On August 31, 2022, the PTAB instituted two inter partes reviews of Chugai and Roche’s tocilizumab patents challenged by Celltrion, adding to the growing list of IPRs instituted against the tocilizumab patent estate. We have been tracking the IPRs instituted against tocilizumab-related patents (see our last post, PTAB Institutes Sixth IPR – Big Molecule Watch – Big Molecule Watch). The two latest IPRs to be instituted concern U.S. Patent No. 8,580,264 (IPR 2022-00578) and U.S. Patent No. 10,874,677 (IPR 2022-00579). The PTAB’s institution decisions are located here (IPR 2022-00578) and here (IPR 2022-00579).
The ‘264 patent claims are directed to methods of treating rheumatoid arthritis (RA) with an anti-IL-6 receptor antibody at a fixed dose of 162 mg every week or every two weeks. The ‘677 patent has claims directed to a subcutaneous administrative device which contains and delivers 162 mg of tocilizumab. Celltrion had petitioned for review of all claims of each patent on the grounds of novelty under 35 U.S.C. 102 and obviousness under 35 U.S.C. 103. Based on the arguments and assertions in the petitions, the PTAB concluded that Celltrion had shown a reasonable likelihood that it would prevail and therefore instituted the inter parties reviews of both patents on all challenged claims and on all of the asserted grounds.
The ‘264 and ‘677 patents are also the subject of pending IPRs brought by Fresenius. Stay tuned to our PTAB Tracker for further updates on these IPRs.
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