Patent statute Section

A thornier issue than written description for ESTs and SNPs, however, is that of utility. Section 101 of the patent statute requires that the subject of a patent must be a "useful invention." Under the Guidelines, an application satisfies the utility requirement if the invention has "specific, substantial, and credible" utility such that "a person of ordinary skill in the art" would recognize the claim as credible "in view of disclosure [contained in the patent application] and any other evidence of record. .. that is probative of the applicant s assertions"(Utility Examination Guidelines, 2001). The Guide-... 

We have now seen what the categories are for patentable inventions and which contain those patents which relate to chemistry and metallurgy. Let us suppose then, that as an inventor, you carefully follow the provisions of Rule 71, and the Patent Office approves your specification as to form, and after a thorough search of the art, finds your invention to be novel, do you then get the patent The answer is not necessarily, because you still must surmount the hurdle provided by Section 103 of the patent statutes, which reads in part as follows ... 

Thus, in the year 1950, an inventor named Tolkmith (IS) presented a patent application claiming a certain methane phosphonic chloride. The only utility stated for the compound was that it was of value as an intermediate for the preparation of more complex phosphorus derivatives and as a constituent of a parasiticide. The Patent Office Board of Appeals in its decision, held that the applicant s showing of utility did not comply with Section 112 of the patent statutes requiring that the manner and process of making and using the invention be described in such exact terms as to enable one skilled in the art to make and use the same. The board went on to say ... 

Further, the court held the process claims invalid because they were too broad and indefinite and hence did not comply with the then Section 33 of the patent statutes this is none other than our old friend, Rule 75, which states that the applicant shall particularly point out and distinctly claim the part, improvement, or combination which he claims as his invention or discovery. In considering these last two grounds, we may recall that it has been frequently held that a patentee is not to be charged with a knowledge of the correct theory or even understanding of his invention (21). Yet we see that, as a practical matter, a misunderstanding of the theory was one reason which caused the court to strike down the method claims. 

Interference practice is derived from certain U.S. statutes (18) enacted pursuant to Article 1, Section 8 of the Constitution. Its underlying principle is that there can be only one valid patent for an invention. 

These sections have particular significance to the drafter of specifications of chemical and metallurgical patents because, following the statute, they enumerate those categories of inventions in which chemical and metallurgical patents are contained—namely, processes, compositions of matter, and uses. 

In determining the patentability of novel homologs, our concern is the "obviousness" statute in our patent law, 35 U.S.C. 103. The phrases discussed are ".. . the subject matter sought to be patented. . . " and ".. . the subject matter as a whole. . These phrases do not mean the same thing. "Obviousness" under Section 103 is a problem of patent law answerable only on the evidence presented as to differences in properties as between a known compound and a claimed compound. The patentability of a compound does not depend on dissimilarity in formulas but on dissimilarities of the tangible embodiments of the two formulas. We have "homologous" cases in the law as well as in chemistry, and it is only upon a study of such cases that a reasonable prediction as to patentability can be made. 

Intelligently to discuss the assigned subject of the patentability of a compound closely structurally related to a prior art compound, I am compelled to give you two hard bits upon which to chew. The first is known popularly as the obviousness statute in our patent law—that is, Section 103 of Title 35 of the United States Code. The second, to which I shall advert later and more briefly, is the necessity for understanding the value of consistency and generality, or the seamless web, of the whole body of patent law. 

Let us go to the subject of next-adjacent homologs and assume methanol known and ethanol the novel subject matter sought to be patented. We face an immediate question as to what manner of using the ethanol was asserted in the patent specification in conformity with the requirement of Section 112 of the statutes for such disclosure, and we will here make an assumption that the disclosed use is as a solvent in formulating an elixir. We will make the further assumption that the art taught methanol to be a solvent for several organic compounds. 

The second section provides basic protection against the passing off of goods as patented or as the product of a patent holder. 35 U.S.C. 292 imposes a maximum 500 fine for every use of the name or imitation of the name of the patentee, use of the patent number, and use of the words patent or patentee or the like, if such act was intended to imitate the mark of a patentee or to deceive the public by inducing them to believe that the thing was made or sold by or with consent of the patentee, or if the act was committed with the intent of leading others to believe falsely that an item was patented. The statute allows private parties to sue for and recover one half of the penalty. Thus,... 

Since a patent is a creation of a statute in every country, it is essential to examine the statutes for which a patent may be granted. To be able to file a patent application a certain number of basic and formal requirements have to be met. Basic requirements are quite similar in the main industrial countries. Formal requirements vary a good deal from one country to another. Inventors, for example chemists, are mainly concerned with basic requirements and some formal requirements like disclosure of the invention, i.e. description (see Section IV.B). 

The statute does refer to timing, i.e., does indicate the exemption should be applied before FDA approval is obtained. No exemption is provided after filing a request for approval with the FDA, and no exemption exits after approval is obtained. As described in the background section above, the statute is structured this way for a reason. Specifically, the exemption is provided before FDA approval so that the patent term is not effectively extended by requiring that one wait for the patent to expire before carrying out the lengthy... 

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