Actelion Pharms. Ltd. v. Kappos
| Decision Date | 23 September 2013 |
| Docket Number | Civil No. 10–01145 (RJL). |
| Parties | ACTELION PHARMACEUTICALS LTD., Plaintiff, v. Hon. David J. KAPPOS, Defendant. |
| Court | U.S. District Court — District of Columbia |
OPINION TEXT STARTS HERE
Thomas Hoxie, Hoxie & Associates, LLC, Millburn, NJ, for Plaintiff.
Mitchell P. Zeff, U.S. Attorney's Office, Washington, DC, for Defendant.
Plaintiff Actelion Pharmaceuticals Ltd. (“Actelion” or “plaintiff”) brought this suit against defendant David J. Kappos in his official capacity as Under Secretary of Commerce for Intellectual Property and Director of the United States Patent and Trademark Office (“USPTO”). Plaintiff claims that USPTO improperly determined the amount of patent term adjustment to which it is entitled. Before the Court are plaintiff's Motion for Summary Judgment and defendant's Cross–Motion for Summary Judgment. Upon consideration of the pleadings, record, and relevant law, plaintiff's motion is DENIED and defendant's motion is GRANTED.
Patents are issued by USPTO for a term ending 20 years from the date the patent application was filed, as opposed to the date the patent is issued. 35 U.S.C. § 154(a)(2). As a result, delays by USPTO in examining a patent application can reduce the effective term of that patent. See Wyeth v. Kappos, 591 F.3d 1364, 1366 (Fed.Cir.2010). To address this issue, Congress provided that a patent term will be extended to account for certain delays. See id.;35 U.S.C. § 154(b).
The procedures for determining such a “patent term adjustment” (“PTA”) are governed by § 154(b)(3). Several types of delay can figure into calculating the overall PTA, two of which are relevant for plaintiff in this case. First, so-called “A Delay” days accrue if USPTO fails to take certain specified actions within certain time periods, such as failing to respond to a patent application within 14 months of its filing. See§ 154(b)(1)(A). Second, “B Delay” days accrue if USPTO fails to issue a patent within three years of the filing of the application. See§ 154(b)(1)(B). After determining the proper amounts of A and B Delay, USPTO determines the extent of any overlap between the two types of delay to arrive at the overall PTA. See§ 154(b)(2)(A).
USPTO makes an initial PTA determination prior to patent issue and includes it with the written “notice of allowance” informing an applicant that he is entitled to a patent. See35 U.S.C. § 154(b)(3)(B)(i); 37 C.F.R. § 1.705(a) (2006). The applicant must pay an issue fee within three months; once payment occurs, USPTO issues the patent and determines the final PTA as of the date of the patent grant, noting this determination on the face of the patent. See35 U.S.C. § 151; 37 C.F.R. § 1.705(d) (2006). If the applicant disagrees with the PTA, the statute entitles him to “one opportunityto request reconsideration of any [PTA] determination made by the Director.” 35 U.S.C. § 154(b)(3)(B)(ii).
Further, the statute permits the applicant to appeal USPTO's PTA determination to a federal district court. Specifically, the statutory provision, entitled “Appeal of patent term adjustment determination,” provides:
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. Chapter 7 of title 5 [5 U.S.C. §§ 701–706] shall apply to such action ...
§ 154(b)(4)(A) (2010).1
On January 7, 2010, in Wyeth v. Kappos, 591 F.3d 1364 (Fed.Cir.2010), the Federal Circuit rejected USPTO's method for determining A and B Delay overlap, finding that USPTO had relied on an erroneous interpretation of 35 U.S.C. § 154(b).2 Following the Wyeth decision, USPTO changed its method for making future PTA determinations to align with the court's holding. In addition, USPTO created an “Interim Procedure,” effective February 1, 2010, that permitted patentees to request a PTA recalculation from USPTO so long as their patent was issued prior to March 2, 2010 and their request for recalculation was filed within 180 days of the patent grant. See Interim Procedure, 75 Fed.Reg. 5043, 5043 (Feb. 1, 2010). Thus, in effect, only patents granted within the 180 days prior to February 1, 2010, were eligible for a PTA recalculation using the new post- Wyeth interpretation of A and B Delay overlap.
The material facts are not in dispute in the instant case. Plaintiff, a pharmaceutical company, holds U.S. Patent No. 7,094,781 (the “'781 Patent”). Compl. [Dkt. # 1] ¶¶ 3, 9. The application for the '781 Patent was filed on May 27, 2003. Id. ¶ 8. USPTO issued the '781 patent on August 22, 2006, with a PTA of 312 days using its pre- Wyeth method of calculating A and B Delay overlap. Id. ¶ 11; Pl.'s Mot. Summ. J. and Mem. Supp. [Dkt. # 9] (“Pl.'s Mot.”) at 4. Plaintiff never filed a request for reconsideration of its PTA with USPTO. Def.'s Cross–Mot. Summ. J. and Mem. Supp. [Dkt. # 10] (“Def.'s Mot.”) at 2. And Plaintiff filed this civil action on July 6, 2010—more than 180 days after the August 22, 2006 patent grant. See Compl.
