Over the history of the Court, patent cases were typically
considered on simpler technologies – such as how to
distribute weight in a train car for coal and the process
recipe for opening a mold shaping rubber products –
but in the last few decades the Court has increasingly begun to
delve into more complex technologies.
This started in many ways with the Supreme
Diamond v. Chakrabarty decision, where the Supreme
Court grappled with the general issue of whether a living thing
– specifically a human-made bacterium – could
be patentable subject matter under 35 U.S.C. § 101 (the
gatekeeper definition of what subject matters can be patented).
In the last few years the Court has expanded to more and more
complex analyses, looking at a series of cases about the
patentability of computer algorithms and so-called "business
method patents." Last year it decided the biotechnology case of
Mayo v. Prometheus, where the Court held that claims
covering a method of measuring the metabolite levels from a
particular treatment and then comparing them to an expected
range of values – but not specifying how to respond if
the results were outside the expected range – were not
patentable under § 101 because they covered a law of
Two currently pending cases this term, however, present
stark attacks to the patent system and its ability to cover
biotechnology advances, and these cases put the entire field of
biotechnology – from agriculture to personalized
medicine – at risk. The first case is Bowman v.
Monsanto. The issue in that case is whether a patent
protects subsequent generations of genetically engineered seed.
Monsanto sells soy beans that have been modified so
they will not be killed by Monsanto's well-known Round-Up
herbicide. These Round-Up-Ready soy beans are sold to farmers
with the agreement that the resulting "second generation" soy
bean crop cannot be replanted to create a third generation of
soy bean. There are no limitations, however, on using the
second generation soy beans for any other purpose, including as
animal feed or as food for humans.
Bowman bought soy beans as seed from a grain elevator and
suspected that second generation Round-Up-Ready seed was
included in his purchase. He planted those seeds and treated
them with Round-Up, confirming his suspicion when third
generation Round-Up-Ready soy beans survived the herbicide
treatment. Monsanto argues that Bowman infringed its patents.
Bowman counters that Monsanto should not control his freedom to
use seed bought elsewhere as he sees fit; in other words,
Bowman says Monsanto can control the use of Round-Up-Ready seed
by contract for those who buy from Monsanto but not by patents
for those who buy seed elsewhere.
As a matter of economics, Bowman asserts that Monsanto is
trying to control farming. These arguments ignore the simple,
specific fact that Bowman can always use seed other than
Round-Up-Ready soy beans as many farmers do. On a
macro-economic scale, Bowman cannot explain why anyone would
conduct research to improve seed if the first sale of that
improved seed to farmers meant they would be able to generate
as much of that improved seed as they want by harvesting the
crop and replanting a portion of it.
In effect, Bowman argues patent exhaustion – that
the first time an item is sold the purchaser is free to use it
for its intended purpose. That argument works for eye glass
inserts (which can only be used for making eye glasses) and for
computer parts (when they have a specific use) but this case is
different. Here, planting seed can have a number of purposes,
making food or generating more seed. You can read more about
this in AIPLA’s
amicus brief to the Supreme Court. This is the first time
the Supreme Court has grappled with the issue of naturally
self-reproducing inventions, where the patentee has made clear
that some uses are licensed but another – making seed
– is not.
It's fairly clear that if a company sells a machine you
cannot then use that machine as a template for making new
machines, i.e. by copying the purchased machine,
without infringing, but in this instance the soy beans
replicate themselves by the shear act of using them as
intended. The Federal Circuit analyzed this argument by looking
at the concept of "making," as found in the patent infringement
statute, and indicated that making new third generation seed
was different from using the second generation seed for other
purposes. (The Federal Circuit also considered a conditional
sale doctrine that went beyond what the Supreme Court has
previously held, which may be subject to some attack at the
Supreme Court.) If Bowman is allowed to succeed, it will choke
off most biotechnological farming investments.
The second case is Association for Molecular Pathology
v. Myriad. The essence of the dispute is whether isolated
DNA is a product of nature and therefore not patent eligible
under section 101, or instead has been isolated by man in such
a way as is never found in nature and therefore can be
The question asked by the Supreme Court, however, is
actually much broader than the issue raised by the case. The
Supreme Court has asked the more general question, "are human
genes patentable?" But that is the wrongly positioned question
for two reasons. First, the concept of patentable includes lots
of statutory tests including whether an invention is new
– human genes exist in the body and therefore
generally are not new (i.e., they are not novel and
nonobvious). Second, the facts of the case are much narrower
than an attempt to patent human genes, the genes as found in
the human body.
The question that the facts of the Myriad case
actually present is whether a specific subset of the human
gene, namely a particular segment of coding DNA, is patent
eligible under Section 101. The patent claims involved in this
case are for man-made strands of DNA. These claimed DNA
sequences are not genes as found in humans, i.e.
"human genes." They are instead disparate but related strands
of DNA that the inventors isolated and arranged into adjacent
coding regions without the naturally-occurring, non-coding
intervening strands. The inventors then correlated certain
strand anomalies or mutations with an increased risk of breast
and ovarian cancer, an expensive and time-consuming
correlation. Patents on these sorts of inventions are exactly
what the Constitution hoped to incentivize by creating patents
to promote "the progress of science and the useful arts."
The Association of Molecular Pathology and its supporters
make broad sweeping statements that the ability to patent
coding segments of DNA stifles innovation. Such hysterical
assertions, that biotechnology patents preempt all scientific
research, are simply wrong and are inconsistent with the
existing law. For instance, 35 U.S.C. § 271(e)(1)
generally exempts medical research development work from
infringement, and there are also are common law exceptions to
infringement for certain types of experimentation. Congress
also has already exempted certain groups conducting medical
processes from being liable for patent infringement, 35 U.S.C.
§ 287(c), and in doing so recognized that genetic material
can be subject of patent protection. Read more about this in
amicus brief to the Supreme Court .
Both the Bowman and Monsanto cases involve
important social and ethical questions, in terms of public
access to new technologies as well as in terms of incentivizing
scientific advances. Hopefully the Supreme Court will get it
right and continue to protect the economic incentives and the
importance of the U.S. biotechnology industry.
AIPLA’s briefs in both cases emphasize how
important protecting innovation is and the central themes of
incentivizing the next generation of scientific advance. It
should be interesting to see whether what the Court says, but
until then thanks for reading.