Source: https://www.pharmapatentsblog.com/2012/03/20/justice-breyer-gets-the-last-word-and-invalidates-prometheus-personalized-medicine-claims/
Timestamp: 2019-04-24 14:14:12+00:00

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On March 20, 2012, Justice Breyer issued the unanimous decision for the Supreme Court in Mayo Collaborative Services v. Prometheus Laboratories, Inc., holding that Prometheus’ claims directed to methods of optimizing the dose of specific drugs used in the treatment of specific conditions are invalid under 35 USC § 101 because they impermissibly claim laws of nature. The Court’s decision reverses the Federal Circuit, which had twice upheld the validity of the claims at issue. While the Court’s opinion provides additional touchstones for distinguishing claims directed to laws of nature (not patent-eligible) from claims directed to specific applications of laws of nature (patent-eligible), because it erases the bright line of the Federal Circuit’s machine-or-transformation test, stakeholders will have to undertake a fact-specific, case-by-case, and (at least for the time being) uncertain analysis in order to determine whether given personalized medicine method claims satisfy § 101.
(b) determining a level of 6-thioguanine in the subject . . .
Subsequently, the Supreme Court held in Bilski that the “machine or transformation test” is not the “only” way to evaluate compliance with § 101, although it can be a useful clue or tool for analyzing § 101 compliance. After deciding Bilski, the Supreme Court vacated its original grant of certiorari in Prometheus, and remanded the case to the Federal Circuit.
To many following Prometheus, the Federal Circuit decisions were somewhat at odds with Justice Breyer’s dissent from the dismissal of the grant of certiorari in Laboratory Corp. of America Holdings v. Metabolite Laboratories, Inc. In both of its decisions (before and after Bilski), the Federal Circuit addressed Metabolite only in a footnote. I wondered if the court was setting itself up for a confrontation with Justice Breyer, and am not surprised that Justice Breyer finally got his say by authoring the Supreme Court decision.
“[L]aws of nature, natural phenomena, and abstract ideas” are not patentable.
a process that focuses upon the use of a natural law also contain other elements or a combination of elements, sometimes referred to as an ‘inventive concept,’ sufficient to ensure that the patent in practice amounts to significantly more than a patent upon the natural law itself.
Turning to Prometheus’ claims, the Court characterized them as “set[ting] forth laws of nature—namely, relationships between concentrations of certain metabolites in the blood and the likelihood that a dosage of a thiopurine drug will prove ineffective or cause harm.” The Court thus framed the issue before it as whether “the patent claims add enough to their statements of the correlations to allow the processes they describe to qualify as patent-eligible processes that apply natural laws.” The Court decided that the recited “administering,” “determining” and “wherein” steps are not sufficient to “transform the nature of the claim” into one that is patent-eligible.
Anyone who wants to make use of these laws must first administer a thiopurine drug and measure the resulting metabolite concentrations, and so the combination amounts to nothing significantly more than an instruction to doctors to apply the applicable laws when treating their patients.
To put the matter more succinctly, the claims inform a relevant audience about certain laws of nature; any additional steps consist of well understood, routine, conventional activity already engaged in by the scientific community; and those steps, when viewed as a whole, add nothing significant beyond the sum of their parts taken separately. For these reasons we believe that the steps are not sufficient to transform unpatentable natural correlations into patentable applications of those regularities.
Many may view the Court’s decision as upsetting the status quo of patent-eligibility that has been followed by the USPTO and upheld by the Federal Circuit. Patent holders in the personalized medicine space should consider seeking the advice of patent counsel, to determine whether this decision may be relevant to the validity of their patents. Even if the granted claims look uncomfortably similar to Prometheus’ claims, it may be possible to strengthen or uphold the validity of the patent through the reissue process. A similar approach can be taken in pending applications, such as by amending or adding claims to more directly focus on specific applications of any underlying laws of nature.
While the Court informs us of the importance of reciting “additional features” to take claims beyond a law of nature, it does not provide much concrete guidance on how to “add enough” so that the claims “qualify as patent-eligible processes that apply natural laws.” Clearly, the Court will not give much weight to any “conventional” steps that are recited in the claims, even if they are concrete or physically transformative. Additionally, the Court seems to say that if a law of nature itself has a limited application, any claims based on such a law of nature must be even more narrow, so as not to preclude others from exploiting or innovating around the law of nature. Although the Court expressed concerns that satisfaction of § 101 should not hinge on clever claim drafting, it is inevitable that patent practitioners like myself will keep this decision in mind as we try to craft claims that look more like those upheld in Diehr and less like those invalidated in Flook and now Prometheus.
While Justice Breyer had the last word here, it is important that patents still be sought and granted in the field of personalized medicine, so that the patent system can continue to incentivize and reward essential research in this area.

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