Term of patent in the United States
Encyclopedia
In the United States
, under current patent law
, the term of patent, provided that maintenance fee
s are paid on time, are:
The patent term
in the United States was changed in 1995 to bring U.S. patent law into conformity with the World Trade Organization
's Agreement on Trade-Related Aspects of Intellectual Property Rights
(TRIPs) as negotiated in the Uruguay Round
. As a side effect, it is no longer possible to maintain submarine patent
s in the U.S., since the patent term now depends on the priority date, not the issue date.
Design patent
s, unlike utility patents, have a term of 14 years from the date of issue.
fails to examine a patent application in time (deadlines for various steps are different), the patent term may be extended. Extensions or other delay taken by the applicant can reduce or eliminate the extension. The patent term may also be reduced by any disclaimer (called a "terminal disclaimer") to the patent term.
A reexamined
patent expires on the day the original granted patent would have ordinarily expired.
Example: The validity of a patent (filing: January 1, 2000; issue: January 1, 2002; end: January 1, 2020) is challenged. The USPTO issues a more restricted patent on January 1, 2004. The reexamined patent is in force until January 1, 2020, assuming payment of all maintenance fees.
The Patent Cooperation Treaty
provides a process for a patent filing to claim the priority date of an earlier foreign patent application. Within one year of filing a patent application in one country, an international patent application (which "designates" certain other countries, by default all contracting states) can be made. This holds the original priority date and starts the 20-year validity clock, while allowing the actual patent application in the designated countries (and the associated expenses) to be deferred an additional 20 months. Such a patent would expire earlier than 20 years after U.S. filing.
in light of one of the applicant's existing patents, the applicant may be required by the USPTO to disclaim a part of the term. For example, an applicant's patent A expires on December 24, 2000. The applicant filed another patent application two years later. Under some conditions, the second patent might expire later than the first. If the applicant files a terminal disclaimer, then the second patent will expire at the same time as the first, the extra portion having been disclaimed. In filing the terminal disclaimer, the applicant also agrees that the second patent will only be enforceable if it and the first patent are commonly owned.
The terminal disclaimer is not always carved in stone. After the Uruguay Round Agreements Act of 1994 (URAA), some patents with terminal disclaimers are eligible to a term extension because their referenced patents received a term extension because of the URAA. This has been discussed in the Manual of Patent Examining Procedure
:
However, a terminal disclaimer does not negate Patent Term Extension that has been granted under 35 U.S.C. 156.
In a pharmaceutical patent dispute, Teva argued that Wyeth’s patent on zaleplon drug products (Sonata) had expired because of a terminal disclaimer. Wyeth (and its exclusive licensee King) argued that patent’s term was ongoing because of a Patent Term Extension due to FDA regulatory review delay. Under 35 U.S.C. 156(a), the term of a patent "shall be extended" after a series of provisions are satisfied. The district court found the language of the statute unambiguous and gives the court "no discretion".
Thus, if the enumerated conditions are satisfied, the patentee is entitled to a term extension calculated pursuant to Section 156. Teva's motion to dismiss was consequently denied because "a terminally disclaimed patent is eligible for extension under [Section] 156." The case is interesting because the patentee in the first instance had expressly disclaimed term subsequent to 2003 to get the patent granted. However, the holding of this case does not apply to Patent Term Adjustment granted under 35 U.S.C. 154. Such term adjustments will be subject to any terminal disclaimer that has been filed.
There is now a similar case wherein a company was given extension under S.156 and the generic entrant arguing against such extension between Merck
and Hi-tech for a drug called "dorzolamide" (TRUSOPT/COSOPT). Here too, the first company (Merck) had filed a standard form terminal disclaimer. This patent was later given an extension and became the crux of the litigation.
(Hatch-Waxman Act) of 1984 provides patent holders on approved patented products with an extended term of protection under the patent to compensate for the delay in obtaining Food and Drug Administration
(FDA) approval.
