October 30, 2020

Volume X, Number 304

Advertisement

October 29, 2020

Subscribe to Latest Legal News and Analysis

October 28, 2020

Subscribe to Latest Legal News and Analysis

October 27, 2020

Subscribe to Latest Legal News and Analysis

Patent Term Adjustment Update - Novartis v. Lee

A recent ruling by the Federal Circuit in Novartis AG v. Lee resolved the issues raised in the Exelixis I,Exelixis II and Novartis decisions regarding the effect of a Request for Continued Examination (RCE) on patent term adjustment (PTA). The Federal Circuit’s ruling states that although an RCE filed more than three years after an application’s filing date will continue to have an impact on PTA, the time period after allowance until issuance should not necessarily be precluded from any B-term delay calculation. The ruling could significantly add to the terms of impacted U.S. patents. 

Statute 35 U.S.C. 154(b)(1)(B) guarantees adjustment of a patent term if the patent is not issued within three years after the filing date of the application (i.e., “B-term delay”). If the patent takes longer than three years from the application filing date to grant, the life of the patent is extended one day for each day after the end of the three-year period until the patent has issued. This three-year guarantee is subject to the limitation of “any time consumed by continued examination of the application requested by the applicant.” Prior to this decision, the United States Patent and Trademark Office (USPTO) interpreted the statute to read that the filing of any RCE would preclude any additional B-term delay. Thus, once an RCE was filed, an application would no longer be eligible for any B-term adjustment. 

At issue in the Novartis case was whether or not PTA should be reduced by the time attributable to an RCE when the RCE is filed after expiration of the three-year date from filing. The Court partially upheld and partially reversed the USPTO’s interpretation of the statute. The Court agreed with the USPTO that no adjustment of time is available for any time consumed by continued examination, even if the continued examination was initiated more than three years after the application’s filing date. Thus, even if the first RCE for an application is filed more than three years after the application’s filing date, no PTA is available under B-delay during the time consumed by continued examination. 

The Court, however, rejected the USPTO’s argument that the time between allowance and issuance is considered “time consumed by continued examination” and therefore would be excluded from PTA. The Court ruled that an “examination” presumptively ends at allowance because prosecution is closed and there is normally no further examination on the merits. Thus, the Court ruled that unless examination on the merits resumes, the time period from the notice of allowance until the application issues is eligible for consideration under B-term delay. 

Accordingly, the effect of the Court’s decision on an RCE is that instead of an RCE terminating the B-delay “clock,” an RCE merely tolls the B-delay clock from the time an RCE was filed until the application is allowed. The takeaway is that a recently issued patent that failed to issue within three years of the filing date of the application may benefit from a review by patent counsel. 

© Copyright 2020 Armstrong Teasdale LLP. All rights reserved National Law Review, Volume IV, Number 24
Advertisement

TRENDING LEGAL ANALYSIS

Advertisement
Advertisement

About this Author

Derick E. Allen, Intellectual Property lawyer, Armstrong Teasdale law firm
Partner

As a registered patent attorney and partner in the firm’s Intellectual Property practice group, Derick Allen assists both emerging and Fortune 500 pharmaceutical, chemical and life science-based companies with the development and application of their technologies. In view of the diverse nature of the companies Derick serves, he has developed a practical, cost-effective and business-oriented approach to secure and protect their intellectual property rights.

Derick has experience in advising such companies in the strategic development and...

314-552-4896
James Heinen, Intellectual Property, Attorney, Armstrong Teasdale, Law Firm
Associate

Jim Heinen, Jr. is a member of the firm’s Intellectual Property practice group. Registered to practice before the U.S. Patent and Trademark Office, his main focus is on the preparation and prosecution of U.S. and foreign patent applications for those in the chemical and biochemical industries.

314-259-4753
Michael G. Munsell, Armstrong Teasdale Law Firm, Intellectual Property Attorney
Partner

As a member of Armstrong Teasdale’s Intellectual Property practice, Mike Munsell provides tailored and focused representation to start-ups and mature businesses. He counsels clients on patent acquisition, licensing, enforcement issues, product clearance, freedom-to-operate, validity, IP due diligence and general business matters.

314-259-4783
Advertisement
Advertisement