Apotex files for non-infringement declaration of Alcon generic

Canada-based pharmaceutical corporation Apotex has filed a complaint for declaratory judgment of non-infringement against medical company Alcon in a patent case over an ophthalmic solution product.

Apotex has sought the declaration of non-infringement of US patent numbers 6,995,186 and 7,402,609, in order to bring its generic 0.2% olopatadine hydrochloride ophthalmic solution product to market.

The complaint was filed in the US District Court for the Southern District of Indiana on November 17.

The ‘186 patent is due to expire in May, 2024, while the ‘609 patent will expire in December 2022, both of which are inclusive of six months of pediatric exclusivity.

Under a provision of the Food and Drug Administration Modernization Act (FDAMA) designed to encourage research into pediatric treatments, the additional six months of exclusivity is provided in return for conducting pediatric studies.

Back in 2009, Alcon and Kyowa Hakko Kirin filed a complaint in the US District Court for the Southern District of Indiana, against Apotex, alleging that the Apotex had engaged in patent infringement.

Apotex had filed an Abbreviated New Drug Application (ANDA) with the Food and Drug Administration (FDA), seeking approval to manufacture and sell a generic version of Pataday ophthalmic solution (olopatadine hydrochloride), prior to the expiration of patents owned by Alcon and Kyowa.

The parties engaged in negotiations over the claims and in 2013 reached a settlement agreement, which formed the basis of the declaratory judgment action.

However, pharmaceutical company Barr Laboratories has obtained final approval from the FDA for its generic product of the ophthalmic solution and is eligible for a 180-day exclusivity period.

Barr is yet to launch its product and its exclusivity period means that Apotex cannot receive final approval of its product. It has received tentative approval from the FDA .

Under the settlement agreement between Alcon and Apotex, if a generic equivalent is not launched in the US by July 1, 2016, Apotex may file an action seeking a declaration that, effective December 29, Apotex’s ANDA product does not infringe the two patents involved because it is a licensed product under the settlement.

“Apotex desires to bring its…product to market and allow the public to enjoy the benefits of generic competition for these products at the earliest possible date under the applicable contractual, statutory and FDA regulatory provisions,” said the filing.

The company is seeking a declaration that, from the end of December, Apotex’s product is licensed and not infringing and that Alcon has waived its right to appeal, under the terms of the settlement agreement.