What many seem to have understood from Gilead Sciences, Inc. v. Natco Pharma Limited (Fed. Cir. 2014), has been clearly set forth in the recent decision In re Cellect, LLC (Fed. Cir. Aug. 28 2023), which is that under Obviousness-type Double Patenting (ODP) an earlier expiring patent can invalidate a later expiring patent having an extended term due to Patent Term Adjustment (PTA), and not just for the PTA period, but for the entire term of the Patent.
Moreover, it is now even clearer that such invalidation is not restricted to cases involving gamesmanship, which was clearly badgered by the Federal Circuit in Gilead, where applicants filed serial formally unrelated applications with different priority dates to achieve patents with different expiration dates. In contrast, the four patents involved in Cellect all claim priority to the same single application, but none of them were divisional applications resulting from a restriction requirement. The patents in Cellect expired at different times due only to PTA having been granted because of USPTO delays during prosecution in all but one of these patents.
ODP is explicitly held to apply to situations like this, i.e., same priority date being claimed by all patents, for the single overriding reason to ensure that the applicant is not receiving an unjust extension of time. As such, the ODP analysis must be performed on patents that have received PTA based on the expiration date including PTA – in other words, a grant of PTA shall not extend the term of a patent past the date of a disclaimer.
This is not a situation that concerns Patent Term Extension (PTE), which was extensively discussed as being different than PTA, where PTE is added to the patent term after consideration of ODP so long as the extended patent is otherwise valid without the extension. (Noted here is that PTA is granted for USPTO delay during prosecution of any patent, while PTE is granted for time lost during the FDA’s review process to one patent covering a FDA-approved product.)
Noteworthy is that no ODP rejections have been made by the USPTO in any of the applications, thus, not actively bringing these issues to applicant’s attention. The failure of applicants and of the Examiner concerning ODP was held to frustrate the clear intent of Congress concerning disclaimers. Equitable considerations of no gamesmanship, good faith, etc., do not lead to a different outcome.
Patentees having believed that they have a strong patent portfolio protecting a technology with various patents from different angles may find that their protection may contain some or maybe lots of invalid patents just by doing what was advisable decades ago, i.e., to protect your technology by a variety of patents while trying to get extended term for any of them where possible.
This even more clearly set forth new reality in Cellect significantly constrains portfolio management and forces a hard choice going forward onto patentees. Should one be proactive in view of this decision and file Terminal Disclaimers in portfolios where ODP may be an issue, thereby giving up valuable patent term in issued patents, or should one risk the validity of a valuable patent for its entire term by doing nothing?
Going forward it will become even more important to evaluate ODP issues in entire portfolios each time a patent is issued that contain claims that may raise ODP issues, which is not always limited to family member patents.
Additionally, efforts should be made during prosecution to strategically force restriction requirements early on in patent families, where the later filed divisional applications would be protected from ODP under the safe harbor provided by 35 USC 121 if the claims are kept consonant with the restriction requirement in the divisional applications.
And, as a final note to give some positive perspective, if it is bad for you, it is also bad for your competitors – use attacks against them for ODP.
For more information or if you have any questions, please contact Csaba Henter at Henter@MWZB.com