Updated on 9 July 2013
Frost and Sullivan life sciences industry analysts Mr Justin Collishaw (left) and Ms Christi Bird
In the wake of US Supreme Court's win-win verdict in Association for Molecular Pathology vs Myriad Genetics case, Frost and Sullivan life sciences industry analysts, Mr Justin Collishaw and Ms Christi Bird, talk to BioSpectrum about the impact of the verdict on the future of breast cancer gene therapy, gene research areas for geneticists, investments and revenues of test and drug developers, as well as on millions of women who are affected by BRCA1 and BRCA2 gene mutations. Excerpts from the interview:
What will be the impact of US Supreme Court's verdict on the future of gene therapy?
Ms Bird: By invalidating human gene patents, diagnostic companies have complete the freedom to develop gene panel diagnostic tests that compete with existing tests, if they do not infringe on upheld cDNA and methods patents. This competition is a win for consumers, as it may lead to improved tests with greater gene coverage. The industry remains divided on how these new patent terms will affect the marketplace. However, there is no doubt that this ruling will cause a new gene testing competitive landscape to emerge.
Will the verdict make BRCA1 and BRCA2 testing cheaper?
Mr Collishaw: The verdict has already made testing cheaper. DNATraits offers a test for the BRCA1 and BRCA2 genes in the US for $995 as compared to Myriad's test that costs $3,000. As additional competitors develop their own versions of BRCA1 and BRCA2 testing, they are likely to compete on cost, and the price will continue to decrease.
How does the Court's ruling on synthetic genes affect breast cancer risk testing?
Mr Collishaw: It still allows companies to protect their synthetic DNA patents, which will ensure intellectual property protection for individual tests such as Myriad's BRACAnalysis. However, the decision also provides competitors with an opportunity to develop their own versions of BRCA1 and BRCA2 gene testing, as long as their versions do not infringe on the patents of Myriad's test. Perhaps most importantly, it allows researchers to freely perform research-related activities on BRCA1 and BRCA2 genes without risk of legal liability, possibly leading to new therapeutics for the treatment of breast cancer.