Bilski: patent-eligible humans or patent-ineligible administering active-ingredients?

This piece builds on earlier pieces starting June 25, 2009, related to Bilski’s machine or transformation test.  In these earlier pieces, the main question is whether or not the machine or transformation test stinks for the electronic and other arts, like biotech.  This piece further explains why those in the biotech industry cringed after reading Bilski, how Bilski’s machine or transformation test might lead to a holding making humans eligible subject matter for patenting, and how the active-ingredient/prodrug distinction might influence whether or not administering claims are Bilski eligible.  

Consider claim 1, which differs from the one in Lab Corp. (see my weblog, June 30, 2009), because the assaying step is assumed absent from in the prior art:

        1. A method for detecting a Disease Y comprising:
        assaying a body fluid for a Mutation X; and
        correlating the presence of Mutation X to the presence or absence of Disease Y.

The inventors found a marker.  Mutation X marks Disease Y, because the presence of Mutation X is sufficient to detect Disease Y. Claim 1 respresents those that appear in many patent applications and patents.

For example, if Mutation X is a SEQ ID NO. X, which differs from prior art sequences, then claim 1 would not take away prior art “assaying,” because, although “assaying” in general may be within the level of ordinary skill in the art,  “assaying … for SEQ ID NO. X” is, in view of the prior art, “new.”  Cf. 35 U.S.C. § 101.  So, for claim 1, Lab Corp’s eligibility concerns would not exist.

But thinking about claim 1’s fate after Bilski’s machine or transformation test would cause some to cringe, and I’ll take the 5th before stating why.

And as long as we’re thinking about common claims and cringing, what would Bilski’s machine or transformation test say about a simple a administering claim?

         2.  A method of treating Disease Y, comprising administering an effective amount of compound X to a human.

Is a human Bilski’s machine or an article capable of Bilski’s transformation?  If you answered yes to either question, then you would that hold a human is eligible subject matter for patenting,  cf.  35 U.S.C. § 101, a hot-potato issue.   If you answered no, then you might think that claim 2 is not eligible for patenting or that claim 2’s administering necessarily transforms Compound X.

Stop.  Not all compounds transform when administered.  So, Bilski’s transformation test might lead to different results depending on the properties of Compound X.  For example, if, on one hand, Compound X is an active ingredient that does not transform in the human until after its activity (treating Disease Y) starts, then Bilski’s transformation test might force one to hold that claim 2 is ineligibile for lacking a machine or transformation.  But if, on the other hand, Compound X is a prodrug that transforms to the active ingredient after administering, as opposed to the active-ingredient itself, then Bilski’s transformation test might hold that claim 2 is eligibile.

Thus, Bilski’s transformation test could lead to a crazy result.  While claim 2 might be Bilski eligible if Compound X were a prodrug, claim 2 might be Bilski ineligible if compound X were an active ingredient.  Now really, would a prodrug/active-ingredient distinction be a proper basis for eligibility?  It might be under Bilski’s machine/transformation test, unless humans are eligible subject matter for patenting, because they are Bilski’s machines and/or articles capable of transformation.

Feel any tension in your face?  If so, you’re likely familar with settled expectations of biotech.