Execs from Interleukin Genetics and BioMarker Strategies are not too worried about the case against Myriad Genetics. They believe that if it’s new and not obvious, it doesn’t matter whether it’s a product of nature.
“Whether it’s a gene, machine, or a lima bean, it’s patentable,” says Lewis H. Bender, CEO of Interleukin Genetics. The company is developing consumer-based tests, such as those for weight management and nutrition, as well as medical diagnostics to be used in clinical trials.
Bender stresses that the consumer tests aren’t simply tools that will tell you whether you have a particular gene that makes you more prone to putting on weight. He explains that they will be set up as interactive web-based tools that will also advise you on what to do and how to manage your weight while continuing to track your genetic profile. Additionally, these tests will be sold at around $100 to $150, making them more affordable and accessible.
On the medical front, Bender says that one of the biggest challenges is to get companies to change their mindset about how to use biomarkers. Most run clinical trials and assess biomarkers as a surrogate endpoint. What Interleukin Genetics is offering is to use its tests and biomarker capabilities for trial design; i.e., finding the most suitable population on which to test a drug.
Another hurdle is that the company is offering tests in osteoporosis and cardiovascular diseases, not indications in which firms usually have a biomarker strategy. While biomarker research is fairly entrenched in oncology drug development, that is not the case in other diseases.
Scott Allocco, president of BioMarker Strategies, is focusing on developing tools and devices that can do live cell and ex vivo research to find functional and dynamic biomarkers. Maintaining solid tumor cells in a live state gets rid of the problems inherent in using FFPE samples. He points to the progress made in leukemia and lymphoma research because of the use of ex vivo techniques. The aim for BioMarker Strategies is to bring the same advances to solid tumors.
“DNA-based tests mark the first generation of molecular diagnostics,” notes Allocco. The future, for him, lies in multianalyte testing through ex vivo methods, which will evolve based on the IP landscape. Getting rid of patents on human genes, he notes, is not going to increase the pace of R&D and may actually hamper it. Even if different companies hold patents to each gene involved in such a multivariate test, licenses can be drawn up to conduct research and royalties paid to market such diagnostics.
Myriad Genetics Comes under Legal Fire for Gene Patents (5/13/2009)