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August 19, 2007




The critical claims at issue (6,13 and 14 i.e. those claiming atorvastatin calcium) were held allowable by the examiner except for a obviousness type double-patenting over two patents. But both cited patents have expiration dates well past the expiration date for the '995 patent. Which means that filing a terminal disclaimer over those two patents will not have any adverse effect.

Thus, Pfizer can simply cancel the other rejected claims (perhaps pursue them in a continuation of the reissue), and get the crucial claims reissued expeditiously.

On the other hand, Pfizer may strategically choose to continue pursuing the other (unimportant) rejected claims simply to delay the issuance of the reissue patent, and thereby delay the anticipated litigation by Ranbaxy. This may have the effect of pushing the litigation well past the 15-month period between the expirations of the '893 and the '995 patents.

But then, if Pfizer lets the allowable claims sit too long in the PTO, other events may change in the interim that may cause the examiner to change his position on allowability.

The Federal Curcuit refused to review the district court's findings of patentability, other than the "dependent claims issue" (i.e. s. 112 p. 4), holding that single issue was dispositive of the case. However, the CAFC unwillingness to review the other issues, may now come back to haunt Ranbaxy. Perhaps these issues can never be relitigated because of collateral estoppel. Even if estoppel won't be applied (at least at the circuit court level), nevertheless the delayed litigation will certainly hurt Ranbaxy.

It's a shame the Federal Circuit did not anticipate these turn of events.


The good news for Pfizer is that it was a "non final rejection." According to Pfizer spokesman Bryant Haskins, "An initial rejection is not uncommon in reissue application proceedings. Once we receive the decision we’ll review it and respond appropriately to address any issues that were raised by the examiner."

If the US Patent and Trademark Office rules against Pfizer, they will be reeling. Lipitor is the best-selling drug in the world, selling around $12.9 billion last year alone. Losing the patent on Lipitor and having no new drug in the pipeline to take its place will be a tough blow for Pfizer to take.

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