Federal Circuit Reconfirms Patentability of Method of Calibrating Drug Dosages

Last year, prior to the Supreme Court’s decision in Bilski v. Kappos, the Federal Circuit reversed a district court holding that Prometheus’s claims to methods of calibrating drug dosages were invalid as not directed to patentable subject matter.  The Federal Circuit has once again reversed the district court decision of unpatentability.

After the Bilski decision, the Supreme Court issued a GVR order in this case.  A GVR Order is where the Supreme Court Grants certiorari in the case, Vacates the lower court’s opinion, and Remands the case back to the lower court to reconsider its decision in light of the newly decided Supreme Court case.

The court reaffirmed its holding that the claims are not drawn to a law of nature, but to a particular application of naturally occurring correlations, and do not preempt all uses of such correlations between metabolite levels and drug efficacy or toxicity.  The Supreme Court decision did not eliminate the Bilski machine-or-transformation test, but merely indicated that it is not the only test.  The claims recite specific treatment steps and not merely the correlations.

Again, the Federal Circuit disregarded the District Court’s and Mayo’s extreme reliance on Justice Breyer’s dissent from the dismissal order in LabCorp.  The court again noted that the opinion is not controlling law as it comes from only three Justices in a dissenting opinion.  The claims in that case were also different from those of the present case.

The court also reiterated that the step of administering a drug is a transformative step within the human body and that determining metabolite levels requires a transformation of the substance being analyzed.  The Federal Circuit continued by noting that the district court erred in holding that the first two steps are merely data gathering steps. The Federal Circuit held that these steps are central to the claimed method and are themselves transformative.


This case has been presented as extremely important and even controversial.  How can methods of administering a drug and determining metabolite levels be patentable?  This would appear to be the reason for the GVR Order. 

In general, the Supreme Court’s Bilski opinion expanded patent-eligible subject matter beyond what the Federal Circuit’s Bilski test permitted.  In other words, the Supreme Court would grant patent eligibility to more patent claims than the Federal Circuit test (unless the claims are somehow directed to a machine or transformation, but are also found to be directed to abstract ideas).  Thus, if the claims in this case met the Federal Circuit’s more stringent test, they should also meet the Supreme Court’s less onerous test.  The court in this case seemed to state as much.

The other interesting case in this area in which the Supreme Court issued a GVR Order is Classen Immunotherapies, Inc. v. Biogen IDEC, where the Federal Circuit issued a ridiculous one paragraph merits opinion rejecting a claim to a method of determining an immunization schedule.  Although it was thought that these cases would come out at the same time, in Prometheus, the court was able to reuse much of its original opinion.  In Classen, presumably the court will feel inclined to issue a new opinion that is longer than 70 words.  They basically need to start over in that case. 

Stay tuned.

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7 Responses to “Federal Circuit Reconfirms Patentability of Method of Calibrating Drug Dosages”

  1. Tweets that mention Federal Circuit Reconfirms Patentability of Method of Calibrating Drug Dosages « INVENTIVE STEP -- Topsy.com Says:

    [...] This post was mentioned on Twitter by Chattertrap, Matt Osenga. Matt Osenga said: Federal Circuit Reconfirms Patentability of Method of Calibrating Drug Dosages: http://wp.me/po0Pf-vO [...]

  2. Pharma & Biotech Global Week in Review 29 Dec 2010 from IP Think Tank Says:

    [...] CAFC: Broad scope of statutory subject matter: Prometheus Laboratories, Inc. v. Mayo Collaborative Services (Patently-O) (Filewrapper) (Patents4Life) (Patent Docs) (Inventive Step) [...]

  3. Supreme Court to Hear More Patent Cases in October 2011 Term « INVENTIVE STEP Says:

    [...] cases during its October 2011 Term.  First, the Court has granted cert. for the second time in Mayo Collaborative Services v. Prometheus Labs., Inc.  This is another patentable subject matter case directed to methods of calibrating drug dosages.  [...]

  4. Federal Circuit Reverses District Court in Gene Patent Case « INVENTIVE STEP Says:

    [...] court distinguished these claims from those at issue in Prometheus because the claims in that case required a transformation step.  The comparison in this case is [...]

  5. Immunization Methods are Patent Eligible « INVENTIVE STEP Says:

    [...] questions as to why the claim was so rejected.  After issuing its decision in Bilski v. Kappos, the Supreme Court issued a GVR order where it directed the Federal Circuit to reconsider its earlier opinion in light of Bilski.  Chief [...]

  6. Patentable Subject Matter at the Supreme Court « INVENTIVE STEP Says:

    [...] Court’s decision in Bilski, the Court ordered the Federal Circuit to reconsider this case.  The Federal Circuit did so and again confirmed the patentability of the claims.  The Supreme Court has again agreed to hear the case, presumably because the Federal Circuit [...]

  7. Supreme Court Continues to Confuse Patentable Subject Matter with Patentability « INVENTIVE STEP Says:

    [...] previously covered the details of the claims at issue in this case.  As a reminder, claim 1 of U.S. Patent No. 6,355,623 reads [...]

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