Merck & Co., Inc. v. Hi-Tech Pharmacal Co., Inc. ruled that patents extended under Hatch-Waxman are still eligible to URAA term extension. However, patents in force on June 8, 1995 solely because of the Hatch-Waxman term adjustment are not eligible.
United States
The United States of America is a federal constitutional republic comprising fifty states and a federal district...
, under current patent law
United States patent law
United States patent law was established "to promote the Progress of Science and useful Arts, by securing for limited Times to Authors and Inventors the exclusive Right to their respective Writings and Discoveries;" as provided by the United States Constitution. Congress implemented these...
, the term of patent, provided that maintenance fee
Maintenance fee (patent)
Maintenance fees or renewal fees are fees that are paid to maintain a granted patent in force. Some patent laws require the payment of maintenance fees for pending patent applications. Not all patent laws require the payment of maintenance fees and different laws provide different regulations...
s are paid on time, are:
- For applicationPatent applicationA patent application is a request pending at a patent office for the grant of a patent for the invention described and claimed by that application. An application consists of a description of the invention , together with official forms and correspondence relating to the application...
s filed on or after June 8, 1995, the patent term is 20 years from the filing date of the earliest U.S. application to which priority is claimed (excluding provisional applications). - For applications that were pending on and for patents that were still in force on June 8, 1995, the patent term is either 17 years from the issue date or 20 years from the filing date of the earliest U.S. or international (PCTPatent Cooperation TreatyThe Patent Cooperation Treaty is an international patent law treaty, concluded in 1970. It provides a unified procedure for filing patent applications to protect inventions in each of its contracting states...
) application to which priority is claimed (excluding provisional applications), the longer term applying.
The patent term
Term of patent
The term of a patent is the maximum period during which it can be maintained into force. It is usually expressed in number of years either starting from the filing date of the patent application or from the date of grant of the patent. In most patent laws, renewal annuities or maintenance fees have...
in the United States was changed in 1995 to bring U.S. patent law into conformity with the World Trade Organization
World Trade Organization
The World Trade Organization is an organization that intends to supervise and liberalize international trade. The organization officially commenced on January 1, 1995 under the Marrakech Agreement, replacing the General Agreement on Tariffs and Trade , which commenced in 1948...
's Agreement on Trade-Related Aspects of Intellectual Property Rights
Agreement on Trade-Related Aspects of Intellectual Property Rights
The Agreement on Trade Related Aspects of Intellectual Property Rights is an international agreement administered by the World Trade Organization that sets down minimum standards for many forms of intellectual property regulation as applied to nationals of other WTO Members...
(TRIPs) as negotiated in the Uruguay Round
Uruguay Round
The Uruguay Round was the 8th round of Multilateral trade negotiations conducted within the framework of the General Agreement on Tariffs and Trade , spanning from 1986-1994 and embracing 123 countries as “contracting parties”. The Round transformed the GATT into the World Trade Organization...
. As a side effect, it is no longer possible to maintain submarine patent
Submarine patent
A submarine patent is a patent whose issuance and publication are intentionally delayed by the applicant for a long time, such as several years. This strategy requires a patent system where patent applications are not published. In the United States, patent applications filed before November 2000...
s in the U.S., since the patent term now depends on the priority date, not the issue date.
Design patent
Design patent
In the United States, a design patent is a patent granted on the ornamental design of a functional item. Design patents are a type of industrial design right. Ornamental designs of jewelry, furniture, beverage containers and computer icons are examples of objects that are covered by design...
s, unlike utility patents, have a term of 14 years from the date of issue.
