Life Science Issues
While Bilski was heard en banc, it was not unanimous. Judges Newman, Mayer, and Rader dissented, adding insights relevant to the life sciences industry. Both Judges Newman and Rader argued that innovation would be hampered by the machine or transformation test. Judge Newman appeared to be concerned with the uncertainties created by the decision, noting that “uncertainty is the enemy of innovation.”
Judge Rader specifically addressed the effect on medical science. “Denial of patent protection for this innovation—precisely because of its elegance and simplicity (the chief aims of good science)—would undermine and discourage future research for diagnostic tools.”
Judge Mayer distinguished between business innovation and innovation in pharmaceuticals. “Although patents are not a prerequisite to business innovation, they are of undeniable importance in promoting technological advances. Only patent protection can make the innovator’s substantial investment in development and clinical testing economically rational.”
Future of Biotech/Medical Claims
The practical effects that the Bilski decision may have on biotechnology and medical diagnosis claims is not yet clear. What is clear are the many unanswered questions the decision poses for such claims. These questions include:
• When is a process tied to a particular machine or apparatus?
• What constitutes a transformation sufficient for such a claim to qualify as patentable subject matter under 35 U.S.C. §101?
• At what point does the use of a specific machine or transformation of an article impose meaningful limits on the claim’s scope so as to impart patent eligibility?
• What is a transformation that is central to the purpose of the claimed process?
Claims may be prone to challenges on the basis of 35 U.S.C. §101, not only by examiners in the course of prosecution, but also for issued patents by accused infringers or potential and existing licensees.
Going forward, a process or method patent application should include claims that either recite a nexus between the process and a machine, or emphasize a transformation step leading to a useful, concrete, and tangible result.
The precise impact of Bilski on biotechnology and medical diagnostic claims remains to be further elucidated by the CAFC, and possibly the U.S. Supreme Court, in the coming months and years. As its nuances are enumerated further, the effects of the application of Bilski’s machine and transformation test on biotechnological and medical diagnosis process claims will become more apparent.