A recent article about Myriad Genetics makes some important points (see; Despite Gene Patent Victory, Myriad Genetics Faces Challenges). Here's an excerpt from it:
Myriad Genetics retained its monopoly on a lucrative genetic test for breast cancer risk when a federal appeals court recently upheld the company’s patents on two human genes — and the validity of gene patents in general. But newer DNA-sequencing techniques are far faster and only a fraction of the cost of the 1990s technology that Myriad uses. Indeed, it will soon be possible to sequence a person’s entire genome, all 22,000 or so genes, for less than Myriad charges for just two genes. Executives at Myriad say they are preparing for changes. Although its major patents start expiring in 2014, the executives say the company’s patent protection should last until at least 2018. They say that will give the company time to adopt new technology and to diversify beyond the breast cancer test, which accounted for $353 million, or 88 percent, of Myriad’s $402 million in revenue in the fiscal year that ended in June. The company also plans to rely less on patents and more on trade secrets. Because it has done so much more testing than anyone else, Myriad has more information on which of the thousands of possible mutations in the two genes actually raise the risk of getting cancer. Myriad used to share such information with a public database maintained by the National Institutes of Health, and it cooperated with academic scientists trying to analyze the mutations. But a few years ago, the company quietly stopped contributing and cooperating, in favor of building its own database....Myriad executives have said that when [another] laboratory finds a mutation in either of the two genes, 20 to 40 percent of the time it does not know if the mutation raises the cancer risk. They say that Myriad’s rate of uncertain findings is just 3 percent.
Myriad was one of the first, and certainly one of the most successful commercial laboratories, to offer molecular diagnostic testing. Their most important test, BRACAnalysis, revealed the predisposition of some women to hereditary breast and ovarian cancer. The genes being tested are BRCA1 and BRCA2. Although this article starts off by referring to recent advances in automated genotyping and patents, it quickly gets to the point. Myriad's strategic advantage lies not in its technology that has been perfected over many years but rather in its trade secrets. These consist of the company's acquired knowledge of exactly which mutations within the BRCA1 and BRCA2 genes are significant, There can be numerous DNA errors at these two loci but not all of them are clinically significant. Myriad, based on experience and its proprietary database, has a better idea which ones to worry about than anyone else.
There is no question that Myriad has a major, and well-earned, advantage with its proprietary database. However, I am not as certain as the company about how long this advantage will last. BRCA1 and BRCA2 mutations are of great interest to academic oncology researchers because they code for cancer in two organs. These researchers will strive to make sense of the underlying genetic mechanism regardless of any transient patent victory that Myriad has achieved. They also have modern genotyping tools and knowledge at their disposal. In other words, Myriad has bought some time and its reliance on trade secrets will protect its revenue stream for a short time. I am betting, however, that this company advantage will not last much longer and certainly not until 2018.