Fed Circuit backs USPTO’s term adjustment for Mayo antibody patent
The US Court of Appeals for the Federal Circuit has affirmed the US Patent and Trademark Office’s (USPTO) patent term adjustment of a Mayo Foundation-owned patent.
In a 2-1 precedential decision, handed down on Monday, September 16, the Federal Circuit rejected non-profit Mayo Foundation’s argument that it was entitled to more time than it was given.
The patent, US number 8,981,063, claims certain antibodies purportedly useful for treating disease conditions characterised by immunosuppression, such as cancer and AIDS.
Earlier this week, the Federal Circuit concluded that the USPTO’s interpretation of “any time consumed by continued examination of the application requested by the applicant under section 132(b)” in 35 USC section 154(b)(1)(B)(i) was correct.
Case background
Under 35 USC section 154(b), applicants can be compensated for three broad classes of delay: when the USPTO doesn’t meet certain deadlines in processing patent applications, when the application remains pending beyond three years, and when the application is pending in an interference proceeding.
Mayo’s appeal concerned the calculation of the second delay (called B Delay).
During prosecution of application 12/421,310 (from which the ‘063 patent was issued), the USPTO rejected the claims as anticipated by US patent 7,635,757.
In September 2011, Mayo filed a Request for Continued Examination (RCE), arguing that it had priority of invention over the ‘757 patent and suggesting an interference.
An interference was then declared and, after two years, The Patent Trial and Appeal Board (PTAB) awarded priority to Mayo’s patent.
The ‘310 application returned to the examiner and, after withdrawing a subsequent rejection based on another patent, the application was issued as the ‘063 patent in March 2015.
The USPTO calculated a patent term adjustment (PTA) of 621 days, with no B Delay, a calculation that Mayo disagreed with.
Mayo filed a request for redetermination, claiming that it was due 685 days because “[t]he examiner’s sua sponte reopening of prosecution after termination of the interference was not” RCE time.
In disagreement, the USPTO asserted that RCE time didn’t end when the interference was declared, but instead when the notice of allowance was mailed.
Mayo requested reconsideration, but the USPTO denied Mayo's request, and so Mayo appealed against the decision to the Eastern District of Virginia, which rejected its appeal.
Arguments before the Federal Circuit
Before the Federal Circuit, Mayo argued that it never requested any examination after the PTAB’s remand and that, under USPTO regulations, an interference can’t be declared unless at least some claims are deemed allowable but for the outcome of the interference.
Mayo also reprised its argument to the district court, claiming that, under Novartis v Lee, RCE time ends “once the [USPTO] takes an official action indicating that all the pending claims are allowable and closes prosecution”.
In response, the USPTO claimed that a declaration of an interference doesn’t close prosecution on the merits, and the office’s operating procedures contemplate that examination may continue afterward.
The USPTO also claimed that Mayo’s rule requiring a determination of when the USPTO deems the claims allowable would turn PTA calculation into a “wildly impractical” and “hotly contested factual inquiry in nearly every PTA case”.
The Federal Circuit sided with the office, concluding that while the USPTO’s regulations 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 board may recommend further action by the examiner, including issuing a rejection.
“We find Mayo’s interpretation of Novartis—that examination ends once the claims are ‘deemed allowable’—strained,” said Circuit Judge Alan Lourie, on behalf of the court.
The Federal Circuit concluded that there was no B Delay and affirmed the decision of the district court.
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