AMP’s BRCA Patent Suit Against Myriad Will Move Ahead, But There May Be a ‘Silver Lining’

A federal district court yesterday said it would hear the case brought by AMP and others against Myriad Genetics in May claiming that the ability to patent genes — namely Myriad’s BRCA IP — is unconstitutional.

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This business model of gene

This business model of gene patenting and exclusive testing and licensing rights for naturally occurring sequences of DNA should, by this point, be obsolete, but is kept afloat by outdated laws. Aside from the simple moral implications of such patenting, which one would expect the vast majority of the population to disagree with (how many people would be happy with the idea that portions of DNA in every cell in their body are owned by corporations), the times have changed and new sequencing and bioinformatics advancements have made linking DNA sequences with disease states a much simpler process than it was 30 years ago.

Companies should now be profiting by creating and patenting novel diagnostic systems/assays to detect mutations or disease states of interest. The money should be there for companies that can produce the fastest, cheapest and most accurate methods for diagnosing particular disease states, etc. Defend your unique technological IP in the courts, don't defend the IP of a sequence of DNA that is naturally occurring in thousands-to-billions of people, plants or animals.

It's time for some new business models in the world of diagnostics.

I wonder why you believe

I wonder why you believe revoking gene patenting would be "calamitous" to clinical labs?

While from an IP perspective this could impact certain organizations and their associated valuations(if specific IP protected gene testing accounts for a significant chunk of their revenue), I think this would benefit the majority of clinical labs currently precluded from running such testing, and ultimately patients.

Furthermore, the ones that will win, in the end, are those with sufficient sales coverage and logistics to effectively serve existing and attract new customers. Given the challenges of supporting a sales force on the meager margins of molecular dx tests, these will likely be the same large organizations who own these patents, and can now expand their bag with other gene based tests.

Let the market decide who wins.

Genetic variants that

Genetic variants that correlate with present or future disease, severity of illness, and drug responsiveness are regularly discovered using routine, automated techniques. Why should the biological relationship between a genetic variant and a clinical result be patentable? Often several groups almost simultaneously report a discovery. Frequently, patents are awarded to investigators in other countries.

From the perspective of a pathologist, the sole effect of these patents is to prevent us from practicing our profession. Most such discoveries have been made by academic researchers who are publicly funded, and for whom the requirements for publication and receipt of research grants provide sufficient incentives to perform their daily work. Patents on such correlations are unnecessary to encourage the introduction of testing, because assays are performed using standard, well-established methods and techniques (which are themselves rightfully patented). Setting up molecular diagnostic tests for gene-variant correlations is typically straightforward and a routine part of our practices.

How would the field of medicine have advanced if relationships such the association between diabetes and elevated blood sugar had been patented? Should one person be given the right to exclude others from listening for heart murmurs and correlating the sound with the presence of aortic stenosis? Pathologists have looked through microscopes to make diagnoses for well over a hundred years. We have examined the features of tissues and correlated them with the presence of disease and appropriate therapy. Advances proceeded in the absence of patents. In recent years we have added the examination of proteins and chemical characteristics to microscopy. Again, patents were unnecessary to stimulate this progress. Now we can look at DNA and RNA changes that have the potential to provide much greater accuracy and are far more predictive of therapeutic responsiveness than previous methods. However, we find progress and advancement stifled by the presence of patents on mere biological relationships for which no inventive work was performed.

Only through broad availability of tests for the natural relationships between genetic variants and diagnosis, prognosis, and response to therapy can the benefits of our increased knowledge be realized and improved upon.