Janssen Pharmaceutica, N.V. v. Rea
| Citation | 928 F.Supp.2d 102 |
| Decision Date | 07 March 2013 |
| Docket Number | Civil Action No. 12–241(CKK). |
| Parties | 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. |
| Court | U.S. District Court — District of Columbia |
OPINION TEXT STARTS HERE
Charles FrancisBenedict 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.
Plaintiff Janssen Pharmaceutica, N.V., filed suit against Teresa Stanek Rea 1 in 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.
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); accord37 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); accord37 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); accord37 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 delay. See Pl.'s Ex. C (May 18, 2010 Decision on Appl. for Patent Term Adjustment) at 1 (). 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) (); see also Defs.' Reply at 11 (). The filing of a petition under section 1.181 “will not stay any period for reply that may be running against the application, nor act as a stay of other proceedings.” 37 C.F.R. § 1.181(f).
Finally, “[a]n applicant dissatisfied with a determination made by the Director” as to the patent term adjustment under section 154(b)(3), “shall have remedy by a civil action against the Director,” filed “within 180 days after the grant of the patent.” 35 U.S.C. § 154(b)(4)(A). The statute further indicates that “Chapter 7 of title 5 shall apply to such action[s],” a cross-reference to the Administrative Procedures Act, 5 U.S.C. §§ 701–706.
Patent application number 11/079,647, which eventually issued as the '356 patent, was filed with the USPTO on March 14, 2005. Compl. ¶ 8; Pl.'s Ex. A (the '356 Patent) at 1. The Plaintiff is the original assignee of the '356 Patent. Compl. ¶ 9; Pl.'s Ex. A at 1. The USPTO mailed the first Office Action (hereinafter the “Restriction Requirement”) on April 9, 2007. Compl. ¶ 26. Before the applicants submitted their response, the USPTO “rescinded and replaced” the action with a revised Restriction Requirement, mailed on July 16, 2007. Id.
The USPTO was required to issue its first notice under 35 U.S.C. § 132, in this case the Restriction Requirement, by no later than 14 months after the application was filed—that is, May 14, 2006. 35 U.S.C. § 154(b)(1)(A)(i); 37 C.F.R. § 1.702(a)(1). The USPTO calculated the A delay attendant to the delayed Restriction Requirement as 330 days, the number of days between the statutory deadline to issue the first action (May 14, 2006) and the initial issuance of the Restriction Requirement (April 9, 2007). Compl. ¶ 27. The Plaintiff contends the term of the '356 patent should have been adjusted an additional 98 days to account for the fact the April 9, 2007 Restriction Requirement was rescinded and replaced on July 16, 2007. Id.
On October 14, 2008, the USPTO made a preliminary determination that the applicant was entitled to 330 days of patent term adjustment based on the first Office Action mailing date.3 Compl. ¶ 12; Pl.'s Ex. B (Req. for Recons. of Patent Term Adjustment under 37 C.F.R. § 1.705) at 2. The Plaintiff filed a request for reconsideration under 37 C.F.R. § 1.705(b) on January 13, 2009, arguing that “[b]ecause the April 9, 2007 Restriction Requirement was not proper, it is believed that the period of USPTO Delay is to be calculated as of July 16,2007, not April 9, 2007.” Pl.'s Ex. B. at 2; accord Compl. ¶ 13. In response, the USPTO confirmed the determination of the relevant portion of A delay. Pl.'s Ex. C at 3 ( ).
The '356 Patent issued on June 22, 2010. Compl. ¶ 15; Pl.'s Ex. A at 1. In issuing the patent, the USPTO credited the patent with 330 days of A-delay in connection with the first office action, rather than the 428 days sought by the applicant. Compl. ¶ 15. On July 19, 2010, the applicants filed a petition pursuant to section 1.181, asking the Director to review the May 10, 2008 decision, challenging the assertion that a later-rescinded communication satisfies the USPTO's obligation to issue a notice under 35 U.S.C. § 132. Compl. ¶ 16; Pl.'s Ex. D ( . The Office of Petitions dismissed the petition on March 15, 2011, indicating that “[t]he vacatur of an Office action, [ ] does not signify that the vacated Office action is void ab initio and is to be treated as if the USPTO had never issued the Office action.” Pl.'s Ex. E (Mar. 15, 2011 Decisio...
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