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Federal Circuit Provides Clarity On Proper Obviousness-Type Double Patenting References
09/18/2024In Allergan USA, Inc. et al., v. MSN Laboratories Private Ltd., et al., the United States Court of Appeals for the Federal Circuit issued a precedential decision relating to obviousness-type double patenting (“ODP”) and patent-term adjustments. The Court held that a claim that is first-filed and first-issued, but later-expiring, cannot be found invalid under the ODP doctrine based on a later-filed, later-issued, but earlier-expiring reference claim that shares the same priority date with that of the challenged claim.
The case involves U.S. Patent No. 7,741,356 (the ’356 Patent), which covers Allergan’s drug product, Viberzi®. Several continuation applications stemming from the ’356 Patent were filed that resulted in two “child” patents, U.S. Patent No. 8,344,011 (the ’011 Patent) and U.S. Patent No. 8,609,709 (the ’709 Patent). During prosecution, the ’356 Patent was awarded with 1,107 days of patent term adjustment (PTA). After disclaiming some of this PTA in the process of securing patent term extension (PTE), the ’356 Patent was set to expire 467 days after the expiration dates of the ’011 Patent and ’079 Patent.
Shortly after Sun Pharmaceuticals Industries filed its abbreviated new drug application (ANDA), Allergan asserted that Sun infringed, among others, claim 40 of the ’356 patent. Sun argued that claim 40 of the ’356 patent was invalid for ODP over the claims of the ’011 Patent and ’709 Patent as they are not patentably distinct. In doing so, Sun asserted that the ’011 Patent and ’709 Patent are proper ODP references because, with the addition of PTA, the ’356 Patent expires after the ’011 Patent and ’709 Patent. Allergan disagreed and argued that the ’356 Patent, being the first-filed and first patent to issue in the family, cannot be subject to an ODP challenge based on later-filed and later-issued patents in the same family.
The District Court for the District of Delaware agreed with Sun and held that claim 40 of the ’356 Patent was invalid for ODP over the reference claims of the ’011 and ’709 Patents. The district court relied on the Federal Circuit’s holding in In re: Cellect, LLC, 81 F.4th 1216 (Fed. Cir. 2023), to conclude that it is the relevant expiration dates of the challenged and reference patents that should be compared when determining if a reference patent is a proper ODP reference. See Allergan USA, Inc. v. MSN Laboratories Private Ltd., 694 F. Supp. 3d 511, 540 (D. Del. 2023) (“The first-filed, first-issued distinction is immaterial. When analyzing ODP, a court compares patent expiration dates, rather than filing or issuance dates.”). Allergan appealed.
The Federal Circuit found that the claims of the ’011 Patent and ’709 Patent were not proper ODP references and could not be used to invalidate claim 40 of the ’356 Patent. Specifically, the Court held that a later-filed, later-issued patent claim cannot be an ODP reference to a first-filed, first-issued patent in the same family. The Federal Circuit distinguished its earlier holding in Cellect, stating that, “Cellect does not address, let alone resolve, any variation of the question presented here—namely, under what circumstances can a claim properly serve as an ODP reference.”
In reversing the district court’s holding, the Federal Circuit has provided some additional clarity to In re Cellect as to what patents may serve as proper ODP references.
