814:, the sufficiency of disclosure requirement is complemented by an additional requirement, generally not found in other national patent jurisdictions: the "best mode requirement". According to the requirement, the disclosure must also contain the inventor's "best mode" of making or practising the invention. For example, if an inventor knows that a liquid should be heated to 250 degrees for optimal performance, but discloses in the patent that the liquid should be heated to "above 200 degrees", then the inventor has not disclosed his "best mode" for carrying out the invention. The best mode must be disclosed for the entire invention, and not only its innovative aspects.
716:
698:) and the methods for identifying its inhibitors, the US5837479 did not provide any specific formulas for the claimed inhibitors. "Accordingly, the court concluded that the patent's claims are invalid for lack of written description," because "it claims a method of achieving a biological effect, but discloses no compounds that can accomplish that result."
515:
Although in theory both "written description" and "enablement" should be applied to individual claims, when US courts find a lack of enablement, they usually invalidate the whole patent rather than individual claims. The historic evolution of the written description and enablement requirements can be
484:
The enablement requirement relates to teaching how to make/use the invention. In contrast, the written description requirement allows the patent owner to justify its claims, which determine the boundaries of the temporal monopoly on the invention. Also noteworthy is that US courts treat enablement as
400:
law, which protects valuable secrets from being misappropriated through unfair means (such as theft or industrial espionage). But unless inventors apply for a valid, enabling patent, they cannot take advantage of patent law's monopoly rights, and thus cannot stop competitors from developing the same
620:
patents covering bar code readers were held to be invalid because the specification was not complete enough for a person of ordinary skill in the art of electrical engineering to have made and used the claimed invention at the time the patent was filed (1954) without undue experimentation. In this
524:
A patent disclosure "enables" the invention, if it allows a person of ordinary skill in the art to practice the invention without undue experimentation. Patents may fail this test if they claim more than they teach: for example, a patent that claims all light bulbs but explains only how to make a
701:
To summarize: without the written description/sufficiency of disclosure requirement, an applicant might delay scientific and technical progress by blocking competitors from inventing something that the applicant has not yet invented (i.e. did not describe in his patent application). The written
688:
inhibit both COX-1 and COX-2, and thus they not only reduce inflammation, but also cause side effects such as stomach upset, irritation, ulcers, and bleeding. This breakthrough discovery prompted the
Rochester scientists to launch a program for developing selective COX-2 inhibitors, and they
769:
Biological (i.e. "capable of self-replication either directly or indirectly") materials (such as yeast, algae, protozoa, eukaryotic cells, cell lines, hybridomas, plasmids, viruses, plant tissue cells, lichens, seeds, vectors, cell organelles etc.) can be patented in the US as
536:
before patent issuance or declared invalid upon re-examination or litigation after issuance. Enablement is determined as of the filing date of the patent, and patent owners cannot use experiments conducted post-application to establish the validity of their patents.
446:
are provided to support essential aspects of the invention, but if these references are not sufficiently precise so that "the skilled person would have to make ... undue efforts to find and get together the information it needs to carry out the invention".
392:
for a given period of time in exchange for the inventor disclosing to the public how to make or practice their invention. If a patent fails to contain such information, then the bargain is violated, and the patent is unenforceable or can be revoked.
693:
issued in 1998, that claimed methods "for identifying a compound that inhibits prostaglandin synthesis catalyzed by mammalian prostaglandin H synthase-2 (PGHS-2)." While disclosing the discovery of the target enzyme (which is an unpatenable
643:
In the United States, the would-be patentee must provide a "written description" of the invention, sufficient to support the claims of the patent during the patent's examination. "Written description" determines the scope of claims.
625:
with two years of experience as of the filing date of the original patent application, 1954. One of the challenges of this court case, which was decided in 2005, was to find experts on the state of the art who were alive in 1954.
428:. Sufficiency is considered by the examiner during examination of a patent application and the requirement of Article 83 must be complied with in order for a patent to be granted. Insufficient disclosure is also a ground for
1133:
827:, US law no longer permits invalidation of a US patent for failure to disclose the best mode, although technically the best mode is still required to be disclosed by the language of 35 U.S.C. Section 112.
