Court holds that statutory deadline to file suit challenging patent term adjustment calculation is tolled by petition for review in USPTO

Bristol-Myers Squibb Co. v. Kappos, No. 1:09-cv-01330-EGS, 2012 WL 252423 (D.D.C. Jan. 27, 2012)

On January 27, 2012, the U.S. District Court for the District of Columbia held that the 180-day deadline to file a civil action seeking review of a patent term adjustment (PTA) determination by the U.S. Patent and Trademark Office (USPTO) is tolled by a timely-filed petition for reconsideration of PTA with the USPTO. Prior to this opinion, many patentees filed civil actions at the 180-day deadline in order to preserve the right of appeal in the federal courts for challenges that were still under USPTO review. This decision is significant because, barring a successful appeal by the USPTO, patentees may no longer need to incur the expense of filing a precautionary lawsuit that is generally remanded to the USPTO for further consideration of the PTA challenge.

Patent Term Adjustment Background

The American Inventors Protection Act (AIPA) of 1999 (codified at 35 U.S.C. § 154) provides for PTA arising from three types of patent examination delays:

• “A Delays” arising from the failure of the USPTO to comply with various statutory deadlines (e.g., failing to mail a first office action within fourteen months of the patent application filing date under 35 U.S.C. § 111(a));
• “B Delays” arising from the failure of the USPTO to grant a patent within three years of the patent application filing date; and
• “C Delays” arising from certain administrative actions (e.g., interferences, secrecy orders, and appeals).

Recently, the U.S. Court of Appeals for the Federal Circuit in Wyeth v. Dudas, 591 F.3d 1366 (Fed. Cir. 2010), affirmed a District Court decision that held the patent term adjustment under 35 U.S.C. § 154 is properly calculated as:

• the number of days of A Delays, plus 
• the number of days of B Delays, less 
• the number of days of overlap between the A Delay and the B Delay, and less 
• the number of days of applicant delay reflecting the failure to diligently conclude prosecution of the application.

The Bristol-Myers Decision

Bristol-Myers Squibb Co. and Kosan Biosciences Inc. (collectively referred to as “Bristol-Myers”) filed suit in the U.S. District Court for the District of Columbia on June 17, 2009 seeking review of patent term adjustment granted by the USPTO for various patents in accordance with the Wyeth decision. After remands and consolidation of a co-pending action, nine patents remained in the suit.

Although Bristol-Myers timely filed a request for reconsideration of the patent term adjustment at the USPTO for each of these nine patents, Bristol-Myers did not file a civil action to appeal the pending PTA decision in the District Court until more than 180 days after each of the nine patents issued. Instead, the suits were filed between 199 and 325 days after the grant of the patents and between 31 and 113 days after the USPTO’s denial of the requests for reconsideration. The total period of time between patent grant and the filing of the suit, less the time consumed by the USPTO’s consideration of a request ranged from 65 to 146 days.

The USPTO filed a motion to dismiss and asserted that Bristol-Myers failed to comply with 35 U.S.C. § 154(b)(4)(A), which requires an applicant dissatisfied with a patent term adjustment determination made by the USPTO to file a civil action appealing the PTA decision with the District Court “within 180 days after the grant of the patent.”

Bristol-Myers countered with a cross-motion for summary judgment, asserting that the civil action was timely filed because the limitation period of 35 U.S.C. § 154(b)(4)(A) was tolled by timely-filed petitions for reconsideration with the USPTO.

The District Court began its analysis by noting that federal courts have “nearly universally” held that a petition timely filed with an agency tolls the period for judicial review. The only exception to this tolling rule cited by the government was in an immigration case where the U.S. Supreme Court found that certain provisions of the Immigration and Nationality Act “reflect[ed] Congress’ expectation that […] the normal tolling rule will not apply.” Although the USPTO argued that the express language of 35 U.S.C. § 154(b)(4)(A) set forth a fixed date, i.e., “from the grant date”, the court explained that the tolling rule is compatible with and further does not violate the statutory provisions.

Effect of the Bristol-Myers Decision

Any appeal of this decision to the U.S. Court of Appeals for the Federal Circuit must be filed within 60 days of the entry of judgment. The USPTO has not indicated whether it will appeal the decision.

In the interim, applicants and patentees challenging the USPTO’s PTA calculations may wish to consider filing a civil action within 180 days of the grant of the patent in the U.S. District Court for the District of Columbia, even if the USPTO has not yet reviewed a previously-filed petition.

Moreover, the decision does not address how long a patentee may wait to file a complaint in the District Court after a final decision by the USPTO. Although (i) the timing of the Bristol-Myers suits relative to USPTO actions and (ii) case law considering the timeliness of challenges to decisions of other agencies may both be informative on this topic, it may be simplest to file a complaint in the District Court promptly after receipt of the USPTO’s final decision (if a complaint has not already been filed) in order to avoid any potential argument related to the timeliness of filing.

Perhaps most importantly, the decision did not consider whether patents issued well before the Wyeth decision can obtain additional patent term adjustment. However, resolution of the Bristol-Myers case should allow currently-stayed lawsuits raising this issue, such as Schering Corp. & Merck & Co. Inc. v. Kappos, Case No. 1:11-cv-00457-JDB, to move forward.

Conclusion

Depending on the ultimate resolution of the Bristol-Myers case, the procedure for correcting erroneous PTA awards may be simplified, with the deadline for filing a civil action extended for a period of time after the USPTO rules on the request for reconsideration.

The laws of patent term adjustment continue to be clarified after the Wyeth decision in 2010. While awaiting further actions from the USPTO in the case, patent owners may wish to review the PTA calculations performed by the USPTO and take appropriate action to best preserve their rights to additional patent term where additional days of PTA are of particular importance.