigation.35
Of course, shortening of term from filing a terminal disclaimer can be a major disadvantage. But crucially additional term due to PTE is not impacted by a terminal disclaimer,36 and often in the life sciences additional term attributable to a PTE is significantly longer than term lost to a terminal disclaimer. If ODP could present a risk to a PTE-extended patent, the expiration dates of potential reference patents should be carefully monitored to ensure that, if necessary, a terminal disclaimer can be filed before expiration date of potential reference patents. As Ezra suggests, if a post-URAA PTE-extended patent’s original expiration is later than a reference patent’s expiration, a court finds ODP, and a terminal disclaimer is not filed to cure ODP prior to expiration of the reference patent, then additional term from the PTE may be “lost” when the PTE-extended patent is invalidated for ODP.
The scenario that neither Ezra nor Breckenridge addressed is whether an earlier-issued patent, with a later expiration due to PTA could be invalid over a related reference patent that has the same original expiration date, but no added term. While the Magna district court decision, relying on Gilead, found that additional term from PTA could render a patent invalid for ODP, the Ezra opinion suggests that an earlier-issued patent extended by PTA may not be unjustifiably extended, and thus not invalid under ODP. In reference to PTE, the Ezra panel states that “this court has described obviousness-type double patenting as a ‘judge-made doctrine’ that is intended to prevent extension of a patent beyond a ‘statutory time limit.’... Here, agreeing with Ezra would mean that a judge-made doctrine would cut off a statutorily-authorized time extension.”37 Like PTE, PTA is a statutorily provided extension of a patent’s term under 35 U.S.C. § 154(c), which is not a product of a patentee’s actions, but rather USPTO delays.
Although, this statement in Ezra suggests that later expiration due solely to PTA may be immune from ODP (as with PTE), because this question has not explicitly been taken up by the Federal Circuit, it remains unanswered. Unlike PTE, which is immune to terminal disclaimer, PTA can be disclaimed.38 In the life sciences — where PTE is often added on top of PTA to extend the term of a patent for many years — patent practitioners and portfolio managers must continue to weigh the risk of having a PTA-extended patent invalidated for ODP against the loss of PTA term from filing a terminal disclaimer in order to safeguard term added by a PTE.