United States District Court, E.D. Virginia, Alexandria Division
[Copyrighted Material Omitted]
For Hossein Mohsenzadeh, Plaintiff: Michael Andrew Oakes, LEAD ATTORNEY, Hunton & Williams LLP (DC-Pennsylvania Ave), Washington, DC.
For Teresa Stanek Rea, Hon.; Acting Under Secretary of Commerce for Intellectual Property and Director of the United States Patent and Trademark Office, Defendant: Antonia Konkoly, LEAD ATTORNEY, U.S. Attorney's Office (Alexandria-NA), Alexandria, VA.
MEMORANDUM OPINION AND ORDER
Gerald Bruce Lee, United States District Judge.
THIS MATTER is before the Court on the parties' cross-motions for summary judgment (Docs. 10 and 13). This case concerns the determination of patent term adjustment (" PTA" ) for Plaintiff Hossein Mohsenzadeh's divisional patents, U.S. Patent No. 8,352,362 (" the '362 patent" ) and U.S. Patent No. 8,401,963 (" the '963 patent" ). The issue before the Court is whether divisional patents should receive PTA that arose due to a delay in the issuance of a restriction requirement in their parent patent's application.
The Court GRANTS Defendant's Motion for Summary Judgment (Doc. 13) and DENIES Plaintiff's Motion for Summary Judgment (Doc. 10) for two reasons. First, the Court holds that the language of 35 U.S.C. § 154 (" the PTA Statute" ) unambiguously applies to only one patent application--providing PTA only for delays that occurred during the prosecution of the application from which the patent issued. Alternatively, the Court holds that to the extent § 154(b)(1)(A) is ambiguous, the United States Patent and Trademark Office's longstanding interpretation of the PTA Statute, as manifested in 37 C.F.R. § § 1.702, 1.703, and 1.704(c)(12), is reasonable and entitled to some deference.
A. Statutory Framework
i. Patent Application Process
The patent application process begins with an applicant filing a patent application at the United States Patent and Trademark Office (" USPTO" ). 35 U.S.C. § 111(a). The patent application undergoes a process of examination to determine whether the requirements for patentability have been met. Id. § 131. Often the first official action of the USPTO is the issuance of a restriction requirement. Id. § 132.
A restriction requirement is issued when a patent examiner determines that a patent application contains two or more independent and distinct inventions. Id. § 121. The restriction requirement divides the claims presented in the application into multiple groups. One group can be pursued in the application where the restriction requirement is made, while the other groups can be pursued by filing one or more divisional applications. Id. Divisional applications constitute new applications that receive special protections differentiating them from original patent applications. First, 35 U.S.C. § 121 mandates that a divisional application " shall be entitled to the benefit of the filing date of the original application." Id. Second, § 121 includes a " safe-harbor" provision whereby the parent application cannot be used as a reference against the divisional application so long as the divisional application was filed before the issuance of parent patent. Id.; see also Pfizer v. Teva Pharms. USA, 518 F.3d 1353 (Fed. Cir. 2008).
ii. Term of a Patent
A patent's enforceability begins on the issue date of the patent and ends twenty years from the patent application's effective filing date, which is the earliest filing date for which priority is claimed. 35 U.S.C. § 154(a)(2). Accordingly, when a divisional application results in a patent, its twenty year term is measured from the filing date of the parent patent application.
Because the examination process takes time, the enforceable lifetime of a patent is necessarily reduced by the amount of time it takes the USPTO to conduct the patent's examination. As such, Congress established patent term adjustments (" PTA" ) to compensate inventors for unreasonably long delays by the USPTO.
a. Patent Term Adjustment Statute (35 U.S.C. § 154)
To understand the role of PTA in the enforceable life of a patent, it is important to understand the history of 35 U.S.C. § 154(b). Prior to 1994, before adoption of the General Agreement on Tariffs and Trade (" GATT" ), a patent term was calculated as seventeen years from the issue date. Novartis AG v. Lee, 740 F.3d 593, 595 (Fed. Cir. 2014). In 1994, Congress changed the effective term of a patent from seventeen years commencing from issuance to twenty years commencing from filing. See Uruguay Round Agreements Act, Pub. L. No. 103-465, § 532, 108 Stat. 4809, 4984 (1994). Under the seventeen-year regime, USPTO delays did not affect patent terms because a term commenced upon issuance rather than filing. Under the twenty-year regime, however, USPTO delays had the potential to consume the entirety of a patent's effective term. See Wyeth v. Kappos, 591 F.3d 1364, 1366 (Fed. Cir. 2010).
