The unorthodox reality presented by the broad Gilead decision in 2014 (Gilead Sciences, Inc. v. Natco Pharma Ltd. (Fed. Cir. 2014)) is that a patentee obtaining a second or subsequent patent on an aspect of an invention risks invalidating previously obtained patents due to obviousness-type double patenting (OTDP) over the later issuing patent. As such, closely related patents and applications, even in the same family, have to be carefully managed.
It is correct that that an invalidated patent due to obviousness-type double patenting can be cured by the filing of a terminal disclaimer. However, this comes often at the cost of losing patent term, for example, obtained as a result of properly obtained Patent Term Adjustment (PTA), and also importantly, the cure is only prospective. As such, an invalidation, even if temporary, often comes at a loss of damages for the period before the terminal disclaimer is filed during the period when the subsequent patent has already issued.
Thus, patentees are faced with a very difficult decision when a second patent is about to issue that is related to an invention already covered by the claims of a previously issued patent, provided that the issue of potential double patenting is even recognized. The patentability of the claims in the already issued patent is not under analysis by the USPTO, and as such, no formal rejection would be made bringing this issue to the attention of the patentee. However, if the claims in the application for the subsequent patent are rejected for OTDP over the claims in the issued patent, this can be used by applicant as a trigger to analyze whether an OTDP rejection could have been made in the already issued patent over the claims of the subsequent to issue application. The patentee’s non-exhaustive choices include the following options, none of which are easy to accept, especially after spending significant efforts and costs on achieving an allowance:
1) file a terminal disclaimer in the already issued patent (this choice is particularly difficult if there would be a loss of term in the already issued patent); 2) not allow the later issuing application to issue as a patent; 3) try to obtain adequate PTA in the later issuing application so that the expiration date would not be before the already issued patent’s expiration date (in this case option 1 would become an easier choice to make); or 4) allow the later application to issue and take the risk of a double patenting challenge under the rationale of Gilead to the already issued patent.
Just to recap, Gilead was a broad decision (often applied by lower courts without caveats) where the Federal Circuit held that the later issued but earlier expiring patent qualified as an invalidating obviousness-type double patenting reference, which is thus available to invalidate the earlier issued but later expiring patent.
The Gilead scenario was as follows:
A clear chip in the applicability of Gilead scenario came in December of 2018, in the form of two decisions from the Federal Circuit, i.e., Novartis v. Breckenridge and Novartis v. Ezra.
Breckenridge involved a double-patenting situation in which the later-filed of two related patents, which share a common specification and effective filing date, expires before the term of the earlier-filed patent due to an intervening change in law by Congress defining a patent’s term (in the URAA from 17 years to 20 years). Thus, in this situation the change in patent term law caused the second patent to expire earlier than the first patent.
The situation in Breckenridge was the following:
Applying Gilead, 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 reference patent to be a proper double patenting invalidating reference.
However, in contrast to the patents at issue in Gilead, the patents here were not both filed after the effective date of the URAA and they did not claim different priority dates.
The Federal Circuit latched onto only one of these distinguishing factors as the explicitly stated reason for distinguishing Gilead and reversing the district court, i.e., that the Gilead “opinion was limited to the context of when both patents in question are post-URAA patents.”
While the Federal Circuit did not indicate that the common filing dates of these applications was controlling, it held that in Gilead the expiration date is the benchmark of obviousness-type double patenting, which is in contrast to relying on issuance dates as in pre-Gilead times, which is prone to significant gamesmanship during prosecution under the URAA . The exemplary situation for gamesmanship provided under the URAA was filing serial applications on obvious variants of the same invention, claiming priority from different applications in each, and arranging for the application with the latest filing date to issue first.
The decision AbbVie (AbbVie v. Mathilda & Terence Kennedy Institute of Rheumatology Trust (Fed. Cir. 2014) was also cited as a prime example of the post-URAA scenario contemplated in view of Gilead. In that case too, the patentee chose a different, later priority date than the one relied on for the first patent so that the second patent expired later than the first patent.
In AbbVie, the Court held that the patent owner had impermissibly sought an undue patent term extension for its later-expiring, patentably indistinct claims by choosing to claim different priority dates for its patent applications, thereby ensuring that the resulting patents would have different expiration dates. Ezra involved a very similar situation to Breckenridge with a holding regarding PTA consistent therewith, but in addition considered the interaction of Patent Term Extension (PTE) and PTA. The Federal Circuit held that if a patent, under its pre-PTE expiration date, is valid under all other provisions of law, then it is entitled to the full term of its PTE.
Noted however is that in Ezra as well, the Court focused on potential gamesmanship not being an issue as in Gilead, e.g., the structuring of priority claims as identified in Gilead by orchestrating longer patent-exclusivity periods by (1) filing serial patent applications on obvious modifications of an invention, (2) claiming different priority dates in each, and then (3) strategically responding to prosecution deadlines such that the application claiming the latest filing date issues first, without triggering a terminal disclaimer for the earlier filed applications.
Patentees who seek multiple patents on a technology now may see a glimmer of hope that this chip in Gileadwill become a larger crack in the situation created by the Federal Circuit in 2014 that resolves the unfortunate double patenting situation for patentees. Despite the Federal Circuit indicating that the decisions of Breckenridge and Ezra were driven by the pre- and post-URAA situation, one cannot help to notice the attention given to the gamesmanship mentioned in all these decisions where applicants filed serial patent applications claiming different priority dates as being of importance. Perhaps down the line this distinction may give relief to post-URAA patents which originate from the same priority document, which would lack at least this type of disapproved gamesmanship.