Apotex and Allergan settle competition dispute over Zymar
The US District Court for the District of Delaware has dismissed a dispute between Apotex and Allergan after the companies entered into a settlement agreement.
The court dismissed the case on Tuesday, April 25, after both parties reported that they had resolved their five-year competition dispute over Zymar (gatifloxacin ophthalmic), a treatment for pinkeye.
Apotex sued Allergan back in February 2012. It also sued Senju Pharmaceutical and Kyorin Pharmaceutical.
According to the 2012 complaint, Kyorin and Senju had earlier operated a scheme to create an “unlawful monopoly” in the market by making “misrepresentations” to the US Patent and Trademark Office in order to obtain US patent number 6,333,045.
The patent was granted in 2001.
Kyorin and Senju gave Allergan a licence to market the gatifloxacin ophthalmic formulations in the US, including a licence to the ‘045 patent, which resulted with Allergan marketing the drug under Zymar.
In 2002, Allergan filed a New Drug Application (NDA) on behalf of Kyorin and Senju, seeking approval to market the drug in the US.
After Allergan filed the NDA, Apotex filed an Abbreviated New Drug Application (ANDA) to compete with Allergan.
Allergan, Senju and Kyorin then filed litigation against Apotex to delay Apotex from marketing its proposed ANDA product.
In its complaint, Apotex said that the three companies took advantage of the delay arising from the 30-month stay in that litigation to market a new gatifloxacin ophthalmic solution to extend their monopoly over gatifloxacin ophthalmic formulations.
The three companies allegedly did this by bringing a new product to market known as Zymaxid.
In the settlement, both parties sought dismissal with prejudice. They will cover their own costs and attorneys’ fees.
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