Janssen Pharmaceutica, N.V. v. Kappos
| Decision Date | 10 February 2012 |
| Docket Number | No. 1:11cv969 (LMB/IDD).,1:11cv969 (LMB/IDD). |
| Citation | 101 U.S.P.Q.2d 1924,844 F.Supp.2d 707 |
| Parties | JANSSEN PHARMACEUTICA, N.V., Plaintiff, v. David J. KAPPOS, et al., Defendants. |
| Court | U.S. District Court — Eastern District of Virginia |
844 F.Supp.2d 707
101 U.S.P.Q.2d 1924
JANSSEN PHARMACEUTICA, N.V., Plaintiff,
v.
David J. KAPPOS, et al., Defendants.
No. 1:11cv969 (LMB/IDD).
United States District Court,
E.D. Virginia,
Alexandria Division.
Feb. 10, 2012.
[844 F.Supp.2d 708]
Charles F.B. McAleer, Jr., Miller & Chevalier, Chartered, Washington, DC, for Plaintiff.
Dennis Carl Barghaan, Jr., United States Attorney's Office, Alexandria, VA, for Defendants.
LEONIE M. BRINKEMA, District Judge.
Plaintiff Janssen Pharmaceutica, N.V. (“Janssen”), a Belgian corporation that is the assignee of U.S. Patent No. 7,741,356 (“the patent” or “the '356 patent”), has sued the United States Patent and Trademark Office and its director, David J. Kappos, seeking a 98–day increase to the term of the '356 patent (“patent term” or “PTA”). Before the Court is defendants' Motion to Dismiss, in which they argue that the Court does not have jurisdiction over this action, because when the complaint was filed on September 9, 2011, the applicable statute, 35 U.S.C. § 154(b)(4)(A), vested exclusive jurisdiction over such actions in the United States District Court for the District of Columbia.1 Defendants also argue that under
[844 F.Supp.2d 709]
the same statute plaintiff's claim is barred by the applicable statute of limitations. For the reasons discussed below, defendants' motion will be granted to the extent that this civil action will be transferred to the United States District Court for the District of Columbia.
After a patent application is submitted, a patent examiner with the United States Patent and Trademark Office (“USPTO”) determines whether the asserted invention meets the requirements for patentability. If the patent examiner determines that the invention in the application is entitled to patent protection, the USPTO sends the applicant a notice of allowance. The notice of allowance specifies the required issue fee, which must be paid within three months of issuance of the notice. 37 C.F.R. § 1.311; Manual of Patent Examining Procedure (“MPEP”) § 1.311. The notice of allowance also includes the USPTO's calculation of the patent term adjustment, that is, the time period for which the patent will remain in effect. See35 U.S.C. § 154(b)(3)(B)(i). Once the issue fee is timely paid, the USPTO will issue the patent. MPEP § 1.314.
Under the current version of the patent statute, a patent's term is limited to 20 years, measured from the date the patent application is filed with the USPTO. 35 U.S.C. § 154(a)(2). The number of days during which an application is pending in the USPTO will therefore decrease the patent's ultimate term. To address the concern that the duration of a patent could be significantly shortened due to administrative delay, 35 U.S.C. § 154(b) provides that the term of a patent may be adjusted to account for various delays that occur between the time a patent application is filed and when the patent is ultimately issued. Among other adjustments, 35 U.S.C. § 154(b)(1)(A) provides for a day-for-day extension of a patent term for each day that the USPTO does not provide a notification pursuant to 35 U.S.C. § 132 or a notice of allowance under § 151, beyond fourteen months from the date the patent application was filed. This delay is known as “A Delay.” Subsection (1)(B) provides for a patent term adjustment when a patent issuance is delayed due to the USPTO's failure to issue a patent within three years of the application being filed (“B Delay”).2
The Director must “prescribe regulations establishing procedures for the application for and determination of patent term adjustments.” 35 U.S.C. § 154(b)(3)(A). Pursuant to such procedures, 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.
Id. § 154(b)(3)(B). The regulations promulgated by the USPTO provide that “[a]ny request for reconsideration of the patent term adjustment indicated in the notice of allowance, except as provided in
[844 F.Supp.2d 710]
paragraph (d) ... must be by way of an application for patent term adjustment.” 37 C.F.R. § 1.705(b). The request must be filed no later than the date when the applicant pays the issue fee, which is due no later than three months from the notice of allowance. Id.; Pl.'s Opp'n Ex. 1 (MPEP § 1306, regarding timing of issue fee). A patentee may also seek reconsideration of a revised patent term adjustment that is reflected in the patent itself, or a revision that should have been reflected in the patent, within two months of the date the patent issued. 37 C.F.R. § 1.705(d). Such a request will be considered untimely as to issues that were raised or could have been raised before the patent issued. Id.