History
The original patent term under the 1790 Patent Act was "not exceeding fourteen years". The 1836 Patent Act (5 Stat. 117, 119, 5) provided (in addition to the fourteen year term) an extension "for the term of seven years from and after the expiration of the first term" in certain circumstances. In 1861 the seven year extension was eliminated and the term changed to seventeen years (12 Stat. 246, 249, 16). The signing of the 1994 Uruguay Round Agreements Act then changed the patent term from seventeen years from the date of issue to the current twenty years from the earliest filing date.| Year | Validity [Years] |
|---|---|
| -1789 | - |
| 1790–1835 | 14 |
| 1836–1860 | 21 |
| 1861–1994 | 17 |
| 1995- | 20 |
Adjustments possible under current law
If the United States Patent and Trademark OfficeUnited States Patent and Trademark Office
The United States Patent and Trademark Office is an agency in the United States Department of Commerce that issues patents to inventors and businesses for their inventions, and trademark registration for product and intellectual property identification.The USPTO is based in Alexandria, Virginia,...
fails to examine a patent application in time (deadlines for various steps are different), the patent term may be extended. Extensions or other delay taken by the applicant can reduce or eliminate the extension. The patent term may also be reduced by any disclaimer (called a "terminal disclaimer") to the patent term.
A reexamined
Reexamination
In United States patent law, a reexamination is a process whereby a third party or inventor can have a patent reexamined by a patent examiner to verify that the subject matter it claims is patentable...
patent expires on the day the original granted patent would have ordinarily expired.
Example: The validity of a patent (filing: January 1, 2000; issue: January 1, 2002; end: January 1, 2020) is challenged. The USPTO issues a more restricted patent on January 1, 2004. The reexamined patent is in force until January 1, 2020, assuming payment of all maintenance fees.
The Patent Cooperation Treaty
Patent Cooperation Treaty
The Patent Cooperation Treaty is an international patent law treaty, concluded in 1970. It provides a unified procedure for filing patent applications to protect inventions in each of its contracting states...
provides a process for a patent filing to claim the priority date of an earlier foreign patent application. Within one year of filing a patent application in one country, an international patent application (which "designates" certain other countries, by default all contracting states) can be made. This holds the original priority date and starts the 20-year validity clock, while allowing the actual patent application in the designated countries (and the associated expenses) to be deferred an additional 20 months. Such a patent would expire earlier than 20 years after U.S. filing.
Terminal disclaimer
If a patent application is obviousInventive step and non-obviousness
The inventive step and non-obviousness reflect a same general patentability requirement present in most patent laws, according to which an invention should be sufficiently inventive — i.e., non-obvious — in order to be patented....
in light of one of the applicant's existing patents, the applicant may be required by the USPTO to disclaim a part of the term. For example, an applicant's patent A expires on December 24, 2000. The applicant filed another patent application two years later. Under some conditions, the second patent might expire later than the first. If the applicant files a terminal disclaimer, then the second patent will expire at the same time as the first, the extra portion having been disclaimed. In filing the terminal disclaimer, the applicant also agrees that the second patent will only be enforceable if it and the first patent are commonly owned.
The terminal disclaimer is not always carved in stone. After the Uruguay Round Agreements Act of 1994 (URAA), some patents with terminal disclaimers are eligible to a term extension because their referenced patents received a term extension because of the URAA. This has been discussed in the Manual of Patent Examining Procedure
Manual of Patent Examining Procedure
The Manual of Patent Examining Procedure is published by the United States Patent and Trademark Office for use by patent attorneys and agents and patent examiners. It describes all of the laws and regulations that must be followed in the examination of U.S. patent applications, and articulates...
:
- To determine the "original expiration date" of a patent subject to a terminal disclaimer, it is generally necessary to examine the language of the terminal disclaimer in the patent file history. If the disclaimer disclaims the terminal portion of the term of the patent which would extend beyond the expiration date of an earlier issued patent, then the expiration date of the earlier issued patent determines the expiration date of the patent subject to the terminal disclaimer. Before June 8, 1995, the terminal disclaimer date was printed on the face of the patent; the date was determined from the expected expiration date of the earlier issued patent based on a seventeen year term measured from grant. When 35 U.S.C. 154 was amended such that all patents (other than design patents) that were in force on June 8, 1995, or that issued on an application that was filed before June 8, 1995, have a term that is the greater of the "twenty year term" or seventeen years from the patent grant, the terminal disclaimer date as printed on many patents became incorrect. If the terminal disclaimer of record in the patent file disclaims the terminal portion of the patent subsequent to the full statutory term of a referenced patent (without identifying a specific date), then the date printed on the face of the patent is incorrect when the full statutory term of the referenced patent is changed as a result of 35 U.S.C. 154(c). That is, the referenced patent's "twenty year term" is longer than the seventeen year term. In such a case, a patentee may request a Certificate of Correction under 37 CFR 1.323 to correct the information printed on the face of the patent. However, if the terminal disclaimer of record in the patent file disclaims the terminal portion of the patent subsequent to a specific date, without reference to the full statutory term of a referenced patent, then the expiration date is the date specified. Several decisions related to disclaimers are posted in the Freedom of Information Act (FOIA) section of the USPTO Internet site (www.uspto.gov).
