AIPLA Urges Federal Circuit Not to Proscribe Patents for Biomedical Diagnostic Tools

The American Intellectual Property Law Association (AIPLA) has filed an amicus brief supporting the patentee in Prometheus Labs. v. Mayo Collaborative Services which is on appeal at the Federal Circuit.  AIPLA is an organization of IP professionals and related entities that generally supports strong IP rights.  AIPLA lobbies Congress and submits amicus briefs on behalf of its membership.

Prometheus is another case where the patent includes Metabolite-type claims.  Claim 1 of U.S. Patent No. 6,680,302 reads:

1. A method of optimizing therapeutic efficacy for treatment of an immune-mediated gastrointestinal disorder, comprising: (a) administering a drug providing 6-thioguanine to a subject having said immune-mediated gastrointestinal disorder; and (b) determining a level of 6-thioguanine or 6-methyl-mercaptopurine in said subject having said immune-mediated gastrointestinal disorder, wherein a level of 6-thioguanine less than about 230 pmol per 8 x 108 red blood cells indicates a need to increase the amount of said drug subsequently administered to said subject and wherein a level of 6-thioguanine greater than about 400 pmol per 8 x 108 red blood cells or a level of 6-methyl-mercaptopurine greater than about 7000 pmol per 8 x 108 red blood cells indicates a need to decrease the amount of said drug subsequently administered to said subject.

In its brief, AIPLA argues that the district court judge in finding the claims to be invalid because they were not patentable subject matter, made several errors.  First, the judge did not apply the machine-or-transformation test set forth in Bilski.  AIPLA argues that the invention involves the physical transformation of a composition of matter, a drug, into a metabolite.

Next, the district court relied to a large extent on Justice Breyer’s dissent from the Supreme Court’s dismissal of Lab. Corp. v. Metabolite Labs. AIPLA argues that only three justices joined the dissent–the majority of the Supreme Court rejected the dissenting opinion–so it is not controlling law.  AIPLA also argues that the current case is different from Lab. Corp, and that the dissent was wrong.  No other judge had addressed the patentable subject matter issue in that case, so the record wasn’t sufficiently developed on the issue.  The dissenting justices were acting as trial judges on this issue.  Finally, the brief notes that “the statements of a Supreme Court justice appear to have had an intimidating effect” on the district court in this case.

AIPLA also argues that the district court applied the preemption test rejected in Bilski.  The preemption test holds that where a patent claim attempts to preempt all uses of a natural phenomenon, the claim is not directed to patentable subject matter.  The Bilski court found this test to be very difficult to apply and had generally rejected the test.  By definition, a patent attempts to exclude, i.e., preempt others from practicing the claimed invention.

Finally, AIPLA implores the court to not proscribe patents for the entire field of biomedical diagnostic tools.  These tools are very important in medicine and the court should not remove the incentives to innovate in this area.  The Federal Circuit addressed issue here.

This case remains in the briefing stage and a decision is not expected until late spring or summer.

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5 Responses to “AIPLA Urges Federal Circuit Not to Proscribe Patents for Biomedical Diagnostic Tools”

  1. Jeff Dixon Says:

    I don’t think the Bilski court rejected a “preemption test” at all. At the outset, the court cites Diehr as drawing a “distinction between those claims that ‘seek to pre-empt the use of’ a fundamental principle, on the one hand, and claims that seek only to foreclose others from using a particular ‘application’ of that fundamental principle, on the other.” Bilski slip op. at 8, citing Diehr, 450 U.S. at 187. The court then explicitly adopts preemption as the central issue on appeal: “The question before us then is whether Applicants’ claim recites a fundamental principle and, if so, whether it would pre-empt substantially all uses of that fundamental principle if allowed.” Bilski slip op. at 10. While conceding that “this inquiry is hardly straightforward,” the court reasons that “[t]he Supreme Court, however, has enunciated a definitive test to determine whether a process claim is tailored narrowly enough to encompass only a particular application of a fundamental principle rather than to *pre-empt* the principle itself,” to wit, the machine-or-transformation test articulated in Benson, Flook and Diehr. Id. at 10-11. In other words, preemption of a fundamental principle was not rejected; rather, it is the central issue, and the machine-or-transformation test is the established test applied by the Supreme Court to determine whether the claim seeks to preempt all applications or only a particular application of the fundamental principle.

