Chapter 2700: Patent Terms
This chapter discusses the intricacies involved with patent terms including how a term may be adjusted or extended.
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For applications filed on or after June 8, 1995 the Uruguay Round Agreements Act amended 35 U.S.C. 154 to provide that the term of a patent (other than a design patent) begins on the date the patent issues and ends on the date that is twenty years from the date on which the application for the patent was filed in the United States or, if the application contains a specific reference to an earlier filed application or applications under 35 U.S.C. 120, 121, or 365(c), twenty years from the filing date of the earliest of such application(s). This patent term provision is referred to as the “twenty-year term.”
Design patents have a term of fourteen years from the date of patent grant, except for any design patent issued from applications filed on or after the date of entry into force of the Hague Treaty as to the United States, has a term of fifteen years from the date of patent grant.
This section provides further coverage on the terms of different application types including; continuing and international applications. It also discusses the impact of foreign priority, domestic benefits, and terminal disclaimers on patent terms.
Utility and plant patents issuing on applications filed on or after May 29, 2000 are eligible for the patent term adjustment provisions of 35 U.S.C. 154(b) (effective May 29, 2000 and amended thereafter) and 37 CFR 1.702 -1.705. Since the term of a design patent is not affected by the length of time prosecution takes place, there are no patent term adjustment provisions for design patents.
This section discusses the rules of patent terms for applications filed between June 8, 1995 and May 28, 2000. Essentially, the 20-year term for patents issuing from applications filed between these dates may be extended for a maximum of 5 years for delays in the issuance of the patent.
This section covers the grounds for adjustment in applications filed on or after May 29, 2000. Essentially, a patent is entitled to patent term adjustment if the Office fails to perform certain acts of examination within specified time frames.
37 CFR 1.703 specifies the period of adjustment if a patent is entitled to patent term adjustment under 35 U.S.C. 154(b)(1) and 37 CFR 1.702.
When a period is indicated as “beginning” on a particular day, that day is included in the period, in that such day is “day one” of the period and not “day zero.” For example, a period beginning on April 1 and ending on April 10 is ten (and not nine) days in length.
This section covers the reduction of the period of adjustment of the patent term. Essentially, the period of adjustment shall be reduced by a period equal to the period of time during which the applicant failed to engage in reasonable efforts to conclude prosecution (i.e., processing or examination) of an application. This section further covers the circumstances that constitute a failure of an applicant to engage in reasonable efforts to conclude processing or examination of the application. Many other details are discussed.
The AIA Technical Corrections Act was enacted on January 14, 2013. The AIA Technical Corrections Act revises the patent term adjustment provisions and is effective for any patent granted on or after January 14, 2013.
A patentee may file a terminal disclaimer at any time disclaiming any period considered in excess of the appropriate patent term adjustment. Note that the Office does not require patentee to file either a request for reconsideration or a terminal disclaimer when the patent term adjustment indicated on the patent is greater than what the patentee believes is appropriate.
Any request for reconsideration of the patent term adjustment indicated on the patent must be by way of an application for patent term adjustment which must filed within two months of the date the patent was granted and accompanied by the fee and a statement of the facts involved. This section further covers the due care showing when requesting a patent term adjustment.
No submission or petition on behalf of a third party concerning patent term adjustment under 35 U.S.C. 154(b) will be considered by the Office, and that any such submission or petition will be returned to the third party, or otherwise disposed of, at the convenience of the Office.
The right to a patent term extension based upon regulatory review is the result of the Drug Price Competition and Patent Term Restoration Act of 1984. The statute enables the owners of patents on certain human drugs, food or color additives, medical devices, animal drugs, and veterinary biological products to restore to the terms of those patents some of the time lost while awaiting premarket government approval from a regulatory agency. This section provides further details on these term extensions.
35 U.S.C. 156(a) sets forth what patents can be extended and the conditions under which they may be extended. 37 CFR 1.710 also addresses the patents that may be extended, and 37 CFR 1.720 describes the conditions under which a patent may be extended.
