The China National Intellectual Property Administration (CNIPA)’s Patent Re-examination Board (PRB) has reportedly invalidated two patents associated with AbbVie (NYSE: ABBV)’s JAK inhibitor, upadacitinib, listed in China’s version of the ‘Orange Book’. This ruling, highlighted by Lusheng Law Firm’s Terry Lu, could set a critical precedent for innovative pharmaceutical companies, emphasizing the necessity for adequate disclosure of experimental data in Orange Book-listed patents.
The PRB’s decision pertains to patent No. ZL2010800692920.6 (Decision No. 561725) and its divisional application ZL201810902092.0 (Decision No. 562232). Si Chuan Gowell Pharma challenged the first patent on grounds of inventiveness, claiming that AbbVie’s prior filing constituted prior art. The PRB concluded that the specific structure of upadacitinib was not adequately disclosed in the priority document. This ruling introduces significant implications for innovative firms, particularly regarding the submission of supplementary data in patent applications; specifically, the effects or activities of such data must be detailed in the original patent description. In this case, the examiner accepted supplementary data demonstrating JAK-3 activity but rejected claims of selective activity against JAK-2/JAK-1 due to insufficient original disclosure.- Flcube.com
