Earlier this month, my colleagues John Conley, Robert Cook-Deegan, James Evans and I published a policy article in the European Journal of Human Genetics (EJHG) entitled “The next controversy in genetic testing: clinical data as trade secrets.”
The EJHG article is open access so you can read the entire article at the EJHG website, but here is the abstract:
Sole-source business models for genetic testing can create private databases containing information vital to interpreting the clinical significance of human genetic variations. But incomplete access to those databases threatens to impede the clinical interpretation of genomic medicine. National health systems and insurers, regulators, researchers, providers and patients all have a strong interest in ensuring broad access to information about the clinical significance of variants discovered through genetic testing. They can create incentives for sharing data and interpretive algorithms in several ways, including: promoting voluntary sharing; requiring laboratories to share as a condition of payment for or regulatory approval of laboratory services; establishing – and compelling participation in – resources that capture the information needed to interpret the data independent of company policies; and paying for sharing and interpretation in addition to paying for the test itself. US policies have failed to address the data-sharing issue. The entry of new and established firms into the European genetic testing market presents an opportunity to correct this failure.
In certain respects, this article is an expansion of a previous piece three of us wrote here on the Genomics Law Report last year discussing Myriad Genetics’ response to the rise of whole-genome sequencing technologies in the context of diagnostic genetic testing. The current EJHG expands upon that discussion, while still using Myriad Genetics as a case study, particularly the company’s development of a proprietary database of DNA sequence variants (including variants of uncertain significance, or VUSs) and related clinical information pertaining to the breast cancer genes BRCA-1 and BRCA-2.
We are encouraged that the EJHG article helped contribute to an ongoing debate regarding the appropriateness of protecting valuable clinical data as a commercial trade secret; excellent coverage, as always, is available from Pharmacogenomics Reporter. In addition, following our publication, the American College of Medical Genetics and Genomics published a position statement arguing for the Public Disclosure of Clinically Relevant Genome Variants and, at a high-profile genetics conference, one academic publicized an ongoing effort to circumvent Myriad Genetics’ own proprietary database by requesting deidentified BRCA information from clinicians. While Myriad itself has not, to our knowledge, addressed this issue publicly, the company is no doubt aware of the conversation (even as its revenues, driven in large part by its BRCA testing product, continue to grow).
And what about the Myriad gene patent litigation? As discussed in the EJHG article, Myriad’s BRCA has been built in large part on the strength of the company’s controversial patents covering the DNA sequence and methods of interpreting those very same genes; patents which have been subject to a long-running and high-profile piece of litigation. That same Myriad gene patent litigation is now back before the Supreme Court, which is expected to privately discuss the parties’ petitions for certiorari on Friday of this week, with a decision to hear the appeal (or not) expected as early as Monday.
With a certiorari ruling on Myriad we will, in all likelihood, at last reach the final step in this long-running litigation which kicked off with great fanfare all the way back in the Spring of 2009. A denial of certiorari will mean the end of this particular piece of litigation, preserving the most recent opinion of the Federal Circuit in this case (and upholding Myriad’s gene patents, but only one of its challenged method patents). A grant of certiorari by the Supreme Court, on the other hand, will pave the way for one final round – certainly the highest profile yet – with a final decision likely arriving later in 2013.
Those guessing whether the Supreme Court will grant certiorari or not are doing just that – guessing – although the Court’s recent willingness to tackle high-profile patent litigation, including two years ago in Bilski v. Kappos and this year in Prometheus v. Mayo, as well as its grant of certiorari earlier this fall in Bowman v. Monsanto Co., another closely watched piece of patent litigation with implications for biotechnology patents, certainly suggest that the Court is not shying away from biotech patents.
Meanwhile, as we point out in the EJHG article, whatever the ultimate outcome of Myriad, the decision to provide access – or not – to proprietary information derived from products and services enabled by genetic patents, such as those at issue in Myriad, will carry consequences for the development of personalized medicine long after the patents themselves expire (or are invalidated). As a result, even as Myriad may be finally drawing to a close, the controversy surrounding Myriad’s gene patents, and their effects, is likely to continue.