Implications for Biotechnology
The Federal Circuit acknowledged that the machine or transformation test (and/or its application) may need to be altered or even supplanted in certain instances by the Supreme Court, or even the United States Court of Appeals for the Federal Circuit (CAFC) itself. “Future developments in technology and the sciences may present difficult challenges to the machine or transformation test…we recognize that the Supreme Court may ultimately decide to alter or perhaps set aside this test to accommodate emerging technologies. And we certainly do not rule out the possibility that this court may, in the future, refine or augment the test or how it is applied.”
Although the opinion does not state explicitly that biotechnological processes will be assessed according to the machine or transformation test, the Federal Circuit does not distinguish such processes from the business methods at issue in Bilski.
Further, the Federal Circuit’s footnote 26 suggests indirectly that the patentability of certain medical diagnostic process claims could be challenged under Bilski. The court notes that “of course, a claimed process, wherein all of the process steps may be performed entirely in the human mind, is obviously not tied to any machine and does not transform any article into a different state.”
In Classen Immunotherapies, Inc. v. Biogen IDEC, Fed. Cir. No. 2006-1634 (December 19, 2008 ) process claims related to risk-assessment of protocols for vaccination followed by immunization were found to be invalid for not meeting either of requirements (1) or (2) under Bilski. The Classen decision is nonprecedential however, and the single paragraph opinion leaves many speculating how to interpret it.
The ultimate effect on biotechnology and medical diagnostics may not become clearer until the Federal Circuit renders decisions in one or more pending cases. In particular:
• Prometheus Laboratories, Inc. v. Mayo Collaborative Services, Fed. Cir. No. 2008–1403, patentability of claims to measuring metabolite levels in patients after administration of a drug to avoid toxic side effects; and
• Ariad Pharmaceuticals, Inc. v. Eli Lilly & Company, Fed. Cir. No. 2009–1023, patent eligibility of claims relating to methods of inhibiting expression of a gene.