Are You Getting Your Maximum Patent Term?
Due to the rapid pace of evolving technology, many patents will have lost their commercial value near the end of their full term. However for patents that are actively generating royalties, blockbuster drugs or other core technology patents, each day of lost patent term is a potential day of lost profits. While the procedures for maximizing patent term under the existing Patent Office rules are well understood, the Wyeth v. Dudas that is currently on appeal may allow patent owners the opportunity to gain significant additional patent term if steps are timely taken.
The number of days of patent term adjustment to be awarded are set forth in parts A and B of 35 U.S.C. § 154(b). Under part A, a patent gets one day of patent term adjustment (PTA) for each day the Patent Office does not provide an Office Action or Notice of Allowance beginning 14 months from the day on which the application was filed. Additional days of PTA are added for each day after four months where the PTO does not reply to a response submitted by the applicant, a decision from the Appeals Board or a decision from a Federal Court. Additional days of PTA are also awarded for each day that the Patent Office does not issue a patent within four months of the issue fee being paid.
Under part B, one day of PTA is added for each day the Patent Office does not issue a patent beginning on the third anniversary of its filing. Not included in the days of PTA awarded are any time consumed by requests for continued examination or any time where the applicant was deemed to have "failed to engage in reasonable efforts to conclude prosecution of the application."[1] The PTO rules set forth a multitude of actions for which the applicant will lose days of PTA.
The time period for a patent owner to contest the number of days of PTA awarded are strict. If an applicant does not agree with the days of PTA calculated by the Office, the applicant must submit an application for patent term adjustment no later than payment of the issue fee.[2] If the Patent Office does not revise the patent term, any requests for reconsideration of the patent term adjustment must be filed within two months of the issue date.[3] Any further remedies for the correction of the number of days of PTA awarded must be obtained in a civil action against the Director filed in the District Court for the District of Columbia within 180 days of patent grant. 35 U.S.C. § 154(b)(4).
The Wyeth v. Dudas Case
In September of 2008, the District Court for the District of Columbia decided a case brought by Wyeth and Elan Pharma International Ltd. against John Dudas in his capacity as Director for the U.S. Patent and Trademark Office. At issue is the office's interpretation of 35 U.S.C. § 154(b)(2)(A) that concerns how the days of overlap in the A and B periods are to be handled. In a nutshell, the PTO was interpreting the statute to give applicants credit for the A delay or the B delay, whichever was larger, but never the sum of the A and B delays. In contrast, it was Wyeth's position that the proper period as defined in the patent statute is the sum of the A and B periods less any period of overlap.
PTO's position is that PTA = longer of Part A or Part B.
Wyeth's position is that PTA = Part A + Part B - Overlap.
The District Court agreed with Wyeth's interpretation of how the days of PTA should be calculated.. On November 11, 2008, The Patent Office appealed the Wyeth v. Dudas case to the Court of Appeals for the District of Columbia.
What To Do Until the Wyeth Case is Decided
If the Patent Office wins the Wyeth case, then patent terms will be calculated as before. If Wyeth wins the case, then the Patent office will have to grant patents issuing after the appeal the sum of the part A and B periods less any overlap.
There is no guarantee that the Patent Office will retroactively grant additional days of patent term for other patents that are eligible. Because the time periods for contesting the number of days of PTA awarded are so strict, owner of patents that are issuing now from applications that were pending for more than 3 years may consider requesting that the PTO grant the number of days of PTA according to the formula approved in the Wyeth case before the issue fee is paid or within 2 months of issue. If the PTO does not respond or denies the request, patent owners should consider filing suit against the office within 180 days of issue in order to ensure that any such request will not be time barred.
While not every patent would justify the expense to make sure that the maximum number of days of PTA are granted, patents owners may have one more "corporate jewels" for which such efforts are warranted.
[1] 35 U.S.C. § 154(b)(2)(C)(i).
[2] 37 C.F.R. § 1.705(a).
[3] 37 C.F.R. § 1.705(d).
6 7 Wyeth v. Dudas, 580 F. Supp. 2d 138, 88 USPQ'2d 1538 (D.D.C., September 30, 2008)