  2. Matt Osenga Says:


    You make a good point regarding the pre-emption test in Bilski. The Federal Circuit certainly did not make the issue crystal clear. In general, I agree with AIPLA’s position on this issue, but some of their language regarding the Bilski court’s characterization of the pre-emption test is probably overboard.

  3. Jeff Dixon Says:

    As an even better example, the CAFC in Bilski reads the Benson decision as acknowledging that the claims had “limitations tying the process to the computer,” but still finding the process ineligible because the algorithm “had no utility other than operating on a digital computer,” and thus, “the claim’s tie to a digital computer did not reduce the *pre-emptive footprint* of the claim.” Slip op. at 13. The fact that the CAFC concedes that claims can pass the machine or transformation test but still be ineligible on pre-emption grounds is hard to reconcile with the idea that the machine-or-transformation test obviates the pre-emption question.

    The AIPLA brief also states that the Bilski court found the “pre-emption test” (I’m pretty sure the Bilski court never refers to a “pre-emption test” per se; rather it is seeks to apply some test to determine whether there is pre-emption) to be “of limited usefulness,” when the Bilski court actually says, “Analogizing to the facts of Diehr or Benson is of limited usefulness because the more challenging process claims of the twenty-first century are seldom so clearly limited in scope as [in Diehr]; nor are they typically as broadly claimed or purely abstract and mathematical as the algorithm of Benson.” Slip op. at 10.

    I do tend to agree that the question raised in Prometheus is not so clear – if all the claim recited were the step of administering the drug to the sick patient to raise his/her metabolite levels, there could be no doubt as to its subject matter eligibility, and so it certainly seems odd (at least at first?) that *adding* a limitation of determining the metabolite levels would suddenly raise a 101 issue.

    But it also seems untenable for a patent system to allow a claim requiring only administering a known drug to a sick patient for a known purpose and then measuring an effect of the drug, where the measurement indicates a need to raise or lower a subsequent dosage. Note that the claim does NOT require a step of actually making the needed dosage adjustment indicated by the observed metabolite level; i.e., the only new step can be wholly performed in the mind, and the resulting mental conclusion need not even be heeded. How to reject such a claim, assuming we agree that it should be rejected? 102 or 103 won’t work if a novel, nonobvious mental step is included.*** Perhaps an argument could be made that the transformation resulting from administering the drug is insignificant extra-solution activity because the mental determination is not required to affect the dosage administered in any way. But it is not 100% clear to me what kind of connection is required for “extra-solution activity” to be “significant.” I may be stumped.

    ***A careful reading of the Prometheus claim shows that it does not even recite a mental step of recognizing that the metabolite level indicates a need to adjust dosage. The clause “wherein a level of 6-thioguanine less than about 230 pmol per 8 x 108 red blood cells indicates a need to increase the amount of said drug subsequently administered” is not a step performed by a human; it is merely a relationship that is inherently either true or untrue whether the person determining the levels is aware of it or not. As recited, a person simply administering the drug and measuring the metabolite levels, having no idea what they mean and no intention to do anything in particular based on the information, could still infringe. So in this case, the relationship between levels and needed dosage adjustment could be ignored for 102 or 103 analysis. But the drafter could have simply rephrased the claim to require someone to actually interpret the determined metabolite levels as indicating a need to adjust dosage, and if that interpretation were new and nonobvious, 102 and 103 would be overcome.

  4. Who Will be the Next Director of the PTO? « Inventive Step Says:

    [...] this stance on the issues, filing an amicus brief in support of the petitioner in Bilski and urging the Federal Circuit not to proscribe patents for biomedical diagnostic tools, among [...]

  5. Justice Stevens to Retire From Supreme Court « INVENTIVE STEP Says:

    [...] He also joined Justice Breyer’s dissent in the LabCorp. case. [...]

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