by Shaukat A. Karjeker
In the race to map the human genome, many of the organizations involved obtained patents on gene sequences that they identified. These patents were granted regardless of whether the applicant had determined any role or function of the sequence. As a consequence, other researchers were effectively “blocked out” of research and development on the patented DNA sequences, unless they were able to negotiate a license.
The unanimous opinion by Hon. J. Clarence Thomas, in Association for Molecular Pathology, et al v. Myriad Genetics, Inc., et al. completely changes the biotech and medical research landscape: DNA is a naturally-occurring composition and therefore not patentable. With a single stroke, the Court has opened the flood gates for the development of customized gene-based medicine. All issued patent claims to DNA sequences are now invalid, the DNA sequences are effectively “in the public domain,” and the sequences may be used in research and development without any need for (costly) licenses.