Although processed RNA can be found in nature, the Supreme Court determined that the generated (think "invented") cDNA products are not naturally occurring and do merit patent protection. The legitimacy of this argument comes from noting that RNA does occur in nature, but cDNA has to be coaxed from the naturally occurring processed RNA.
From the biotechnology field’s perspective, this distinction between genomic DNA and cDNA is of paramount importance. Many biologically based therapeutics rely on cDNA technology, and invalidation of these patents would have irrevocably changed the biopharmaceutical landscape.
While cDNA’s patentability had been assumed (as had DNA by some), the Supreme Court’s ruling solidifies for now that cDNA products can be protected. On some level, knowing that cDNA intellectual property is inherently protectable may help pharmaceutical companies rest easier.
Outside the realm of human genetic considerations, the ruling provides some optimism for those wishing to challenge gene patents from other organisms, including many bacterial and viral patents. However, the excitement of being able to contest other patents should be tempered with concerns over how invalidating other gene patents could affect other areas of the biotechnology industry. For example, other patents related to products produced by nonhuman organisms might be subject to challenges, thereby broadening the impact of the BRCA1/2 decision into other areas, including pharmaceuticals, nutraceuticals, and genetically modified foods.
These broader possibilities imply that the BRCA1/2 patent ruling may be just an important chapter in a longer story of biological patents that will be worth following in coming years.
Dr. Matthew R.G. Taylor is trained in both internal medicine and clinical genetics and is associate professor and director of the Adult Clinical Genetics Clinic at the University of Colorado, Denver.