Novelty requirement

A fundamental statutory prerequisite to patentabiHty is novelty. A lack of novelty occurs when each and every element of the invention, as it is claimed, is found in a single disclosure which occurs before the date of invention. Such a disclosure may occur in any of a number of forms. To be an adequate disclosure, it should be catalogued or inventoried as a book might be in a reference Hbrary and open to pubHc dissernination. The novelty requirement presents the inventor with an extensive Hst of "cans" and "caimots." Unfortunately, the natural course of research and development often leads to activities which are much more readily categorized as "caimots" than "cans." Ultimately these activities may even proscribe the issuance of a patent if an appHcation is not filed in a timely fashion. 

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 purpose of the novelty requirement is to prevent a monopoly being granted on something which the public already has in its possession. 

The second type of method-of-use claims relates to methods of using the invention. In terms of pharmaceuticals, method-of-use claims typically relate to the use of a particular drug in the treatment of specific diseases or conditions. FDA approval of a new drug is linked to specific therapeutic uses, and therefore these types of method claims provide important protection for the innovator. These claims are important because they provide patent protection that is in addition to any composition-of-matter claims that may be applicable. Method-of-treatment claims are particularly important for compounds that are already subject to composition-of-matter claims or for which composition-of-matter claims are not available. For example, an inventor may discover that a previously known compound possesses unreported and unexpected antiinflammatory properties. The inventor may not obtain composition-of-matter protection for the compound itself because the compound is contained in the literature and therefore does not meet the novelty requirement for patentability. However, the inventor may instead obtain a method-of-use claim based on the unexpected anti-inflammatory properties because a compound s unexpected properties may be enough to support patentability. 

Section 101 of the Patent Act expresses the novelty requirement in general terms. 

Section 101 of the Patent Act expresses the novelty requirement in general terms. Section 102 attempts to spell out just what is not to be considered novel in the patent law sense. With regard to the utility, this is only considered in the Section 101 and in the first paragraph of Section 112 which states ... 

The other significant problem in obtaining valid and effective patent protection relates to requirements of the patent law variously referred to in different countries as the requirement for nonobviousness, or attainment of a sufficient inventive level. Normally the requirement that an invention be useful or capable of industrial application is not a problem. The novelty requirement is also not usually a problem. However, even in the usual case where compounds... 

This assumes that the co-crystal, once discovered, has not itself been publicly disclosed prior to filing a patent application. Such a public disclosure defeats the novelty requirement from the patent law perspective. 

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