DNA sequence patents have been controversial from the very beginning. Legal scholars have expressed concerns that patents on DNA sequence impede valuable research in the field of biotechnology. One of the specific areas of concern is rooted in the fact that a majority of innovative genetic tests involve multiplex assays, which could potentially use hundreds of different DNA sequences in a single assay. Thus, the development of these multiplex genetic tests may, in large part, be dependent on the ability to acquire rights to existing patents on all the DNA sequences included in the test.
This Comment focuses on current challenges posed by DNA sequence patents on the development of multiplex genetic tests, specifically discussing the restrictions imposed by patent law on use of patent protected DNA sequences. In light of the expected benefits of multiplex genetic tests to the general public health, the Comment argues for a need to address the impact of DNA sequence patents on patient access to genetic tests. It proposes possible solutions to overcome the challenges faced in the development of multiplex genetic test and argues in favor of a heightened utility standard for DNA sequence patents by limiting the scope of claims to the utility disclosed in the patent at the time of filing.