PTO to reissue Lipitor patent
The U.S. Patent and Trademark Office is reissuing a key Lipitor (atorvastatin) patent covering an enantiomer of the drug. The agency allowed Pfizer to resubmit the patent, which expires in 2011, to correct technical defects after the U.S. Court of Appeals for the Federal Circuit ruled that the patent was invalid due to these defects (1"The Pink Sheet," Aug. 20, 2007, In Brief). Pfizer does not expect generic competition for Lipitor until November 2011 after its settlement with Ranbaxy, the first to file an ANDA and challenge Lipitor patents (2"The Pink Sheet," June 23, 2008, p. 22). Pfizer remains in litigation with Teva and Apotex, which have ANDAs pending for generic Lipitor
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Pfizer expects to hold off generic competition for Lipitor (atorvastatin) in the United States until November 2011 under a settlement agreement with Ranbaxy
The Patent and Trademark Office sent a "nonfinal rejection" notice to Pfizer in response to its request for the agency to reissue a key Lipitor (atorvastatin) patent. The PTO noted that Ranbaxy had protested reissuance of the patent, contending that the patent claims were anticipated by prior art or were obvious. The agency agreed that some of the claims were anticipated or obvious but found that others were not. The U.S. Court of Appeals for the Federal Circuit ruled last year that a patent covering a Lipitor enantiomer was invalid due to technical defects in the patent. In January, Pfizer asked the PTO for permission to resubmit the patent to correct these defects. "It's common for the patent office to initially reject requests of this sort," a Pfizer spokesperson said. "We believe we have a strong argument" to address the concerns raised by PTO...
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