AbbVie commenced proceedings in the US District Court of Delaware against Sandoz, Hetero Labs, Aurobindo Pharma, Intas Pharmaceuticals, Accord Healthcare and Sun Pharma, alleging infringement of 34 Rinvoq® (upadacitinib) patents, including compound, process and method of treatment patents. The alleged infringements arise from the respondents’ respective submissions of Abbreviated Biologic License Applications (aBLA) to the FDA seeking approval of their Rinvoq® biosimilars.
AbbVie is seeking injunctions preventing the supply of the upadacitinib biosimilars, and damages. AbbVie has also sought orders that the effective date of any FDA approval of the respondents’ ANDAs be no earlier than the last expiry date of the allegedly infringed patents (with the earliest expiring patent on 9 June 2029, and the latest expiry is 9 March 2038) or any later exclusivity expiry.
On 18 May 2023, the FDA approved an expanded indication for Rinvoq® to include adults with moderately to severely active Crohn’s disease who have had an inadequate response or intolerance to one or more tumour necrosis factor blockers.