On Mar. 06, 2023, Federal Circuit affirmed PTAB that claims of US 8,815,830 are unpatentable as anticipated by
the asserted prior art.

 

US’830 patent belongs to The Regents of the University of Minnesota which covers sofosbuvir among other compounds. Gilead filed IPR and argued that the claims (1−9, 11−21, and 23−28) were not entitled to their claimed priority date and were therefore anticipated by US 2010/0016251 (“Sofia”), which was published on January 21, 2010. The ’830 patent filed on March 28, 2014 claims priority from four applications filed on the dates outlined below:

U.S. Provisional App. 60/634,677 (“P1”)      Dec. 9, 2004
Int. App. PCT/US2005/044442 (“NP2”)       Dec. 8, 2005
U.S. Patent App.11/721,325 (“NP3”)           June 8, 2007
U.S. Patent App. 13/753,252 (“NP4”)          Jan. 29, 2013

 

The Board held that NP2-P1 failed to provide written description sufficient to support the ’830 patent’s priority
claim. According to the Board, these documents contained neither ipsis verbis support nor sufficient blaze marks to
guide the skilled artisan to the claims of the ’830 patent. Thus, they were thus anticipated by Sofia. Minnesota appealed.

 

Minnesota on appeal argued that that P1 claim 47, combined with P1 claim 45 (with its disclosure of R6 substituents), P1 claim 33 (with its disclosure of R5 substituents), P1 claim 21 (with its disclosure of the R3 substituent), P1 claim 13 (with its disclosure of R2 substituents), P1 claim 2 (with its disclosure of R1 substituents), and P1 claim 1 (with its disclosure of R4 substituents and of X), provides an ipsis verbis disclosure of the subgenus claimed in the ’830 patent. Federal Circuit, however, did not agree and held that this maze-like path, each step providing multiple alternative paths, is not a written description of what might have been described if each of the optional steps had been set forth as the only option. Court next addressed whether NP2-P1 combined provided sufficient blaze marks to provide written description support for the ’830 patent claims. Court said that the point at which one must leave the trail to find the tree is not well marked in P1 and NP2. Thus, P1 and NP2 do not provide sufficient written description support for the subgenus of challenged claim 1. Because NP3 provides the same disclosure as NP2, it too does not provide sufficient written description to support the ’830 patent claims. The claims of the ’830 patent were therefore entitled to a priority date no earlier than March 28, 2014, making Sofia prior art to them.

 

And as the parties did not dispute that Sofia discloses each and every limitation of the ’830 patent claims, the challenged claims of the ’830 patent were anticipated by Sofia.