Ertapenem sodium – USA

Ertapenem sodium – USA

On October 7, 2016, Judge Richard Andrews of the U.S. District Court for the District of Delaware issued a decision in Merck’s patent infringement lawsuit against Hospira (a subsidiary of Pfizer) involving Hospira’s ANDA for a generic version of Invanz (ertapenem sodium).

Invanz (ertapenem sodium) is a penem antibacterial indicated for the treatment of certain infections. Invanz is approved in the form of a sterile lyophilized powder for reconstitution with an appropriate diluent for intravenous or intramuscular use. Each vial of Invanz contains ertapenem sodium equivalent to 1 g ertapenem. Each vial also contains sodium bicarbonate and sodium hydroxide as inactive ingredients.

There is one unexpired patent remaining in the Orange Book for Invanz: U.S. Patent No. 5,952,323 (set to expire on May 15, 2017, with pediatric exclusivity until November 15, 2017). The ’323 patent states that ertapenem, when powder-blended with sodium bicarbonate, will produce a stabilized carbamate form of ertapenem upon reconstitution. The stabilized form of ertapenem will convert back into ertapenem over time. The ’323 patent covers the stabilized carbamate form of ertapenem.

Merck also owns U.S. Patent No. 6,486,150 (set to expire on October 27, 2020), which is not listed in the Orange Book. The ’150 patent covers certain processes for manufacturing ertapenem.

Judge Andrews issued his decision in the lawsuit. Judge Andrews issued a decision in favor of Merck with respect to the ’323 patent and rejected Hospira’s challenges to the validity of that patent. Although Judge Andrews agreed with Merck that the ’150 patent covers Hospira’s proposed manufacturing process, he concluded that the ’150 patent is invalid due to obviousness in view of the ’323 patent.

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