Патенттік құқықта ашудың жеткіліктілігінің маңызы

Concept in patent law

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 disclosure requirement lies at the heart and origin of patent law. An inventor, or the inventor's assignee, is granted a monopoly 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. Inventors who do not wish to teach the world about their invention still have some protection under trade secret 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 product or process through proper means (such as independent invention or reverse engineering). Enabling disclosure is the price an inventor pays for patent monopoly.

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. 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 opposition under
For instance, an insufficiency of disclosure might arise if references to standardisation documents 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". Insufficiency is also a ground for revocation under Section 72 of the UK Patents Act.

The patent law in the United States requires, among other things, that the patent specification "contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same." US Federal Courts and legal commentators have interpreted this statement as having two related but distinct requirements: written description and enablement. Also noteworthy is that US courts treat enablement as a ‘‘question of law based on underlying factual findings,’’ (i. e. with a judge having the final word), while written description requirement is a question of fact, decided by a jury.

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. 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 Federal Circuit explained in Amgen Inc. v. Hoechst Marion Roussel, Inc. 314 F.3d 1313, 1330 (Fed. Cir. 2003), "[t]he purpose of the written description requirement is to prevent an applicant from later asserting that he invented that which he did not." An illustrative landmark decision on the issue of "written description" was University of Rochester v. Searle, related to patents on COX 2 inhibitors. In the early 1990s scientists at the University of Rochester discovered two disctinct cyclooxygenases, referred to as COX 1 and COX 2. For most patents it is desirable to inhibit COX 2 and not COX 1. 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)." While disclosing the discovery of the target enzyme (which is an unpatenable product of Nature) 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." 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 description requirement thus reinforces the idea that patents are a reward for inventing by requiring the applicant to show they possess the invention.

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 compositions of matter or as articles of manufacture, provided that they are useful, novel and non obvious. However, a precise description (such as molecular structure) is not always possible in such cases, which makes it difficult to meet written description and enablement requirements for claims involving biological materials. One option to claim such biological inventions is by using plant patents. Another option is to use regular utility patents in combination with a deposit of the claimed biological material according to Budapest Treaty 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 reexamination), however many other countries require deposits before patent filing. The purpose of the “best mode” requirement is to ensure full disclosure, such that the inventor may not “disclose only what he knows to be his second best embodiment, retaining the best for himself.”

The "best mode requirement" only applies to what the inventor knows at the time the application is filed, not to what is subsequently discovered. Post AIA, 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.