Personalized medicine offers the hope of better outcomes by tailoring treatments to each patient's personal characteristics.
However, the promise of personalized medicine is premised on the development of numerous in vitro diagnostic tests. If patent protection of such innovative tests is not ensured, in vitro diagnostics companies will not be able to recoup their investments. Without being able to recoup such investments, these
tests will never be developed.
Michael R. Samardzija
For the US Patent and Trademark Office to issue a patent on an invention, the applicant must first fulfill several requirements,
including that the invention claim patent-eligible subject matter, be novel, nonobvious, and meet certain disclosure requirements.
For many years, satisfying the patent-eligible subject matter requirement had not been difficult. However, on October 30,
2008, the US Court of Appeals for the Federal Circuit, in In re Bilski, significantly increased the hurdle for method claims.
In Bilski, the Federal Circuit required that method claims be tied to a machine or a transformation of an article. According to the
ruling, if a method claim does not use a machine, such as a special-purpose computer, or transform a state or thing, such
as when bones and tissues are transformed into an x-ray image of the same, then the method consists of patent-ineligible subject
Then, on December 19, 2008, Classen Immunotherapeutics v. Biogen Idec further increased this restriction for patents. The Federal Circuit invalidated a claim to a method of conducting vaccine
The Classen decision does affect in vitro diagnostics. But when viewed broadly in the context of patent reform and the movement to restrict patent scope, the Classen decision has the potential to render numerous in vitro diagnostic claims unpatentable.
Before Bilski, patent applicants of in vitro diagnostic inventions were allowed to broadly claim their methods. Such method claims were not limited to a certain set of
instruments, nor was there any mention of what item the method was seeking to transform. For example, if the actual method
and targeted compound were already known, the patent applicants sought to claim the correlation between the target measured
and the condition. For example, Laboratory Corporation of America had discovered that elevated levels of total homocysteine
were because of a deficiency in cobolamine. Assaying total homocysteine levels was well known, yet Laboratory Corporation
of America obtained a patent on the correlation between elevated levels of homocysteine and a deficiency in cobolamine. Also,
if the patent claimed a method of detecting an alteration in or screening for a new isolated DNA sequence, the patent applicants
sought to claim the method without regard to instrumentation. Following the Bilski and Classen decisions, however, many of these patents may now be challenged as not claiming patent-eligible subject matter.
Recently, the US Supreme Court decided to review the Federal Circuit's decision in In re Bilski. This indicates that the Supreme Court likely disagrees with the Federal Circuit on what constitutes patent-eligible subject
matter; a decision is expected in the first half of 2010. Also, in an upcoming decision in Prometheus v. Mayo, the Federal Circuit will directly review whether in vitro diagnostic method claims contain patent-eligible subject matter. In this case, the Federal Circuit has an opportunity to soften
its stringent test of patent-eligibility. If it does not, it will significantly impede the progress of personalized medicine.
The views expressed in this article are solely those of the author and are not necessarily those of Bracewell & Giuliani,
Michael R. Samardzija, PhD, is counsel at Bracewell & Giuliani LLP, Houston, TX, 713.221.1112, firstname.lastname@example.org