![]() International consensus about general patent criteria does not, however, necessarily lead to consistent interpretation and implementation across jurisdictions. The process for ensuring that these criteria are met is patent examination. Moreover, a patent must describe an invention in sufficient detail that a “person having ordinary skill in the art” will be able to make and use it without “undue experimentation.” The patent must be “enabling” and the “written description” sufficient. An invention must also meet three criteria for patentability: ( a) novelty, ( b) nonobviousness (the European term is inventive step), and ( c) utility (or in Europe and most other jurisdictions, industrial application). definition is “any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof” ( 227). ![]() An invention must be patentable subject matter. The procedural rules differ somewhat, but the criteria for granting patents are broadly similar worldwide. Patent offices grant patents in response to patent applications. A patent is, in effect, a license to sue someone for making, using, or selling an invention without permission. That right is enforced by national courts. Whole-genome sequencing will confront uncertainty about infringing granted patents but jurisprudence trends away from upholding the broadest and potentially most troublesome patent claims.Ī patent is a document issued by a government entity that confers the right to exclude others from making, using, selling, importing, or offering to sell an invention claimed in the patent. Patents on methods and DNA sequences relevant to clinical genetic testing show less evidence of benefits and more evidence of problems and impediments, largely attributable to university exclusive licensing practices. In instrumentation and for therapeutic proteins, patents have largely played their traditional role of inducing investment in engineering and product development, including expensive postdiscovery clinical research to prove safety and efficacy. Patents on DNA technologies are a central feature of this story, illustrating how patent law adapts-and sometimes fails to adapt-to emerging genomic technologies. These fields grew to prominence in an era of growth in government and nonprofit research funding, and of even greater growth of privately funded research and development in biotechnology and pharmaceuticals. Genomics and human genetics are scientifically fundamental and commercially valuable.
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