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In re Cellect: Is Your Patent Portfolio Vulnerable to Double Patenting Challenges?

November 13, 2023

By: Christine M. Wise and Alice O. Carroll

  • For the first time, the Federal Circuit addressed how Patent Term Adjustment (PTA) interacts with obviousness-type double patenting (ODP).
  • A patent can be invalidated based on ODP where later expiration is due to PTA.

For the first time, the Federal Circuit in the case of In re: Cellect, LLC (Case No. 22-1293, decided August 28, 2023) addressed how Patent Term Adjustment (PTA) interacts with obviousness-type double patenting (ODP). 

As background, there are five patents in a family with claims directed to image sensors, each patent claiming priority from a single application. All of the patents would have expired on the same day except that four of the five patents received PTA for USPTO delays during prosecution.  ODP was not raised in any of the family members during prosecution.   

Cellect sued Samsung for infringement of the four patents having PTA.  Samsung then requested the underlying ex parte reexaminations, asserting that the patents were unpatentable based on ODP.  An ODP determination requires assessing whether the claims of a later-expiring patent are obvious over the claims of the earlier-expiring patent.  If so, and without a terminal disclaimer, the later expiring claims are invalid.  While ODP was not raised during prosecution, in each reexamination proceeding, the Examiner held that the four later-expiring patents were invalid for ODP over the one patent that did not have PTA.  The one patent that did not have PTA expired as of the appeal, so filing terminal disclaimers to cure ODP was not an option.    

Cellect appealed to the Patent Trial & Appeal Board, which affirmed.  Cellect then appealed to the Federal Circuit, which ultimately affirmed the decision of the Board.  Cellect did not dispute the finding of obviousness, but rather argued that whether claims are unpatentable under ODP should be based upon the expiration date prior to the addition of any PTA.  Cellect argued that PTA should not be considered in the ODP analysis, similar to PTE (Novartis AG v. Ezra Ventures LLC, 909 F.3d 1367, Fed. Cir. 2018, where the Novartis Court held that ODP should be considered from the expiration date of the patent before the addition of patent term extension (PTE), which restores some patent term lost due to FDA review).  The Federal Circuit, in affirming the decision of the Board, held that, contrary to the holding with respect to PTE in Novartis, with respect to PTA, the ODP analysis should be considered from the expiration date of the patent after the addition of PTA.

The outcome in In re Cellect is particularly important for pharmaceutical and life sciences patent holders where market exclusivity often relies on PTA, each day of patent term keeping competing drugs off the market.  Patent holders with multiple patents in a family may want to proactively consider the following to preserve patent rights from ODP challenges:

  • Audit patent portfolios at certain timepoints, such as, prior to patent expiration without the addition of PTA or PTE, prior to filing a formal complaint for infringement, and at the start of a patent lawsuit, to determine if an ODP rejection may be raised and whether it may be cured by filing a terminal disclaimer.
  • Develop claim drafting strategies for a first filed application to force a restriction requirement so that the later filed divisional applications would be protected from ODP under the safe harbor provided by 35 U.S.C. §121, provided the claims are in-line with the restriction requirement in the divisional applications.
  • For subsequently filed continuation applications, develop claim drafting strategies to pursue patentably distinct claims to avoid ODP challenges.