Mayo v Prometheus - Gwu - George Washington University

Mayo v Prometheus: No Patents on Conventional Implementations ofNatural Principles and Fundamental Truths 511
"What Diehr claims to have discovered, in essence,
is a method of updating the original estimated curing
time by repetitively recalculating that time pursuant
to a well-known mathematical formula in response
to variations in temperature within the mold. Their
method of updating the curing time calculation is
strikingly reminiscent of the method of updating
alarm limits that Flook sought to patent." 74
Diehr marked the end of the court's interest in
patent-eligibility for three decades," until the 2010 Bilski
opinion. We turn now to the Prometheus opinion.
The claim under analysis in Prometheus
Before considering the main issues involved in
Prometheus, a preliminary point deserves attention. The
representative claim that the Supreme Couti considered 76
is drafted atrociously. 77 There is a reason for that, but not
a good one.
Although styled "a method of optimizing therapeutic
efficacy for treatment of an immune-mediated
gastrointestinal disorder", the claimed process does no
treating except in the first ("administering") step, which
is old, and it does no optimising at all. The claimed
process only directs a user of the process to administer a
drug that metabolises to 6-thioguanine and then detennine
a blood level of 6-thioguanine; it directs no further acts.
The remainder of the claim-a pair of wherein clauses-is
simply a didactic statement, which technically is neither
an act nor a true claim limitation. The optimising method
as claimed is incomplete.
This creates one of the problems with the claim. It
allows anticipation by the prior art. Such mere didactic
observations as those of Prometheus's wherein clauses
do not limit and thus effectively distinguish the claim's
only recited acts from the prior art. And surely some
doctors in the past have administered a thiopurine and
ascertained the resulting blood level of 6-thioguanine, 78
thereby practising and thus anticipating the only acts
specified in what this patent claims. The wherein clauses
sought to distinguish the claim over the prior art, but they
were ineffective expedients. That raises the question of
why did Prometheus not simply recite the acts of
increasing or decreasing drug dosage according to the
assay results. That is what a claim draftsman considering
"a method of optimizing therapeutic efficacy for treatment
••• " 79 would normally do. That would distinguish the
claim from the prior art, assuming that doctors were not
previously making a point of staying above 230 and below
400 pmol of metabolite when dosing their patients. But
there is a difficulty with claiming the complete method.
Prometheus had a business reason to draft its claim
without the acts of increasing or decreasing drug dosage
according to the assay results. Prometheus does not treat
patients as a doctor would. It is a laboratory that sells
diagnostic services to hospitals or doctors, and so are its
competitors. Prometheus wants to be able to sue
laboratory competitors that offer the same assay. But like
Prometheus, such laboratories do not perform the steps
of increasing or decreasing drug dosage for patients to
whom they administer drugs.
If the process claim were complete, competitive
laboratories would not directly infringe the patent by
using the assay in competition against Prometheus,
because they do not perfonn all of the steps. A process
claim is directly infringed only if the accused infringer
performs each step of the claim; omission of any step
avoids direct infringement. 80 Prometheus could therefore
successfully sue competitive laboratories, if at all, only
for inducing infringement or contributory
infringement-the elements of proof for which are
notoriously troublesome. 81 To be in a position to sue
competitors for direct infringement and sidestep the
difficulties of proving induced or contributory
infringement, Prometheus needed to avoid directly
74 Diehr 450 U.S. 175, 209 (1981).
75 There was one exception, however, although oflittle significance to patent-eligibility doctrine. The court approved the eligibility of newly developed sexually reproduced
plants for utility patent protection in J.E.M. Ag Supply v Pioneer Hi-Bred Jut '1534 U.S. 124 (2001 ). In addition, there was an abortive effort in LabCOJ]J of Am. v Metabolite,
Inc 548 U.S. 124 (2006), to review the judgment in a case much like Prometheus. After granting certiorari, the court dismissed the writ as improvidently granted. Justice
Breyer, with whom Justices Stevens and Souter joined, dissented from the dismissal as unwananted, stating that what was claimed was a natural principle, for reasons
similar to those given in the Prometheus opinion: Labcmp at [ 138].
76 See text following fn.l1 above.
77 There has been a great deal of protest among members of the US patent bar that the claim that the Supreme Court addressed in Prometheus is bad and therefore should
not be the basis of an important precedent. I think that this grumbling reflects resentment and some sort of wishful thinking by the bar that the underlying 1uling of a
unanimous Supreme Comi could and should be made to go away because the patent bar do not like it. The problem with Prometheus's claim is not one of draftsmanship.
It is far more fundamental, and proper drafting would not cure the claim or change the result, as becomes clear when the claim is revised properly.
78 The opinion says as much: Prometheus 132 S. Ct. at [1289], [1295] (2012).
79 Actually this claimed invention, as claimed, is not so much a method of optimising treatment as it is a method of determining how to optimise treatment.
8° Canton Bio-Medical, Inc v Integrated Liner Technologies, Inc 216 F. 3d 1367, 1370 (Fed. Cir. 2000) ("Infringement of process inventions is subject to the 'all-elements
rule' whereby each of the claimed steps of a patented process must be performed in an infringing process, literally or by an equivalent of that step, with due attention to the
role of each step in the context of the patented invention"); EMf Group North America, Inc v Intel Cmp 157 F. 3d 887, 896 (Fed. Cir. 1998) ("For infringement of a process
invention, all of the claimed steps of the process must be performed, either as claimed or by an equivalent step").
81 See, e.g., Global-Tech Appliances, Inc v SEB SA l3l S. Ct. 2060 (2011); DSU Med. Cmp v JMS Co 471 F. 3d 1293 (Fed. Cir. 2006) (en bane).
[2012] E.J.P.R., Issue 8 © 2012 Thomson Reuters (Professional) Uk Limited and Contributors