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Patents and Trade Secrets in Biotechnology
Pages 91-97

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From page 91...
... (The organism in question had been genetically engineered not through recombinant DNA techniques but through the transfer of naturally occurring plasmids.) This landmark decision led to a surge of patent applications and approvals in the area of biotechnology.
From page 92...
... Nevertheless, the Chakrabarty decision has sparked new interest in using the patent system to protect intellectual property resulting from biotechnology. As the ramifications of the decision continue to spread, and as new court cases and legislative initiatives arise, many of the remaining uncertainties and problems in protecting innovations in biotechnology will diminish.
From page 93...
... "When you purify a material and it has never existed in that form before, it is novel." This provision has been used to patent a wide variety of chemical substances in the past, including vitamins, hormones, and pure cultures of naturally occurring microorganisms, and it applies equally well to the products of biotechnology. A patent application must also contain enough information to enable a person who is skilled in the field to make and use the claimed invention without undue experimentation.
From page 94...
... patent law, samples of patented microorganisms must generally be provided to independent repositories, which then furnish the cell lines to members of the public on request. patent." For instance, if the scope is not properly denned in a patent, a competitor may be able to use and possibly patent a protein with a different combination of amino acids that has essentially the same biological function.
From page 95...
... We have to have that same strong patent system for the genetic engineering industry." Already the Patent and Trademark Office has issued patents for a wide range of products resulting from biotechnology, including altered genes, DNA probes, vectors, and microorganisms. As for processes, it has issued patents covering such diverse procedures as the enhanced expression of a protein, the alteration of gene components, the preparation of vectors, the synthesis of proteins, the production of hybrid bacteria, and the purification of DNA sequences.
From page 96...
... One possible modification of this requirement would be to deposit the original organism and file an enabling description of how it has been genetically altered. Another option may be to restrict the use of microorganisms by third parties in a way that prevents patent infringement without limiting the public's access to the patented information.
From page 97...
... These problems will undoubtedly diminish as examiners and patent attorneys become more knowledgeable about the field and as precedents are established. But "it takes time," says Saliwanchik, "upwards of ten years or so in conflict situations." Finally, the cost of seeking a patent has to be kept within bounds so that individuals and organizations will take advantage of the system.


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