Term of patent in the United States

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Under United States patent law, the term of patent, provided that maintenance fees are paid on time, is 20 years from the filing date of the earliest U.S. or international (PCT) application to which priority is claimed (excluding provisional applications). [1] [2] [3]

Contents

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 patents in the U.S., since the patent term now depends on the filing date, not the issue date.

Design patents have a shorter term than utility patents. Design patents filed on or after May 13, 2015, have a term of 15 years from issuance. [4] [5] Design patents filed prior to May 13, 2015, have a term of 14 years from issuance. [6]

History

The original patent term under the 1790 Patent Act was decided individually for each patent, but "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, when the inventor hasn't got "a reasonable remuneration for the time, ingenuity, and expense". In 1861 the seven-year extension was eliminated and the term changed to seventeen years (12  Stat.   246, 248). The enactment 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 filedMaximum term of validityEstablished by
-1789--
1790–183514 years from issuance Patent Act of 1790
1836–186021 years from issuance Patent Act of 1836
1861–199417 years from issuance Pub. L. Tooltip Public Law (United States)  36–88 (12  Stat.   246)
1995-20 years from filing Uruguay Round Agreements Act

Adjustments possible under current law

USPTO processing extension

If the United States Patent and Trademark Office (USPTO) fails to examine a patent application in time (deadlines for various steps are different), the patent term may be extended. [7] Extensions or other delay taken by the applicant can reduce or eliminate the extension. [7]

This extension is known as a patent term adjustment (PTA). Its intention is to accommodate for delays caused by the USPTO during the prosecution of a US patent application. The total PTA is an addition to the 20-year lifespan of a US patent. The delays are broadly classified into 4 types:

Calculation:

Reissue and reexamination

Even if the scope of a patent is narrowed, neither reissue nor reexamination changes the original expiration date. A reissued or 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 Certificate of Reexamination on January 1, 2004. The reexamined patent is in force until January 1, 2020, assuming payment of all maintenance fees.

FDA approval extension

The Drug Price Competition and Patent Term Restoration Act (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. [11] ruled that patents extended under Hatch-Waxman are still eligible to URAA[ clarification needed ] term extension. However, patents in force on June 8, 1995, solely because of the Hatch-Waxman term adjustment are not eligible.

Patent Term Adjustment (PTA) and Patent Term Extension (PTE) compensate a patent applicant for delays that occur during patent prosecution. Patent Term Adjustment (PTA) (see above) compensates applicants for USPTO-caused delays; Patent Term Extension (PTE) compensates a patent owner for delays caused by the regulatory review (e.g. by FDA) before a product can be commercially marketed. PTA and PTE lengthen the term of the patent, theoretically permitting patent owners to enjoy more than 20-year patent term from the time of first non-provisional filing. [12] [ better source needed ]

Terminal disclaimer

A terminal disclaimer is a process by which a patent's term is shortened because it duplicates the claims of another patent which expires sooner. If any claim of a pending patent application would have been obvious in light of at least one claim of the applicant's issued patents, the USPTO may reject that claim for obviousness-type double patenting and require the applicant to disclaim a part of the term of the pending application. 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 (based upon the respective earliest claimed priority dates). If the applicant is required to file, and does file, a terminal disclaimer in the later filed patent, then the later filed patent will expire at the same time as the earlier filed patent, the extra term having been disclaimed ("terminal disclaimer"). In filing the terminal disclaimer, the later filed patent and the earlier filed patent must be, and remain, commonly owned. In the case of co-pending applications, either or both of the applications may have claims rejected for obviousness-type double patenting, and a terminal disclaimer may be required in either or both, in which case the earlier expiration date will control.

After the Uruguay Round Agreements Act of 1994 (URAA), some patents with terminal disclaimers were eligible for a term adjustment because their referenced patents received a term adjustment under the URAA. Patents whose parents received extensions were eligible to file to receive a similar extension, because the claims they depended on were still protected. This has been discussed in the Manual of Patent Examining Procedure . [13]

A terminal disclaimer does not negate Patent Term Extension that has been granted under 35 U.S.C. 156. [14] 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. [15]

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 the drug dorzolamide (Trusopt). 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. [16]

See also

Related Research Articles

Under United States patent law, a continuing patent application is a patent application that follows, and claims priority to, an earlier-filed patent application. A continuing patent application may be one of three types: a continuation, divisional, or continuation-in-part. Although continuation and continuation-in-part applications are generally available in the U.S. only, divisional patent applications are also available in other countries, as such availability is required under Article 4G of the Paris Convention.

