Biological patents in the United States
As with all utility patents in the United States, a biological patent provides the patent holder with the right to exclude others from making, using, selling, or importing the claimed invention or discovery in biology for a limited period of time - for patents filed after 1998, 20 years from the filing date.
Until recently, natural biological substances themselves could be patented (apart from any associated process or usage) in the United States if they were sufficiently "isolated" from their naturally occurring states. Prominent historical examples of such patents on isolated products of nature include adrenaline, insulin, vitamin B12, and gene patents. However, the US Supreme Court ruled in 2013 that mere isolation by itself is not sufficient for something to be deemed inventive subject matter.
The United States has been patenting chemical compositions based upon human products for over 100 years. The first patent for a human product was granted on March 20, 1906, for a purified form of adrenaline. It was challenged and upheld in Parke-Davis v. Mulford.Judge Hand argued that natural substances when they are purified are more useful than the original natural substances.
The 1970s marked the first time when scientists patented methods on their biotechnological inventions with recombinant DNA. It wasn’t until 1980 that patents for whole-scale living organisms were permitted. In 1980, the U.S. Supreme Court, in Diamond v. Chakrabarty, upheld the first patent on a newly created living organism, a bacterium for digesting crude oil in oil spills. The patent examiner for the United States Patent and Trademark Office had rejected the patent of a living organism, but Chakrabarty appealed. As a rule, raw natural material is generally rejected for patent approval by the USPTO. The Court ruled that as long as the organism is truly "man-made," such as through genetic engineering, then it is patentable. Because the DNA of Chakrabarty's organism was modified, it was patentable.
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