CAFC Says ‘First-Filed, First-Issued, Later Expiring Claim’ is Not Invalid for ODP

The U.S. Court of Appeals for the Federal Circuit (CAFC) ruled today in a precedential decision that a “first-filed, first-issued, later-expiring claim cannot be invalidated by a later-filed, later-issued, earlier-expiring reference claim having a common priority date” under the judicially-created doctrine of obviousness-type double patenting (ODP). In so ruling, the CAFC distinguished In re Cellect, explaining that Cellect answered a different question than one at issue here, “namely, under what circumstances can a claim properly serve as an ODP reference”? Judge Lourie, who also authored the Cellect opinion, wrote for the court, with Judge Dyk partially dissenting.

The U.S. District Court for the District of Delaware initially determined that claim 40 of U.S. Patent 7,741,356, which Allergan USA Inc. et. al. asserted against Sun Pharmaceutical Industries Limited, was invalid due to ODP, and that the claims of Allergan’s U.S. Patents 11,007,179; 11,090,291; 11,160,792; and 11,311,516 were invalid under 35 U.S.C. § 112 for lack of written description. The ‘356 patent covers “eluxadoline tablets,” which mitigate the symptoms of irritable bowel syndrome with diarrhea (IBS-D).

The CAFC reversed both of the district court’s holdings, explaining that the purpose of the ODP doctrine is “to prevent patentees from obtaining a second patent on a patentably indistinct invention to effectively extend the life of a first patent to that subject matter”—not to block a first-issued patent that expires later, as was the case here.

In Cellect, the CAFC held that patent term extension (PTE) and patent term adjustment (PTA) are not the same for purposes of an ODP analysis and that “ODP for a patent that has received PTA, regardless whether or not a terminal disclaimer is required or has been filed, must be based on the expiration date of the patent after PTA has been added.”

In the Allergan case, Sun argued that “claim 40 of the ’356 patent is invalid for ODP over claim 33 of the ’011 patent and claim 5 of the ’709 patent because the claims are not patentably distinct and because claim 40, having been awarded 467 days of PTA, expires after the reference claims of the ’011 and ’709 patents.” Allergan responded that since the ’356 patent was “the first patent claiming eluxadoline to be filed and the first patent to issue, claim 40 is not subject to ODP over the later-filed, later-issued claims of the reference patents.”

The district court found Allergan’s distinction “immaterial” because, under Cellect, “[w]hen analyzing ODP, a court compares patent expiration dates, rather than filing or issuance dates,” said the court. It found Cellect bound it to consider only expiration dates in the context of ODP and, thus, found claim 40 invalid.

But in its discussion rejecting the district court’s analysis, the CAFC explained that Cellect “is only controlling in this case to the extent that it requires us to consider, in our ODP analysis, the ’356 patent’s June 24, 2026 expiration date (i.e., the expiration date after the addition of PTA), not the March 24, 2025 expiration date that it would have shared with the ’011 and ’709 reference patents in the absence of a PTA award.”

As far as the contention that the ‘356 patent must be invalidated by the ‘011 and ‘709 patents because it expires later, Judge Lourie said the majority concludes that “the claims of the ’011 and ’709 reference patents are not proper ODP references that can be used to invalidate claim 40 of the ’356 patent.” The opinion added:

“To hold otherwise—that a first-filed, first-issued parent patent having duly received PTA can be invalidated by a later-filed, later-issued child patent with less, if any, PTA—would not only run afoul of the fundamental purposes of ODP, but effectively abrogate the benefit Congress intended to bestow on patentees when codifying PTA.”

Sun relied heavily on Gilead Scis., Inc. v. Natco Pharma Ltd., 753 F.3d 1208, 1215–17 (Fed. Cir. 2014) for its holding that “a later-issued but earlier-expiring patent can qualify as a ODP reference to invalidate an earlier-issued but later-expiring patent.”   The CAFC conceded in Allergan that “taken on its face, we can understand why” Sun placed so much stock in Gilead, but determined that “that case too is not inconsistent with our holding today.”

But contrasting the two cases, the CAFC said that “claim 40 of the ’356 patent was filed before, shares a priority date with, and issued before the reference claims of the ’011 and ’709 patents. Because the ’356 patent was the first patent in its family to be filed and to issue, it does not extend any period of exclusivity on the claimed subject matter.”

With respect to written description, the CAFC found the district court had erred in its reading of the specification and the finding that it did not “reasonably convey to a person of ordinary skill in the art that the inventors had possession of a formulation without a glidant,” and therefore reversed the district court’s conclusion that the asserted claims are invalid for lack of written description.

Judge Dyk dissented as to the written description analysis, calling the district court’s decision on that point “well-reasoned” and faulting the majority’s reading of the specification as describing an optional “glidant-free” formulation of the invention.

Reactions

Robert Sahr of Wolf Greenfield, who discussed this issue on a panel held during IPWatchdog’s most recent Life Science Masters Program, said today’s ruling will save a lot of pharmaceutical patents:

“Like the ‘356 patent, many patents directed to FDA approved pharmaceuticals to which patent term extension (PTE) has been applied under 35 USC 156 are first-filed, first-issued patents that have received patent term adjustment (PTA) by the USPTO under 35 USC 154 due to USPTO examination delay.

By immunizing first-filed, first-issued patents within a family against ODP challenges based on reference claims in later-filed, later-issued progeny, the Federal Circuit has spared many pharmaceutical patents that have both patent term adjustment (PTA) and patent term extension (PTE) that might otherwise have been doomed by ODP and left with a valid PTE period but invalid claims.”

Steve McBride of Carmichael IP, who authored an article for IPWatchdog on the precise topic of this decision in May, also applauded the opinion, but said it could have gone even farther:

“Allergan is a big step in the right direction in ODP law… However, I would have liked to see the decision go farther. First, I would have liked to see the decision more forcefully abrogate In re Cellect. I agree with Judge Andrews’ district court decision that In re Cellect has no exceptions for the situation presented in Allergan. Second, I would have liked to see the panel take its excellent background analysis of ODP and the URAA to its logical conclusion and eliminate ODP altogether. By failing to establish these bright-line rules, the Federal Circuit has left a patchwork approach to ODP in place that parties will likely fight over in the future. Hopefully, the Federal Circuit will take up ODP law en banc in the near future and unify recent Federal Circuit precedent on ODP.”

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