Mayo v Prometheus – A Shift in the Machine or Transformation Test

(This is a guest post by Adam Breier.  Adam is a 2L at Stanford Law School. He has a PhD in Biophysics from UC Berkeley, and is a student associate at the intellectual property law firm of Finnegan, Henderson, Farabow, Garrett & Dunner, LLP. This post has been prepared solely for educational and entertainment purposes to contribute to the understanding of U.S. intellectual property law. This material reflects only the current views of the author, and is not individualized legal advice. It is understood that each case is fact-specific, and that the appropriate solution in any case will vary. Therefore, this material may or may not be relevant to any particular situation. Finnegan, Henderson, Farabow, Garrett & Dunner, LLP is not bound either philosophically or as a representative by any comments expressed in this material.)

The way the Court handled the machine or transformation test (at p. 19 of the opinion) in Prometheus seemed subtly different from its handling in Bilski, especially as Bilski had been interpreted in intervening Federal Circuit case law. In Bilski, the test was described as non-exclusive but a useful and important clue. The Federal Circuit basically took this as meaning that claims that pass the test are generally patent eligible (with perhaps an exception for processes that could be performed mentally but for a recitation of a computer or other electronic device), but claims that fail the machine or transformation test may or may not be patent eligible. The test was also relatively easy to pass (see, e.g., the decision below in Prometheus that was reversed).

Here, the Court emphatically subordinated the machine or transformation test to the law of nature exception (slip. op. at 19): “Regardless, in stating that the ‘machine-or-transformation’ test is an ‘important and useful clue’ to patentability, we have neither said nor implied that the test trumps the ‘law of nature’ exclusion” (citing Bilski’s discussion of the test as an important and useful clue but not an exclusive test, and reaffirmation of the historical exceptions to patent eligibility, including the law of nature exception–but Bilski held that the failure of the machine or transformation test was not dispositive of patent eligibility, not that claims that pass it are not necessarily patent eligible).

The Court also dismissed the ‘administering’ step as irrelevant because it “simply helps to pick out the group of individuals who are likely interested in applying the law of nature,” and it concluded that the second step was not actually transformative because it “could be satisfied without transforming the blood, should science develop a totally different system for determining metabolite levels that did not involve such a transformation.”

Thus, the machine or transformation is both less important and less easily satisfied as a result of this decision. Strictly speaking, the discussion of the test not trumping the law of nature exception is dicta because, given the way the court limited the test itself (administering is irrelevant and determining is not actually sufficiently transformative because of speculative future possibilities), the claim failed the test. Nonetheless, I think those dicta are quite strong.

The discussion of the difference between Diehr and Flook (part B-1, starting at p. 11) also seems important; the 101 line is somewhere between Diehr and Flook, but where the line is seems opaque. The court indicated that Flook controlled this case: “The claim before us presents a case for patentability that is . . . no stronger than the (unpatentable) claim in Flook.” (p. 13). The Court said that there was no inventive concept apart from the unpatentable formula in Flook, but it is not clear to me what about Diehr made it an inventive application of its law of nature or the extent to which this clarifies the nature of the distinction between these cases (an inventive concept seems like a qualitative requirement, but some of the discussion makes it seem more like the difference is a matter of degree–how does one determine whether a law of nature is being inventively applied versus merely used?).

It is also not at all clear how much this will influence gene patents. Law of nature doctrine does not seem to me to have much to say about composition of matter claims, which have been analyzed previously under the natural product exception.

Adam Breier

Click here for more CLB commentary and analysis of the Prometheus decision.