Because No One is Immune to the Law
June 11, 2019 - United States, Biotech, Pharma, Intellectual Property

Patent Term Adjustment: A Post-Supernus Update from the Patent and Trademark Office

A New Year's Gift for Patent Applicants?

On May 9, the United States Patent and Trademark Office (“PTO”) published a notice in the Federal Register that it is modifying its patent term adjustment (“PTA”) procedures in view of the Federal Circuit’s decision in Supernus Pharmaceuticals v. Iancu.[1] Under the PTO Duty of Disclosure requirements, patent applicants are required to disclose any information that may be material to the patentability of an application, which can include documents cited by a foreign patent authority in a counterpart application. A failure to disclose such information in a timely manner can result in a reduction of PTA, which is a mechanism to add patent term for delays caused by the PTO, subject to reduction if the patentee fails to engage in reasonable efforts to conclude prosecution. 

The PTO currently uses a system designated Patent Application Locating and Monitoring (“PALM”) to track information relevant to PTA calculations. However, PALM is only equipped to register internal PTO events. Thus, the provision of information received from a foreign patent authority may not be recognized by PALM as a relevant prosecution event and can result in inaccurate PTA calculations, as demonstrated by the Supernus case. There, the PTO incorrectly reduced the PTA of a patent by 546 days, during which time the patentee had not yet received notice of the information from the foreign patent authority and was therefore incapable of disclosing the information to the PTO.  

Responding to the Supernus decision, the Federal Register Notice asserts that the PTO will continue to use PALM to calculate PTA based solely on internal events, but announces a procedure to allow a patentee to request reconsideration of PTA calculation under 37 CFR 1.705(b) if “there was no identifiable effort the patentee could have under taken to conclude prosecution.” The request must include the relevant information not recorded in the PALM system and the required fee, and must be filed within two months of patent grant. An extension of up to five months may be obtained by paying additional fees. Patentees are encouraged to work with counsel to review PTA of a granted patent to ensure all PTA to which a patent is entitled has been awarded.

[1] Supernus Pharm., Inc. v. Iancu, 913 F.3d 1351 (Fed. Cir. 2019).