Utility or Industrial Applicability

Patentable inventions must be useful, reduced to practice (35 USC, 102) and, by legal definition in most countries, also amenable to an industrial application. The German concept of a patentable invention describes it as Lehre zum technischen Handeln (teaching of a technical operation). The Polish law even requires a strictly technical character of the invention and currently excludes from patentability any biological product as well as pharmaceuticals and chemicals, even if these derive from a technical process. The technical process which is used to make such products, however, is patentable in almost all countries, irrespective of whether these refuse to grant patents on certain or all products of nature. 

According to the general purpose of a patent, its utility must be described in such detail that the average expert is able to reproduce the invention. Thus, the descriptive part of a patent application closely resembles the materials and methods section of a scientific paper. This requirement of utility prevents patents on mere theories. 

Every patent applicant will, of course, try to extend the scope of his patent as far as possible by claiming all obvious and imaginable applications besides those which are described. Whereas the obvious extensions are likely to be accepted, speculative applications are probably claims on theories or on a principle of nature, which are excluded from patentability. Claims on theories without utility in the present form would be against the spirit of patents. They would be an attempt to control future inventions in this field and thus are not acceptable. 

It is currently unclear whether, based on the current state of the art, a patent following the above-mentioned example could be extended to recombinant derivatives of the native protein. One might argue that, once the native protein is known and accessible, it needs no inventiveness to sequence the amino acids for parts of this protein, synthesize the corresponding DNAs, use these as probes to identify and isolate the entire coding sequence of the protein, which is then inserted into a suitable expression system to produce the protein in any desired form and quantity. Experience, however, teaches that it still requires some non-obvious steps and usually more than a limited degree of experimentation (often even a stroke of luck) to get there and to achieve the desired utility with recombinant polypeptides. For a vaccine it may be necessary to find and express the important epitopes in an appropriate (still unknown) way and to develop adequate purification and further processing protocols (with unpredictable technical 

The fact that some methods are obvious to try does not mean that the desired result is also obvious  

---

Sufficiency of disclosure is a more straightforward requirement. Sufficient technical detail must be provided in the patent application such that somebody of ordinary technical skill in the area could reproduce/repeat the innovation. Utility or industrial applicability is the last major prerequisite to patenting. This simply means that the innovation must have some applied use. 

Utility or Industrial Application. Utility and industrial application are similar, but not identical, criteria. In the United States, the definition of utility is not mere functionality but, rather, whether the invention is useful for its described purposes. For inventions involving DNA sequences, utility is considered to be established if a substantial, credible, and specific use is demonstrated in the patent application. In Canada, utility is understood to mean whether the invention works [69]. It does not have to work well or for a prolonged period of time, nor does a model or prototype have to be presented. Simple evidence that the invention, as it is claimed in the patent application, will work is sufficient. 

---