Mesalamine – USA

Mesalamine – USA

On Jun 15, 2017 a Florida federal judge vacated her earlier decision on reconsideration and found that Mylan’s proposed generic version of Shire’s gastrointestinal drug Lialda does not infringe U.S. Patent Number 6,773,720 (expiring in Jun 2020).
U.S. Judge Charlene Edwards Honeywell of the Middle District of Florida made the ruling after the U.S. Court of Appeals for the Federal Circuit unanimously reversed a patent infringement decision in favor of Shire against Watson Pharmaceuticals Inc., finding that Watson’s generic version of the same drug did not infringe the ‘720 patent.
“Having considered the motions, having heard argument from counsel, and otherwise being fully advised in the premises, [the Court] will grant the Motion for Reconsideration Pursuant to Rules 59(e) and 60(b) … [b]ecause Mylan has demonstrated that there has been an intervening change in controlling law,” Judge Honeywell wrote in her Order, adding that in light of this change, “The Court has reconsidered its Opinion and Order and will vacate its Opinion and Order and Final Judgment and Permanent Injunction.”
Zydus & Watson have already received favorable opinion form CAFC on non-infringement in May 2017 & Feb 2017 respectively. Zydus has recently got final approval from USFDA & was the first ANDA applicant for Mesalamine Delayed-Release Tablets USP, 1.2 g, to submit a substantially complete ANDA with a paragraph IV certification.
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