Tuesday, April 23, 2002
"The PTO's new guidelines clearly describe the current criteria for patenting gene-based inventions. They've raised the bar by requiring that an invention show a specific and substantial utility, thus effectively eliminating patents on sequences of unknown function (such as first-generation EST patents). But the new guidelines still haven't answered all the questions posed by researchers, nor have they put to rest some genuine concerns voiced by academia. Despite the controversy and stiffer requirements, however, the PTO should grant scores of new gene patents in the next few years. Whether these patents will hold up in court is another matter -- as Amgen and TKT are still discovering.Judge Young's lengthy decision is published, and while the article references an appeal it does not appear to have been pursued. An interesting related item: In February, BIO and Ernst & Young announced their collaboration on "a new primer and resource of first resort for the federal judiciary: A Jurists’ Guide to 21st Century Biotechnology." The site, which is up but still in "draft" form, provides background on how patent law has developed and been applied to the genetic and other biotechnology fields. Judges will find it useful, as it links to relevant materials, defines technical terms, and presents things in a neutral, even-handed manner. The site's "unresolved issues" page also looks promising as a way to highlight areas of controversy, but for now it strikes me as pretty brief.
. . .Judge Young concluded that 'In order to avoid infringing a product claim, a competitor must not make that product regardless whether the process used to do so differs in some way from the process or processes described in the patent. If indeed the same product is ultimately obtained, it matters not that in order to do so the competitor tweaked the process in some manner.' "
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