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A recent unanimous decision (Mayo Collaborative Sevices. v.
Prometheus Labs. Inc.) by the United States Supreme Court has
invalidated two patents held by Prometheus Labs Inc. on the basis
that the claims contained patent ineligible subject matter.
Prometheus' claims covered a method of optimizing treatment
of gastrointestinal disorders by administering a drug providing
6-thioguanine to a subject and then determining the level of
6-thioguanine in the subject. A 6-thioguanine level below a
specified amount indicated a need to increase drug dosage and a
level of 6-thioguanine greater than a specified amount indicated a
need to decrease drug dosage.
The Supreme Court reversed the decision of the Federal Circuit
Court of Appeals and held that in claims incorporating elements
based on "laws of nature", the other elements must be
separated out to determine whether they meet patentability
requirements of novelty, non-obviousness, enablement and patentable
subject matter. The decision also held that a determination of
patent eligibility (that is patentable subject matter) must be
made, even when a decision on patent validity could be made on the
other grounds of novelty, non-obviousness or enablement (written
description requirements).
Applicability of the "machine-or-transformation" test
in determining patentability also came under fire again. In
2010's Bilski v. Kappos decision, the Supreme Court
determined that the test cannot be the exclusive test for
patentability. In Mayo, the Court states that the test may
also not be sufficient for determining patentability of claims
applying the laws of nature.
The decision will have significant repercussions not only for
diagnostic and life science-based patentees, but in other
technology areas as well. Particularly, in the case of business
method and software patents reciting a natural law such an
algorithm, it may now need to be determined if the remaining
elements of the claim add sufficient patentable subject matter for
the claim to be considered patent eligible.
The content of this article is intended to provide a general
guide to the subject matter. Specialist advice should be sought
about your specific circumstances.
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