Summary judgment is appropriate when the record shows that there is no genuine dispute as to any material fact and the moving party is entitled to judgment as a matter of law. Fed.R.Civ.P. 56; Celotex Corp. v. Catrett, 477 U.S. 317, 322, 106 S.Ct. 2548, 91 L.Ed.2d 265 (1986). The court will accept as true the evidence of the non-moving party, and draw “all justifiable inferences” in his favor. Anderson v. Liberty Lobby, Inc. 477 U.S. 242, 255, 106 S.Ct. 2505, 91 L.Ed.2d 202 (1986) (citation omitted). A genuine dispute about a material fact only exists if “the evidence is such that a reasonable jury could return a verdict for the nonmoving party.” Id. at 248, 106 S.Ct. 2505.
Plaintiff moves for summary judgment, seeking a recalculation of its PTA based on the post- Wyeth methodology for computing A and B Delay overlap. 3 Plaintiff attempts to achieve this result by bringing three claims. First, plaintiff claims USPTO improperly calculated its PTA and directly appeals that calculation under 35 U.S.C. § 154(b)(4)(A). Compl. ¶¶ 18–24; Pl.'s Mot. at 11–13. Next, plaintiff argues USPTO's implementation of its post- Wyeth methodology and its failure to provide plaintiff the remedy of recalculating its PTA under that new methodology violated the Administrative Procedure Act (“APA”), 5 U.S.C. § 551 et seq. Compl. ¶¶ 25–28; Pl.'s Mot. at 13–15. Lastly, plaintiff argues USPTO's failure to correct its PTA was a “taking” of property without due process or just compensation in violation of the Fifth Amendment of the Constitution. Compl. ¶¶ 29–30; Pl.'s Mot. at 16–18. Defendant cross-moves for summary judgment, arguing that plaintiff's appeal under that statute is untimely, and that its APA and “taking” arguments are meritless.4See generally Def.'s Mot. Because all material facts in this case are undisputed, and for the reasons discussed below, summary judgment in favor of defendant is appropriate.
I. Statutory Claim
Challenges to USPTO's determination of a PTA are governed by 35 U.S.C. § 154(b)(4)(A), which specifically provides that such appeals must be filed with this District Court “ within 180 days after the grant of the patent.” § 154(b)(4)(A) (emphasis added). Plaintiff filed the instant action on July 6, 2010, well over 180 days—in fact, nearly four years—after the '781 Patent was granted on August 22, 2006. The plain language of the applicable statute therefore renders plaintiff's complaint untimely. The only question, then, is whether the 180–day filing deadline should not apply to plaintiff for some reason.
Plaintiff argues that the time limit in § 154(b)(4)(A) is not jurisdictional and is instead a “claim-processing rule,” and therefore it should be equitably tolled to allow plaintiff's suit due to the change in the law effectuated by Wyeth. See Pl.'s Mot. at 11–13; Holland v. Florida, 560 U.S. 631, 130 S.Ct. 2549, 2560, 177 L.Ed.2d 130 (2010) (). Defendant counters that § 154(b)(4)(A)'s time limit is jurisdictional and thus bars plaintiff's claim because jurisdictional filing deadlines are not susceptible to equitable tolling. See Def.'s Mot. at 5–10; Dolan v. United States, 560 U.S. 605, 130 S.Ct. 2533, 2538, 177 L.Ed.2d 108 (2010) (). In the alternative, defendant argues that, even if the time limit is non-jurisdictional, plaintiff does not warrant the extraordinary remedy of equitable tolling. See Def.'s Mot at 10–16.
Thus, as an initial matter, this Court must decide whether the statute is jurisdictional. See Henderson ex rel. Henderson v. Shinseki, ––– U.S. ––––, 131 S.Ct. 1197, 1202, 179 L.Ed.2d 159 (2011) (); Obaydullah v. Obama, 688 F.3d 784, 788 (D.C.Cir.2012). For the following reasons, I find that the 180–day time limit for seeking judicial review is, in fact, jurisdictional, and because plaintiff filed suit after that deadline, plaintiff's statutory claim under § 154(b)(4)(A) is untimely and this Court lacks subject matter jurisdiction to hear it.
For threshold requirements to bringing suit, such as the time limit at issue here, the Supreme Court has drawn a distinction between “jurisdictional” rules and “claim-processing rules.” A jurisdictional rule is one that “governs a court's adjudicatory capacity, that is, its subject-matter or personal jurisdiction.” Henderson, 131 S.Ct. at 1202;see also Kontrick v. Ryan, 540 U.S. 443, 455, 124 S.Ct. 906, 157 L.Ed.2d 867 (2004). By contrast,...
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