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Janssen Pharmaceutica, N.V. v. Rea

United States District Court, District of Columbia

March 7, 2013

JANSSEN PHARMACEUTICA, N.V., Plaintiff,
v.
Teresa Stanek REA, Acting Under Secretary of Commerce for Intellectual Property and Acting Director of the United States Patent and Trademark Office, et al., Defendants.

Charles Francis Benedict McAleer, Jr., Miller & Chevalier, Chartered, Washington, DC, Joseph Lucci, Esq., Woodcock Washburn LLP, Philadelphia, PA, for Plaintiff.

John G. Interrante, U.S. Attorney's Office, Washington, DC, for Defendants.

MEMORANDUM OPINION

COLLEEN KOLLAR-KOTELLY, District Judge.

Plaintiff Janssen Pharmaceutica, N.V., filed suit against Teresa Stanek Rea [1] in

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her official capacity as the Acting Under Secretary of Commerce for Intellectual Property and Acting Director of the United States Patent and Trademark Office and the United States Patent and Trademark Office (" USPTO," collectively " Defendants" ), alleging the Defendants improperly calculated the term of United States Patent No. 7,741,356 (" the '356 Patent" ). Upon transfer of this action from the United States District Court for the Eastern District of Virginia, the Defendants moved to dismiss the complaint as untimely. Upon consideration of the pleadings,[2] the relevant legal authorities, and the record for purposes of this motion, the Court finds the petitions to reconsider that the Plaintiff filed with the USPTO tolled the statute of limitations for filing suit in district court. Accordingly, the Defendants' [32] Motion to Dismiss is DENIED.

I. BACKGROUND

A. Patent Terms & Adjustments

Pursuant to 35 U.S.C. § 154(c)(1), the term of a patent filed prior to June 8, 1995, is the later of (1) seventeen years from the date the patent issued; or (2) twenty years from the earliest filing date of an application on which the patent's priority date is based. Utility patents filed after June 8, 1995, are subject to a term " beginning on the date on which the patent issues and ending 20 years from the date on which the application for the patent was filed in the United States." 35 U.S.C. § 154(a)(2). However, the prosecution of a patent application may take more than three years. In order to ensure that all patents have terms of at least seventeen years— the historic patent term— Congress provided that certain delays during prosecution are excludable from the calculation of the patent term. Id. at § 154(b).

The first category of delay, known as " A delay," occurs when the USPTO fails to take certain action within timeframes specified by statute. 35 U.S.C. § 154(b)(1)(A); accord 37 C.F.R. §§ 1.702(a), 1.703(a). To account for any such delays, " the term of the patent shall be extended 1 day for each day after the end of the period specified ... until the action described ... is taken." 35 U.S.C. § 154(b)(1)(A). A delay includes any delay by the USPTO in issuing a notice of rejection, objection, or requirement under 35 U.S.C. § 132. 35 U.S.C. § 154(b)(1)(A)(i); accord 37 C.F.R. § 1.702(a).

The second category of delay, known as " B delay," provides that, subject to certain limitations, if the USPTO fails to " issue a patent within 3 years after the actual filing date of the application in the United States ... the term of the patent shall be extended 1 day for each day after the end of that 3-year period until the patent is issued." 35 U.S.C. § 154(b)(1)(B). Both A and B delay may be offset by periods of delay attributable to the applicant's failure to " engage in reasonable efforts to conclude prosecution of the application." Id. at § 154(b)(2)(C). The Plaintiff only challenges the calculation of the A delay for the '356 Patent. E.g., Compl. ¶ 27-28.

The Director must determine " 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." 35 U.S.C. § 154(b)(3)(B); accord 37 C.F.R. § 1.705(a). Because the notice of allowance issues well before the patent is granted, the notice of patent term adjustment contains only the USPTO's calculation of A

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delay. See Pl.'s Ex. C (May 18, 2010 Decision on Appl. for Patent Term Adjustment) at 1 (noting " [k]nowledge of the actual date the patent issues is required to calculate the amount, if any, of additional patent term patentee is entitled to for" B delay). A party may seek reconsideration of the patent term adjustment included in the notice of allowance " by way of an application for patent term adjustment." 37 C.F.R. § 1.705(b). An application for patent term adjustment under section 1.705(b) must be filed by no later than the payment of the issue fee, id., which is due three months from the date of the notice of allowance. MPEP § 1306 (8th ed. rev. Aug. 2012).

A revised patent term adjustment determination— including both A and B delay— will appear on the patent upon issue. 37 C.F.R. § 1.705(d). " If the patent indicates or should have indicated a revised patent term adjustment, any request for reconsideration of the patent term adjustment indicated in the patent must be filed within two months of the date the patent issued." Id. However, any request for reconsideration under section 1.705(d) that raises issues that were raised or could have been raised in an application for patent term adjustment under section 1.705(b), the request for reconsideration " shall be dismissed as untimely as to those issues." 37 C.F.R. § 1.705(d).

Parties may further appeal the patent term adjustment finding to the Director under 37 C.F.R. § 1.181(a) (indicating a petition may be taken to the Director " [f]rom any action or requirement of any examiner in the ex parte prosecution of an application ... which is not subject to appeal to the Patent Trial and Appeal Board or to the court" ); see also Defs.' Reply at 11 (" Given the general nature of the rule, a Rule 1.181(a)(3) petitions may be submitted to request reconsideration of a USPTO decision, including a USPTO decision on a Rule 1.705(b) or 1.705(d) request for reconsideration of a PTA determination." ). The filing of a petition ...


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