Utility Patents!! In the light of US Laws.

‘In order that an invention may be patentable it must not only be bestowed upon the public by its inventor, but when bestowed it must confer on them a benefit.’

Under the American laws, in order to be patentable, a claimed invention has to be ‘useful’. This expression can be found both in the Patent code (35 USC # 101) as well as in the Constitution of USA (wherein ‘useful arts’ was used). Discussing about what is ‘utility’ Justice Story had made the well known statement that a ‘useful’ invention is one ‘which may be applied to a beneficial use in society, in contradistinction to an invention injurious to the morals, health, or good order of society, or frivolous and insignificant’. It might well come to one’s mind that such an expressed requirement for usefulness is unnecessary because no one would be interested to invent and patent something useless. However there is a purpose behind this requirement of utility and that is to secure a quid pro quo for the society. It is important to ensure that the invention is functioning for its intended purpose and is therefore, operative. Therefore the requirement can be summed up such that, before giving the exclusive right to an inventor to exclude others from making, using, or selling his invention, he must provide society with an invention that operate in accordance with its intended purpose or as it is often said, a purpose discernible by a person ordinarily skilled in the art.

The first US patent law of 1790 had also this requirement for utility in it and it is still carried forward in the present provision – ‘Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefore, subject to the conditions and requirements of this title.’This principle has been upheld in the decisions of the US Patent office and also the courts of law. For example, in Application of Bremner the court upheld the rejection of the Patent office, stating that ‘it as never intended that a patent be granted upon a product, or a process producing a product, unless such product be useful.’ However the definition of ‘utility’ has widened after this decision.
In Application of Nelson, the court held that for granting a patent it need not to be shown that the product has any ultimate utility, the patent can even be granted if the process is useful to the researchers during the research to manufacture the final product. This is the present trend more or less and the court considers that it is sufficient that a process produces the intended result and is not detrimental to the public interest.

The doctrine of utility was famously discussed in the case of Brenner v. Manson . The fact of the case stated that in December 1957 Ringold and Rosenkranz applied for a patent on an allegedly novel process for making certain steroids, claiming priority as of December 1956. A patent issued thereon in 1959. In January 1960 respondent filed an application to patent the same process, asserting that he had discovered it prior to December 1956, and requesting that an "interference" be declared to test the issue of priority. Respondent's application was denied by a Patent Office examiner, the Board of Appeals affirming, for failure "to disclose any utility for" the compound produced by the process. The Court of Customs and Patent Appeals (CCPA) reversed, holding that "where a claimed process produces a known product it is not necessary to show utility for the product" as long as it is not detrimental to the public interest.

In the case of In re Brana, the position taken by the courts were quite different. The fact of the case was as follows:
Brana developed non-symmetrical substituted compounds for use as anti-tumor compounds. Similar compounds were shown to be active in vivo in mice having an implanted lymphocytic leukemia, which were widely used by NCI to test anti-tumor activities of compounds (Declaration evidence submitted later verified activity.) Compounds were shown to have “good activity” in vitro in a human tumor cell culture system (i.e., not toxic).
The examiner rejected their application and the decision of the examiner was upheld by the Board on the ground that the application failed to describe specific disease(s) against which the claimed compounds were active and the animal model used to test the compounds was not credible. This decision was appealed to the federal court. The court laid down a two step test, now known as the Brana two step test. It held that if a claimed invention does not have utility, the specification cannot enable one to use it. It also said that the activity of similar compounds against lymphocytic leukemia implied a specific utility. Therefore it was held that one effective use is enough. And for drugs, FDA approval is not needed.
The US Patent office lays down guidelines for screening and determining the utility aspects of the patent applications. The Application of the Revised Interim Utility Guidelines10 states that ‘the examiner should determine whether any asserted utility is specific and substantial, and if so, determine whether such asserted utility is credible. In determining credibility the examiner should consider whether or not there currently are similar or equivalent materials and/or procedures available for achieving that utility. If there are, the utility is credible and no rejection under 35 U.S.C. § 101 should be made.’
It also defines some different classes of utility. the types of such utilities can be briefly defined as follows:

“Credible utility” – Where an applicant has specifically asserted that an invention has a particular utility, that assertion cannot simply be dismissed by Office personnel as being “wrong”. Rather, Office personnel must determine if the assertion of utility is credible (i.e., whether the assertion of utility is believable to a person of ordinary skill in the art based on the totality of evidence and reasoning provided.

“Specific utility” – A utility that is specific to the subject matter claimed. This contrasts with a general utility that would be applicable to the broad class of the invention.

"Substantial utility" - a utility that defines a "real world" use. Utilities that require or constitute carrying out further research to identify or reasonably confirm a "real world" context of use are not substantial utilities.

"Well established utility" - a specific, substantial, and credible utility which is well known, immediately apparent, or implied by the specification’s disclosure of the properties of a material, alone or taken with the knowledge of one skilled in the art.