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Actelion Pharms., Ltd. v. Kappos

United States District Court, District of Columbia

September 23, 2013

ACTELION PHARMACEUTICALS LTD., Plaintiff,
v.
HON. DAVID J. KAPPOS, Defendant

Decided: September 22, 2013.

For ACTELION PHARMACEUTICALS LTD., Plaintiff: Thomas Hoxie, LEAD ATTORNEY, HOXIE & ASSOCIATES, LLC, Millburn, NJ.

For DAVID J. KAPPOS, Honorable, Under Secretary of Commerce for Intellectual Property and Director of the United States Patent and Trademark Office, Defendant: Mitchell P. Zeff, LEAD ATTORNEY, U.S. ATTORNEY'S OFFICE, Washington, DC.

OPINION

Page 52

MEMORANDUM OPINION

RICHARD J. LEON, United States District Judge.

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.

BACKGROUND

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. See 35 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. See 35 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 opportunity

Page 53

to 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 ...


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