This section also covers the fact that patents may be extended under 35 U.S.C. 156 even though it has been terminally disclaimed. In addition, it covers the meaning of a product as defined in 35 U.S.C. 156. Further details on 35 U.S.C. 156 are provided.
This section covers the signature requirements for the extension of a patent term as well as the date of the filing of the extension.
37 CFR 1.740 sets forth the requirements for a formal application for extension of patent term. The requirements consist of a complete identification of the approved product as by appropriate chemical and generic name, physical structure or characteristics so as to enable the Director to make a determination of whether the patent claims the approved product, or a method of using or manufacturing the approved product. In addition, a complete identification of the federal statute including the applicable provision of law under which the regulatory review occurred. When the regulatory review of the product took place under more than one Federal statute, each appropriate statute should be listed. This section covers further details on the contents of an application for extension of a patent term.
The filing date of an application for patent term extension is the date on which a complete application is received in the USPTO or filed pursuant to the certificate of mailing provisions or the Express Mail provisions. Patent term extension applications must not be filed by facsimile or the Office’s electronic filing system (EFS-Web). However correspondence setting forth a change of address and other papers relating to a patent term extension may be sent by facsimile to the Office of Patent Legal Administration or via EFS-Web.
This section covers details on the determination as to whether a patent is eligible for extension.
This section covers the correspondence between the USPTO and the regulatory agency when dealing with patent term extensions. Information regarding eligibility for extension and the preliminary eligibility decision are discussed.
The regulatory agency is responsible for the determination of the length of the regulatory review period for the approved product on which the application for patent term extension is based.
The determination by the regulatory agency is made based on the application as well as the official regulatory agency records for the approved product. The determination of the length of the regulatory review period is solely the responsibility of the regulatory agency. Further details are discussed on the regulatory agencies determination of the length of the regulatory review period.
After reviewing the information provided by the regulatory agency, if the Office determines the patent to be eligible for extension, the Office then calculates the length of extension for which the patent is eligible under the appropriate statutory provisions. This section provides further details on the calculation of the patent term extension.
Once a determination is made pursuant to 37 CFR 1.750 that a patent is eligible for extension of its term, a certificate of extension, under seal, will be issued to the patent owner at the correspondence address specified in the application for patent term extension. Upon issuance of the certificate of extension, a notice is published in the Official Gazette.
This section covers the handling of potentially confidential material within an application for patent term extension. Essentially, this information will not be made public as part of the patent file before a certificate of extension is filed. Further information on the expungement of confidential information from the patent file is covered.
Only one patent may be extended for a regulatory review period for any product. If more than one application for extension is filed for a single patent by different applicants, the certificate of extension of the term of the patent, if appropriate, would be issued based upon the first filed application for extension of patent term. Further information on multiple applications for extension of a patent's term is provided here.
A duty of candor and good faith rests on the patent owner or its agent, on each attorney or agent who represents the patent owner, and on every other individual who is substantively involved on behalf of the patent owner in a patent term extension proceeding.
All such individuals who are aware, or become aware, of material information adverse to a determination of entitlement to the extension sought, which has not been previously made of record in the patent term extension proceeding, must bring such information to the attention of the Office or the Secretary as soon as it is practicable to do so after the individual becomes aware of the information.
Information is “material” when there is a substantial likelihood that the Office or the Secretary would consider it important in determinations to be made in the patent term extension proceeding.
Although the statute specifically provides for public input into the determination of the regulatory review period, i.e., the filing of a due diligence petition before the regulatory agency, no such provision was made for proceedings before the Office.
Since applicant already has a duty of disclosure to both the Office and the regulatory agency, and Congress expected that it would be an administratively simple proceeding, no input from third parties is permitted.
Accordingly, 37 CFR 1.765(d) precludes submissions to the Office by or on behalf of third parties, thereby making patent term extension proceedings in the Office an ex parte matter between the patent owner or its agent and the Office.
Any request for withdrawal of an application for extension of patent term after a determination has been made pursuant to 37 CFR 1.750 must be submitted on or before the date permitted for reply to the final determination, and be accompanied by a petition under 37 CFR 1.182 with the appropriate petition filing fee.
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