Addressing invalidity resulting from obvious-type double patenting (ODP) based mostly on later-filed-related patents, the US Court of Appeals for the Federal Circuit reversed a district courtroom’s utility of In re Cellect (Fed. Cir. 2023) and held that the later-filed, earlier-expiring continuation patents weren’t obtainable as ODP references in opposition to the earlier-filed, later-expiring patent. Allergan USA, Inc. v. MSN Labs Private Ltd., Case No. 24-1061 (Fed. Cir. Aug. 13, 2024) (Lourie, Dyk, Reyna JJ.)
In 2015, the US Food and Drug Administration accredited a brand new drug utility for a drug bought by Allergan to deal with the signs of irritable bowel syndrome. In 2019, Sun Pharma filed an abbreviated new drug utility (ANDA) in search of to market a generic model of the drug. Allergan then sued Sun Pharma and MSN Labs for infringement of 4 patents associated to the drug. One of the patents, which claims a compound of the drug, had been granted virtually three years of patent time period adjustment (PTA) and was adopted by two extra patents from continuation functions in the identical patent household. The different three patents all claimed pill types of the drug. The claims of one of many patents recited {that a} glidant was non-obligatory whereas the claims of the opposite two patents didn’t require a glidant in any respect.
The US District Court for the District of Delaware held a three-day bench trial and concluded that the asserted declare of the compound patent was invalid beneath the ODP doctrine and that the claims of the three pill patents have been invalid for lack of written description. On the difficulty of ODP, the district courtroom discovered Allergan’s “first-filed, first-issued” distinction “immaterial.” The district courtroom acknowledged that “[w]hen analyzing ODP, a court compares patent expiration dates, rather than filing or issuance dates.” Allergan appealed.
The Federal Circuit reversed on each points. The Court held that the claims of the later-filed, earlier-expiring continuation patents weren’t obtainable as ODP references in opposition to the primary patent as a result of the aim of the ODP doctrine is to forestall patentees from acquiring a second patent to successfully prolong the lifetime of the primary patent. The Federal Circuit defined that the district courtroom misinterpret Cellect as binding it to solely take into account expiration dates within the ODP evaluation. The Court defined that Cellect solely controls to the extent that it requires a courtroom to think about the later-filed patent’s expiration date (i.e., the expiration date after the addition of PTA) in its ODP evaluation, not the expiration date that it might have shared with the reference patents within the absence of a PTA award. The panel majority emphasised that it doesn’t comply with that the later-filed patent should be invalidated by the earlier-filed reference patents just because it expires later. The majority famous 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 – and therefore has little to say on the precise issue before us.”
The Federal Circuit additionally discovered written description assist based mostly on two embodiments the place a glidant was not required and based mostly on the unique declare from the patent utility, which didn’t recite a glidant.
Judge Dyk filed a separate opinion concurring with the double-patenting determination however dissenting as to written description. He concluded that the district courtroom’s written description discovering was supported by unrebutted knowledgeable testimony {that a} glidant could be utilized in each formulation and by a specification itemizing of non-obligatory substances that didn’t embody a glidant.
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