Lansoprazole (Prevacid) ODT tablets: Teva Receives Favorable Court Decision; Innovator appeled in CAFC

Innovator Takeda has appealed against the U.S. District Court for the District of Delaware decision, wherein, court found no infringement by Teva in a patent dispute on Lansoprazole (Prevacid) ODT tablets.

Earlier, generic player Teva Pharma announced (in a press release Here ) that the U.S. District Court for the District of Delaware has issued a decision in its litigation over the Company's Abbreviated New Drug Application (ANDA) to market its generic version of Takeda Pharmaceuticals North America, Inc.'s Prevacid® (Lansoprazole) SoluTab.

The Court found that Teva's generic Lansoprazole orally disintegrating tablets do not infringe the following disputed patent:

US5464632 (Assignee: Laboratoires Prographarm ; Date of Filing: November 29, 1994; Date of expiry: May 7, 2013) The patent covers a rapidly disintegratable tablet for oral administration with or without the use of water, said tablet comprising an active substance and a mixture of excipients, wherein said active substance is multiparticulate and in the form of coated microcrystals, coated microgranules or uncoated microgranules and wherein said mixture of excipients comprises excipients which are responsible for the disintegration, said tablet being intended to be swallowed said disintegration occurring in less than sixty seconds under the action of the excipients which are responsible for the disintegration and which are selected from the group consisting at least one disintegrating agent and at least one swelling agent.

To overcome above claim, Teva used Starlac (a coprocessed excipients with 85% of Lactose and 15% of corn starch). The generic company and innovator provided testimony in the court w.r.t mechanism of disintegration of Starlac, however, opposing party could not prove convincingly that either lactose or corn starch was responsible for the rapid disintegration of generic product. In the light of above findings, court concluded that Teva’s generic version would not be covered under the scope of ‘632 patent.

As per press release, Teva intends to complete an analysis of the decision before deciding upon its next course of action.

Annual sales of the brand product were approximately $500 million in the United States for the twelve months that ended June 30, 2009 based on IMS sales data.