An interference proceeding, also known as a priority contest, is an inter partes proceeding to determine the priority issues of multiple patent applications. It is a proceeding unique to the patent law of the United States. Unlike in most other countries, which have long had a first-to-file system, until the enactment of the Leahy-Smith America Invents Act (AIA) in 2011, the United States operated under a first-to-invent. The interference proceeding determines which of several patent applications had been made by the first inventor.

Patent prosecution describes the interaction between applicants and their representatives, and a patent office with regard to a patent, or an application for a patent. Broadly, patent prosecution can be split into pre-grant prosecution, which involves arguing before, and sometimes negotiation with, a patent office for the grant of a patent, and post-grant prosecution, which involves issues such as post-grant amendment and opposition.

<span class="mw-page-title-main">Design patent</span> US Patent Law

In the United States, a design patent is a form of legal protection granted to the ornamental design of an article of manufacture. 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 patents.

In most patent laws, unity of invention is a formal administrative requirement that must be met for a patent application to proceed to grant. An issued patent can claim only one invention or a group of closely related inventions. The purpose of this requirement is administrative as well as financial. The requirement serves to preclude the possibility of filing one patent application for several inventions, while paying only one set of fees. Unity of invention also makes the classification of patent documents easier.

Under United States patent law, a provisional application is a legal document filed in the United States Patent and Trademark Office (USPTO), that establishes an early filing date, but does not mature into an issued patent unless the applicant files a regular non-provisional patent application within one year. There is no such thing as a "provisional patent".

Sufficiency of disclosure or enablement is a patent law requirement that a patent application disclose a claimed invention in sufficient detail so that the person skilled in the art could carry out that claimed invention. The requirement is fundamental to patent law: a monopoly is granted for a given period of time in exchange for a disclosure to the public how to make or practice the invention.

The term of a patent is the maximum time during which it can be maintained in force. It is usually expressed in a 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, annuities or maintenance fees have to be regularly paid in order to keep the patent in force. Thus, a patent may lapse before its term if a renewal fee is not paid in due time.

The United States is considered to have the most favorable legal regime for inventors and patent owners in the world. Under United States law, a patent is a right granted to the inventor of a (1) process, machine, article of manufacture, or composition of matter, (2) that is new, useful, and non-obvious. A patent is the right to exclude others, for a limited time from profiting of a patented technology without the consent of the patent-holder. Specifically, it is the right to exclude others from: making, using, selling, offering for sale, importing, inducing others to infringe, applying for an FDA approval, and/or offering a product specially adapted for practice of the patent.

In patent law, a disclaimer are words identifying, in a claim, subject-matter that is not claimed or another writing disclaiming rights ostensibly protected by the patent. By extension, a disclaimer may also mean the amendment consisting in introducing a negative limitation in an existing claim, i.e. "an amendment to a claim resulting in the incorporation therein of a 'negative' technical feature, typically excluding from a general feature specific embodiments or areas". The allowability of disclaimers is subject to particular conditions, which may vary widely from one jurisdiction to another.

Maintenance fees or renewal fees are fees 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 concerning not only the amount payable but also the regularity of the payments. In countries where maintenance fees are to be paid annually, they are sometimes called patent annuities.

The Manual of Patent Examining Procedure (MPEP) is published by the United States Patent and Trademark Office (USPTO) 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 their application to an enormous variety of different situations. The MPEP is based on Title 37 of the Code of Federal Regulations, which derives its authority from Title 35 of the United States Code, as well as on case law arising under those titles. The first version of the MPEP was published in 1920 by the Patent and Trademark Office Society.

A patent application is a request pending at a patent office for the grant of a patent for an invention described in the patent specification and a set of one or more claims stated in a formal document, including necessary official forms and related correspondence. It is the combination of the document and its processing within the administrative and legal framework of the patent office.

