The U.S. Supreme Court recently issued its decision in the case of Association for Molecular Pathology v Myriad Genetics, Inc. This decision has been long awaited and has proven controversial as it sets the U.S. apart from other global patent systems on the exclusion from patentability of isolated genes.

 

Myriad Genetics, Inc (Myriad) produces and sells a diagnostic test that can detect mutations in the BRCA 1 and BRCA 2 genes. Certain mutations in these genes can indicate an increased risk of breast and ovarian cancer. Myriad determined the location and sequence of the BRCA 1 and BRCA2 genes and sought patent protection for their gene sequences.

 

Genes include coding regions (exons) and non-coding regions (introns). The coding regions are the functional part of DNA and they produce the instructions needed to create proteins. It had long been the practice at the United States Patent & Trademark Office (USPTO) that claims to both the isolated DNA, the sequence of both coding and non-coding regions of a gene as it would exist excised from the rest of the genomic DNA, and complementary DNA (cDNA), a copy of only the coding region of the gene, were patentable and the Myriad patents contain both types of claim.

 

In its decision, the Supreme Court states 'claims directed to "isolated" human deoxyribonucleic acid (DNA) sequences "BRCA1" and "BRCA2," and mutations in those sequences associated with predisposition to breast and ovarian cancers, claim naturally occurring phenomena and thus are not drawn to patentable subject matter'. The Supreme Court held that no alteration of the encoded genetic information had occurred and, as the isolated DNA claims of the Myriad patents simply claimed the sequence of the genes as they existed in nature, this constituted claims directed to naturally occurring phenomena.

 

The Supreme Court however found that claims to cDNA were eligible for patentability 'since cDNA is not naturally occurring and differs from natural DNA, in that non-coding "introns" have been removed, and since cDNA sequence, although it is dictated by nature and retains naturally occurring exons, is newly created product that is distinct from DNA from which it is derived'.

 

The USPTO has yet to provide a substantive response to the Myriad decision. However, a memo circulated following the decision indicated that with immediate effect claims to isolated DNA were no longer patentable and would be objected to as naturally occurring phenomena.

 

Isolated gene sequences are patentable at the European Patent Office and this is provided in the Biotechnology Directive 98/44/EC:

Article 5(2): An element isolated from the human body or otherwise produced by means of a technical process, including the sequence or partial sequence of a gene, may constitute a patentable invention, even if the structure of that element is identical to that of a natural element.

 

However, the gene product of the isolated gene must have a known function and the isolated DNA must also fulfil the requirements of being novel, comprising an inventive step, and having an industrial application.

 

In light of the Myriad decision and if filing in the U.S. is foreseeable, we would advise ensuring that all future patent applications to DNA technology include both isolated and cDNA claims. This will ensure the greatest scope of protection for patent systems outside of the U.S. and, after deletion of the isolated DNA claims on filing, provide allowable claims to cDNA inside the U.S.