Under Wyeth v. Kappos, decided January 7, 2010 by the Court of Appeals for the Federal Circuit (Federal Circuit), if your U.S. patent failed to issue within three years from the filing date, the Patent & Trademark Office (PTO) may have under-calculated the adjustment of the term of your patent due to examination delays. If you have an allowed application, an application for which you recently paid the issue fee, or a patent that issued within the last six months, you are encouraged to review the Wyeth decision to verify that the PTO has determined the proper adjustment to your patent term. You should act quickly, because the right to contest the PTO's term calculations otherwise might expire.
Essentially, the Federal Circuit ruled that the Patent Office misinterpreted the law by "overlapping" certain examination delays that are required by the law to be "added together" when determining the adjustment of the term of a patent. Accordingly, under the Wyeth decision, many allowed applications and soon to issue and issued patents are entitled to a patent term adjustment beyond that calculated by the Patent Office.
Background
By way of background, the term of a patent filed on or after June 8, 1995 begins on the date the patent issues and ends 20 years from the filing date. It follows that the longer the Patent Office takes to examine a patent application, the shorter the effective life of the patent. To account for delays in the examination process, the law provides for "patent term adjustment" (PTA). The PTA laws provide for an extension of patent term for certain PTO delays.
There are two types of delay at issue in the Wyeth case - Type A and Type B delays. Type A delays accumulate if: 1) the PTO does not issue a substantive examination within 14 months from the filing date, 2) the PTO fails to respond to a reply or appeal within four months from the date the reply was filed or appeal was taken, 3) the PTO fails to take action within four months from the date of a decision by the Patent Board or a Federal court, or 4) the PTO does not issue the patent within four months from payment of the issue fee.
Type B delay accumulates if the patent fails to issue within three years from the filing date, not counting time consumed by a request for continued examination and/or during certain activities such as interference proceedings, secrecy orders, and appellate reviews.
Any available extension is limited by applicant delays and terminal disclaimers1. Additionally, the law provides that Type A delays may not overlap with Type B delays. The Wyeth decision centered on what was meant by delay overlaps.
The PTO took the position that the Type A and Type B delays ran concurrently and determined PTA as the larger of the Type A and B delays. In contrast, Wyeth countered that the Patent Act requires the Type A and Type B delays to be added together, except when the delays actually occur on the very same day, when the delays run concurrently. The Federal Circuit sided with Wyeth.
Example
Whether the Type A and Type B delays overlap or add together is significant. Take, for example2, an application in which a substantive examination (First Action) is mailed at 25 months, a reply is received at the PTO at 28 months, a Second Action is mailed at 31 months, a reply is received at the PTO at 34 months, a Notice of Allowance is mailed at 37 months, the issue fee is paid at 40 months, and the patent issues at 44 months.
Patent Office Determination of PTA = 11 months
Wyeth Determination of PTA = 19 months
Patent Owner is entitled to an additional 8 months of PTA!
For this application, the Type A delay is 11 months, because a substantive examination was not issued within 14 months from the filing date. The Type B delay is eight months, because the patent failed to issue within three years from the filing date.
Under the PTO's calculation, the delays run concurrently, thus the PTA is the larger of the Type A delay (11 months) and the Type B delay (8 months), that is, 11 months. Under Wyeth's calculation, the delays are added together. Thus the PTA is the sum of the Type A delay (11 months) and the Type B delay (8 months), that is, 19 months.
This makes a difference of eight months!
What Can You Do?
What can you do to get more PTA under Wyeth? Audit and act by the proper time. Audit your allowed applications and patents issued within the last six months for Type B delays, i.e., patents pending for longer than three years. If you have Type B delays and the right Type A delays, you may be entitled to a longer patent term than indicated by the PTO.
To act, you may file a petition with the Patent Office for reconsideration of the PTA on or before payment of the issue fee, or, if your patent has issued, within two months from the issue date.
If dissatisfied with a determination made by the Patent Office, you may seek judicial review in the U.S. District Court for the District of Columbia within 180 days from issuance.
If you missed these deadlines, the law is not clear as to whether the PTO's term calculations are binding. In other words, you may be entitled to a longer patent term irrespective of whether the PTO calculated the term correctly.
Alternatively, you may wish to investigate the mechanisms under Chapter 25 of the Patent Act for correcting a patent. A certificate of correction fixes a mistake incurred through the fault of the Patent Office or the patentee. A reissue corrects a defect in a patent resulting from an error, including, for example, not only an error of fact but also an error of law. One or both of these mechanisms may be available to amend PTA, because the Patent Office under-calculated the term of your patent. Beware of timeliness. Under Ex Parte Anthony, 230 U.S.P.Q. 467 (Bd. Pat. App. & Interferences 1982), substitution of a later expiration date would necessarily vertically or temporally broaden the scope of the patented claims, therefore such activity would be considered to be statutorily time barred unless reissue were filed within two years from the issuance of the patent.
In Bayer AG v. Carlsbad Technology Inc., 64 U.S.P.Q.2d 1045 (Fed. Cir. 2002), the patentee used a petition to have the Patent Office correct its records substituting a later expiration date for a prior expiration date of a patent set forth in a terminal disclaimer. On the reasoning that a new law altered the patent term from seventeen years from the date of issuance to twenty years from the date of filing, the expiration date changed by operation of law. By way of comparison, for an analogous new law, that of the decision in Wyeth altering PTA, the expiration date changes, thus requiring the Patent Office to correct its records.
Many allowed applications, applications where issue fees have been recently paid, and recently issued patents are entitled to additional PTA beyond that calculated by the PTO under Wyeth. You can take steps now to preserve your ability to obtain additional PTA. Actions taken now can be tailored to your specific needs. In Bayer, the patentee used a petition to have the Patent Office correct its records, filing the petition within one month of the adoption of the new law. If the Patent Office under-calculated the term of your patent, you may be able to get more PTA if you audit and act by the proper time.
1Applicant delays reduce the adjusted term of the patent. In general, an applicant who fails to conclude processing within three months is charged with delay; shortened statutory periods have no effect. Terminal disclaimers prohibit the patent term from extending beyond the full patent term of the patent or application to which the disclaimer is filed.
2For simplicity, "months" are used in this example although patent term adjustments are determined as a number of "days."
No comments:
Post a Comment