The United States Supreme Court unanimously ruled that although isolated, natural gene sequences are unpatentable, cDNA (referred to as synthetic DNA) is officially considered patentable subject material. The ruling was issued after the court reviewed patents owned by Myriad Genetics Inc. in the high-profile case, Association for Molecular Pathology v. Myriad Genetics. The patents claimed the genes, BRCA1 and BRCA2, as well as methods for detecting mutations in the genes which have been linked to breast and ovarian cancer. The court supported this legal claim stating that “cDNA is not a ‘product of nature,’ so it is patent eligible …”.

GenScript’s gene synthesis service, is a valuable method for circumventing the isolation of natural DNA sequences for use in biological research studies. The service provides non-natural, de novo DNA sequences synthesized according to a client’s specified design, allowing natural gene sequences or gene cassettes to be engineered for in vivo, or in vitro use, including diagnostic tests. Additionally, GenScript’s OptimumGene™ codon optimization technology can alter the sequence of natural genes, to increase the expression of the subsequent protein in a number of expression systems. The OptimumGene™ algorithm considers nearly every parameter affecting the central dogma process, from transcription to protein folding, and has been proven to optimize protein production in bacterial, mammalian, yeast and insect expression systems. OptimumGene™ codon optimizationin combination of gene synthesis can generate novel, non-naturally occurring sequences, with high-utility and attractive patentable features. To preserve the intellectual property rights of clients, GenScript does not claim any rights to specialized synthetic or OptimumGene™ codon optimized genes. Custom project details are kept strictly confidential, with all intellectual property rights belonging to the client.

It may be too soon to speculate on how the recent court ruling will affect the future patentability of DNA sequences. However, as the pace of molecular biology research quickens, the use of synthetic DNA will inevitably become a mainstay in every research lab, ensuring that at the very least, more court rulings on the patentability of DNA are sure to come. GenScript offers gene synthesis and codon optimization solutions for the present and future of gene patent law and remains committed to supporting innovation and protecting intellectual property.

*GenScript is not a legal practitioner and the content above is in no way intended to provide legal advice for patent prosecution, litigation or any associated legal matters thereof.