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December 03, 2008


I realilze this site is specifically interested in biotech and pharma, but I wonder just how big the potential list of PTA adjustment cases may be. Can anyone estimate the possible effective total dollar value? Would that dollar value trip any other federal guidelines that the Office must work with?

I know that this past week I have reviewed four cases all showing the USPTO calculations to be off. Three will be pursued and the fourth is merely a matter of days in a non-bio area and not worth the effort to correct.

I seem to recall from the earlier discussion of this case that there was a statute of limitations of some sort, i.e., the case had to have issued within ... 3 months of filing suit? Or something?

Am I wrong? What is the statute of limitations?


You raise some interesting questions. When I first wrote about the Wyeth case, I did a search of the USPTO database to determine the number of issued patents that might be impacted by the decision (i.e., patents issuing within 30 days from applications that were filed after AIPA was passed and that were prosecuted for more than three years). This search generated a list of 15,266 patents. However, one would have to examine the Image File Wrappers for a sample of these patents to estimate the percent of patents that would actually be affected by Wyeth. As for estimating the cost from "lost" PTA, it might be a good idea to look at Orange Book listed patents. Nevertheless, you suggest some interesting research projects.


Incredibly Curious:

There are three deadlines that would come into play. At the time of payment of the issue fee, an applicant must file a request for reconsideration of a PTA determination the applicant knows to be incorrect. Within two-months of issuance, a patentee must file another request for reconsideration for PTA determinations that are still incorrect or which have become incorrect since the notice of allowance was issued (e.g., as a result of publication delay). And finally, for PTA determinations that have not been corrected (or in response to a denial of the above requests), a patentee must file a suit against the USPTO Director in the District Court for the District of Columbia within 180 days of issuance.

The Office could argue that the failure to file either of the first two requests would constitute a waiver of any PTA owed under Wyeth (when, and if, the Office loses its appeal in Wyeth). I believe this would be a good argument vis-a-vis Chevron, since a court would likely determine that the deadlines specified in 37 C.F.R. for filing the two requests are merely procedural rules.



One correction to my comment above: I meant to write 60 days and not 30 days.


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