The Supreme Court, In re Bilski and the Lingering Question of Labcorp v. Metabolite

    By Kevin E. Noonan --

The Supreme Court today granted certiorari to the patent applicants in the In re Bilski case, an en banc decision from the Federal Circuit last fall.  In doing so, the Court continued its recent history of more direct supervision of the Federal Circuit, a decision made more notable by the Federal Circuit's express reliance on its interpretation of Supreme Court precedent in crafting a legal test for patentability of method claims.  Since it is rare for the Supreme Court to take a decision merely to affirm (something the Court has even more rarely done with Federal Circuit opinions), it is likely that the Federal Circuit's "machine or transformation" test will be modified if not completely abrogated.

This should not be much of a surprise, since the Federal Circuit once more crafted a "bright-line" test for method claim patentability, and the Supreme Court (by temperament and inclination) does not favor bright line rules.  Indeed, almost the entire history of the Court's recent patent jurisprudence reversing the Federal Circuit has come in nullifying such bright line rules.  In KSR International Co. v. Teleflex Inc.; eBay Inc. v. MercExchange, LLC; Quanta Computer, Inc. v. LG Electronics, Inc.; Microsoft Corp. v. AT&T Corp.; Festo Corp. v. Shoketsu Kinzoku Kogyo Kabushiki Co.; Dickinson v. Zurko; and Medimmune, Inc. v. Genentech, Inc., the Court has rebuked the Federal Circuit for developing and enforcing "bright line" rules where the Court believes a "totality of the circumstances" approach is more flexible and more consistent with the public interest that affects patent rights.  This stems, in part, from how the Supreme Court sees the Federal Circuit, more as a regional circuit court, subject to the Court's own vision of consistency in how certain legal principles -- such as declaratory judgment actions and injunctions, recently -- are applied, rather than as a court with a particularized, specific Congressional mandate to harmonize U.S. patent law nationwide and bring consistency to patent law interpretation.

In many ways, Bilski was a stark departure from the Federal Circuit's institutional self-image, the majority opinion being almost fawning in its blatant subservience to its interpretation of Supreme Court precedent.  Indeed, the "machine or transformation" test was mandated by Supreme Court precedent, according to the CAFC, and was based in large part on the Supreme Court's decision in Gottschalk v. Benson, 409 U.S. 63 (1972).  In addition to Benson, the Federal Circuit cited Diamond v. Diehr; Tilghman v. Proctor, 125 U.S. 136 (1888); and Cochrane v. Deener, 95 U.S. 355 (1877), as well as prior U.S. patent law (all the way back to the 1793 Patent Act) and the British Statute of Monopolies.

The certiorari petition addressed these interpretations of Supreme Court precedent forthrightly:

Whether the Federal Circuit erred by holding that a "process" must be tied to a particular machine or apparatus, or transform a particular article into a different state or thing ("machine-or-transformation" test), to be eligible for patenting under 35 U.S.C. § 101, despite this Court's precedent declining to limit the broad statutory grant of patent eligibility for "any" new and useful process beyond excluding patents for "laws of nature, physical phenomena, and abstract ideas."

Another avenue for the Supreme Court to reverse the Bilski decision stems from an interpretation of 35 U.S.C. § 273:

Whether the Federal Circuit's "machine-or-transformation" test for patent eligibility, which effectively forecloses meaningful patent protection to many business methods, contradicts the clear Congressional intent that patents protect "method[s] of doing or conducting business."  35 U.S.C. § 273.

This question stems from the plain meaning of the statute, enacted in 1999 as part of the American Inventors Protection Act, which appears to codify the Federal Circuit's "useful, concrete and tangible result" from State Street Bank & Trust Co. v. Signature Financial Group.

While these issues are important for business methods patents, they are also of considerable interest for the biotechnology community.  Recently, in Classen Immunotherapies Inc. v. Biogen Idec, the Federal Circuit affirmed that the following claim was invalid as being directed to non-statutory subject matter:

A method of determining whether an immunization schedule affects the incidence or severity of a chronic immune-mediated disorder in a treatment group of mammals, relative to a control group of mammals, which comprises immunizing mammals in the treatment group of mammals with one or more doses of one or more immunogens, according to said immunization schedule, and comparing the incidence, prevalence, frequency or severity of said chronic immune-mediated disorder or the level of a marker of such a disorder, in the treatment group, with that in the control group.

And it did so in a decision that took fewer words to write than the claim it invalidated:

In light of our decision in In re Bilski, 545 F.3d 943 (Fed. Cir. 2008) (en banc), we affirm the district court's grant of summary judgment that these claims are invalid under 35 U.S.C. § 101.  Dr. Classen's claims are neither "tied to a particular machine or apparatus" nor do they "transform[] a particular article into a different state or thing."  Bilski, 545 F.3d at 954.  Therefore we affirm.

The Bilski decision (as applied under Classen) also looms large in how the Federal Circuit might rule in Prometheus Labs, Inc. v. Mayo regarding a district court decision invalidating the following claim based in large part on Bilski:

A method of optimizing therapeutic efficacy for treatment of an immune mediated gastrointestinal disorder, comprising:
    (a)  administering a drug providing 6-thioguanine . . . ; and
    (b)  determining the level of 6-thioguanine in said subject . . . and
    (c)  wherein the levels of 6-thioguanine greater than about 400 pmol per 8x10(8) red blood cells indicates a need to decrease the amount of said drug subsequently administered to said subject.

