Anticipate This!™ | Patent and Trademark Law Blog

Post-Wyeth PTA Calculation Errors?

Posted in Practice Commentary by Jake Ward on April 22, 2010

As many practitioners understand,  a patentee is entitled under 35 U.S.C. 154(b)(1)(A-C) to a patent term adjustment (PTA).  Subject to certain limitations, a PTA is determined if (A) the USPTO fails to take certain actions during the examination and issue process within specified time frames, if (B) the USPTO fails to issue a patent within three years of the actual filing date of the application, and for (C) delays due to interference, secrecy order, or successful appellate review.  Delay due to the applicant (D) is also taken into account in calculating the entirety of the PTA. 

Earlier this year, the USPTO announced an interim recalculation procedure to comply with the Federal Circuit Decision in Wyeth v. Kappos, which had held that the USPTO had been calculating under 35 U.S.C. § 154 incorrectly.  Under its previous interpretation of the PTA rules, the USPTO had calculated PTA such that the patentee received the longer of the (A) delay or the (B) delay under the statute.  Wyeth contended, and the CAFC agreed, that a patentee deserves both the (A) delay and the (B) delay, minus any time that the adjustments overlap.  The recalculation procedure has been made available to any patentee whose patent issued prior to March 2, 2010, and who requests the PTA recalculation no later than 180 days after the issue date.

Many patentees have availed themselves of the post-Wyeth recalculation procedure, sometimes with the result of significantly greater PTA.  We have seen PTA increases ourselves on the order of 200-400 days.  Strangely, however, a number of recalculations have also resulted in a lower PTA than was originally calculated.  This author is aware of at least three such patents where the post-Wyeth calculation determined that no (B) delay was present during examination (e.g., due to the filing of an RCE that cut short the pendency for purpose of the PTA calculation under 37 CFR 1.703(b)(1)).  Even though no (B) delay should result in the same PTA as originally calculated, however, the PTA was subsequently determined to be a handful of days fewer under the post-Wyeth calculation!

When the Office of Patent Legal Administration was contacted about these patents, it was suggested that the USPTO possibly had been making errors pre-Wyeth that were different from those identified in Wyeth, which errors may have accidentally credited the patentee with additional days of PTA under the pre-Wyeth calculation.  Surprisingly, when the USPTO Legal Administration was asked to identify what may have now changed in the (A),  (C), or (D) calculations to cause a decrease in post-Wyeth PTA, it was stated that the earlier PTA determinations were no longer available for comparison, as they were deleted when the new PTA determinations were made.  In other words, unless the patentee had printed off a copy of the PTA determination at PAIR prior to requesting the recalculation, it is very difficult to identify what the USPTO did differently pre-Wyeth for purposes of identifying the error causing the difference in PTA.

To be fair, the PTA decreases observed in the handful of patents affected were on the order of 2-4 days.  Nothing too significant for the particular patents in question.  But one can certainly envision patents (e.g., big Pharma) where these 2-4 days could be of immense value.   

Patentees do have means for challenging PTA recalculation decisions such as the ones described above.  First, they may call the Office of Patent Legal Administration at 571-272-7702 with questions concerning the decision.  Prior to issuance of a certificate of correction reflecting the recalculated PTA, the patentee is also afforded an opportunity to request reconsideration.  The request must be made within thirty (30) days, with no extension of time being granted.  The request must comply with 37 CFR 1.705(b)(2) and have a statement of the facts involved, including the correct PTA and the basis for the adjustment. 

We observe that the request for recalculation is made particularly difficult by the apparent fact that the pre-Wyeth determination is destroyed by the USPTO when PAIR is updated with the post-Wyeth determination.  However, we conjecture that the pre-Wyeth determination probably exists in a backup somewhere at the USPTO, should one really wish to press the issue in order that such a comparison may be made. 

Have any of our readers also come across this situation?  Any thoughts on how a determination of no (B) delay under the post-Wyeth calculations can result in a lower PTA than was originally calculated?  We’ll update this post in due course, should we come across any answers with respect to the abovementioned patents.  In the meanwhile, your comments are welcomed.

One Response

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  1. Jamie Maxwell said, on March 30, 2011 at 3:34 pm

    Impressive work by Wyeth, but if you make multi-million $ per day on your patented drug, I guess you have a good inventive for challenging the USPTO.

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