District Court Denies Equitable Tolling, Fifth Amendment Taking In Novartis Patent Term Adjustment Case

In another significant Patent Term Adjustment (PTA) case decided last week (Novartis AG v. Kappos, Civ. Action No. 10-cv-1138 (Nov. 15, 2012)), the U.S. District Court for the District of Columbia found that Novartis could benefit from "ordinary tolling" but not "equitable tolling" in its efforts to obtain additional PTA for 23 patents. This decision by Judge Huvelle addresses several interesting issues that may arise in other PTA cases.

The PTA Issues

Novartis sought two types of additional PTA:

Wyeth-type PTA, based on the USPTO's miscalculation of overlap between "A delay" and "B delay" (discussed in this article) Exelixis-type PTA, based on the USPTO's misinterpretation of the impact of filing an RCE on the availability of "B delay" (discussed in this article). The Statutory Deadline for Judicial Review

The PTA statute provides for judicial review of PTA awards in 35 USC § 154(b)(4)(A), which states:

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.

Novartis argued that this provision relates only to challenges of a PTA award provided with a Notice of Allowance, and not to challenges of post-issuance PTA awards provided with a granted patent. The district court rejected this interpretation of the statute, noting that "[f]rom its plain language, it is clearly intended to relate to all PTA determinations, regardless of when they occur."

Ordinary Tolling is Available

For one of the patents at issue (U.S. Patent 7,470,792), Novartis timely filed a request for reconsideration with the USPTO within two months of the grant date, in accordance with 37 CFR § 1.705(d). After the USPTO denied the request for reconsideration, Novartis filed suit in the district court. The suit was filed within 180 days of the USPTO decision, but more than 180 days after the patent had issued.

The district court considered the USPTO's arguments against the availability of tolling, but decided that "ordinary tolling" applies to 35 USC § 154(b)(4)(A), such that the 180-day period does not begin to run "until the agency action is final," and is "tolled during the period of agency reconsideration." In reaching this conclusion, the court cited the January 2012 district court decision to the same effect in Bristol-Myers Squibb Co. v. Kappos (D.D.C. 2012). (The...