October 5, 2022

A swimsuit was filed on Thursday within the District of New Jersey by plaintiff Merck Sharp & Dohme LLC (Merck) towards defendant Gland Pharma Restricted (Gland). The criticism for patent infringement alleges that Gland’s abbreviated new drug software (ANDA) product will infringe on present patents held by the plaintiff.

Merck at present holds a brand new drug software, or NDA, to fabricate and market Noxafil. The criticism notes that the drug is an injection “authorised for the prophylaxis of invasive fungal infections in high-risk sufferers.” Noxafil is listed within the FDA’s Accredited Drug Merchandise with Therapeutic Equivalence Evaluations publication (the Orange Ebook) together with its supporting patents.

The plaintiff holds two patents (patents-in-suit) in reference to Noxafil, each titled “Posaconazole Intravenous Resolution Formulations Stabilized by Substituted Beta-Cyclodextrin.” The patents had been issued in 2015 and 2016 and had been issued to Merck by america Patent and Trademark Workplace (USPTO).

The defendant just lately filed an ANDA with the FDA in search of approval to “market and promote inside america the Generic Posaconazole IV Resolution Product earlier than the expiration of the patents-in-suit.” Together with the ANDA, defendant Gland claimed that the patents-in-suit defending Merck’s drug had been invalid or wouldn’t be infringed upon within the manufacturing of Gland’s ANDA product.

On August 1, 2022, Merck acquired a discover letter from Gland informing them of the ANDA they’d filed and stating their claims that the patents-in-suit are invalid. Merck contends within the criticism that Gland’s “Generic Posaconazole IV Resolution Product has the identical energetic ingredient as NOXAFIL for Injection, has the identical methodology of administration, dosage kind, and energy as NOXAFIL for Injection and is bioequivalent to NOXAFIL for Injection.”

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The criticism cites two separate counts of infringement for every of the patents-in-suit. Merck argues that they are going to be “considerably and irreparably harmed by the infringing actions… until these actions are enjoined by this Courtroom.” Merck is in search of favorable judgment on every depend, an injunction stopping the defendant kind producing their ANDA product previous to the expiration of the patents-in-suit, financial aid if the infringement continues, and extra.

Merck is represented within the litigation by Gibson, Dunn & Crutcher LLP and McCarter & English, LLP.