Pressure-reducing eye drop patents in dispute
Licensing partners aim to prevent the introduction of a proposed eye drop generic treatment before the expiration of four patents.
Ophthalmic firms Bausch & Lomb and its licensing partner Nicox have filed a complaint against Gland Pharma, alleging that its proposed generic eye-drop solution infringes four of their patents.
The suit was brought before the US District Court for the District Court of New Jersey on June 30 by the plaintiffs jointly since Bausch & Lomb Ireland exclusively licences the patents-in-suit from the owner, France-based Nicox.
Gland Pharma, founded in India, had filed an Abbreviated New Drug Application (ANDA) for its generic of the patented Vyzulta, an ophthalmic solution with an active ingredient of latanoprostene bunod for the reduction of intraocular pressure in patients with open-angle glaucoma or ocular hypertension.
The plaintiffs received a notice letter from Gland Pharma regarding the ANDA in May 2022, which seeks approval of Gland’s generic latanoprostene bunod product that is “the same, or substantially the same, as Vyzulta”.
But Bausch & Lomb and Nicox argue that “approval for the commercial manufacture, use, import, offer for sale” in the US of Gland’s generic infringes the patents before they have expired, including any patent term extensions (PTEs).
Applications for PTEs to the four patents are pending and the plaintiffs request that the effective date of any Food and Drug Administration approval of Gland’s generic “be a date that is not earlier than the expiration of the asserted patents, including any PTEs, or such later date as the court may determine”.
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