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term adjustment of 197 days, from the patent examiner’s erroneous issuance of a restriction requirement, until it was withdrawn in favor of a corrected restriction requirement.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.

The Author

Joseph Robinson

Joseph Robinson has over 20 years of experience in all aspects of intellectual property law. He focuses his practice in the pharmaceutical, life sciences, biotechnology, and medical device fields. His practice encompasses litigation, including Hatch-Waxman litigation; licensing; counseling; due diligence; and patent and trademark prosecution. He has served as litigation counsel in a variety of patent and trademark disputes in many different jurisdictions, and has also served as appellate counsel before the Court of Appeals for the Federal Circuit. Joe also focuses on complex inter partes matters before the U.S Patent and Trademark Office, inventorship disputes, reexaminations and reissues. His experience includes numerous interferences, a particular advantage in new U.S. Patent and Trademark Office post-grant proceedings. He also counsels on patent–related U.S. Food and Drug Administration issues, including citizen petitions, Orange Book listing, and trademark issues. For more information and to contact Joe please visit his profile page at the Troutman Sanders website.

Joseph Robinson

Robert Schaffer is an intellectual property partner at Troutman Sanders. Bob applies more than 30 years of experience to IP counseling and litigation. His work includes patent procurement, strategic planning and transactional advice, due diligence investigations, district court patent cases, and Federal Circuit appeals. He regularly handles complex and high-profile domestic and international patent portfolios, intellectual property agreements and licensing, IP evaluations for collaborations, mergers, and acquisitions. In disputed court cases Bob’s work includes representing and counseling client in ANDA litigations, complex patent infringement cases and appeals, and multidistrict and international cases. In disputed Patent Office matters his work includes representing and counseling clients in interferences, reexaminations, reissues, post-grant proceedings, and in European Oppositions. For more information and to contact Bob please visit his profile page at the Troutman Sanders website.

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Discuss this

There are currently 2 Comments comments.

  1. Simon Elliott January 29, 2016 1:38 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.

  2. Gene Quinn January 29, 2016 1:55 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.