The USPTO has filed a motion requesting reconsideration in Bristol Meyers Squibb Co. v. Kappos, where the U.S. District Court for the District of Columbia found that the statutory deadline for bringing a civil action to challenge the Patent Term Adjustment (PTA) awarded by the USPTO is tolled when the patentee pursues reconsideration of the agency decision. As I wrote previously, the court’s original ruling was significant, because the 180-day statutory period often runs before the USPTO has issued its final decision. If the deadline is not tolled, a patentee must decide whether to bring a civil action to contest a PTA award even before the USPTO has made it’s final PTA calculation.

Review Of Patent Term Adjustment Awards

The PTA statute (35 U.S.C. § 154) provides two different avenues of review of a PTA award.:

(A) The Director shall prescribe regulations establishing procedures for the application for and determination of patent term adjustments under this subsection.
(B) Under the procedures established under subparagraph (A), the Director shall-
(i) make a determination of the period of any patent term adjustment under this subsection, and shall transmit a notice of that determination with the written notice of allowance of the application under section 151; and
(ii) provide the applicant one opportunity to request reconsideration of any patent term adjustment determination made by the Director. . . . .

(A) An applicant dissatisfied with a determination made by the Director under paragraph (3) 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. Chapter 7 of title 5 shall apply to such action. Any final judgment resulting in a change to the period of adjustment of the patent term shall be served on the Director, and the Director shall thereafter alter the term of the patent to reflect such change.

The USPTO rules (37 CFR § 1.705) require that a request for reconsideration under § 154(b)(3) must be filed no later than the Issue Fee payment or within two months of the patent grant date (depending on the ripeness of the PTA issue at allowance).  When the USPTO issues its decision on a request for reconsideration, a patentee usually has two months to request reconsideration of the decision. It is usually the decision on that (second) request for reconsideration that is designated as a “final” agency decision. Indeed, the PTA award and/or rationale often changes between the first decision and the second decision.

The District Court Decision

The district court applied the “general rule” that “Judicial review of agency actions is ordinarily tolled until the agency action is final.”

The court explained as a practical matter:

In the instant case, once the plaintiffs filed their petitions for reconsideration with the PTO, it would have been a “pointless waste of judicial energy for the court to process any petition for review before the agency . . . acted on the request for reconsideration.”

The USPTO’s Request For Reconsideration

The USPTO’s request for reconsideration is founded on the assertion that the PTA statute sets a deadline for bringing a civil action that is independent of a final agency decision:

[T]he PTA statute’s limitation period begins to run when the patent issues, which date is independent of the USPTO’s action – the PTA determination – for which reconsideration is requested; filing a petition for reconsideration of the PTA determination would not change the date the patent issues and thus would not deactivate the PTA limitation period’s triggering event.

The BMS Opposition

BMS has opposed the USPTO’s motion, focusing largely on procedural grounds:

Because PTO’s motion for reconsideration is “little more than a rehash of the arguments raised in [its prior pleadings],” Black v. Tomlinson, 235 F.R.D. 532, 533 (D.D.C. 2006), it should be rejected.

The Merits Of The Original Decision

Even the USPTO acknowledges the merits of the original decision, noting that it “may be the correct outcome as a matter of policy or efficiency.” Indeed, requiring a patent holder to bring suit to challenge an agency decision that still is under review can lead to a tremendous waste of resources. The patentee has to challenge a decision that may change in its favor while the case is pending, the USPTO has to defend a decision that it ultimately may not agree with, and the court has to take jurisdiction over a case when the underlying facts are still in flux.

The USPTO emphasizes that the statute sets a fixed time period for bringing suit, but there is always some deadline that has not been met when a tolling issue arises. The USPTO argues that because the statute does not tie the time period to the date of a final agency decision, Congress must not have intended the deadline to be subject to tolling pending agency review.

But an alternative interpretation of Congressional intent is that Congress wanted to ensure that patentee’s had a full 180 days from the patent’s grant date to decide whether to bring suit. (The 180 day period is long when compared to the 2 months that 35 USC § 145 and 37 CFR § 1.304 give applicants to challenge a USPTO Board decision refusing to grant a patent.) Congress simply may not have contemplated that it would take the USPTO more than 180 days to issue a final PTA determination.

I find it ironic that the USPTO wants to be let off the hook for taking a long time to issue a final agency decision on PTA, which itself is awarded to patent holders because the USPTO took too long to examine and grant the patent in the first place!