• Diagnostic Methods Under Attack: S. Ct. to revisit diagnostic method patents

Prometheus v. Mayo

For the second time, on June 20, 2011, the Supreme Court granted certiorari in Prometheus v. Mayo.  The previous certiorari was granted last June in which the Court remanded the case to the Federal Circuit for a rehearing consistent with the Court’s Bilski decision.  On rehearing last December, the Federal Circuit affirmed its pre-Bilski decision (based on the machine-or-transformation test) but this time using the reasoning articulated by the Court in Bilski.  Nonetheless, included in that reasoning was the particular persuasiveness of the transformative nature of the claims under the machine-or-transformation test, a test the Bilski Court held to be “a useful and important clue, an investigative tool, for determining whether some claimed inventions are processes under Section 101” albeit not the sole test for making that determination.

The granted writ of certiorari poses the following question:

  • Whether 35 U.S.C. § 101 is satisfied by a patent claim that covers observed correlations between patient test results and patient health, so that the claim effectively preempts all uses of these naturally occurring correlations.

As framed, Mayo may have stacked the deck in its favor by incorporating into the question the very highly charged term “observed correlations” language that has been before the Court once before in 2006 in Laboratory Corp, a certiorari that the Court dismissed as improvidently granted but not without Justice Breyer first weighing in on the issue, by way of a strongly worded dissent of the dismissal, in which he effectively viewed diagnostic “observed correlations” to be unpatentable subject matter.  Lab Corp. of Am. Holdings (LabCorp) v. Metabolite Labs, Inc., 126 S. Ct. 2921, 2922–2923 (2006) (Breyer, J., dissenting).

In Prometheus, the claims involve more than simply the “observed correlations” that arbuably form a part of the “wherein” recitations.  Claim 1, for example,  recites “administering a drug providing 6-thioguanine . . . “ and “determining the level of 6-thioguanine in said subject . . . .”  Hence, lumping all of the claims under the “observed correlations” language propounded by Mayo may be inapropos for Prometheus if, as the Federal Circuit stated in its post-Bilski decision, for example, “[d]etermining the levels of 6-TG or 6-MMP in a subject necessarily involves a transformation, for those levels cannot be determined by mere inspection. Some form of manipulation, such as the high pressure liquid chromatography method specified in several of the asserted dependent claims or other modification of the substances to be measured, is necessary to extract the metabolites from a bodily sample and determine their concentration.”  Prometheus v. Mayo, 2008-1403, at 18 (Fed. Cir. 2010)

Nonetheless, the question as posed by Mayo is the question upon which the certiorari was granted and which will define the debate.

It remains to be seen whether this time around, these arguments lead to a sea change in the patenting of diagnostic method patents or become yet another example of good lawyering, this time done on the part of Mayo, which like Microsoft lawyers in the i4i case, presented facially convincing arguments that fall apart after the Court does its own analysis.  The hearing on Prometheus is expected to be scheduled for this Fall 2011 Term of the Court with a decision likely next year.  What the Court does with this case will echo through the medical diagnostic industry.

The Juhasz Burge PC Firm can help you to better understand the effect of Prometheus on your patents. For more information regarding Prometheus and advice on how this decision may affect your patents, please contact The Juhasz Burge PC Firm.

Your patents may be your most important asset. To help you protect your patents contact Juhasz Burge PC, the firm committed to Positioning Your Patent Beyond The Horizon℠.

For an analysis on Global-Tech Appliances v. SEB  go to Supreme Court Round-up – Part 2 of 3:  “Willful Blindness” Induced Infringement as Culpable as Actual Knowledge in Global-Tech.

For an analysis on Stanford v. Roche go to Supreme Court Round-up – Part 3 of 3:  Only if There is an Assignment, Only Then If the Employer is a Federal Contractor Does Bayh-Dole Apply in Stanford v. Roche.