TOKYO - Daiichi Sankyo Ltd. announced in a press release that it has brought patent infringement litigations against 11 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 9 generics companies: ISEI Co. Inc., Iwaki Seiyaku Co. Ltd., KYORIN Rimedio Co. Ltd., Kobayashi Kako Co. Ltd., Daiko Pharmaceutical Co. Ltd., Tatsumi Kagaku Co. Ltd., Nipro Genepha Corporation, BIOTECHBAY Co. Ltd. and Fuji Pharma Co. Ltd. and in Osaka District Court against 2 generics companies: Kyowa Pharmaceutical Industry Co. Ltd. and Zensei Pharmaceutical Industries Co. Ltd.
The 11 companies noted above have all received approvals and are currently scheduled to market and sell generic versions of Levofloxacin Hydrate.
The patents for Levofloxacin Hydrate were originally extended until May 27, 2011 with the additional indication for Legionella pneumophila. However, late November 2008, the Japan Patent Office invalidated the extensions beyond December 25, 2008.
Daiichi Sankyo appealed the invalidations of the ruling to the Intellectual Property (IP) High Court on December 24, 2008 and the cases are 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.
In addition, this action is followed the litigations which we announced on March 23, 2009 against other 13 generics companies.
Daiichi Sankyo deems its IP 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.
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