Daiichi Sankyo Brings Lawsuit Before Intellectual Property High Court

Daiichi Sankyo has brought a lawsuit before the Intellectual Property High Court to have the decision to nullify a portion of the patent term extension for Levofloxacin Hydrate revoked.

The company said that on October 28, 2009, the High Court issued its ruling to sustain the decision. In view of this ruling, the company had considered to appeal its case to the Supreme Court, but wishes to herewith announce that it has decided not to appeal its case.

According to Daiichai Sankyo, the patent numbers for the Levofloxacin Hydrate preparation are No 2008845 for the compound patent and No 1659502 for the use patent. Based on an approval for an additional indication of Levofloxacin Hydrate for the treatment of genus Legionella, an extension of the term of the patents until May 27, 2011, was granted following an examination by the Patent Office.

However, 13 generic drug manufacturers requested the nullification of this extension of the term of the patents on the grounds that the extension was invalid. At the end of November 2008, the Patent Office made a decision that extending the term of the patents beyond December 25, 2008, corresponding to the terms for overseas clinical trials and the like, was invalid, the company said.

Reportedly, Daiichi Sankyo brought a lawsuit before the High Court on December 24, 2008, requesting that the said invalidation decision be revoked on the grounds that it was in error. As noted previously, the High Court issued a ruling to sustain the invalidation decision.