August 29, 2010:   The USPTO has implemented a revised PAIR Patent Term Adjustment tab showing several new details of its PTA calculation. New fields include separate totals for "A," "B," and "C" USPTO delays under 35 USC 154(b)(1), and overlaps therebetween. Major changes are highlighted below:

July 21, 2010:   The USPTO has issued a Federal Register Notice indicating it will no longer review Duty of Candor and Good Faith Letters. Instead, such letters will simply be placed in the file wrapper without further review, and certificates of correction will not be issued based on such letters.

Historically, applicants have used Duty of Candor and Good Faith Letters to disclose where the USPTO has granted PTA greater than what the applicant believes is appropriate. The USPTO would typically review its PTA calculation in light of such letters and make corrections as warranted.

Now, even where the USPTO errs in granting excessive PTA, the applicant must use the procedures in 37 CFR 1.705 to obtain USPTO reconsideration of a PTA determination. This includes satisfying the formal requirements and deadlines set forth in Rule 1.705 and paying a $200 fee. Alternatively, a patentee may file a terminal disclaimer disclaiming the period considered in excess of the appropriate PTA, but presumably this will not invoke substantive PTA reconsideration by the USPTO.

The USPTO did not provide an opportunity for comments prior to this Notice, and did not explain the effect of unreviewed letters. The USPTO indicated it will revise appropriate MPEP sections accordingly in due course.

Please review the Federal Register Notice for details.

July 13, 2010:   On July 6th, Novartis filed suit against the USPTO seeking PTA correction under Wyeth for eleven US patents. Of note, since the subject patents issued as early as December 2003, Novartis is seeking to retroactively apply Wyeth well beyond the 180 day deadline set forth in 35 USC 154(b)(4) and the USPTO Interim Procedure to Request PTA Recalculation. Novartis alleges, inter alia:

• For older patents, the USPTO does not provide an administrative remedy to recapture PTA deprived under its flawed overlap interpretation overturned in Wyeth. The USPTO's refusal to accord the benefits of Wyeth to older patents is "arbitrary, capricious, an abuse of discretion, or otherwise not in accordance with law and in excess of statutory jurisdiction, authority or limitation."
• The 180 day deadline set forth in 35 USC 154(b)(4) applies only to PTA determinations made in conjunction with a notice of allowance, not PTA determinations made at issuance.
• Even if the 35 USC 154(b)(4) deadline applies to Novartis' claims, it is tolled under the common law doctrine of equitable tolling. In that case, the 180 day period would begin on January 7, 2010 (Federal Circuit affirms Wyeth) or January 21, 2010 (USPTO announces it will not appeal Wyeth).
• The USPTO's "purposeful and deliberate diminution of the patent term ... constitutes a taking of Novartis' property without just compensation, in violation of the Fifth Amendment of the Constitution of the United States."

January 29, 2010:   The USPTO announced the following interim procedure to request PTA recalculation under Wyeth:

• Patentees can request PTA recalculation under Wyeth without a fee or petition.
• The procedure is only available for patents issued prior to March 2, 2010.
• A recalculation request must be filed no later than 180 days after the patent issue date.
• The interim procedure is only available if the sole basis for alleged error is the Wyeth issue.
• Form PTO/SB/131 has been made available to make the recalculation request.
• The USPTO has submitted a Federal Register Notice setting forth details.

One leading commentator, however, has questioned the USPTO's authority to provide this interim procedure.

Prudent applicants are advised to recheck all parts of USPTO-calculated PTA, observing the formal deadlines under 35 USC 154(b)(4) and 37 CFR 1.705 where possible. Otherwise, applicants may have limited recourse to correct erroneous USPTO recalculations, especially if the recalculation is made more than 180 days after issue.

January 22, 2010:   The USPTO has announced that it, and the Department of Justice, have decided not to seek further review of the Federal Circuit's decision in Wyeth v. Kappos.

The USPTO further stated it is preparing guidance for expediting requests for PTA recalculation in light of Wyeth, which will be issued as soon as possible.

The USPTO again reminds applicants and patent owners dissatisfied with a USPTO-calculated PTA of "the requirement to seek review of that determination within 180 days of patent issuance and the time periods set in the implementing regulations. See 35 USC sec. 154(b)(4) and 37 CFR 1.705."

