Federal Circuit Denies Patent Term Adjustment for Erroneous Restriction Requirement

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81-2. Federal Circuit Denies Patent Term Adjustment for Erroneous Restriction Requirement

Pfizer, Inc. v. Lee, No. 2015-1265, 2016 U.S. App. LEXIS 1088 (Fed. Cir. January 22, 2016) (Before Newman, Dyk, and O’Malley, J.) (Opinion for the court, O’Malley, J.). Click Here for a copy of the opinion.

The Federal Circuit affirmed an Eastern District of Virginia decision upholding the USPTO’s refusal to extend the term of a Pfizer patent directed toward chemotherapy treatments.

The Patent Term Guarantee Act, 35 U.S.C. § 154(b), provides for the restoration of patent term in three circumstances: (i) an “A-Delay,” for delays arising from the USPTO’s failure to act by certain examination deadlines; (ii) a “B-Delay,” for an application pendency exceeding three years; and (iii) a “C-Delay,” for delays due to interferences, secrecy orders, and appeals. The USPTO calculates patent term adjustments by adding the A-, B-, and C-Delays, subtracting any overlapping days, and then subtracting any days that are attributable to applicant delay.

Judge Kathleen O'Malley

Judge Kathleen O’Malley

More specifically, “A-Delays” arise where the USPTO fails to provide certain notifications pursuant to 35 USC § 132.  In Pfizer, the applicant sought an “A-Delay” term adjustment of 197 days, from the patent examiner’s erroneous issuance of a restriction requirement, until it was withdrawn in favor of a corrected restriction requirement.  Ordinarily, a restriction requirement would be considered an office action under Section 132, thus allowing for a term adjustment for USPTO delays related thereto, because it informs the applicant of reasons why its claims are considered to be directed to separate inventions.  Pfizer argued that the original restriction requirement, because it was incomplete, created a delay by failing to provide Pfizer with adequate notice of the basis for rejecting its claims. The restriction requirement omitted six claims from its categories. According to Pfizer, proper notice was only given in the revised restriction requirement, when the claims were included.

However, the District Court ruled that the initial restriction requirement, while arguably incomplete, did in fact place Pfizer on notice of grounds for rejecting its claims, therefore satisfying § 132 and justifying denial of additional term adjustments. The Federal Circuit affirmed, also finding that the first restriction requirement satisfied the examiner’s narrow obligation to timely provide Pfizer with the “broad” basis for rejecting the claims. Specifically, the examiner gave detailed descriptions of each of the distinct inventions contained within the application and warranting the restriction requirement, and included a complete list of all claims subject to restriction. This was enough, even though some claims were not placed in one of the restriction categories.


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2 comments so far.

  • [Avatar for Gene Quinn]
    Gene Quinn
    January 29, 2016 01:55 pm

    I agree with Simon. You might be able to legally weave your analysis through the statute to get to this point, but this is clearly not what PTA is supposed to be about.

    Also, when did restriction requirements start to become substantive and about rejections? I know that for term addition restrictions are considered substantive to satisfy the PTO responsibility to act within 14 months, but restrictions are not substantive, period. Substance is supposed to be about rejections under Title 35. The examiner is not in any way, shape or form telling you anything about whether the claim or claims will ultimately be rejected when you get a restriction. They are merely saying you have more than one invention, or too many claims to examine in one application.

    So the Federal Circuit is wrong to say that restrictions are about substance or have anything to do with rejections, period.

  • [Avatar for Simon Elliott]
    Simon Elliott
    January 29, 2016 01:38 pm

    The central premise of the law appears to have been clouded by byzantine web of regulations, and this latest decision seems wrong from a policy perspective. The PTA act encourages compact, efficient prosecution. If an applicant is slow, PTA is lost. If the USPTO is slow or incompetent, PTA is added. Here, there is PTO error, so there should be PTA added.