The most important aspect for biotechnology of the Supreme Court's consideration of the Federal Circuit's Bilski decision may be to permit the Court to address the issues raised by Justice Breyer in a dissent over the Court's decision to dismiss its granted certiorari petition (as improvidently granted) in the Laboratory Corp. v. Metabolite Laboratories, Inc. case regarding the patent-eligibility of this claim:

A method for detecting a deficiency of cobalamin or folate in warm-blooded animals comprising the steps of:  assaying a body fluid for an elevated level of total homocysteine; and correlating an elevated level of total homocysteine in said body fluid with a deficiency of cobalamin or folate.

Justice Breyer (joined by Justices Souter and Stevens) argued in dissent that:

The researchers who obtained the present patent found that an elevated level of homocysteine in a warm-blooded animal is correlated with folate and cobalamin deficiencies.  As construed by the Federal Circuit, claim 13 provides those researchers with control over doctors' efforts to use that correlation to diagnose vitamin deficiencies in a patient.  Does the law permit such protection or does claim 13, in the circumstances, amount to an invalid effort to patent a "phenomenon of nature"?  I concede that the category of non-patentable "phenomena of nature," like the categories of "mental processes," and "abstract intellectual concepts," is not easy to define.  See Flook, supra, at 589 ("The line between a patentable 'process' and an unpatentable 'principle' is not always clear"); cf. Nichols, 45 F. 2d, at 122 ("[W]e are as aware as anyone that the line [between copyrighted material and non-copyrightable ideas], wherever it is drawn, will seem arbitrary").  After all, many a patentable invention rests upon its inventor's knowledge of natural phenomena; many "process" patents seek to make abstract intellectual concepts workably concrete; and all conscious human action involves a mental process.  See generally 1 Chisum §1.03, at 78–295.  Nor can one easily use such abstract categories directly to distinguish instances of likely beneficial, from likely harmful, forms of protection.  Cf. FTC, To Promote Innovation: The Proper Balance of Competition and Patent Law and Policy, ch. 3, p. 1 (Oct. 2003) (hereinafter FTC) (collecting evidence that "issues of fixed cost recovery, alternative appropriability mechanisms, and relationships between initial and follow-on innovation" vary by industry); Burk & Lemley, Policy Levers in Patent Law, 89 Va. L. Rev. 1575, 1577–1589 (2003) ("Recent evidence has demonstrated that this complex relationship [between patents and innovation] is . . . industry-specific at each stage of the patent process").

But this case is not at the boundary.  It does not require us to consider the precise scope of the "natural phenomenon" doctrine or any other difficult issue.  In my view, claim 13 is invalid no matter how narrowly one reasonably interprets that doctrine.

                                                *    *    *

Even were I to assume (purely for argument's sake) that claim 13 meets certain general definitions of process patentability, however, it still fails the one at issue here:  the requirement that it not amount to a simple natural correlation, i.e., a "natural phenomenon."  See Flook, supra, at 588, n. 9 (even assuming patent for improved catalytic converter system meets broad statutory definition of patentable "process," it is invalid under natural phenomenon doctrine); Diehr, 450 U. S., at 184–185 (explaining that, even if patent meets all other requirements, it must meet the natural phenomena requirement as well).

At most, respondents have simply described the natural law at issue in the abstract patent language of a "process."  But they cannot avoid the fact that the process is no more than an instruction to read some numbers in light of medical knowledge.  Cf. id., at 192 (warning against "allow[ing] a competent draftsman to evade the recognized limitations on the type of subject matter eligible for patent protection").  One might, of course, reduce the "process" to a series of steps, e.g., Step 1: gather data; Step 2: read a number; Step 3: compare the number with the norm; Step 4: act accordingly.  But one can reduce any process to a series of steps.  The question is what those steps embody.  And here, aside from the unpatented test, they embody only the correlation between homocysteine and vitamin deficiency that the researchers uncovered.  In my view, that correlation is an unpatentable "natural phenomenon," and I can find nothing in claim 13 that adds anything more of significance.

It is, of course, possible that the Court will resolve Bilski in a way that does not impact biotechnology claims.  Chief Justice Roberts took no role in the decision to remand on the grounds that certiorari had been improvidently granted, and as a consequence, his views are unknown.  In addition, Justice Souter will have left the Court by the time the Court considers Bilski, and the views of the Justice who will replace him are unknown (and, indeed, unknowable).  Moreover, the Bilski case is not focused on a biotechnology claim, and the Court could decide that the question of the patent-eligibility of diagnostic method claims as in LabCorp, Classen, and Prometheus is not before them.  However, it is also likely that the Court will take the occasion to fashion a test for determining patent eligibility for method claims that will directly impact the patentability of biotechnology method claims.  These considerations suggest that biotech amici may share their views with the Court, and that biotechnology and diagnostics and pharmaceutical companies (and their counsel) should watch this case with great interest.

Comments

[me]

Very nice piece! PatentDocs is the most content rich (and opinionated?) patent blog going!

[Keep It Real]

Assuming she is appointed (which seems nearly 100% likely), what are the odds that Justice Sotomayor will be involved in the Supreme Court's decision with respect to Bilski? Does the timing work out? Is she perceived to be an advocate for "more patents" or "better patents" or "stronger patents"?