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6 May 2014

Allergan sues Aurobindo over eye drop generic

Allergan, along with Japan-based Senju and Kyorin have sued Indian pharma Aurobindo for infringing claims in the Japanese pharmaceutical companies’ reexamined US patent 6,333,045.

The case was launched on May 2, after Aurobindo filed an Abbreviated New Drug Application with the US Food and Drug Administration for approval to make and sell a generic version of Allergan’s Zymaxid (gatifloxacin) drug, an eye drop solution used to treat eye infections.

According to the complaint, filed at the US District Court for the District of Delaware, Senju and Kyorin own the entire right, title and interest in the ‘045 patent, which covers “aqueous liquid pharmaceutical composition comprised of gatifloxacin”.

Allergan is the exclusive licensee of the patent, which was issued in 2001 and is due to expire in 2019.

In a patent infringement case between Senju and Lupin, also fought at the Delaware court, the claims of the ‘045 patent reexamination certificate were ruled to be infringed by the defendants, but were held to be invalid for obviousness.

That decision is currently on appeal, and is due to be argued at the Court of Appeals for the Federal Circuit tomorrow (May 7), with a decision expected later in the year.

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