Mayo v. Prometheus: BIO Statement on Supreme Court Decision

Patently BIOtech

By Hans Sauer, Deputy General Counsel for Intellectual Property, Biotechnology Industry Organization

We are surprised and disappointed in the Court’s decision, which disregarded the considered judgment of the Executive Branch experts and numerous amici such as BIO, who warned about the unintended consequences of attempting to use patent eligibility as a basis to strike down these patents for biomarker-based diagnostic methods.

While we are still analyzing the opinion, we are concerned that it introduces new and confusing concepts into the traditional body of patent law, which patent examiners and lower courts will struggle to consistently and rationally implement.  While the opinion’s lack of guidance may limit its practical impact, we are troubled that the Court’s opinion fails to appropriately recognize the importance of personalized medicine, and of the research and investment incentives needed to develop new individualized therapies for untreated diseases.

BIO will work with the Administration and the U.S. Patent and Trademark Office to ensure that the future application of this opinion does not irrationally restrict the ability of innovators to protect inventions that lead to cures, medical breakthroughs, and other technologies that make our lives and our environment cleaner, safer and healthier.

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One Response to Mayo v. Prometheus: BIO Statement on Supreme Court Decision

  1. This decision makes an utter mess out of the already convoluted doctrine of statutory subject matter. Now, we are told that the statutory subject matter inquiry requires us to disaggregate patent claims and determine whether individual features are separately novel and non-obvious. This needlessly conflates the issues of novelty and non-obviousness with statutory subject matter.

    Moreover, in this particular case, the portion of the claim that recited the “natural law” required no manipulative steps. As a result, the “natural law” step should have been given no patentable weight. In that case, and if the SCOTUS opinion is correct in stating that the remaining claim elements were known, presumably the claim could have readily been invalidated on obviousness grounds.

    The open question is what happens if you do recite a specific manipulative step that is guided by a newly discovered natural law? In this case, the key limitations simply stated that when concentrations of the thiopurine drugs reached certain levels, it “indicated a need” to either increase or decrease the patient’s dosage. The claims could have recited affirmative manipulative steps such as “increasing the patient’s dosage when the concentration is X” or the like. Hopefully, the PTO would make this distinction, but even if they do, this decision provides no certainty that patent claims with such affirmative steps would survive in litigation.

    Regardless of where you stand on these types of inventions, businesses need more certainty than these Supreme Court patent decisions are providing in order to make good investment decisions. At every turn, they seem to issue opinions that thwart the goal of providing predictability and guidance to clients.

    For those interested in more on this case, I posted an article on my blog at http://hanseniplaw.com/2012/03/20/today%E2%80%99s-supreme-court-decision-threatens-the-patentability-of-diagnostic-test-methods/

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