On a weekend trip in 1983, a Bay Area biotechnology scientist had a flash of inspiration. Kary Mullis, Ph.D., realized that a combination of readily available laboratory reagents and materials would promote the exponential replication of DNA in a test tube. He realized that over a billion copies of a DNA fragment could be made in an afternoon! Upon returning to Cetus Corporation, he started laboratory work that would lead to a revolutionary patent.
In 1987, US Patent 4,683,202 "process for amplifying nucleic acid sequences" issued. The Polymerase Chain Reaction or PCR method would soon be used world wide to perform biotechnology experiments, clone genes, identify pathogens, and convict criminals. It also did not take long for it to make the leap to Hollywood: PCR was highlighted in the movie Jurassic Park and is used weekly in the CSI television series.
A patent is a monopoly granted by the US government on inventions. Hoffman-La Roche, a Swiss pharmaceutical giant recognized the commercial potential for PCR and purchased the family of PCR patents for $300 million in 1990. The original Mullis patent expired a few years ago, but a "picket fence" of other patents still protects various aspects of the method. Hoffman-La Roche licensed the technology broadly and has developed many of its own products based upon the method. The return on investment of their $300 million has been huge!
A patent can be issued on "any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement method". Dr. Mullis and the Cetus Corporation had to prove to the patent office that their invention was useful, novel and non-obvious http://www.uspto.gov/main/patents.htm They had ample evidence that the invention was useful since it was rapidly adopted by biotechnologists after publication of the method in 1985. Examination of the scientific literature demonstrated that it was novel because no prior use of PCR could be found. They also successfully demonstrated that it was non-obvious to one skilled in the art since all the chemicals and methods were commonly used in biotechnology laboratories prior to 1983, but no one had the flash of inspiration to combine them in a fashion to exponentially amplify genetic material. Kary Mullis truly changed the world of biotechnology and has received numerous scientific awards including the Noble Prize in Chemistry in 1993
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