In March, the U.S. District Court for the Southern District of New York gave its decision on seven patents held by Myriad for the BRCA1 and BRCA2 genes, mutations of which are responsible for the majority of hereditary forms of breast and ovarian cancers, finding all seven to be invalid.
Myriad, thanks to its 23 patents regarding these genes, is the only company in the US that can carry out DNA testing on them to assess the risk of a patient developing cancer.
The key issue faced in this case was whether or not isolated and purified genes are patentable. Substances occurring naturally in nature are not, but it is generally accepted that, for example, while a compound naturally present in a plant is not patentable, that same compound in isolation is. In keeping with this, there is a precedent in US case law for the granting of patents covering genes in their isolated form.
Given this, the ruling in this case was unexpected. Judge Sweet ruled that the isolated and purified form of the BRCA1 and BRCA2 genes was not significantly different to the forms found in the human body. On this basis, the genes are products of nature and inherently unpatentable. The methods covered by the patents were also judged to be non-patentable as they were considered merely mental processes of comparing and analysing (ie comparing the DNA sample from a patient with Myriad’s isolated DNA) or to cover the scientific method itself, such as a broad concept of slower cell growth in the presence of a substance being an indicator of therapeutic potential against cancer. On page 135 of the ruling, Justice Sweet sums up Myriad’s work in the following way:
The identification of the BRCA1 and BRCA2 gene sequences is unquestionably a valuable scientific achievement for which Myriad deserves recognition, but that is not the same as concluding that it is something for which they are entitled to a patent.
This decision comes in the midst of ongoing debate regarding the patentability of genes. Many in the scientific and medical fields have welcomed this decision as they believe that patents covering the human genome stifle innovation and prevent medical advances. There are many, however, with concerns over the adverse effects this may have on research; if there is no likelihood of a company being able to recoup their research and development costs through intellectual property rights, then there is little incentive for them to carry out the research in the first place. This will potentially shift more of the burden and cost of medical research onto academic institutions.
Myriad have already stated their intention of appealing against the decision and the case is likely to go to the Court of Appeals. If upheld, this decision has potential implications for the owners of the patents on some 2,000 other genes.
28 May 2010