Patentability criteria

Table 4.1 Some products of nature that are generally patentable under US patent law. Additional patenting criteria (e.g. utility) must also be met. For many products, the patent will include details of the process used to purify the product. However, process patents can be filed, as can use patents. Refer to text for further details...

In this section, we compare patent rules and patent criteria for biotechnological innovation in the United States, Europe, Japan, and Canada. Although attempts have been made to harmonize patent laws globally, so far it has been impossible to achieve international consensus. TRIPs sets minimum standards that must be included in national patent legislation enforced by all WTO members, but it has not had the effect of creating consistent national patent laws. 

Patent Criteria. Patent criteria are applied to determine whether a product or process described in a patent application is an invention. If the product or process fails to meet the criteria, the innovation is not patentable. The deliberation on whether an invention meets the patent criteria is distinct from whether the invention falls within the category of patentable subject matter. An invention may meet all the patent criteria, but its subject matter may fall into a category that a priori cannot receive patent protection. 

As is true of utility/industrial application and novelty as well, each of the provisions for non-obviousness and inventive step are similar. It is, therefore, the wording and interpretation of each nation s criterion that is critical because it ultimately determines if an invention is patentable within that jurisdiction. These variations in national patent criteria may cause an invention to be denied patent protection in one country while being granted such protection in another. 

The first criterion was associated with improved secondary and tertiary petroleum recovery processes. This is the justification for the patent appHcations issued to the Dow (50) and Exxon (51) corporations. The additional costs of production and the increased adsorption of such modified water-soluble polymers are detrimental to the commercial appHcation of such polymers and even the academic studies in this area have decreased in recent years. 

The RP systems currently in force differ in practice, first in accordance with the size of the market covered. This in turn depends on the equivalence criterion chosen to classify drags, and also on the inclusion or otherwise of patented drags. 

Again a searcher, ignorant of the fact that the transposition of the steps of a process is patentable only when the result attained thereby is both unexpected and useful, will have no criterion for dealing with such inversion. Therefore, in his searches he will either fail to cite any references with transposition or he will cite all such references without discrimination as to applicability to the case under consideration. 

The Central Medical Pharmaceutical Committee (CMPC) has an advisory role which consists of drawing up and monitoring a list of nonregistered indications and medicines that satisfy these conditions. Besides the above-mentioned criterion, the Committee is also of the opinion that the medicine to be evaluated must be reasonably assumed not to qualify for registration for economic reasons, for instance, because it is no longer protected by a patent. If the product can be prepared by a pharmacist, the insurance fund is advised to reimburse only this product. Table 5 presents the medicines and indications reviewed by the CMPC. 

I now return to the motivation behind capitalist innovation. If we assume that the capitalist is a consistent profit-maximizer, he will innovate maximally within the feasible set to the extent that it is known to him. Marx has little to say about the detenninants of the latter. In particular, he does not mention the vast extension of the set of economically-as distinct from technically - profitable inventions that were brought about by the introduction of the patent system. He does offer, however, some comments on the motivation behind capitalist innovation that are more specific than the rather general statement quoted above. These concern, first, the impact of technical change on the class struggle, and, secondly, the suboptimal consequences of the profit-maximizing criterion of innovation. The first problem is also linked to the issue of maximizing vs. satisficing" discussed in 1.2.1. 

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 ... 

Chemical novelty is not as important a criterion for inclusion in a primary fragment library because unique composition of matter desirable for patent protection is expected to be added later during the sprouting and merging HTL chemistry phase. There are several vendors of fragment libraries who accumulate fragments from various sources and then cluster, package and resell them. 

Even in the hrst patent laws, the criterion of novelty was regarded as insufficient. German Patent Law therefore demanded that for a patent to be granted, it had to have a certain inventive height (or inventive level ) or a certain technical advance. The United States Patent Laws speaks of unobviousness. ... 

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) ... 

Diverse sets of inhibitors were compiled manually for eleven well-established pharmaceutical targets. The main - subjective - selection criterion was to cover as many different compound classes as possible for each target. Compounds were retrieved from the WDI and from available complex crystal structures in the PDB [75]. Where patent literature was consulted in addition, references are given in the following list. The final data set consisted of ... 

According to the American law of patents, the criterion of inventive step is replaced by the criterion of unobviousness. Nonobvious subject matter and conditions for patentability are set forth in Section 103 of the US Patent Law which states that ... 

The criterion of utility found in American law is quite close to the criterion of industrial application which is found in the laws of a good number of countries and in particular in the EPC. A chemical product for which no industrial application nor any pharmacological property had been found would not be patentable under the United States patent law, because it would not have any utility. 

The European Biotechnology Directive, which must be adhered to by all EU member states and the EPO, sets out specific requirements for the industrial application of DNA patents. The directive states that an invention involving DNA must indicate the function of the DNA and in order to comply with the industrial application criterion, it is necessary in cases where a sequence or partial sequence of a gene is used to produce a protein or part of a protein, to specify which protein or part of a protein is produced or what function it performs [67]. 

The definition of industrial application included in the Japanese patent law is similar to that imposed by the EPO in the EPC [72]. However, the fact that Japanese patent applications are rarely refused for lack of industrial application suggests that Japan s application of this criterion may be less stringent than that of the EPO. 

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