Patents inventive step

In general, a patent can be granted for an invention which is new (the novelty requirement), is not obvious (the inventive step requirement), is commercially or industrially useful (the utility requirement) and is not otherwise barred by law from being the subject of a patent (for example, at least at the European Patent Office (EPO) plant and animal varieties are not patentable, and inventions the publication or exploitation of which are contrary to morahty are not patentable). The requirements for a patentable invention are outlined in Table 12.1. 

The product or process invention claimed in a patent must have an inventive step that is to say the invention must not be obvious to a person skilled in the art . The rationale for this is to prevent novel, but trivial or obvious, variants of a known product or process from being given a monopoly. Inventive step is a separate requirement from novelty the question Is there an inventive step is only relevant once the novelty ol a claimed invention has been established. At least at the EPO, lor the purposes of inventive step, and for the purposes of sufficiency of disclosure (see below) the fictional person skilled in the art is deemed to have the same degree of knowledge, and for bicatalysis inventions is likely to be a team of suitably qualified people e g. one Ph.D. researcher assisted by two laboratory technicians fully acquainted with the known techniques relevant to the technolog> in question. 

The European patent equivalent to the nonobviousness requirement in the United States is referred to as the inventive step requirement. Although the terminology is different, the overall effect is generally the... 

The basic requirements of national laws on protection of inventions by patents are novelty, inventive step, and industrial application, which are now examined in turn. 

The stance of the European Patent Office in general is to consider as indicative of the presence of the inventive step the existence of surprising or superior properties, which could not be anticipated by persons skilled in the art. In the case of a new protein, for instance, this might be fewer or less severe side effects, better absorption, or greater stability. 

Tables 15.1 and 15.2 summarize the requirements for novelty and inventive step for patentability of DNA sequences and mAbs.

Under the terms of Article 8 of the Brazilian Industrial Property Law, patentable inventions are those that have the three basic requirements of novelty, inventive step, and industrial application. Additionally, from Article 50, II, if the specification does not clearly and sufficiently describe the subject matter so as to enable its reproduction by a technician in the subject, the so-called sufficiency of disclosure, it is against the provisions of Article 24, and is thus not accepted (Art. 50, II). 

Brazilian Law 9279/96. According to the latter provision, all or part of living things are not patentable, except transgenic microorganisms that meet the three patentability requirements (novelty, inventive step, and industrial application) set forth in Article 8 of the law and that are not mere discoveries. 

It is not necessary for a patentable invention to be the result of an ingenious idea. Article 56 EPC requires an "inventive step" which is "not obvious to a person skilled in the art", regarding the state of the art at the time the application was filed. Similarly in the USA "... a patent may not be obtained. .. if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains" (35 USC, 103). 

Oppositions on the grounds of obviousness also depend on earlier publications, patents, and other evidence which demonstrates that the invention could have been deduced by a person skilled in the art without an inventive step. Objections against the utility of a patent are rare, because in most cases it will be very difficult to call into question that the subject of the invention will (also in future) be of no use. 

There are three basic requirements for patentability novelty non-obviousness or inventive step and usefulness or industrial applicability. Each requirement may differ from country to country and is set forth by the statutes and regulations of each country. 

Unobviousness. The third, and most difficult, criterion is unobviousness, or inventive step, as it is known outside the United States. The process for deciding whether or not an invention is obvious was succinctly stated in a US court decision (the Deere case). According to the Deere decision, the Patent Examiner should determine obviousness using a three-prong approach ... 

After publication of the application and the search report, the applicant has to request substantive examination for patentability to be performed at the EPO. The examination of the application is performed by the Examining Division of the EPO. On completion of the examination, which includes an examination for inventive step as well as for novelty (novelty and inventive step are basic requirements for patentability see Section IV. A.), either the application is rejected or the European patent is granted. The specification as granted is published and the grant of the European patent leads to national patents being registered in the designated EPC countries. 

Article 52(1) EPC requires an invention to involve an inventive step if it is to be patentable, and Article 56 EPC states that ... 

The state of the art for this purpose is defined as not including documents under Article 54(3) EPC, that is, patent applications which were not published at the flUng date of the patent application under consideration. It cannot really be expected that an invention B should display an inventive step as compared with another invention A which was totally unknown at the hling date of the application B being considered. (As to novelty, the contents of European patent applications still unpublished at the hlling date are retained, to avoid granting two patents for the same invention, i.e. double patenting). 

Since the criterion for an inventive step is expressed in a negative manner, no positive virtues are required in order to satisfy Article 56. In other words, there is no requirement for a technical advance. However a technical advance may be useful in arguing for the existence of an inventive step. As noted by Dr. R. Singer (Chairman of the Legal Board of Appeal of the European Patent Office) ... 

An unexpected effect in one species or subgenus selected from a known group and it is sufficient to render the species or subgenus patentable, because an inventive step can be acknowledged. Such inventions are called selection inventions. The principle of selection invention has been upheld by the EPO in many decisions. 

Patent applications have fixed formats that often vary between patent offices but nevertheless require a similar information submission a background, summary, details of invention, and so on. The patent application must be comprehensive to demonstrate novelty and the inventive step in light of prior art it should be understood that the purpose is not to fool the patent examiner into allowance, but to protect the invention from competitors who will challenge it, should it be worth anything. A full disclosure is required to keep the infringers out, to decrease the chance of their success in knocking out a patent. Additional statements are included defining the features of the invention for use as a basis for specific... 

To obtain a patent on an invention in the United States, the inventor or inventors must, as the initial step, file a patent application describing the invention in such terms as to teach one of ordinary skill in the art how to make and use the invention and claiming the subject matter that the inventor (or inventors) regards as the invention. The subject matter of the claimed invention must be within the statutory classes of patentable inventions. In addition, the claimed invention must have utility and be both new and nonobvious. The requirements for patentability (especially as to what constitutes patentable subject matter) can vary considerably throughout the world. 

The pharmaceutical industry is one of the major users of the patent system, which requires that three criteria are met in order to grant a patent. These criteria are novelty, presence of an inventive step and industrial applicability. Although an invention might be novel, it might not be patentable if it could have been predicted from prior art , that is, knowledge in the public domain. Hence, there is a need for an inventive step. 

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