BIO, the Biotechnology Industry Organization, filed an amicus brief last Thursday asking the Supreme Court to overturn the Federal Circuit decision in Bilski v. Doll, a decision which created the "machine-or-transformation" test in which a method or process is only patentable if it is tied to a machine or if it transforms an article or substance into something different.
BIO joins many other industries who have voiced concerns about the uncertainty of the MOT test as applied to their technologies. For the biotech industry, BIO points out how biological, diagnostic, and other medicinal method patents could be challenged by the MOT test resulting in negative impacts on the biotech industry.
A key concern is that investors will shy away from the industry due to a lack of confidence in biotech patents as a vehicle for recouping research and development costs. Developing products in the biotech industry is an expensive and lengthy process often involving scientific research, clinical trials, and regulatory approval. Without strong, enforceable patent rights, it is doubtful the industry could survive and innovation would be stifled.
Clarification on the issues presented in Bilski is certainly warranted in regard to biotech IP. The MOT test does not seem to translate well into the biotech area. For example, the natural phenomena utilized to produce biotech patents are not analagous to the abstract ideas utilized to produce business method patents. A distinction cannot easily be made between patentable and nonpatentable subject matter in biotech by requiring a machine or transformation. Photosynthesis is a process that could pass the MOT as it transforms carbon dioxide, but should not be patentable as it is a natural occuring process. But by the same test, a diagnostic method would be deemed unpatentable if it does not incorporate a machine or if the patient is not "transformed." For biotech, a better test would better focus on whether something is a man-made biological process or a naturally occuring biological process.