Board finding of no written description of genus claims in priority applications and anticipation affirmed

Regents of the University of Minnesota v. Gilead Sciences, Inc.

Docket No. 2021-2168 (IPR 2017-01712) (


March 6, 2023

Brief Summary:   Board IPR FWD finding UM’s genus claims lack a sufficient written description in priority applications and are therefore anticipated affirmed.

Summary:  UM appealed USPTO Board IPR final written decision (FWD) holding claims 1-9, 11-21 and 23-28 of US 8,815,830 “directed to phosphoramidate prodrugs of nucleoside derivatives that prevent viruses from reproducing or cancerous tumors from growing” (claim 1, including multiple Markush groups, patent including separately claimed subgenera).  Gilead’s FDA approved sofosbuvir used to treat hepatitis C falls within the genus of ‘830 claim 1.  Gilead petitioned for IPR of the claims, arguing that the claims were not entitled to their claimed priority dates and therefore anticipated by Gilead’s US patent publication (“Sofia”).   Non-provisional (“NP) application 4 (“NP4”) was filed after Sofia was published (2013 and 2010, respectively), and NP2 and NP3 were both filed before Sofia and contain the same disclosure (2005 and 2007, respectively).  Priority document provisional 1 (“P1”) was filed in 2004.  The FC panel reviewed the Board’s legal determinations de novo (In re Elsner, FC 2004) and its factual findings for substantial evidence (In re Gartside, FC 2000; Consol. Edison, US 1938).  UM argued the Board erred in finding that N2 and P1 “do not show a written description of what is claimed in the ’830 patent”, “afoul of requirements set forth in the Administrative Procedure Act (‘APA’)”, and UM “is a sovereign state entity immune from IPR.”  The FC panel explained that the written description (WD) requirement requires “that the disclosure show that one actually made the invention that one is claiming, i.e., that it possessed the invention as claimed” (Amgen, FC 2003).  For a “genus of chemical compounds”, it wrote, “written description of a broad genus requires description not only of the outer limits of the genus but also of either a representative number of members of the genus or structural features common to the members of the genus, in either case with enough precision that a relevant artisan can visualize or recognize the members of the genus” and “[a] broad outline of a genus’s perimeter is insufficient” (Ariad, FC 2010 (en banc); Lockwood, FC 1997; In re Wertheim, CCPA 1981).  It also explained that MN did not argue here “that it described a sufficient number of species to constitute a written description of the claimed subgenus” but “its earlier NP2-P1 applications literally described, or provided blaze marks to, the subgenus of the ’830 claims in its broad outlines”, with which the Board disagreed.  The FC panel explained that “[t]he disclosure of NP2-P1, being broader than claim 1 of the ’830 patent, has a relationship of genus to the narrower subgenus of the ’830 patent claims”.  The Board found no “ipsis verbis disclosure of the subgenus of challenged claim” and the FC panel agreed (e.g., a “maze-like path”, “all those optional choices do not define the intended result that is claim 1”, “laundry list”; Fujikawa, FC 1996).  The Board also found insufficient “blaze marks” (Fujikawa; e.g., “must be clear because ‘it is easy to bypass a tree in the forest, even one that lies close to the trail”, “the point at which one must leave the trail to find the tree is not well marked in P1 and NP2”) and the FC panel agreed (e.g., “the structures of P1 claim 47, which, through its multiple dependencies, encompasses a significantly larger genus than that claimed in the ’830 patent, are not sufficiently common to that of claim 1”).  The FC panel also found the Board did not err under the APA (e.g., it is not bound by a prior non-precedential FWD (Power Integrations, FC 2019) and it is not immune (“absent reversal en banc or by the Supreme Court [already declined], it is bound by the holding in Regents of the University of Minnesota v. LSI Corp., 926 F.3d 1327 (Fed. Cir. 2019)”.  The Board decision was therefore affirmed.

This entry was posted in Anticipation (35 USC 102), Inter Parties Review (IPR), IPR, Markush, Priority, Written description. Bookmark the permalink.

Leave a Reply

Fill in your details below or click an icon to log in: Logo

You are commenting using your account. Log Out /  Change )

Twitter picture

You are commenting using your Twitter account. Log Out /  Change )

Facebook photo

You are commenting using your Facebook account. Log Out /  Change )

Connecting to %s

This site uses Akismet to reduce spam. Learn how your comment data is processed.