Patent claims pharmacologically active compound

Patentable subject matter is ... any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof Patent laws provide that patents may be granted only for inventions that are deemed to be new and useful. These requirements exclude pharmaceutical inventions that have not been shown to be reasonably safe and effective and chemical compounds that have no use except as intermediates for additional research. However, some special considerations have traditionally been applied in the case of chemical compounds, particularly those possessing therapeutic or pharmacological activity. A compound that is useful as an intermediate for the manufacture of a pharmacologically active compound may be claimed and afforded patent protection because it satisfies the utility requirement and is considered to be useful. Further, a compound need not show therapeutic utility in humans to meet the utility requirement of patentability pharmacological activity in animals or in vitro activity is considered sufficient in some cases. If the patent application purports to claim the use of a compound for the treatment of humans, the inventor must show that the compoimd is both safe and effective in humans. 

This may seem at odds with In re Joly, id., but one should appreciate that in that case it appeared that structural similarity was the sole basis for the utility argument rather than in addition to other information or data. In other cases, such as In re Jolles, id., a close structural relationship in addition to a shared pharmacological activity with known useful compounds were sufficient for patentability. One should use caution in this regard, however, since such arguments may also be used against an applicant or patentee with a charge that the claimed compounds are obvious in view of the prior art. 

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