Lupin and Sun settle Bromsite patent suit after ruling
Sun Pharmaceuticals and Lupin Pharmaceuticals have decided to settle a patent suit related to Sun’s Bromsite (bromfenac) eye drops, invalidating an opinion handed down by the US District Court for the District of New Jersey in September.
In a motion to vacate submitted on Monday, September 7, Sun requested that the court vacate its opinion, claiming that all matters between itself and Lupin had been settled.
The next day, chief district court judge Freda Wolfson vacated the order.
Sun said that the situation favoured vacatur because it would eliminate Sun’s pending motion for reconsideration or an appeal to the Federal Circuit, therefore being the more “judicially efficient” option.
“The parties have entered into a settlement that will fully and finally resolve the case upon entry of the Stipulation of Dismissal with Prejudice, which the parties will file upon the granting of the instant motion.
“If vacatur is not granted, then plaintiffs’ motion for reconsideration and the appeal in this matter will proceed, as well as further litigation if the Federal Circuit remands the case following consideration of an appeal.”
Sun also cited several other cases including Hospira, v Sandoz (2014), claiming that Federal Circuit precedent supports their unopposed motion to vacate.
Case background
Lupin filed an Abbreviated New Drug Application with the Food and Drug Administration to create and market a generic of Bromsite in 2018.
Upon being notified of this, Sun sued Lupin on February 15 2018, claiming that the generic contained a “chemically identical bromfenac ophthalmic solution”. However, Lupin argued that it did not infringe the patent because its generic had a different viscosity, and moved to challenge the validity of Sun’s patent.
The New Jersey Court invalidated Sun’s patent relating to Bromsite in an opinion handed down on September 30, 2021.
Lupin’s planned generic did not infringe claims of the Sun’s US patent 8,778,999, and the patent itself was invalid for indefiniteness and obviousness, Wolfson claimed in her opinion.
The patent was invalid in light of a prior Sun patent related “Sustained release ophthalmic compositions containing water-soluble medicaments”.
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