Blog Big Molecule Watch January 10, 2022

PTAB Institutes Two IPRs on Tocilizumab Patents

Last week, the PTAB instituted inter partes review of two Chugai patents directed to methods of treating rheumatoid arthritis with a combination of tocilizumab and methotrexate.  Fresenius filed petitions for inter partes review on U.S. Patent Nos. 7,521,052 (“the ’052 patent”) and 10,744,201 (“the ’201 patent”) on June 28, 2021.  In separate decisions, the PTAB instituted review of all claims of both patents finding that Petitioners have demonstrated a reasonable likelihood that they will prevail in showing the unpatentability of the claims challenged in the Petitions.

Fresenius presented three grounds for the invalidity of the single claim of the ’052 patent.  The PTAB indicated that it found the Petitioners had established a basis for institution on two of the grounds—anticipation by the Yoshizaki prior art reference and obviousness over a combination of the Nishimoto and Weinblatt prior art references—but the PTAB did not find Petitioners were reasonably likely to establish anticipation by Nishimoto.  As required under SAS, however, after determining that institution was generally required, the PTAB instituted on all three grounds.

Concerning the claims of the ’201 patent, the PTAB similarly found that Petitioners had established a basis for institution on the ground of obviousness in light of the combination of Nishimoto and Weinblatt, but that the Petitioner had not established a basis for institution on the ground of anticipation by Nishimoto.  Again, as required under SAS, the PTAB instituted on both grounds.

Of particular note, the Patent Owner argued that the expected litigation under the BPCIA counsels against institution under the PTAB’s discretion based upon 35 U.S.C. § 314(a).  The PTAB rejected this argument, concluding that “[b]ecause Patent Owner has not identified an existing parallel proceeding to consider, we decline Patent Owner’s invitation for us to consider discretionary denial of the institution under Fintiv.

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