By Donald Zuhn --
Thursday, the Federal Circuit determined in Wyeth
v. Kappos that the U.S. Patent and Trademark Office had erred in making PTA
calculations for two patents owned by Wyeth and Elan Pharma International Ltd.
(see Patent Docs report). Since the appellate court rendered its
decision, many patent practitioners and applicants have been wondering what
steps the Office might take in response.
The Office provided an initial glimpse when it posted an announcement on its
website regarding the Federal Circuit's decision in the Wyeth case. The notice states:
On January 7, 2010, the Federal Circuit issued a decision in Wyeth v. Kappos, No. 2009-1120, regarding the calculation of patent term adjustments under 35 U.S.C. 154(b). The Federal Circuit's decision rejects the USPTO's interpretation of the "overlap" limitation in Section 154(b)(2)(A). The Solicitor General will determine whether to seek further review of this decision. Pending that determination, the USPTO is in the process of changing the manner it will calculate patent term adjustments under Section 154(b) to conform with the Federal Circuit's decision.
Applicants and Patent Owners dissatisfied with a patent term adjustment determination by the agency are reminded 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.
The Office's notice is interesting in at least two respects. First, there is the Office's reminder about the 180-day time limit for seeking review of PTA determinations; under 35 U.S.C. § 154(b)(4)(A), "[a]n applicant dissatisfied with a [PTA] determination made by the Director . . . shall have remedy by a civil action against the Director filed in the United States District Court for the District of Columbia within 180 days after the grant of the patent." While this reminder is fine for patentees who have yet to encounter the 180-day deadline for a particular patent, what about patents for which the deadline has long since passed?
In February 2009, we discussed an approach that one patentee had tried under such circumstances (see "More § 154(b)(4)(A) Actions Filed against Director"). In particular, General Hospital Corp. filed a complaint against the Director on January 16, 2009, requesting correction of a PTA determination with respect to U.S. Patent No. 7,367,341, which issued on May 6, 2008. For a patent issuing on that date, a complaint should have been filed by November 2, 2008. Thus, General Hospital missed the deadline for filing its complaint by 76 days. Nevertheless, General Hospital contended in its complaint that "[the District Court for the District of Columbia's] decision in Wyeth v. Dudas constituted a change in the law sufficient to invoke the doctrine of equitable tolling to allow for the filing of this complaint at this time." The doctrine of equitable tolling preserves a plaintiff's claims when strict application of the statute of limitations would be inequitable.
A recent check of PACER shows that the District Court stayed General Hospital's case on March 30, 2009, pending the outcome of the Wyeth appeal. Therefore, whether the doctrine of equitable tolling will prove useful in this case remains an open question. Interestingly, General Hospital's deadline for filing its complaint was 34 days after the District Court decided Wyeth v. Dudas. Therefore, even if the District Court determines that the doctrine is inapplicable for patentees such as General Hospital, the doctrine still may work where a patentee relied on the USPTO's 2004 guidance regarding A- and B-delay overlap and was granted a patent more than 180 days before the District Court issued its decision in Wyeth v. Dudas.
The Office's notice is also interesting in that it indicates that the Office will be changing the manner in which it calculates PTA to conform with the Federal Circuit's decision. Again, while this is fine for patentees who have yet to encounter the deadlines specified in 37 C.F.R. § 1.705(b) and (d), what about applicants for whom these deadlines have long since passed? As a reminder, 37 C.F.R. § 1.705(b) states that:
Any request for reconsideration of the patent term adjustment indicated in the notice of allowance, except as provided in paragraph (d) of this section, and any request for reinstatement of all or part of the term reduced pursuant to § 1.704(b) must be by way of an application for patent term adjustment. An application for patent term adjustment under this section must be filed no later than the payment of the issue fee but may not be filed earlier than the date of mailing of the notice of allowance.
And 37 C.F.R. § 1.705(d) states that:
If the patent indicates or should have indicated a revised patent term adjustment, request for reconsideration of the patent term adjustment indicated in the patent must be filed within two months of the date the patent issued and must comply with the requirements of paragraphs (b)(1) and (b)(2) of this section. Any request for reconsideration under this section that raises issues that were raised, or could have been raised, in an application for patent term adjustment under paragraph (b) of this section shall be dismissed as untimely as to those issues.
Neither the issue fee payment deadline of § 1.705(b) nor the two-months after issuance deadline of § 1.705(d) are statutory, so it's possible that the Office could waive these deadlines for patents that were granted before the Wyeth case was decided. However, patent practitioners and applicants will have to wait to see how the Office decides to handle patents that issued before Wyeth.