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.