17Feb 2016

Takeaways from the Recent Pfizer v. Lee Ruling by Silvia Salvadori{3 minutes to read}  In the recently decided case Pfizer v. Lee, the Federal Circuit affirmed the decision of the U.S. District Court for the Eastern District of Virginia, upholding the lower court’s ruling that the patent term adjustment calculation should stop the clock from running against the United States Patent & Trademark Office (USPTO) when an examiner issues an incomplete restriction requirement.

The patent term adjustment accounts for the delays that accrue when the USPTO fails to meet the specific dates during the examination of a particular patent application. When the USPTO is late in acting on an application, the time by which the application was delayed is given back to the applicant at the end of the process—when the application becomes a patent.

In this case, the original application was filed on May 2, 2003. On June 2, 2004, “a delay” began to accrue against the USPTO (a first office action should issue within 14 months from filing the application). On August 9, 2005, the USPTO issued an incomplete restriction requirement that was 404 days late. On February 6, 2006, the applicant contacted the examiner about the incomplete restriction requirement. Finally, on February 23, 2006, the USPTO sent a revised version of the restriction requirement. The first restriction requirement was deemed incomplete because it did not address all of the dependent claims. At the end of the examination, when the application was finally approved for issuance, the USPTO awarded only the delay calculated from June 2004 to August 2005. Pfizer challenged that amount of time, seeking an additional 197 days based on the date of the issuance of the second restriction requirement.

However, the USPTO disagreed with Pfizer, and the Federal Court sided with the Office. The Court noted that the summary of the restriction requirement clearly showed that all of the claims were subject to the restriction. Therefore, according to the court, the applicants was already on notice that the claims were restricted. Thus, the court upheld the USPTO determination that the incomplete restriction requirement stopped the 14-month clock from running, i.e., it stopped the accrual of additional delay.

What applicants should learn from this is that while applicants have to submit a substantially complete response to an office action (because an incomplete reply would cut into the patent term adjustment time), the same standard does not apply to the USPTO, which can send an incomplete office action without benefiting the applicant with additional patent term adjustment time. There is a different standard applied, and applicants need to be aware of this distinction.


Contact me with questions or comments at silvia@salvadorilaw.com.


Silvia Salvadori, PhDSilvia Salvadori, PhD

(212) 897-1938