Updated: January 20, 2022
Based on Novartis v. Lee (Fed. Cir. 2014), if patent prosecution lasted more than 3 years and you filed a request for continued examination, you should investigate whether you are due a patent term extension and file any request for correction within 180 days of patent issuance.
In 1994, Congress changed the method of measuring the effective term of a patent to more closely conform to the 20-year patent term used by other countries. Before the change, a patent’s term generally ran from the date that the patent was issued until the end of a period measured from that date – typically seventeen years, subject to certain extensions. Under the 1994 law, the term still begins on the issuance date, but it generally ends twenty years after the earliest relevant priority patent application is filed. With this change, the effective term of the patent varied based on the time period the Patent Office needed to review and issue the patent application. If the review and issue process lasted 5 years, then the effective patent term for the patent was 15 years, not 17 years as it was before the change.
In 1999, Congress provided for certain patent term extensions to compensate for certain application-processing delays caused by the Patent Office. In particular, Congress guaranteed that the patent application would be pending no more than 3 years. For each day beyond the 3 year mark, the term of the patent would be extended by one day. Put simply, Congress wanted the term of the patent to be at least 17 years as it was before they changed the patent term. However, Congress was unable to control the work productivity at the Patent Office. Hence, Congress extended the patent’s term at the back of the life of the patent. For example, if the patent was issued more than 3 years after it was filed and such delay was caused by the Patent Office, Congress compensated the patent owner on the back end of the patent term through an adjustment to the patent term (PTA).
Whether the adjustment is warranted depends on whether the delay should be attributed to the Patent Office. During prosecution of a patent application, the patent application may be appealed, closed then reopened with a request for continued examination, or closed upon notice of allowance then reopened if the patent applicant files an information disclosure statement thereafter. If the patent application is being reviewed under continued examination, then such time period is not attributed as a delay by the Patent Office. The term of the patent is not extended while the patent application is under a request for continued examination. The following case further refines this rule on how Patent Office delays are determined.
2. Novartis v. Lee (Parties contentions)
In Novartis v. Lee (Fed. Cir. 2014), Novartis appealed a number of decisions of the PTO in relation to the patent term. One part of the decision changes the method the PTO uses to measure or calculate the term of a patent involved in the continued examination. Under the statute, the time the patent application spends in continued examination (e.g., request for continued examination) is not included in the calculation for the 3 year time period for patent prosecution.
Novartis argued that once a notice of allowance is mailed during the continued examination, the time period between the notice of allowance and the issuance of the patent should be counted as PTO delay and the term of the patent extended for that time period. Novartis’ logic was as follows. Since the time period between the notice of allowance and issuance was attributed to the Patent Office during normal examination or examination outside of continued examination, that same time period should be attributed to the Patent Office even during the continued examination. The Patent Office argued that the time period at issue should not be attributed to the Patent Office.
The Federal Circuit disagreed with the PTO’s interpretation. The Federal Circuit reasoned that since the time period between the notice of allowance and issuance is attributed as part of the original 3 year guarantee period when the patent application is not in the continued examination, that same time period should also be attributed as part of the 3 year period when the patent application is in the continued examination.
These cases disputing the patent term are generally litigated by pharmaceutical or biotech patent owners since the profits generated by a pharmaceutical drug can reach millions of dollars per day. Each day matters. For the small to mid-sized companies, these types of fights are typically not financially worthwhile since, as in the Novartis case, the most you will gain is a few months extension in patent term. Nonetheless, these types of cases conducted only by the larger corporations aid the smaller companies in increasing the term of their patents since the Patent Office will calculate the patent term adjustment in accordance with the rules defined during this litigation.
I invite you to contact me with your patent questions at (949) 433-0900 or [email protected] Please feel free to forward this article to your friends. As an Orange County Patent Attorney, I serve Orange County, Irvine, Los Angeles, San Diego, and surrounding cities.