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Hi-Tech denied motion in bid to reclaim generic Cosopt exclusivity

This article was originally published in Scrip

Executive Summary

In November, Hi-Tech challenged the US FDA's decision that the firm was not legally entitled to the 180-day exclusivity for a generic version of the glaucoma treatment dorzolamide-timolol ophthalmic solution, comparable to Merck & Co's Cosopt. This followed a launch by the company on October 28th without exclusivity. In a December 10th ruling, the US District Court for the District of Columbia determined that Hi-Tech "cannot succeed on the merits", and it denied the company's motion for preliminary injunction, permanent injunction, and declaratory judgement, and granted Apotex's motion for summary judgement. It also entered summary judgement in favour of the FDA. The court concluded that summary judgement in favour of defendants "is appropriate here, because, as a matter of law, FDA's October 28th, 2008 exclusivity forfeiture decision was based on a consideration of the relevant factors…is supported by the administrative record, and is not 'arbitrary, capricious, an abuse of discretion, or otherwise not in accordance with law'".

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