Chapter 1: Anything Under the Sun: Patent Law and Micro-Organisms
[U]nder section 101 a person may have invented a machine or a manufacture, which may include anything under the sun that is made by man. (P.J. Federico, Principal draftsman of the Patent Act 1952 (US))1 A treatise writer, Philip Grubb, comments that biotechnology has a long history, pre-dating the discovery of the double-helix by James Watson and Francis Crick: Classical biotechnology may be deﬁned loosely as the production of useful products by living micro-organisms, and as such it has been with us for a long time. The production of ethanol from yeast cells is as old as history, and over 50 years ago the production of various industrial chemicals such as acetic acid and acetone by fermentation processes was well known.2 Notably, in 1873, Louis Pasteur was granted a patent by the United States Patent and Trademark Oﬃce (USPTO), claiming ‘yeast, free from organic germs of disease, as an article of manufacture’.3 The patent attorney, Grubb, noted: ‘In the USA, in spite of the precedent of the Pasteur patent . . . it had become the practice of the Patent Oﬃce to refuse claims to living systems as not being patentable subject matter.’4 The long-standing practice of the USPTO was to refuse claims to living systems as not being patentable subject matter. In 1889, the Commissioner of Patents rejected a patent application which lay claim to ‘cellular tissues of the Pinus australis’ tree separated from the ‘silicous, resinous, and pulpy parts of the pine needles and subdivided into...
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