However, a terminal disclaimer does not negate Patent Term Extension that has been granted under 35 U.S.C. 156.
In a pharmaceutical patent dispute, Teva argued that Wyeth’s patent on zaleplon drug products (Sonata) had expired because of a terminal disclaimer. Wyeth (and its exclusive licensee King) argued that patent’s term was ongoing because of a Patent Term Extension due to FDA regulatory review delay. Under 35 U.S.C. 156(a), the term of a patent "shall be extended" after a series of provisions are satisfied. The district court found the language of the statute unambiguous and gives the court "no discretion".
Thus, if the enumerated conditions are satisfied, the patentee is entitled to a term extension calculated pursuant to Section 156. Teva's motion to dismiss was consequently denied because "a terminally disclaimed patent is eligible for extension under [Section] 156." The case is interesting because the patentee in the first instance had expressly disclaimed term subsequent to 2003 to get the patent granted. However, the holding of this case does not apply to Patent Term Adjustment granted under 35 U.S.C. 154. Such term adjustments will be subject to any terminal disclaimer that has been filed.
There is now a similar case wherein a company was given extension under S.156 and the generic entrant arguing against such extension between Merck
Merck & Co.
Merck & Co., Inc. , also known as Merck Sharp & Dohme or MSD outside the United States and Canada, is one of the largest pharmaceutical companies in the world. The Merck headquarters is located in Whitehouse Station, New Jersey, an unincorporated area in Readington Township...
and Hi-tech for a drug called "dorzolamide" (TRUSOPT/COSOPT). Here too, the first company (Merck) had filed a standard form terminal disclaimer. This patent was later given an extension and became the crux of the litigation.
Hatch-Waxman
The Drug Price Competition and Patent Term Restoration ActDrug Price Competition and Patent Term Restoration Act
-Overview:The Drug Price Competition and Patent Term Restoration Act, informally known as the "Hatch-Waxman Act" [Public Law 98-417], is a 1984 United States federal law which established the modern system of generic drugs...
(Hatch-Waxman Act) of 1984 provides patent holders on approved patented products with an extended term of protection under the patent to compensate for the delay in obtaining Food and Drug Administration
Food and Drug Administration
The Food and Drug Administration is an agency of the United States Department of Health and Human Services, one of the United States federal executive departments...
(FDA) approval.
Merck & Co., Inc. v. Hi-Tech Pharmacal Co., Inc. ruled that patents extended under Hatch-Waxman are still eligible to URAA term extension. However, patents in force on June 8, 1995 solely because of the Hatch-Waxman term adjustment are not eligible.
Further reading
- For a detailed description of the laws and rules governing patent terms in the U.S., see the Manual of Patent Examining ProcedureManual of Patent Examining ProcedureThe Manual of Patent Examining Procedure is published by the United States Patent and Trademark Office for use by patent attorneys and agents and patent examiners. It describes all of the laws and regulations that must be followed in the examination of U.S. patent applications, and articulates...
, Chapter 2700.
External links
- Contents and term of patent; provisional rights- 2701 Patent Term - 2700 Patent Terms and Extensions in Manual of Patent Examining ProcedureManual of Patent Examining ProcedureThe Manual of Patent Examining Procedure is published by the United States Patent and Trademark Office for use by patent attorneys and agents and patent examiners. It describes all of the laws and regulations that must be followed in the examination of U.S. patent applications, and articulates...
(MPEP), USPTO