When I wrote my first “Foaming at the Mouth” article (see Foaming at the Mouth: The Inane Ruling in the Gene Patents Case) on Association for Molecular Pathology v. USPTO (hereinafter AMP, but also known as “the gene patent case” or “the Myriad case” or “ACLU v. Myriad”), I never expected it to become a sequel. But Judge Sweet’s inane 152-page ruling on the ACLU challenge to the Myriad patents was soon to be followed by the new and equally inane Becerra Bill by Congressman Xavier Becerra (D-California, aka “The Gene Patent Terminator”) that would plunge us into an “anti-gene patenting hell” with the potential to destroy American biotech industry. See Foaming at the Mouth II: My Alternative to the New But Inane Becerra Bill . And then came the U.S. Supreme Court ruling last week in Bilski v. Kappos. See Section 273 is NOT a Red Herring: Stevens’ Disingenuous Concurrence in Bilski where I “foamed” on and waxed lyrical about now retired Justice Stevens’ disingenuous sophistry in his concurrence.
One reason I was quite interested in Bilski was because the Supreme Court (not surprisingly) ruled that the Federal Circuit’s “machine or transformation” test was too inflexible, much like the “teaching, suggestion and motivation” (TSM) test in KSR International v. Teleflex. So why my intense interest in the Supreme Court (aka the Judicial Mount Olympus) relegating the “machine or transformation” (aka MoT) test to “second class status” in Bilski? Besides the inanity of MoT as the sole test for patent-eligibility, I am interested because of Judge Sweet’s ill-advised reliance on MoT (now smitten by the thunderbolts from our Judicial Mount Olympus in Bilski) for invalidating Myriad’s method claims using its BRCA1 and BRCA2 gene sequence technology.
With the AMP case now on appeal to the Federal Circuit, I could just hear in my own mind the judicial mental knives being sharpened to cut up this portion of Sweet’s opinion into microscopic pieces. In fact, I predicted that AMP might be the Federal Circuit’s first opportunity to clarify the “fuzzy” (and do mean very “fuzzy”) ruling by the Supreme Court in Bilski as to what is now the standard for patent-eligibility under 35 U.S.C. § 101.
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Another issue lurking in the Supreme Court’s Bilski ruling was one left unresolved by them in the 2006 Laboratory Corp. v. Metabolite Laboratories, Inc. case on the patent-eligibility of comparative/correlative medical diagnostic method claims. By “comparative/correlative medical diagnostic method claims,” I mean those method claims which typically involve a first step of gathering/analyzing data, and then comparing/correlating in a second step that gathered/analyzed data to a “bench mark” value to see if, for example, a certain medical condition exists or there is potentially a predisposition to such a medical condition.
In fact, I opined that the Supreme Court’s Bilski ruling might also give the Federal Circuit the opportunity (in AMP) to reconcile two other apparently inconsistent rulings by the Federal Circuit which are based on the “machine or transformation” test as applied to comparative/correlative medical diagnostic method claims. Compare Prometheus Laboratories, Inc. v. Mayo Collaborative Services (drug dosage calibration patent claims are “transformative” and therefore patent-eligible) with Classen Immunotherapies, Inc. v. Biogen Idec (with no/minimal explanation, claimed method for essentially calibrating an immunization schedule for a treatment group, relative to a control group is patent-ineligible in view of Federal Circuit’s Bilski) which I discussed in my article CAFC: Method for Calibrating Drug Dosage Is Transformative .
But then we received another “thunderbolt” from our Judicial Mount Olympus last Tuesday when the Supreme Court summarily granted certiorari in Prometheus and Classen, and then vacated and remanded both cases to the Federal Circuit to consider (with equally “fuzzy” guidance) in light of the Supreme Court’s ruling in Bilski. See Eric Steffe’s and Michelle Holoubek’s Diagnostic Testing in the Wake of Bilski v. Kappos . This could mean the Prometheus and Classen cases would resolved by Federal Circuit the before AMP. Or maybe the Federal Circuit would do an en banc trio of these cases. Who knows now what the Federal Circuit is going to do with this trio of cases.
So much for my prediction that AMP might be the first case where the Federal Circuit would shed light to us “mere mortals” as to what the Supreme Court’s opinion in Bilski means. In any event, the Federal Circuit (unlike our Judicial Mount Olympus) can’t simply dodge the impact of the Supreme Court’s Bilski ruling, including what does it mean for the patent-eligibility of comparative/correlative medical diagnostic method claims in the Prometheus, Classen, and AMP cases.
For those wishing to prevent their IP in medical diagnostic technologies from sinking into oblivion, the hope would be that the Federal Circuit would affirm its ruling in Prometheus (as being either “transformative” or on some other basis consistent with the Supreme Court’s Bilski ruling), as well as reverse the rulings in Classen and AMP for relying upon the “smitten” MoT test to invalidate those method/process claims. In other words, the Federal Circuit will decide to stand “tall in the saddle,” and not be “bullied” by our Judicial Mount Olympus into creating a new patent-ineligible class of subject matter (i.e., for comparative/correlative medical diagnostic method claims) to be added to the abstract idea “dead zone?”
But then again, the Federal Circuit has been thumped repeatedly, starting with KSR International and now ending with Bilski, for tests which are considered by our Judicial Mount Olympus to be too inflexible (and perhaps too pro-patent). Will the Federal Circuit simply grow timid (and weary) from this repeated onslaught from our Judicial Mount Olympus, turn tail, and run in the direction of simply casting yet another class of subject matter into the patent-ineligible “dead zone,” with adverse consequences for American innovation and job creation in the medical diagnostic industry? Will the Federal Circuit be pummeled (again) in to submission by the Judicial Zeus and simply make Justice Breyer’s dissenting opinion Laboratory Corp. (which opined against the patent-eligibility of such comparative/correlative medical diagnostic method claims) come true?
Rather than prognosticate further, maybe it’s time to simply consult the Oracle at Delphi as to what the Federal Circuit’s answer will be in the Prometheus, Classen, and oh yes, AMP cases. I can’t see how we could do worse in view of our Judicial Mount Olympus who wouldn’t know patent-eligible subject matter if it hit them square in the face.
© 2010 Eric W. Guttag.