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The purpose of the âbest modeâ requirement is to ensure full disclosure, such that the inventor may not âdisclose only what he knows to be his second-best embodiment, retaining the best for himself.â
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inventions, very little description is required. A mere flow chart of a piece of software, for example, is adequate. Source code is not normally required. In the âunpredictable artsâ, such as
661:
1134:
https://scholar.google.com/scholar_case?case=16767896458902625336&q=Rochester,+Searle,+federal+circuit&hl=en&scisbd=2&as_sdt=4,60,131,189&as_ylo=2000&as_vis=1
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314 F.3d 1313, 1330 (Fed. Cir. 2003), "he purpose of the written description requirement is to prevent an applicant from later asserting that he invented that which he did not."
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The purpose of this rule is to avoid applicants speculatively filing for patents for inventions that they have not yet invented in order to get priority over competitors. As the
883:, point 23 of the Reasons: "A basic principle of the patent system is that exclusive rights can only be granted in exchange for a full disclosure of the invention, (...)."
1146:
https://scholar.google.com/scholar_case?case=7591116462080156066&q=Rochester,+Searle,+federal+circuit&hl=en&as_sdt=4,60,131,189&as_ylo=2000&as_vis=1
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https://scholar.google.com/scholar_case?case=7591116462080156066&q=Rochester,+Searle,+federal+circuit&hl=en&as_sdt=4,60,131,189&as_ylo=2000&as_vis=1
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product or process through proper means (such as independent invention or reverse engineering). Enabling disclosure is the price an inventor pays for patent monopoly.
635:. However, the Court stated that the specification may call for a reasonable amount of experimentation to make and use the full scope of the claimed invention.
429:
783:
486:
695:
1156:
Michael A. Greene, Comment, Gilding the Lilly: The § 112 Written
Description Requirement Separate From Enablement, 52 B.C. L. Rev. E. Supp. 213 (2011),
1132:. (en banc rehearing denied in University of Rochester v. GD Searle & Co., Inc : petition for rehearing en banc is denied. 2004. No. 03-1304.
702:
description requirement thus reinforces the idea that patents are a reward for inventing by requiring the applicant to show they possess the invention.
560:
Undue experimentation is not based on quantity of experimentation as much as it is on unpredictability of outcome. In the "predictable arts", such as
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Sampson, Margaret (2000). "The
Evolution of the Enablement and Written Description Requirements Under 35 U.S.C. § 112 in the Area of Biotechnology".
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The "best mode requirement" only applies to what the inventor knows at the time the application is filed, not to what is subsequently discovered.
584:
957:
Holman, Christopher M. (April 2018). "Enablement
Invoked as a 'Super-Written Description Requirement' to Overturn $ 2.5 Billion Jury Verdict".
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504:. On the other hand, the purpose of enablement is to teach a person of ordinary skill in the art how to make and use the invention without
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filaments in a lightbulb, but it does not disclose how to make tungsten filaments, and there is no publicly known method of making them.
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of 1977. The US law allows for such biological deposit(s) to be made at any time before the patent issuance (and in some cases during
500:. A patentee is not allowed to claim something that is not supported by the text of patent disclosure â this is the purpose of the
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and enablement requirements for claims involving biological materials. One option to claim such biological inventions is by using
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of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to
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is a key part of the patent "bargain"- an inventor gets a monopoly in return for teaching the world about their invention.
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US Federal Courts and legal commentators have interpreted this statement as having two related but distinct requirements:
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any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same."
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disclose the invention in a manner sufficiently clear and complete for it to be carried out by a person skilled in the art
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802:), however many other countries require deposits before patent filing. Such deposits are typically made for 30 years.
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481:. Although enablement and written description requirements share many similarities, their purposes are different.
