Inventive step requirement

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 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 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 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 claim for a specific mAb, however, will be inevitably restricted. The surprising technical effect required to establish the presence of an inventive step imposes limits on the possibilities of generalizing the invention, that is, the scope of protection. 

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). 

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. 

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 ... 

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) ... 

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... 

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. 

Japanese law also defines novelty, inventive step and industrial application as the basic criteria required for an invention. 

TRIPs requires an invention to be new, to have an industrial application, and to have an inventive step [49], Inventions that meet these criteria are protected against use, offer for sale, and sale and importation by anyone who is not the rights-holder for a minimum term of 20 years [49], Moreover, TRIPs requires nations to grant patent rights for all fields of technology without discrimination and for both inventive products and processes [49]. 

In this step, we need to identify what features of our future system are required. In the case of inventive designing, requirements related to novelty may be particularly important and they may require that our designing must lead to a patent or a class of patents, which will become the intellectual property of our company. Similarly to the previous step dealing with constraints, our analysis of requirements should result in a requirements tree showing how these requirements are interrelated. 

Beginning of protection application date Varieties not patentable, but any other grouping of plants Requirements novelty, inventive step, industrial applicability (= NIA)... 

Requirements novelty, inventive step, industrial applicability (=N1A)... 

However, more difficult than novelty is a unified, clear, and objective assessment of the inventive step. The original idea was, that not every new but logically deducible obvious modification of the state of the art, which would occur to the skilled person as a simple further development of his or her daily routine worlt, should be protected automatically pursuant to its mere novelty. The third and last requirement, industrial applicability, does as a rule not raise any problem when assessing the patentability of biologically active compounds. 

The selected examples demonstrate that only few decarboxylative couplings are close to synthetic maturity. Many inventive steps are still required to overcome remaining limitations and to unleash the full potential of this new reaction craicept. New decarboxylation catalysts have to be designed that operate at low temperatures and tolerate a broad variety of carboxylic acids. For several decarboxylative reactions, the proof of concept has been achieved (Mily for a very limited scope of substrates. Extending these processes to the full range of carboxylic acids remains a challenging task. 

Outside the United States, this is usually expressed as a requirement for an inventive step . 

In drafting a patent appHcation, proceeding methodically through the several steps necessary to produce the type of disclosure legally and technically sufficient to satisfy the requirements of the laws of the United States is absolutely essential to a successful granting of the patent. A first step is to outHne those elements of the invention which are absolutely essential to its practice. A body of disclosure should be outlined for each of the essential elements of the claim. This disclosure should describe each element in terms of its function, as weU as the parameters that are relevant to the essential nature of the individual element. For example, if a chemical mixture has a component which acts so as to thicken the mixture, it is appropriate to outHne the family of constituents that can serve this function. At the same time, a full outHne of the disclosure of this individual element will include mention of those chemicals that are preferred for use within the mixture so as to perform the desired thickening function. 

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