For patents outside the listed deadlines, perhaps some practitioner will succeed in retroactively obtaining the benefit of Wyeth (e.g., certificate of correction, petition to director, equitable tolling), but that path is less certain.

January 12, 2010:   While not yet implemented, the USPTO has announced it is in the process of changing its PTA calculation algorithm to conform with Wyeth, pending a determination by the Solicitor General of whether to seek further review of the Federal Circuit holding.

Until the change is implemented and tested, Applicants are advised to carefully check USPTO-calculated PTA under Wyeth.

The USPTO reminds applicants and patent owners dissatisfied with a USPTO-calculated PTA of "the requirement to seek review of that determination within 180 days of patent issuance and the time periods set in the implementing regulations. See 35 USC 154(b)(4) and 37 CFR 1.705." For patents outside the listed deadlines, perhaps some practitioner will succeed in retroactively obtaining the benefit of Wyeth (e.g., certificate of correction, petition to director, equitable tolling), but that path is less certain.

January 12, 2010:   PatentTerm Online has issued a press release briefly explaining, in layperson's terms, the history and holding on the issue presented in Wyeth.

See Inventors Take Heart: Federal Court Restores Patent Term Guarantees, at Last Protecting Innovators from Patent Office Delays, Noted Professor Says.

January 7, 2010:   [Updated] Today, the Federal Circuit unanimously affirmed the DC District Court ruling in Wyeth, overturning a USPTO statutory interpretation that resulted in reduced terms for tens of thousands of US patents.

This holding, long advocated by the founders of PatentTerm Online, LLC, will result in significantly greater PTA for many patent applications pending more than three years. Click here to download the Wyeth v. Kappos opinion.

Applicants are advised to carefully check USPTO-calculated PTA to ensure the full grant of proper adjustment credits under Wyeth. By default, our calculator will automatically apply the Wyeth holding in calculating PTA. (Or, optionally, the calculator can also apply the pre-Wyeth USPTO interpretation.)

To learn more about the PTA benefits of Wyeth, please review our updated simplified example.

August 24, 2009:   [Wyeth Briefing Update] Briefing was completed in Wyeth v. Kappos, No. 09-1120 (Fed. Cir.), on June 22, 2009. Oral argument has been scheduled for October 7, 2009.

June 5, 2009:   We have confirmed that the USPTO is rejecting some Applications for PTA requesting additional days under the Wyeth ruling. To seek review of a USPTO PTA determination, applicants must file a civil action in the DC District Court within 180 days after the grant of the patent. See 35 USC 154(b)(4)(A). This deadline may apply even where the USPTO has not acted on a pending PTA petition.

November 28, 2008:   The USPTO appealed the ruling in Wyeth et al. v. Dudas, 580 F.Supp.2d 138 (D.D.C. 2008). The initial appeal was to the DC Circuit Court, but was subsequently transferred to the Federal Circuit.

November 25, 2008:   On November 7, 2008, Ironwood Pharmaceuticals filed suit against the USPTO seeking additional PTA under Wyeth. Of note, the applicant proceeded directly to the DC District Court within 180 days of issue under 35 USC 154(b)(4)(A) without first seeking correction in the USPTO under 37 CFR 1.705.

October 2, 2008:   There has been a significant development in PTA law. On September 30, 2008, the DC District Court overturned the USPTO's interpretation of 35 USC 154(b)(2)(A) (the "Actual Delay" limitation) in Wyeth et al. v. Dudas, 580 F.Supp.2d 138 (D.D.C. 2008).

• Many patents pending more than three years will be entitled to additional PTA under Wyeth.
• Please review our simplified example and Wyeth's summary judgment motion to learn more about the PTA benefits of this ruling.
• For recipients of recently issued patents, the time to seek the benefit of Wyeth may be limited under Rule 1.705 and 35 USC 154(b)(4)(A). See our simplified example for more information.
• To perform PTA audits under the Wyeth interpretation using this calculator, just ensure the appropriate checkbox is checked on the Apply Term Rules tab. (This is now the default after you run the Rules Engine.)
• See the Open Letter to Practitioners, identifying this issue at the time the USPTO's interpretation was promulgated.
• See Professor Kayton's paper, Patent Term Duration and Its Calculation, for a detailed discussion of this issue.

July 10, 2008:   An updated version of Professor Kayton's paper, Patent Term Duration and Its Calculation, is available. Visit our Legal Resources page to download.