H.R. 6621 (112th) Results in Important Changes to Patent Term Adjustment
Patent Term Adjustment (PTA) is an alteration of patent term due to examination delay caused by the U.S. Patent and Trademark Office (USPTO). The USPTO is obligated to meet certain requirements related to timing during the examination of an application for patent. When these requirements are not met, the patent holder is given PTA as a remedy. The result is that the patent is enforceable beyond the base expiration date, by however many days of PTA to which the USPTO determined the patent was entitled.
The USPTO’s method of calculating PTA has been a hotly disputed issue over the last several years and Honigman Miller Schwartz and Cohn LLP has been at the forefront of the debate. See, Honigman Intellectual Property Alert, November 8, 2012. Recently, the law has been changed to answer some of the questions at the heart of the issue.
H.R. 6621 (112th) was enacted after being signed by the President on January 14, 2013. The purpose of the bill is "To correct and improve certain provisions of the Leahy-Smith America Invents Act and title 35, United States Code." There are important changes to the law regarding PTA.
In particular, the revisions will have the following impact:
- The USPTO is required to provide a determination of PTA "no later than the issuance of a patent." Before the revision to the law, the USPTO was required to provide a determination of PTA with the Notice of Allowance. One result of the revision is that pre-issue petitions for PTA will no longer be necessary. According to the Code of Federal Regulations (CFR) prescribed by the USPTO, an applicant dissatisfied with the PTA determination accompanying the Notice of Allowance is required to petition the office no later than payment of the issue fee. While a request for reconsideration of PTA can be filed within two months post-issue, under the CFR such a request cannot raise any issues that could have been raised in a pre-issue petition. However, the USPTO takes the position that "B period" delay cannot be calculated until the patent issues and thus dismisses any pre-issue petition regarding "B period" as premature. This change will prevent applicants from having to submit pre-issue petitions for "B period" delay, which are routinely denied by the USPTO, solely for the purpose of complying with the CFR. Unfortunately, a second result of the revision is that the applicant may have significantly less time between learning the USPTO’s determination of "A period" delay and the deadline for filing the request for reconsideration.
- A civil action may be brought by a patent holder dissatisfied with the Director’s decision on the request for reconsideration of PTA. Previously, the law allowed a patent holder to appeal the Director’s determination of PTA. The former law did not require the patent holder to first submit a petition with the USPTO. The result of the revision might prevent civil suits in cases where a request for reconsideration was not first filed with the USPTO.
- The deadline for filing a civil suit is now 180 days from the date of the Director’s decision on the request for reconsideration. Previously, the law stated that any civil action to appeal the determination of PTA had to be filed within 180 days after the grant of the patent. This revision is in line with the District Court’s decision in Bristol-Myers Squibb Co. v. Kappos, No. 1:09-cv-01330-EGS, 2012 WL 252423 (D.D.C. Jan. 27, 2012), which held that the deadline for challenging the determination of PTA is tolled by the filing of a petition for review by the USPTO.
- For international applications filed under 35 U.S.C. § 371, the calculation of "A period" and "B period" delay will begin with the "commencement of the national stage." Previously, "A period" was calculated from the fulfillment of the requirements of section 371 and "B period" was calculated from the actual filing date of the application in the United States. In reality, the change will only effect the determination of "A period" delay, because the CFR already states that "B period" is calculated from commencement of the national stage. While the USPTO was not initially complying with its own regulations, it issued a formal notification acknowledging its error on September 9, 2009 as the result of a petition by Japan Tobacco. In most cases, this change will favor patent holders. However, it is important to note that in the case where an applicant files the national application early, but does not expressly state the intent to commence processing at that time, the national stage will not commence for purposes of PTA calculation until the expiration of 30 months from the earliest priority date.
The full text of the bill can be found here: http://www.govtrack.us/congress/bills/112/hr6621/text.
Feel free to contact Noel E. Day, Ph.D., Thomas A. Wootton or Jonathan P. O’Brien, Ph.D. with any questions you may have regarding Patent Term Adjustment.