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Pfizer, Inc. v. Lee

United States District Court, E.D. Virginia, Alexandria Division

November 6, 2014

MICHELLE K. LEE, Deputy Under Secretary of Commerce for Intellectual Property and Deputy Director of the United States Patent and Trademark Office, Defendants

For Pfizer, Inc., a Delaware corporation, Wyeth Holdings Corporation, a Maine corporation, Plaintiffs: William Boyle Porter, LEAD ATTORNEY, Blankingship & Keith PC, Fairfax, VA.

For Michelle K. Lee, Under Secretary of Commerce for Intellectual Property and Director of the United States Patent and Trademark Office, Defendant: Bernard G. Kim, Stephen Obermeier, LEAD ATTORNEYS, U.S. Attorney's Office (Alexandria-NA), Alexandria, VA; Dennis Carl Barghaan, Jr., LEAD ATTORNEY, United States Attorney's Office, Alexandria, VA.

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Gerald Bruce Lee, United States District Judge.

THIS MATTER is before the Court on Plaintiffs Pfizer, Inc. and Wyeth Holdings Corporations' (collectively, " Pfizer" ) Motion for Summary Judgment (Doc. 28) and Defendant Michelle K. Lee on behalf of the USPTO's Motion for Summary Judgment (Doc. 32). This case involves the United States Patent and Trademark Offices' (" USPTO" or " PTO" ) decision of abandonment as to Patent Application No.

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10/428,894 (" '894 Application" ) and the Patent Term Adjustment applied to U.S. Patent No. 8,153,768 (the " 768 Patent" ). Pfizer seeks a determination of no abandonment from the Court, and what it deems, a correction, of the patent term adjustment. The USPTO alleges that the Court lacks jurisdiction as to the issue of abandonment and claims the patent term adjustment applied to the '768 Patent need not be modified.

There are two issues before the Court. The first issue is whether the Court should grant Plaintiffs' Motion for Summary Judgment to reverse the USPTO's determination that the '768 patent was abandoned, where Pfizer argues that the PTO's decision of abandonment was not based on substantial evidence, and relied on several erroneous factual findings. The Court DENIES as MOOT Pfizer's Motion for Summary Judgment as to the abandonment issue because the USPTO, since the filing of these motions, reviewed its ruling and withdrew the agency's earlier finding of abandonment.

The second issue is whether the Court should grant Pfizer's Motion for Summary Judgment and modify the Patent Term Adjustment (" PTA" ) granted to Pfizer from 404 to 601 days, where Pfizer argues the first Office Action--a Restriction Requirement, was defective and thus the time for " A-Delay" continued to run until the corrected Restriction Requirement was issued 197 days after the defective one. The Court DENIES Pfizer's Motion for Summary Judgment on the issue of PTA because the defects in the initial Restriction Requirement do not entitle Pfizer to an additional 197 days of " A-Delay," and the Court GRANTS Defendant Michelle Lee of the USPTO's Motion for Summary Judgment because the relevant statutory provision clearly and unambiguously provides that a notification, like a Restriction Requirement will " stop the clock" on the accumulation of " A-Delay," absent any requirement that the notice be free of defects.


Prior to a recitation of the facts, it is a worthwhile exercise to discuss the statutory framework relevant to the case. Particularly, an overview of the patent application process, the term of a patent, and Patent Term Adjustment calculation are necessary to understand the analysis applied by the Court.


1. Patent Application Process

The patent application process begins with an applicant filing a patent application with the 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 group(s) can be pursued by filing one or more divisional applications. Id.

2. 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

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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, or 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 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.[1] 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.

A-Delay is applicable to 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 ...

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