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could carry out that claimed invention. The requirement is fundamental to patent law: a monopoly is granted for a
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a ââquestion of law based on underlying factual findings,ââ (i.e. with a judge having the final word), while
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In May 2023, the U.S. Supreme Court did not specifically address the eight Wands factors in its decision in
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The patent law in the United States requires, among other things, that the patent specification "contain a
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that can be considered when determining whether a disclosure requires undue experimentation:
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Best Mode: A Plea to Repair or
Sacrifice This Broken Requirement of United States Patent Law
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particular type of light bulb. A patent may also be non-enabling, if it claims the use of
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Merges, Duffy. Patent Law and Policy: Cases and
Materials. 5th edition. 2011. Lexi Nexis
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University of
Rochester v. GD Searle & Co., Inc. 2004. F 3d. 358/No. 03-1304, 916:
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University of
Rochester v. GD Searle & Co., Inc. 2004. F 3d. 358/No. 03-1304, 916.
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684:. For most patents it is desirable to inhibit COX-2 and not COX-1. Previously known
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A patent claim that does not meet the enablement requirement may be rejected by the
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Decision T 1452/06 of 10 May 2007 (Boards of Appeal of the
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in exchange for a disclosure to the public how to make or practice the invention.
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developed an assay to screen for such inhibitors, which was a subject of patent
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in combination with a deposit of the claimed biological material according to
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case the court held that a person of ordinary skill in the art was a degreed
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An illustrative landmark decision on the issue of "written description" was
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For instance, an insufficiency of disclosure might arise if references to
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The disclosure requirement lies at the heart and origin of patent law. An
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Insufficiency is also a ground for revocation under
Section 72 of the
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In other words, the purpose of written description is to support the
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Disclosure of the invention under the European Patent Convention
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deal primarily with the United States and do not represent a
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553:) of the invention cannot make and use the invention without
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EPO Board of Appeal decision T 1191/04 of 22 November 2007
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Matthew J. Dowd, Nancy J. Leith and Jeffrey S. Weaver,
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the predictability or unpredictability of the art; and
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requirement is a question of fact, decided by a jury.
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847:Sufficiency of disclosure in Canadian patent law
1201:Ajinomoto Co. v. International Trade Commission
1158:http://www.bc.edu/bclr/esupp_2011/17_greene.pdf
1086:In re Wands, 858 F.2d 731, 737 (Fed. Cir. 1988)
111:Patentability requirements and related concepts
594:the amount of direction or guidance presented;
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723:The examples and perspective in this section
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597:the presence or absence of working examples;
1097:"Amgen Inc. v. Sanofi, 598 U.S. ___ (2023)"
1014:"Basic of US patents and the patent system"
576:, a very detailed description is required.
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741:, or create a new section, as appropriate.
654:Amgen Inc. v. Hoechst Marion Roussel, Inc.
591:the quantity of experimentation necessary;
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987:In Re '318 Patent Infringement Litigation
757:Learn how and when to remove this message
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668:. In the early 1990s scientists at the
606:the relative skill of those in the art;
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616:In a 2005 U.S. court case, several of
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790:. Another option is to use regular
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1012:Elliott, George (September 2007).
639:Written description and possession
134:Inventive step and non-obviousness
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364:in sufficient detail so that the
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183:By region / country
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1326:European Patent Convention
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612:the breadth of the claims.
422:European Patent Convention
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240:By specific subject matter
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1309:Patent Cooperation Treaty
672:discovered two disctinct
444:standardisation documents
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366:person skilled in the art
343:Sufficiency of disclosure
191:Patent Cooperation Treaty
170:Sufficiency of disclosure
149:Person skilled in the art
119:Patentable subject matter
959:Biotechnology Law Report
895:, Reasons 2, Facts V. 6.
664:, related to patents on
162:Other legal requirements
139:Industrial applicability
776:articles of manufacture
670:University of Rochester
772:compositions of matter
842:Reduction to practice
555:undue experimentation
541:Undue experimentation
506:undue experimentation
16:Concept in patent law
1281:Steven B. Walmsley,
1030:10.1208/aapsj0903035
735:improve this section
384:, or the inventor's
370:given period of time
19:For other uses, see
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780:molecular structure
632:Amgen Inc v. Sanofi
623:electrical engineer
502:written description
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475:written description
464:written description
353:requirement that a
70:Procedural concepts
1340:United States Code
837:Incredible utility
618:Jerome H. Lemelson
420:Article 83 of the
355:patent application
175:Unity of invention
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1238:Resources, MPEP.
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