15 July 2015Americas

Apotex sued over proposed eye drug generic

Japanese drug maker R-Tech Ueno has sued Apotex for patent infringement after the Canadian-based pharmaceutical company allegedly applied to create a generic version of one of its eye treatment drugs.

In a lawsuit filed at the US District Court for the District of Delaware, R-Tech accused Apotex and its subsidiary Apotex Corp of attempting to make a generic version of its glaucoma treatment drug Rescula.

According to the complaint, Apotex applied to market R-Tech’s drug, which contains an “unoprostone isopropyl ophthalmic solution”, before two patents protecting it are due to expire.

The ‘675 patent expires on November 24, 2018, while the ‘836 patent is due to expire on July 9, 2021.

R-Tech claimed it received a notice letter from Apotex confirming that the company, Canada’s largest maker of generic drugs, had submitted an Abbreviated New Drug Application (ANDA) to the US Food and Drug Administration (FDA) on June 1.

In the lawsuit, filed on July 10, R-Tech cited US patent numbers 6,770,675 and 6,458,836 as those that will be infringed by the proposed generic. R-Tech said it filed the lawsuit within 45 days of receiving Apotex’s notice letter.

R-Tech added in the complaint that Apotex induced infringement of the patents by “actively and knowingly” submitting the ANDA.

“If defendants manufacture, use, offer to sell, or sell within the US, or import into the US, the ANDA product prior to the expiration of the ‘836 and ‘675 patents, defendants will infringe one or more claims of the patents-in-suit,” R-Tech said.

R-Tech is seeking a judgment that Apotex infringed the patent and a permanent injunction preventing the company from marketing a generic version until the two patents have expired.

Apotex had not responded to a request for comment at the time of publication but we will update the story should the company get in touch.

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