Actelion Pharmaceuticals Ltd. v. Lee

216 F. Supp. 3d 680, 2016 U.S. Dist. LEXIS 146393, 2016 WL 6154922
CourtDistrict Court, E.D. Virginia
DecidedOctober 19, 2016
DocketCivil Action No. 1:16-cv-304
StatusPublished
Cited by2 cases

This text of 216 F. Supp. 3d 680 (Actelion Pharmaceuticals Ltd. v. Lee) is published on Counsel Stack Legal Research, covering District Court, E.D. Virginia primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
Actelion Pharmaceuticals Ltd. v. Lee, 216 F. Supp. 3d 680, 2016 U.S. Dist. LEXIS 146393, 2016 WL 6154922 (E.D. Va. 2016).

Opinion

Memorandum Opinion

Liam O’Grady, United States District Judge

This matter comes before the Court on a Motion for Summary Judgment filed by Plaintiff Actelion Pharmaceuticals LTD., Dkt. No. 12, and a Cross Motion for Summary Judgment filed by Defendant Michelle K. Lee, Director of the United States Patent and Trademark Office (“PTO”). Dkt. No. 15. Both motions concern the interpretation of, 35 U.S.C. § 154, the statute which provides for a patent term adjustment—the amount of time added to the life of a patent due to delays during the patent application period. The dispute, amounting to a difference of four or five days of additional patent term may appear inconsequential. However, each additional day of patent term is of value to the holder, especially in the context of pharmaceutical patents.

I. Background

The questions at issue in this case are governed by an extensive statutory regime. The dispute between the parties has also progressed through multiple administrative actions before reaching the Court. Accordingly, this background describes the statutory framework at some length before turning to the administrative hearings precedent to the present action.

A. Statutory Background

The patent application in this case was filed by means of an international application pursuant to the Patent Cooperation Treaty (“PCT”). This section describes the framework for Patent Term Adjustment under United States law and then illuminates the relevant interrelationship between that framework and the PCT.

1. Patent Term, Adjustment

The law governing the content and term of a patent is outlined in 35 U.S.C. § 154. Under § 154 a patent grant is issued for twenty years measured from the earliest filing date of the application. Id. Understanding that delays in the examination process might decrease the length of a patent term, Congress created provisions under which a patent owner can seek a patent term adjustment (“PTA”) for certain delays caused by the PTO between the filing and issuance of a patent. Section 154(b)(1) outlines the three general sources of delay for which a PTA can be sought. The first, commonly referred to as “A-Delay,” allows for a patent term extension if the PTO fails to provide a notification under § 132 or a notice of allowance within fourteen months of an application filing. 35 U.S.C. § 154(b)(1)(A)®. The second, commonly referred to as “B Delay,” allows for a one day extension for every day that the PTO fails to issue a patent after three years have passed between the application and allowance dates. Id. at § 154(b)(1)(B). Finally, a “C Delay” allows a PTA for some types of delays excluded from the computation of a “B Delay.” Id. at § 154(b)(1)(C).

A-Delay is applicable to this case. The relevant portion of § 154 describing A-Delay provides as follows:

(A) Guarantee of prompt Patent and Trademark Office responses.—Subject to the limitations under paragraph (2), if the issue of an original patent is delayed due to the failure of the Patent and Trademark Office to—
(i) provide at least one of the notifications under section 132 or a notice of allowance under section 151 not later than 14 months after—
(I) the date on which an application was filed under section 111(a); or
[682]*682(II) the date of commencement of the national stage under section 371 in an international application;
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the term of the patent shall be extended 1 day for each day after the end of the period specified in clause (i), (ii), (iii), or (iv), as the case may be, until the action described in such clause is taken.

35 U.S.C. § 154(B)(1)(A).

If an applicant is dissatisfied with the PTO’s determination of PTA, § 154 grants the applicant an opportunity to request reconsideration of the PTA determination. Id. § 154(b)(3)(B)(ii). If an applicant is still dissatisfied following the PTO’s reconsideration of PTA, the applicant “shall have exclusive remedy by a civil action against the Director filed in the United States District Court for the Eastern District of Virginia within 180 days after the date of the Director’s decision on the applicant’s request for reconsideration.” Id.; § 154(b)(4).

2. The Patent Cooperation Treaty

The PCT enables applicants to file patent applications in multiple member countries by means of a single international application. While patent protection may later be sought in any member country, the filer receives the benefit of the same filing and priority dates associated with the international application.

A patent applicant who seeks enforcement of a patent in a PCT member nation must provide paperwork and a national fee to the designated Office for that nation not later than the expiration of 30 months from the priority date. PCT Art. 22(1) (2002). The application will not be reviewed before the expiration described above unless the applicant makes an “express request” for early examination. See id. Art. 23. The United States incorporated the 30 month requirement at 35 U.S.C. § 371(b) while permitting an exception at the express request of the applicant. See 35 U.S.C. § 371(f).

The rules issued under the PCT are also legally binding on the PTO. See Helfgott & Karas, P.C. v. Dickinson, 209 F.3d 1328, 1335 (Fed. Cir. 2000) (finding that PCT Rule 91.1 is legally binding on the Commissioner of the PTO). Rule 80.5 of the PCT provides that:

If the expiration of any period during which any document or fee must reach a national Office or intergovernmental organization falls on a day:
(i) on which such Office or organization is not open to the public for the purposes of the transaction of official business;
(ii) on which ordinary mail is not delivered in the locality in which such Office or organization is situated;
(iii) which, where such Office or organization is situated in more than one locality, is an official holiday in at least one of the localities in which such Office or organization is situated, and in circumstances where the national law applicable by that Office or organization provides, in respect of national applications, that, in such a case, such period shall expire on a subsequent day; or

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Cite This Page — Counsel Stack

Bluebook (online)
216 F. Supp. 3d 680, 2016 U.S. Dist. LEXIS 146393, 2016 WL 6154922, Counsel Stack Legal Research, https://law.counselstack.com/opinion/actelion-pharmaceuticals-ltd-v-lee-vaed-2016.