Nebivolol: USPTO Office Action in the patent re-examination, rejected all pending claims

Innovator Forest Lab announced that an Office Action in the Reexamination of Orange Book listed patent US6545040 was received from the U.S. Patent and Trademark Office (USPTO) by Janssen Pharma the patent holder of the '040 patent. In the Office Action, the USPTO has rejected all of the pending claims as unpatentable in view of the cited prior art US4654362
Nebivolol was approved for 2.5, 5 and 10-mg/tablet formulation by USFDA on Dec 17, 2007. The NCE exclusivity for this product will expire on Dec 17, 2012.

There are two orange book listed patents for this product
US5759580 (Expiry: Jun 2, 2015): which covers a pharmaceutical composition comprising a pharmaceutically acceptable carrier and as active ingredient nebivolol or a pharmaceutically acceptable salt thereof characterized in that the active ingredient is in a micronized solid form and wherein the pharmaceutically acceptable carrier comprises a filler, lubricant, disintegrate, binding agent and wetting agent.
US6545040 (Expiry: Apr 8, 2020): which covers A composition consisting of the compound [2R,.alpha.S,2'S,.alpha.'S]-.alpha.,.alpha.'-[iminobismethylene]bis[6-fluo ro-3,4-dihydro-2H-1-benzopyran-2-methanol]

Eralier, the European equivalent of ‘040 patent EP0334429 was invalidated by a UK court on complaint by Actavis pahrma, as reported earlier by Ippharmadoc Here