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Mayo v. Prometheus
by: Jon M. Gibbs
Lowndes, Drosdick, Doster, Kantor and Reed PA
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Autoimmune Disease
• Inappropriate immune response to
substances or tissues normally present in
a body
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Thiopurine Drugs
• Commonly used to treat certain
autoimmune diseases
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Claim 1 of the ‘623 Patent
A method of optimizing therapeutic efficacy for treatment of an immunemediated gastrointestinal disorder, comprising:
(a) administering a drug providing 6-thioguanine to a subject having
said immune-mediated gastrointestinal disorder; and
(b) determining the level of 6-thioguanine in said subject having said
immune mediated gastrointestinal disorder,
wherein the level of 6-thioguanine less than about 230 pmol per 8x108
red blood cells indicates a need to increase the amount of said drug
subsequently administered to said subject, and
wherein the level of 6-thioguanine more than about 400 pmol per 8x108
red blood cells indicates a need to decrease the amount of said drug
subsequently administered to said subject.
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In Essence . . .
A method of determining whether a drug is
effective or toxic comprising:
- giving a drug
- testing for the drug; and
- using the results to determine whether
more or less of the drug should be given at a
later time.
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Background Facts
• Prometheus sole and exclusive licensee of
the subject patents.
• Sold tests to Mayo.
• Mayo announced it would begin using and
selling its own test using a different
threshold for toxicity.
• Prometheus sued.
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District Court
• Mayo’s test was an infringement.
º Toxicity risk level numbers that Mayo used
were too similar to those in the patent.
• However, Court granted summary
Judgment in favor of Mayo.
º finding that a correlation between certain
levels of a drug and its toxicity and
therapeutic values is a natural phenomenon
and therefore ineligible for patent protection
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Federal Circuit
• REVERSED
º the “administration and determination” steps
of the method involve transformation of the
human body and therefore the patents
satisfied the Fed. Circuit’s “machine or
transformation test” thereby satisfying 35 USC
§101.
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Supreme Court
• VACATED
º Ordered that the matter be reconsidered in
light of Bilski which held that the “machine or
transformation test” was not the definitive test
for patent eligibility, but an important test
nonetheless.
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Federal Circuit II
• PATENTABLE
º Applied the “machine or transformation”
º The test led to a clear and compelling
conclusion that the claims of the subject
patents do not encompass laws of nature and
therefore contained patentable subject matter
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Supreme Court II
• Question:
º whether the subject 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.
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Supreme Court II, continued
• NO, they do not.
º “if a law of nature is not patentable, then
neither is a process of reciting a 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.”
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Supreme Court II, Continued
• Doctors used thiopurine drugs to treat patients
suffering from autoimmune disorders long before
the subject patent claims were asserted.
• Researchers routinely measured thiopurine
metabolites as part of the investigation into
whether drug levels are effective or toxic
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Analysis of Prior Cases
• Diamond v. Diehr – Patent eligible method
of molding rubber
• Parker v. Flook – Unpatentable formula for
adjusting alarm limits.
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Finding
• Claims at issue in Mayo were:
º Weaker than Diehr; and
º No stronger than Flook.
Claims, therefore, invalid under 35 USC §101.
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Consider
• A method of driving on I-4 comprising:
º administering pressure to the throttle of a vehicle
travelling on I-4; and
º determining the speed of the vehicle by viewing a
speedometer attached to the vehicle,
wherein a speed of less than 45 mph indicates a need
to increase the speed of the vehicle and wherein a
speed of greater than 70 mph indicates the need to
decrease the speed of the vehicle.
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Post Mayo?
• Fed Circuit has issued no real opinions
• Next big case will be Myriad
º Isolated DNA
º Method of screening potential cancer
therapeutics
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Myriad
• July 29, 2011, Federal Circuit
º Determined that isolated DNA and method of
screening cancer therapeutics were
patentable.
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Myriad, continued
• March 26, 2012, Supreme Court
º Vacated July 29 Order and remanded in light
of Bilski.
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Myriad, continued
• April 30, 2012, Federal Circuit entered
Order:
º Recalling the July 29, 2012 Opinion and
reinstating the Appeal;
º Requiring parties to file supplemental briefs
addressing applicability of Mayo on subject
claims; and
º Scheduling oral argument for July 20, 2012