Blog Big Molecule Watch October 21, 2019

Briefing completed in trastuzumab IPR appeals

On October 15, 2019, Genentech filed reply briefs in support of its Federal Circuit appeals from the PTAB’s final written decisions of unpatentability of the challenged claims of U.S. Patent Nos. 7,846,441 and 7,892,549, which are directed to methods of treating HER2+ cancer with trastuzumab (Cases Nos. 19-1263, 19-1265, 19-1267 and 19-1270). As we previously reported, Genentech argued in its opening briefs that the PTAB adopted an erroneous claim construction, that by applying that erroneous claim construction the PTAB erred in finding the claims unpatentable as obvious, and that in some instances the PTAB erred by denying Genentech’s motion to amend its claims. After petitioners Celltrion, Pfizer and Samsung Bioepis withdrew from the appeals due to settlements with Genentech, the USPTO intervened in the appeals and, on September 3, 2019, submitted responsive appellate briefs defending the PTAB’s final written decisions. In its reply briefs, Genentech argues that the USPTO’s attempt to defend the PTAB’s claim construction fails and that the obviousness ruling cannot stand under a proper claim construction. Further, in Case No. 19-1263, Genentech argued that the PTAB’s decision to prohibit Genentech’s motion to amend should be reversed because the plain text of 35 U.S.C. § 316(d)(1) grants Genentech a statutory right to amend.

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