Under the statute, “[t]he Director shall proceed to grant the patent after completion of the Director's determination of a patent term adjustment under the procedures established under this subsection [§ 154(b)(3) ], notwithstanding any appeal taken by the applicant of such determination.” 35 U.S.C. § 154(b)(3)(D). The statute also sets forth the mechanism under which “[a]n applicant dissatisfied with a determination made by the Director under paragraph (3)” may seek judicial review. Section 154(b)(4)(A) states that such an applicant
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 [the Administrative Procedure Act], shall apply to such action.3
Patent Application No. 11/079,647, which ultimately issued as the '356 patent, was filed on March 14, 2005. The USPTO issued its first office action concerning the application on April 9, 2007. That office action was rescinded and replaced by a different office action on July 16, 2007. See Pl.'s Opp'n Ex. 3 (July 16, 2007 office action). Both the first and second office actions occurred more than 14 months after the application was filed, entitling the applicant to an extension of the patent term for A Delay. When the USPTO mailed the applicant a notice of allowance on October 14, 2008, the notice stated that the application would receive 207 days of PTA, based on the April 9, 2007 date of the first office action. Compl. ¶ 12. Had the July 16, 2007 “rescind and replace” date been used, the applicant would have received 98 additional days of PTA. See Compl. Ex. B.
On January 13, 2009, after receiving the notice of allowance but before the patent issued, plaintiff submitted its first Request for Reconsideration pursuant to 37 C.F.R. § 1.705(b), in which it argued that the PTA calculation should have been based on the July 16, 2007 “rescind and replace” office action and, accordingly, the patent term should be extended by an additional 98 days due to A Delay. See Compl. Ex. B. The USPTO dismissed plaintiff's Request for Reconsideration on May 18, 2010 (“Decision I”), explaining that
the subsequent mailing of a communication by the examiner altering the previous action does not negate the fact that the Office took action in this application within the meaning of § 1.702(a)(1) on April 9, 2007. The examiner does not have the authority to vacate, rescind, or withdraw an Office action. Unless vacated by the Technology Center Director, for purposes of calculating patent term adjustment, the action originally
[844 F.Supp.2d 711]
mailed by the examiner on April 9, 2007 will be used to calculate the amount of Office delay.
Compl. Ex. C at 3. The '356 Patent was issued on June 22, 2010, reflecting a total PTA of 1009 days, including 330 days of USPTO “A Delay” based on the April 9, 2007 first office action. Id. ¶ 15.4
On July 19, 2010, plaintiff filed a petition pursuant to 37 C.F.R. § 1.181 (“Rule 181 Petition”), seeking review of Decision I by the Director and again arguing that the patent term should be extended by an additional 98 days due to A Delay. See Compl. Ex. D. The Rule 181 Petition was dismissed on March 15, 2011 (“Decision II”) in an opinion issued by a senior USPTO attorney. See Compl. Ex. E. The USPTO explained that
[t]he fact that the Office later set aside the restriction requirement of April 9, 2007 does not negate the fact that the Office responded within the meaning of 35 U.S.C. § 154(b)(1)(A)(i) and 37 CFR 1.702(a)(1) on April 9, 2007. Unless expunged from the record (which is not warranted in this situation), for purposes of calculating patent term adjustment, the Office action entered by the examiner on April 9, 2007 was properly used to determine whether the USPTO delayed the issuance of the above-identified patent by failing to provide a notification under 35 U.S.C. § 132 within 14 months after the date on which the application was filed....
Id. Plaintiff sought reconsideration of Decision II on April 15, 2011. The USPTO denied reconsideration on September 6, 2011 (“Decision III”). See Compl. Exs. F, G. Decision III stated that it was “a final agency action within the meaning of 5 U.S.C. § 704 for the purposes of seeking judicial review.” Compl. Ex. G at 1 n. 1. In Decision III, the USPTO adhered to its reasoning in Decision II, holding that
the 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.
Id. at 5. Plaintiff filed the complaint in this action on September 9, 2011, once again seeking a 98–day increase to the patent's term. Compl. ¶¶ 22, 27.
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