This has been an eventful year in terms of bringing diagnostic technology and gene patents to the public’s attention. First, in a highly publicised announcement on 14th May 2013, actress Angelina Jolie announced her decision to undergo a preventative double mastectomy following genetic testing that confirmed she carried a mutation in her BRCA-1 gene. BRCA-1 stands for Breast Cancer 1 and encodes a protein expressed in breast tissue that repairs DNA. Mutations in this gene (or in a related gene BRCA-2) result in damaged DNA not being repaired, which sharply increases the risk of breast cancer.
Jolie’s announcement has resulted in increased publicity of companies which offer genetic tests to determine personal risk for developing conditions such as the hereditary breast cancer correlated to mutations in BRCA1 or BRCA2 (eg, Myriad Genetics Inc). This is illustrative of the ongoing trend towards personalised medicine, which presents a number of challenges from a commercial and patenting point of view, such as the challenge and expense in creating diagnostic tests given the extent of genetic variability within the population. Nevertheless, Myriad has been successful in this area, holding patents in the United States and other countries on diagnostic kits and methods involving the BRCA genes, as well as the genes themselves.
This issue was again in the spotlight when, on 13th June 2013, the US Supreme Court issued its decision in Association for Molecular Pathology v Myriad Genetics, Inc. The decision focused on whether genes were patentable subject matter. The court held that isolated DNA encoding a gene occurring in nature, such as a mutated BRCA1 gene, is not patentable. However, synthetic DNA (eg, complementary DNA (cDNA) for BRCA1 and BRCA2 genes) i patentable. The court held that a naturally occurring DNA segment is a product of nature and not patent eligible simply because it has been isolated. The court also held that Myriad’s discovery of the location of BRCA1 and BRCA2 genes did not render the genes patent eligible. However, cDNA may be patentable as it is not a product of nature; it is a result of significant human manipulation.
The decision has been considered a game-changer by many US commentators and is predicted to have an immediate impact on US biotechnology patent practice. The biotechnology community is continuing to assess the decision's impact on its biotechnology patent portfolios and investment and patenting strategies.
In Canada, there has not yet been a direct court challenge on the patentability of naturally occurring genes. Genes have been treated as patentable subject matter by the Canadian Intellectual Property Office (CIPO). For example, Myriad holds Canadian patents covering the BRCA1 and BRCA2 genes.
There is a solid foundation in Canadian jurisprudence for doing so. Patentable subject matter is governed by the definition of 'invention' in Section 2 of the Patent Act, which covers “any new and useful art, process, machine, manufacture, or composition of matter” as well as improvements therein. That genes are patentable subject matter was confirmed in the Canadian Supreme Court’s 2004 decision in Monsanto v Schmeiser, in which the patentability of unnatural chimeric genes was affirmed.
CIPO practice has therefore been that isolated nucleic acids (eg, DNA, RNA, and cDNA) are patentable. There has been no indication that CIPO will depart from its longstanding practice of allowing patents for genetic material. The impact on innovative companies’ patent entitlements therefore seems less likely to change in Canada.
The publicity given to these issues by Jolie’s announcement and the US Supreme Court decision seems to have yielded a net positive impact from a public awareness perspective. Access to genetic testing for BRCA1 and BRCA2 is increasingly available in Canada through insurance plans and healthcare programmes.The public is now more aware than ever of the possibilities and potential for forms of personalised medicine such as genetic testing.
This article first appeared in IAM magazine. For further information please visit www.iam-magazine.com.