Lupin challenge to levofloxacin patent term extension in US fails

Lupin challenged the validity of the PTE of the levofloxacin patent number 5,053,407, in order to seek the approval of its own generic levofloxacin products.

Reportedly, on 10 May 2010, a panel of the US Court of Appeals for the Federal Circuit affirmed the decision of the US District Court for the District of New Jersey, which held that Daiichi Sankyo’s PTE on the patent covering its broad spectrum antibacterial agent, levofloxacin, is valid and would be infringed.

Lupin’s petition for rehearing by the full Federal Circuit was denied and Lupin’s time to appeal to the US Supreme Court has run out, which means that Lupin’s challenge to the validity of the PTE and the underlying patent in the US is at an end.

In the US, Daiichi Sankyo has granted an exclusive license to Johnson & Johnson to manufacture, use and market pharmaceutical preparations containing levofloxacin, with the right of sublicense.

Ortho-McNeil-Janssen Pharmaceuticals, a subsidiary of Johnson & Johnson, is the exclusive sublicensee for levofloxacin products in the US and markets levofloxacin products under the trade name Levaquin.