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.
Article 83 of the European Patent Convention states that an application must disclose the invention in a manner sufficiently clear and complete for it to be carried out by a person skilled in the art.
"[3] US Federal Courts and legal commentators have interpreted this statement as having two related but distinct requirements: written description and enablement.
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.
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 undue experimentation.
Enablement is a key part of the patent "bargain"- an inventor gets a monopoly in return for teaching the world about their invention.
[8] In 1988 Federal Circuit established 8 Wands factors that can be considered when determining whether a disclosure requires undue experimentation:[9] In a 2005 U.S. court case, several of Jerome H. Lemelson 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 case the court held that a person of ordinary skill in the art was a degreed electrical engineer with two years of experience as of the filing date of the original patent application, 1954.
[citation needed] In May 2023, the U.S. Supreme Court did not specifically address the eight Wands factors in its decision in Amgen Inc v. Sanofi.
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.
An illustrative landmark decision on the issue of "written description" was University of Rochester v. Searle,[12] related to patents on COX-2 inhibitors.
Previously known NSAIDs 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 developed an assay to screen for such inhibitors, which was a subject of patent US5837479 issued in 1998, that claimed methods "for identifying a compound that inhibits prostaglandin synthesis catalyzed by mammalian prostaglandin H synthase-2 (PGHS-2)."
Another option is to use regular utility patents in combination with a deposit of the claimed biological material according to Budapest Treaty of 1977.