USPTO Acknowledges Miscalculation in Patent Term Adjustment

U.S. Patent and Trademark Office Acknowledges that it Has Been Miscalculating Patent Term Adjustment for Patents Issued from 35 U.S.C. 371 National Stage Filings

Fish & Richardson and our pharmaceutical client Japan Tobacco Inc. (JT) have discovered a significant error in the manner by which the U.S. Patent and Trademark Office (PTO) calculates the amount of patent term adjustment (PTA) to which a patent is entitled under 35 U.S.C. 154(b). This error is independent of the error at issue in the highly publicized case Wyeth v. Dudas, 580 F. Supp. 2d 138 (D.D.C. 2008), which concerned the PTO’s method of calculating overlap between “A Delay” (resulting from the PTO’s failure to issue actions within specified time frames) and “B Delay”(resulting from application pendency that exceeds three years).

Distinct from the Wyeth v. Dudas issue, the error identified by Fish & Richardson and JT concerns how the PTO calculates the length of B Delay for patents granted from most 35 U.S.C. 371 national stage filings. The PTO’s practice has been to award B Delay beginning three years after completion of the requirements under 371(c) (e.g., submission of inventor’s oath or declaration). However, the statute and regulations require that this period begin three years after the national stage has “commenced” under 35 U.S.C. 371(b) or (f). This commencement is often, though not always, prior to completion of the requirements under 371(c). As a result, PTA resulting from B Delay is often longer than that provided by the PTO’s practice. This difference can be many months or even more than a year. For biotech and pharma patents in particular, these additional days of patent term can be of significant value.

Fish & Richardson challenged the PTO’s practice on behalf of one of JT’s patents and has recently received a favorable Decision from the Office of Petitions. From our conversations with the PTO, it is our understanding that the PTO intends to eventually change its internal system to apply the correct PTA calculation method going forward. However, until it is clear that this is being done consistently, we recommend that this issue be reviewed independently for all patents derived from 371 national stage filings and for which maximizing patent term is important. Fish & Richardson monitors this issue as part of a comprehensive PTA review available to all of our clients. We currently have several additional post-issuance Applications for PTA pending with the Office of Petitions addressing this same point.

To read the Law360 article from July 23, 2009, click here.

Jack Brennan
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