We have previously reported on the progress of the “Myriad Gene Case”. A suit was brought against Myriad by a number of parties, including the Association of Molecular Pathology, in which the validity of a number of patents owned by Myriad relating to isolated sequences of DNA was challenged.
The patents claimed isolated DNA fragments that encoded for the BRCA1 and BRCA2 proteins, certain mutations of which have been linked to an increased likelihood of developing breast and ovarian cancer. In March 2010, the District Court ruled that claims relating to isolated genes in seven of Myriad’s patents were invalid, as isolated genes were classed as products of nature and so were excluded from patentability. This decision was largely overturned by the Federal Circuit on appeal, which reversed the decision of the District Court insofar as it related to claims to isolated genes but upheld that the method claims in the patents were invalid.
The decision of the Federal Circuit was then appealed to the Supreme Court, which has now ruled that isolated DNA sequences are not patentable subject matter. Myriad had argued that an isolated DNA molecule is not naturally occurring, and is therefore not a product of nature. However, the Supreme Court stated that Myriad had not created anything by isolating the BRCA1 and BRCA2 proteins, and that simply separating them from their surrounding genetic material is not an act of invention. Hence, the Supreme Court held that the genes, which existed in nature before they were identified and isolated by Myriad, were products of nature and therefore not patentable subject matter.
In their decision, the Supreme Court did draw a line between DNA and cDNA (complementary DNA). cDNA molecules are synthetically created exon-only strands of nucleotides, synthesised from messenger RNA from which all introns have been removed. As cDNA is man-made, the Supreme Court ruled that it was not excluded from patentability.
This decision represents a significant change in practice in the US, where gene patents have been allowed in the past. It raises questions regarding the validity of the thousands of gene patents which have previously been granted by the US Patent and Trademark Office, as well as having serious implications going forward for biotechnology companies working in this area. The Supreme Court’s judgement will doubtless be welcomed by campaigners and pressure groups opposed to gene patenting on policy grounds. However, the danger is that the restriction on the availability of patent protection that it imposes will have a detrimental effect on the commercial viability of research in this field, with the possible result that beneficial diagnostic tests and therapies may not be developed.
18 June 2013