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Sughrue Attorneys Help Client Secure Favorable Judgment

7/1/2013
Sughrue's client Hanmi Pharmaceutical Company Limited and Hamni’s marketing partner Amneal Pharmaceuticals, LLC, received a positive decision on a litigation judgment from the United States District Court for the District of New Jersey for its product esomeprazole strontium delayed-release capsules.

According to a press released from Hanmi, the judgment removes a major hurdle for esomeprazole strontium delayed-release capsules. These capsules are Korea’s first domestically developed 505(b)(2) NDA drug product poised to receive final FDA approval.

Hamni stated that pursuant to a confidential settlement agreement, a consent judgment has been entered by the United States District Court for the District of New Jersey with respect to the ongoing patent infringement litigation between Hanmi and AstraZeneca PLC involving Hanmi’s proposal to market esomeprazole strontium delayed-release capsules. AstraZeneca originally filed suit in February of 2011 alleging that Hanmi’s product infringed two AstraZeneca patents involving its heartburn drug, Nexium®.

According to the press release, the consent judgment provides that (1) Hanmi has acknowledged that the two asserted patents are enforceable and valid, and (2) the Hanmi product does not infringe the claims of the two asserted patents based upon the claim construction ruling issued by the District Court on December 12, 2012. Although AstraZeneca has reserved its right to appeal the District Court’s claim construction, Hanmi believes that the District Court's claim construction ruling is sound and, accordingly, Hanmi's non-infringement position is on solid ground.

Hanmi reported that its product obtained tentative FDA approval on April 30, 2013. Hanmi and its marketing partner, Amneal Pharmaceuticals LLC, anticipate receiving final FDA approval shortly. Hanmi’s product would be the first non-innovator pharmaceutical product commercialized in the United States that contains the active moiety esomeprazole. Hanmi would also be the first Korean company to enter the United States market under the Hatch-Waxman statutory framework.