A recently published Federal Circuit decision has clarified when a patent term extension may be applied to a granted patent. In Novartis AG vs. Lee, the Federal Circuit ruled that patent term adjustment should not take into account the period an application spends in examination following a request for continued examination (RCE), even if the RCE was filed later than three years from the application filing date.

Patent Term Extensions are granted under 35 U.S.C. § 154 to account for various US Patent Office (US PTO) delays in processing a patent application. This decision was concerned with 35 U.S.C. § 154(b) (1) (B) which relates to extensions granted for a delay of more than three years from filing in the issue of a patent. The issue in question was whether the statute should be read as allowing patent term extensions in instances in which a request for continued examination (RCE) has been filed.

If dissatisfied with a patent term adjustment applied by the US PTO, an applicant may request reconsideration of the decision. Novartis filed such reconsideration requests in respect of 23 patents. Novartis argued that the Director of the US PTO erred by not counting towards the three year delay period both the time from initiation of continued examination to allowance and, in addition, the time from allowance to issuance, even though the latter period is undisputedly counted toward the three years in a case not involving a continue examination. Many of the 23 patents were dismissed on the grounds that Novartis had failed to file their reconsideration request within a 180 day limit. However, the Federal Circuit ruled on a number of other Novartis patents.

The Federal Cicruit ruled that U.S.C. § 154 (b) (1) (B) should be interpreted to ensure patent term adjustment time is calculated by determining the length of time between application filing date and patent issuance, then subtracting any continued examination time (and any other time specified in the provision) and determining the extent to which the result exceeds three years. This interpretation was considered to be in line with the purpose of the statute: to compensate for delays attributable to the US PTO.

However, the judge did agree with a particular argument raised by Novartis, namely that "the time consumed by continued examination" should be limited to the time before allowance. Thus, it was ruled that the time between allowance to issue should be taken into account, even if continued examination had been requested. Should an application re-enter examination following allowance e.g. in the event that new prior art is filed, the patent term will be further adjusted accordingly.

Practical Considerations

In view of this decision, in certain situations it may be advisable to avoid filing an RCE during prosecution of a patent application so as to maximise patent term extension. One alternative to an RCE is the After-Final Consideration Program Pilot 2.0 which allows an examiner additional time to consider an application after a Final Office Action and if required schedule an interview with the applicant with a view to placing the application in order for allowance