Friday, May 10, 2013

Lialda patent upheld by district court of Florida

Lialda (mesalamine) is a once daily treatment indicated for the induction and maintenance of mild to moderate ulcerative colitis  and was approved in 2007 by the USFDA. In a five day bench trial in the Southern District of Florida, Judge Middlebrooks issued a ruling upholding the validity of the patent covering LIALDA, US Patent No. 6,773,720 (the “’720 patent), and holding that the proposed ANDA formulation infringes the claims of that patent. The 720 patent expires in 2020. Other Para-IV applicant on Lialda include Zydus Cadila
Accordingly, Judge Middlebrooks confirmed that Shire is entitled to an injunction, which he will issue separately, which prohibits the FDA from approving the ANDA formulation until the expiration of the ‘720 patent.

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