Daiichi Sankyo Company has brought patent infringement litigation against 13 generics companies for the substance patent (2008845) and usage patent (1659502) for Levofloxacin Hydrate (brand name: Cravit tablets and Cravit fine granules). Levofloxacin Hydrate broad-spectrum oral anti-bacterial agents originated by Daiichi Sankyo, has been marketed by the company in Japan since 1993.

Daiichi Sankyo brought patent infringement actions in Tokyo District Court against 7 generics companies: Shiono Chemical Co Ltd, Taiyo Yakuhin Co Ltd, Takata Seiyaku Co Ltd, Nichi-Iko Pharmaceutical Co Ltd, Nihon Generic Co Ltd, Mylan Seiyaku Ltd, and Yoshindo Inc. and in Osaka District Court against 6 generics companies: Ohara Pharmaceutical Co Ltd, Sawai Pharmaceutical Co Ltd, Taisho Pharm. Ind Ltd, Choseido Pharmaceutical Co Ltd, Towa Pharmaceutical Co Ltd and Nipro Pharma Corporation.

The 13 companies noted above have all received approvals and are currently scheduled to market and sell generic versions of Levofloxacin Hydrate.

The patent for Levofloxacin Hydrate was originally extended until May 27, 2011 with the additional indication for Legionella pneumophila. However, late November 2008, the Japan Patent Office invalidated the extension beyond December 25, 2008. Daiichi Sankyo appealed the invalidation of the ruling to the Intellectual Property High Court on December 24, 2008 and the case is currently under review. The company brought the litigations against generics companies as a measure to swiftly halt the manufacture and sales of Levofloxacin Hydrate if the invalidation would be overturned.

Daiichi Sankyo deems its intellectual property as a vital part of its resources. The company is committed to protecting its rights and will seek the appropriate legal measures in order to do so.

The brand names for Levofloxacin Hydrate are Levaquin in the US and Tavanic in Europe respectively.