Merck Sues Gland Pharma for Patent Infringement in ANDA Suit

A suit was filed on Thursday in the District of New Jersey by plaintiff Merck Sharp & Dohme LLC (Merck) against defendant Gland Pharma Limited (Gland). The complaint for patent infringement alleges that Gland’s abbreviated new drug application (ANDA) product will infringe on existing patents held by the plaintiff.

Merck currently holds a new drug application, or NDA, to manufacture and market Noxafil. The complaint notes that the drug is an injection “approved for the prophylaxis of invasive fungal infections in high-risk patients.” Noxafil is listed in the FDA’s Approved Drug Products with Therapeutic Equivalence Evaluations publication (the Orange Book) along with its supporting patents.

The plaintiff holds two patents (patents-in-suit) in connection with Noxafil, both titled “Posaconazole Intravenous Solution Formulations Stabilized by Substituted Beta-Cyclodextrin.” The patents were issued in 2015 and 2016 and were issued to Merck by the United States Patent and Trademark Office (USPTO).

The defendant recently filed an ANDA with the FDA seeking approval to “market and sell within the United States the Generic Posaconazole IV Solution Product before the expiration of the patents-in-suit.” Along with the ANDA, defendant Gland claimed that the patents-in-suit protecting Merck’s drug were invalid or would not be infringed upon in the production of Gland’s ANDA product.

On August 1, 2022, Merck received a notice letter from Gland informing them of the ANDA they had filed and stating their claims that the patents-in-suit are invalid. Merck contends in the complaint that Gland’s “Generic Posaconazole IV Solution Product has the same active ingredient as NOXAFIL for Injection, has the same method of administration, dosage form, and strength as NOXAFIL for Injection and is bioequivalent to NOXAFIL for Injection.”

The complaint cites two separate counts of infringement for each of the patents-in-suit. Merck argues that they will be “substantially and irreparably harmed by the infringing activities… unless those activities are enjoined by this Court.” Merck is seeking favorable judgment on each count, an injunction preventing the defendant form producing their ANDA product prior to the expiration of the patents-in-suit, monetary relief if the infringement continues, and more.

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