This week, the U.S. Supreme Court reshaped the landscape of
patent law with its long-awaited decision in Mayo Collaborative
Services v. Prometheus Laboratories. The Court ruled
that certain claims of patents licensed to Prometheus, claims that
related to the use of thiopurine drugs in the treatment of
autoimmune diseases such as Crohn's disease, were invalid
because they did not constitute patent eligible subject
matter. In so doing, the Court held that the patent claims
recited a "law of nature" – specifically, the
relationship between concentrations of certain metabolites in the
blood and the likelihood that a thiopurine drug dosage will be
ineffective or cause harm – which is not itself
patentable, and that the various steps in the method claim were
insufficient to transform an unpatentable law of nature into a
patent-eligible application of such a law. The decision will
be welcomed by certain patient advocate groups and medical
associations, but many in the medical industry consider that the
decision will discourage investment and innovation, particularly in
the diagnostics field.
Mayo challenged two patents licensed to Prometheus in response to a
lawsuit for patent infringement. The U.S. District Court for
the Southern District of California found that that Mayo's
diagnostic tests infringed Prometheus's patents but granted
Mayo's motion for summary judgment on the grounds that the
asserted process claims effectively claimed natural laws or natural
phenomena and that such claims were not patentable. The
Federal Circuit reversed the summary judgment decision, finding
that the process claims constituted patent-eligible subject matter
under its "machine or transformation test." Mayo
twice appealed the decision to the Supreme Court. After the
first appeal, the Supreme Court returned the case to the Federal
Circuit for reconsideration in view of another recent Supreme Court
decision in Bilski v. Kappos. On remand, the Federal
Circuit again held that the process claims constituted
patent-eligible subject matter; this second appeal to the Supreme
Court followed.
The Court analyzed a claim apparently representative of the claims
of the two patents:
A method of optimizing therapeutic efficacy for treatment of an
immune-mediated gastrointestinal disorder, comprising:
-
administering a drug providing 6-thioguanine to a subject having said ... disorder; and
-
determining the level of 6-thioguanine in said subject having said ... disorder, wherein the level of 6-thioguanine less than [a specified amount] indicates a need to increase the amount of said drug subsequently administered to said subject and wherein the level of 6-thioguanine greater than [another specified amount] indicates a need to decrease the amount of said drug subsequently administered to said subject.
In its analysis, the Court stated that "Prometheus'
patents set 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 then went on to
consider "whether the claims do significantly more than simply
describe these natural relations," or put another way, 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." Although the three steps in the claimed process
(the administering step, the determining step, and the wherein
step) were not themselves natural laws, the Court found that they
were insufficient to transform the nature of the claim into patent
eligible subject matter. In particular, the Court stated that
the "steps in the claimed processes (apart from the natural
laws themselves) involve well-understood, routine, conventional
activity previously engaged in by researchers in the
field." The Court went on to state that if "a law
of nature is not patentable, then neither is a process reciting the
law of nature, unless that process has additional features that
provide practical assurance that the process is more than a
drafting effort designed to monopolize the law of nature
itself."
With regard to the "administering" step, the Court stated
that it "simply refers to the relevant audience, namely
doctors who treat patients with certain diseases with thiopurine
drugs." With regard to the "wherein" step, the
Court stated that it simply tells a doctor about the relevant
natural laws, adding, at most, a suggestion that the test results
be considered when making treatment decisions. With regard to
the "determining" step, the Court stated that it tells a
doctor to measure the metabolite through whatever process the
doctor wishes to use. Because methods for making such
determinations were well known in the art, the Court characterized
this step as simply "telling doctors to engage in
well-understood, routine, conventional activity previously engaged
in by scientists who work in the field." The Court
declared that such activity "is normally not sufficient to
transform an unpatentable law of nature into a patent-eligible
application of such a law." In so doing, the Court
inferred that the three steps were merely "'conventional
or obvious' '[pre]-solution activity'" or
"insignificant post-solution activity." The Court
reasoned that 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."
The decision likely will call into the question the validity of
many issued patent claims in the diagnostics field, including some
of the claims under review in The Association of Molecular
Pathology v. Myriad Genetics, as well as the patentability of
pending patent applications. For example, in many diagnostics
patents, the claimed invention is premised on the discovery of a
particular correlation between the presence, absence or amount of
one or more biomarkers and a medical condition. However, the
claimed processes often only include steps that are
well-understood, routine and conventional activities by those
working in the field. In addition, the decision may also
impact the patentability of methods of conducting personalized
medicine, for example, where treatment regimens for a subject are
tailored based on the presence, absence or amount of one or more
biomarkers that correlate with treatment efficacy. The full
reach of the decision's impact, potentially well beyond the
diagnostics field, is not yet clear. The Court observed that
"all inventions at some level embody, use, reflect, rest upon,
or apply laws of nature, natural phenomena, or abstract
ideas." That observation acknowledged that not all
inventions can be unpatentable simply because they have some
relationship with a law of nature. At the same time, the
observation also serves as a warning that the impact of
Prometheus will not be limited to one class of invention
or one field of technology.
In its concluding remarks, the Court indicated that it is up to
Congress to craft finely tailored rules if, from a policy
perspective, more protection for discoveries of diagnostic laws of
nature are desirable.
Even in the diagnostics field many inventions will remain
patent-eligible, including new and inventive methods for detecting
biomarkers, and reagents and other tools for detecting
biomarkers. Similarly, in the therapeutics field the Court
distinguished the unpatentable methods of Prometheus from
a presumably patent-eligible "new drug or a new way of using
an existing drug." On the other hand, the
Prometheus decision will have an unavoidable impact on
certain other technologies and business plans, an impact that
companies and investors ignore at their peril. For example,
unless Congress intervenes, companies that routinely patented
diagnostic inventions in the past may conclude that future
diagnostic inventions are better kept as trade secrets. More
broadly, it is important that those in the medical industry (and
beyond) take this opportunity to reevaluate their intellectual
property positions, as the strategies on which companies have
relied in the past may no longer be optimal in the
post-Prometheus world.
Goodwin Procter LLP is one of the nation's leading law firms, with a team of 700 attorneys and offices in Boston, Los Angeles, New York, San Diego, San Francisco and Washington, D.C. The firm combines in-depth legal knowledge with practical business experience to deliver innovative solutions to complex legal problems. We provide litigation, corporate law and real estate services to clients ranging from start-up companies to Fortune 500 multinationals, with a focus on matters involving private equity, technology companies, real estate capital markets, financial services, intellectual property and products liability.
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