Recently, this topic has been in headline news due the legal battle between different groups (including ACLU) and Myriad Genetics (the patent holders for the DNA sequence containing BRCA1 and BRCA2 mutations – mutations responsible for most hereditary breast and ovarian cancers).

This story has been reported by several news outlets. You can read more at USA Today, Wall Stree Journal (subscription required), and Reuters.

The concept of patenting a human gene violates the rules of obtaining a patent (i.e. a patent cannot be placed on something that exists in nature). However, Myriad Genetics’ patent is not on the gene itself, the patent is on identifying mutations that occur in that gene. Identification of this mutation is used to determine someone’s risk of developing hereditary subtypes of breast and/or ovarian cancers.

Groups suing Myriad Genetics claim the patent is hampering scientific research/innovation. It is not clear to me, at this time, why/how the patent would prevent advancing research in this area. I will have to dig deeper into this.

Nonetheless, the objective of the lawsuit is to invalidate the patent. If the patent on the BRCA1/BRCA2 mutation is invalidated, a new start-up can develop a genetic test to detect this mutation. Since this new company did not invest any research money or time in identifying the mutations (which Myriad had to do), they can afford to price their genetic test very inexpensively compared to Myriad.

On the surface, an inexpensive test sounds appealing, doesn’t it?

The problem, however, is that Myriad will have to lower their prices too and, as a result, may be unable to recoup the money they invested in research, time, money, and resources. What would this mean to Myriad? Not clear, exactly, but it certainly would not be good news.

On a more global scale, what would this mean to other companies who are trying to develop other innovative genetic tests to determine an individual’s susceptibility for a specific disease? Will anyone invest in these companies if such investment may not be financially worthwhile in the long term?

Companies and investors are willing to take a risk by spending money, time, and research with the hope that some day their investments will pay off when the product goes to market.

What happens, then, if that incentive goes away?

I think the answer is simple: no one would invest in generating scientific discoveries or translating these discoveries to products that would benefit society.

And this is certainly not good news for advancements in the field of genetic testing.

So what is the solution?

It is critical for the courts who are handling this legal battle to be careful not to compromise the future of ventures that aim to develop genetic tests.

Obviously, there is no straightforward solution. We must identify a balance; we have to figure out how a company that conducts research and develops a product can profit, without hampering scientific innovation or progress in that area of research.