Most recently, in 1999, the American Inventors Protection Act (" AIPA" ) amended 35 U.S.C. § 154(b) to address this problem and protect patent terms from the effects of USPTO delay. " The new Act promised patent applicants a full patent term adjustment for any delay during prosecution caused by the PTO." Wyeth, 591 F.3d at 1366. Under the amended statute, the USPTO calculates patent term adjustments by considering three classes of USPTO delay: (i) an " A-delay," which awards PTA for delays arising from the USPTO's failure to act by certain examination deadlines; (ii) a " B-delay," which awards PTA for an application pendency exceeding three years; and (iii) a " C-delay," which awards PTA for delays due to interferences, secrecy orders, and appeals. The USPTO calculates PTA by adding the A-, B-, and C-delays, subtracting any overlapping days, and then subtracting any days attributable to applicant delay. Wyeth, 591 F.3d at 1367.
The A-delay is the delay applicable in this case. The relevant portion of the PTA Statute 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--
(1) the date on which an application was filed under section 111(a);
. . .
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).
The PTA Statute also accounts for delays by the patent applicant. PTA is reduced for a patent applicant's " fail[ure] to engage in reasonable efforts to conclude prosecution of the application." Id. § 154(b)(2)(C)(i). Section 154(b)(2)(C)(iii) explicitly provides that " [t]he Director shall prescribe regulations establishing the circumstances that constitute a failure of an applicant to engage in reasonable efforts to conclude processing or examination of an application." In addition to this grant of substantive rulemaking authority, the PTA Statute provides for general procedural rulemaking authority in section 154(b)(3)(A) stating that " [t]he Director shall prescribe regulations establishing procedures for the application for and determination of patent term adjustments under this subsection."
To the extent that an applicant is dissatisfied with the USPTO's determination of PTA, the PTA Statute grants the applicant one opportunity to request reconsideration of the PTA determination. Id. § 154(b)(3)(B)(ii). If an applicant is still dissatisfied following the USPTO'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).
b. Patent Term Adjustment Implementing Regulations
Promptly after passage of the AIPA, the USPTO promulgated 37 C.F.R. § § 1.702-1.704 establishing procedures for the application and determination of patent term adjustments. See Changes to Implement Patent Term Adjustment Under Twenty-Year Patent Term, 65 Fed. Reg. 56366 (Sept. 18, 2000) (final rules); 65 Fed. Reg. 17215 (Mar. 31, 2000) (proposed rules). Together, § § 1.702, 1.703, and 1.704 implement the PTA Statute by setting forth the precise circumstances warranting PTA credits and PTA reductions, as well as corresponding mathematical rules by which the USPTO computes the actual PTA. The relevant portions of the final PTA regulations provide:
§ 1.702 Grounds for adjustment of patent term due to examination delay under the Patent Term Guarantee Act of 1999 (original applications, other than designs, filed on or after May 29, 2000).
(a) Failure to take certain actions within specified time frames. Subject to the provisions of 35 U.S.C. 154(b) and this subpart, the term of an original patent shall be adjusted if the issuance of the patent was delayed due to the failure of the Office to:
Mail at least one of a notification under 35 U.S.C. 132 or a notice of allowance under 35 U.S.C. 151 not later than fourteen months after the date on which the application was filed under 35 U.S.C. 111(a) or fulfilled the requirements of 35 U.S.C. 371 in an international application;
§ 1.703 Period of adjustment of patent term due to examination delay.
(a) The period of adjustment under § 1.702(a) is the sum of the following periods:
The number of days, if any, in the period beginning on the day after the date that is fourteen months after the date on which the application was filed under 35 U.S.C. 111(a) or fulfilled the requirements of 35 U.S.C. 371 and ending on the date of mailing of either an action under 35 U.S.C. 132, ...