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Myriad's Trade Secret Trump Card: The Myriad Database of Genetic Variants

18 July 2013 PharmaPatents

One of the most interesting arguments that Myriad made in its Motion for Preliminary Injunctive Relief in its infringement action against Ambry Genetics Corporation relates to the database of genetic information that Myriad has developed over its years of conducting BRCA1 and BRCA2 genetic testing. Myriad asserts that the proprietary database makes its testing more accurate than Ambry’s–is the Myriad database Myriad’s trade secret trump card?

Myriad’s Proprietary Database

Myriad makes the following assertion in the “Statement of Facts” in its Motion for Preliminary Injunctive Relief:

These efforts [in improving its testing] have also led to an extensive database of genetic variant information, which was developed in part utilizing research and a $100 million investment by Myriad Genetics. This database has allowed Myriad Genetics to further improve its test quality by ensuring that over 97% of the patients tested with BRACAnalysis®, who receive a report identifying a genetic variation, will be informed as to the clinical significance of the variant.

An article led by Robert Cook-Deegan of the Institute for Genome Sciences & Policy and Sanford School of Public Policy at Duke University seems to support Myriad’s claims regarding the value of its database. In “The next controversy in genetic testing: clinical data as trade secrets,” Eur. J. Hum. Gen 21: 585-88 (2013), the authors discuss the importance of “broad access to DNA sequence variants and clinical information about those tested” to accurate genetic testing. As explained in this article, Myriad’s database gives it an advantage in being able to interpret “variants of unknown significance (VUS).” The article reports that “Myriad claims that the fraction of cases resulting in a VUS is 3% in its hands, and 20% for most European BRCA-testing services,” likely because Myriad has “an extensive database that relates variants of uncertain significance to phenotype, details their frequency in various populations and includes genetic studies on patient families.”

Is the Database Myriad’s Trump Card?

In the “Argument” section of its Motion for Preliminary Injunctive Relief, Myriad states:

The public interest is advanced by more patients receiving tests from Myriad because of Myriad’s exclusive access to its proprietary and extensive database of known genetic variants when making a comparison with a patient test sample. …. This database allows Myriad to report definitive findings to over 97% of its patients. …. Ambry, in contrast, can do this only 70-75% of the time. …. Thus, Ambry will inform 25-30% of patients tested that they have a genetic variant, but will give them no further information about the clinical implications of that variant. Because insurance will not reimburse for a second, repetitive test, most patients will not be able to be tested again. Thus, those patients and their medical providers will be left to guess at an appropriate course of treatment. Some patients, knowing they have a genetic variant of unknown significance, will assume the worst and undertake unnecessary prophylactic measures, including potentially surgery, even though the underlying variant may be benign. …. Allowing Ambry to proceed with its intent to enter the marketplace would be injurious to the public interest, and Ambry should be enjoined from doing so.

While these arguments are made to show that Myriad’s genetic testing serves the “public interest,” Myriad no doubt will rely on its database in its “marketing strategy to advise the public of the superiority of its BRACAnalysis® test.”

On the other hand, Cook-Deegan and his co-authors suggest that Myriad and other private entities should be encouraged–or even required–to share their “sequence data and interpretive algorithms,” to support public health or as a condition for payment.

The True Cost of Free-Riding

In it’s Motion, Myriad accuses Ambry of “‘free-riding’ off of the hundreds of millions of dollars invested by Myriad Genetics in developing the science and market for clinical diagnostic testing for hereditary cancers.” While Myriad recognizes that its patents will expire soon, it appears to be planning to rely on its database to distinguish its services in the marketplace. However, Cook-Deegan and his co-authors would deprive Myriad of that advantage as well.

Before we rush to demand that Myriad and other private entities surrender their intellectual property in the interests of public health, we should be careful not to discourage private investment in personalized medicine in the first instance. If it takes “hundreds of millions of dollars” to develop a genetic test and supporting database of genetic information, future advances will need private investors — not just public tax dollars — to reach the marketplace.