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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