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Patent Term Adjustment Denied For Interference-Related Delays

The US Court of Appeals for the Federal Circuit affirmed the US Patent and Trademark Office’s (PTO’s) calculation of patent term adjustment (PTA), finding that for purposes of PTA, time spent on a requested continued examination (RCE) of an application did not end once an interference was declared. Mayo Foundation for Medical Education and Research v. Andrei Iancu, Case No. 18-2031 (Fed. Cir. Sept. 16, 2019) (Lourie, J) (Newman, J, dissenting).

The American Inventors Protection Act compensates applicants for three broad classes of delays during the pendency of their patent application. One of these classes is a “B Delay,” which generally entitles the applicant to PTA for each day the application is pending beyond three years. While 35 USC § 154(b)(1)(B) generally “guarantee[s] . . . no more than 3-year application pendency,” that three-year period is subject to several exclusions, including “any time consumed by continued examination of the application requested by the applicant under section 132(b).”

Mayo owns a patent directed to antibodies for treating autoimmune diseases. Upon issuance of Mayo’s patent, the PTO calculated a PTA of 621 days with no B Delay. Mayo filed a request for redetermination, claiming that it was due 685 days because the examiner sua sponte reopened prosecution after termination of the interference, which was not RCE time under the relevant statute. Mayo calculated the RCE time as 148 days, which was the time between the filing of the RCE and the declaration of the interference. In support of its argument, Mayo claimed that RCE time ends once the PTO takes an official action indicating that all the pending claims are presumptively deemed allowable, and its claims were presumptively deemed allowable when the interference was declared. The PTO disagreed, finding that RCE time did not end when the interference was declared because the PTO may still determine questions of patentability in an interference. Mayo appealed.

The majority panel of the Federal Circuit agreed with the PTO, finding that while the PTO’s regulations do indicate that at least one claim in an application should be in condition for allowance before an interference is declared, the regulations also explicitly contemplate that the Patent Trial and Appeal Board (PTAB) may recommend further action by the examiner, including issuing a rejection. Accordingly, the Court affirmed the PTAB’s decision, finding that where an RCE had previously been filed, the time between termination of an interference and the date of mailing of the notice of allowance is time consumed by continued examination, and thus the PTO correctly determined that there was no B Delay.

In dissent, Judge Newman argued that the post-interference examination time should have been included in the adjustment calculation because it was an examination delay due to PTO procedures, and the majority’s holding was contrary to statute, regulation and policy that provides PTA for such delays.

© 2019 McDermott Will & Emery

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About this Author

Sami Sedghani IP Litigation Attorney McDermott
Associate

Sami Sedghani focuses his practice on IP litigation and related intellectual property matters in the life sciences and medical device industries. He has extensive experience litigating patent and trade secret cases on behalf of plaintiffs and defendants involving a wide range of technologies in federal and state courts and before the International Trade Commission. Sami also advises clients on the complex laws and regulations under the Hatch-Waxman Act.

Prior to law school, Sami earned a bachelor’s degree in biology from University of Southern...

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