This is a list of legal terms relating to patents and patent law. A patent is not a right to practice or use the invention claimed therein, but a territorial right to exclude others from commercially exploiting the invention, granted to an inventor or his successor in rights in exchange to a public disclosure of the invention.

In the United States, an Office action is a document written by an examiner in a patent or trademark examination procedure and mailed to an applicant for a patent or trademark. The expression is used in many jurisdictions.

An information disclosure statement refers to a submission of relevant background art or information to the United States Patent and Trademark Office (USPTO) by an applicant for a patent during the patent prosecution process. There is a duty on all patent applicants to disclose relevant art or background information that the applicant is aware of and that may be relevant to the patentability of the applicant's invention, as established by the United States Code title 35 and related sections of 37 CFR and the Manual of Patent Examining Procedure (MPEP). If a patent applicant, with deceptive intent for art known to the applicant, fails to submit material prior art to the USPTO, then any patent that later issues from the patent application may be declared unenforceable because of inequitable conduct. Furthermore, the duty to submit such relevant information to the USPTO lies not only on the applicant or inventor, but also on any patent attorney or other legal staff employed by the applicant.

Double patenting is the granting of two patents for a single invention, to the same proprietor and in the same country or countries. According to the European Patent Office, it is an accepted principle in most patent systems that two patents cannot be granted to the same applicant for one invention. However, the threshold for double patenting varies from jurisdiction to jurisdiction.

Title 35 of the United States Code is a title of United States Code regarding patent law. The sections of Title 35 govern all aspects of patent law in the United States. There are currently 37 chapters, which include 376 sections, in Title 35.

The copyright status of the content of patent applications and patents may vary from one legal system to another. Whether scientific literature can be freely copied for the purpose of patent prosecution is also a matter for discussion.

<span class="mw-page-title-main">Backlog of unexamined patent applications</span>

Although not clearly defined, the backlog of unexamined patent applications consists, at one point in time, of all the patent applications that have been filed and still remain to be examined. The backlog was said to be 4.2 million worldwide in 2007, and in 2009 it reportedly continued to grow. Alone, the United States Patent and Trademark Office (USPTO) was reported to have, in 2009, a backlog of more than 700,000 patent applications.

References

  1. ↑ 35 U.S.C.   § 154(a)(2)
  2. ↑ 35 U.S.C.   § 365(c)
  3. ↑ 2701 Patent Term (R-2); - 2700 Patent Terms and Extensions
  4. ↑ "Government Printing Office p. 126, stat. 1532"
  5. ↑ "Price Heneveld" Archived 2014-01-10 at the Wayback Machine
  6. ↑ USPTO web site, MPEP - 2701 Patent Term (R-2)
  7. 1 2 35 U.S.C.   § 154(b); American Inventors Protection Act (AIPA), enacted on November 29, 1999.
  8. ↑ "Mohsenzadeh v. Lee". scholar.google.com. June 25, 2015. Archived from the original on 2023-05-14. Retrieved 14 May 2023.
  9. ↑ CHRISTOPHER M. HOLMAN. Patent Term Adjustment: Recent Developments at the Federal Circuit and PTO. 39 Biotechnology Law Report 266 Number 4, 2020. DOI: 10.1089/blr.2020.29191.cmh
  10. ↑ "EXPLANATION OF PATENT TERM ADJUSTMENT CALCULATION".
  11. ↑ 80 F.3d 1543 (Fed. Cir. 1986)
  12. ↑ https://www.finnegan.com/en/insights/blogs/prosecution-first/reclaiming-their-time-patent-term-adjustment-pta-and-patent-term-extension-pte-post-supernus-novartis-i-and-novartis-ii.html
  13. ↑ USPTO web site, MPEP, 2701 Patent Term (R-2) - 2700 Patent Terms and Extensions
  14. ↑ King Pharma v. Teva, 78 USPQ2d 1237 (D.N.J. 2006)
  15. ↑ See 35 U.S.C.   § 154(b)(2)(B) ("No patent the term of which has been disclaimed beyond a specified date may be adjusted under this section beyond the expiration date specified in the disclaimer").
  16. ↑ "Opinion - USCA – #30 in MERCK & CO., INC. v. HI-TECH PHARMACAL CO., INC. (D.N.J., 3:06-cv-00266)". CourtListener. Retrieved 2022-11-13.

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