The U.S. Court of Appeals for the Federal Circuit has issued an opinion that provides guidance for how Patent Term Adjustments should be calculated.
Between June 2009 and May 2011, Novartis filed four civil lawsuits against the Director of the United States Patent and Trademark Office (PTO) in the United States District Court for the District of Columbia claiming that, for twenty-three of its issued patents, the Director had improperly determined the amount of patent term adjustment (PTA). On February 16, 2012, the district court consolidated the cases.
Novartis claimed that the Director’s determinations of the patent term adjustment were erroneous because they were based on two mistaken interpretations of the PTA statute as it applies to an applicant’s request for continued examination (RCE). The District Court held that for the patents where review of PTA was applicable, the Director’s determinations were incorrect, and granted Novartis the additional patent term. On appeal, the Federal Circuit court affirmed-in-part and reversed-in-part the District Court’s ruling, concluding that Novartis was entitled to most—but not all—of the additional patent term adjustment it sought.
The portion of the PTA statute relevant to this case is set out in in 35 U.S.C. § 154(b). This provision states:
if the issue of an original patent is delayed due to the failure of the United States Patent and Trademark Office to issue a patent within 3 years after the actual filing date of the application under section 111(a) in the United States or, in the case of an international application, the date of commencement of the national stage under section 371 in the international application, not including—
(i) any time consumed by continued examination of the application requested by the applicant under section 132(b);
(ii) any time consumed by a proceeding under section 135(a), any time consumed by the imposition of an order under section 181, or any time consumed by appellate review by the Patent Trial and Appeal Board or by a Federal court; or
(iii) any delay in the processing of the application by the United States Patent and Trademark Office requested by the applicant except as permitted by paragraph (3)(C), the term of the patent shall be extended 1 day for each day after the end of that 3-year period until the patent is issued.
Novartis asserted that the PTA it was granted on its patents was incorrect because the Director erroneously interpreted this provision to provide that (1) time spent in any continuing examination, no matter when initiated by the applicant, does not count towards tolling the statute’s three year allotment, and (2) both the time from initiation of continued examination to allowance and the time from allowance to issuance do not count toward tolling the three year allotment. The Federal Circuit agreed with the PTO on the first issue and Novartis on the second.
In finding that the Director's first interpretation of § 154(b) is correct, the court held that the best reading of the statute is that "the [PTA] time should be calculated by determining the length of the time between application and patent issuance, then subtracting any continued examination time and determining the extent to which the result exceeds three years." The court concluded that this interpretation is fairest to the applicant while also conforming to the statute's purpose.
In ruling for Novartis on the second issue, the court determined that there is no basis in the statute for distinguishing a continued-examination case from a case not involving a continued examination. As a result the court held that any time between allowance and issuance should count toward the PTO’s three year allotment, regardless of whether there has been any continued examination.
The full opinion is available here.