Tag Archives: Composition

Should human genes be patentable? That’s the
central question in Association for Molecular Pathology v.
Myriad Genetics, Inc., a case argued before the U.S. Supreme
Court this week. The lawsuit was organized by the American Civil
Liberties Union on behalf of
several professional organizations that have long opposed such
patents, which the U.S. Patent and Trademark Office has been
granting since the 1980s. Patent law is arcane, and arguments about
it can sound a lot like haggling over the number of angels that can
dance on the head of pin. But in this case, it is tens of billions
of dollars in research, products, and profits that are doing the
dancing.
At the issue are several patents related to two breast cancer
genes, BRCA 1 and BRCA 2. In the 1990s, researchers at Myriad
identified and isolated two genes in which certain mutations
dramatically increase the risk of breast and ovarian cancer. The
company then offered a product, called BRACAnalysis, which compares
patients’ BRCA genetic sequences to the company’s reference
sequence to identify the mutations. Armed with the knowledge that
they are at greater risk, patients can then engage in protective
actions ranging from more frequent mammograms and ultrasound
examinations to having their breasts and ovaries surgically
removed. The court must decide if Myriad is merely using products
of nature (which cannot be patented) or if it has invented a “new
and useful process, machine, manufacture, or composition of matter,
or any new and useful improvement thereof” (which can).
Why do the plaintiffs want to invalidate human gene patents? As
a matter of public policy, it’s mainly because they believe such
patents impede rather than speed valuable research and development.
(The Association for Molecular Pathology, for example,
cites estimates that “about 20 percent of the human genome is
under patent,” and
argues that “scientific research has been delayed, limited or
even shut down due to concerns about gene patents.”) As a matter of
law, the groups argue that a gene isolated by Myriad conveys the
same genetic information as a gene found in a human body, and that
it thus “represents the same laws of nature as genomic DNA.”
Myriad, the ACLU concludes, “is in effect arguing that it may
obtain a patent on a product or law of nature itself if it finds a
new use for it.”
In its
brief, Myriad counters that no one would contest a patent on a
new chemical that could be applied to a blood or tissue sample to
detect a higher cancer risk. “That is what Myriad’s patented
molecules are,” the company claims, “and they were never available
to the world until Myriad’s scientists applied their faculties to a
previously undistinguished mass of genetic matter in order to
identify, define, and create the isolated DNA molecules.”
Who’s right? It’s illuminating to consider how the patent office
applies the product of nature doctrine to issuing a patent. In one
training
example, the office notes that exposure to sunlight is known to
affect some people’s moods. If someone tried to patent a method for
treating seasonal affective disorder that amounts to exposing a
patient to sunlight, the application would be rejected, since it
“is no more than the law of nature plus telling people to ‘apply
it.’” Nor would the office issue a narrower patent on exposing the
patient to a source of white light, since the sun is also a source
of white light. But it would patent a treatment in which a
patient is precisely positioned for a specified length of time near
a white light source from which ultra-violet rays have been
filtered. In fact, just such a treatment was patented
in 2002.
So are Myriad’s molecules more like advising a patient to sit in
the summer sunlight or more like creating a contraption that
exposes him to white light in the depths of winter? I am not patent
lawyer, but it seems to me that gene patents are more like the
latter—that the isolated DNA molecules are the result of human
ingenuity and are composed, manufactured, and improved, not merely
discovered or found.
The public policy issue raises a different question: Do gene
patents promote progress, or do they impede discovery and
invention? In its brief, Myriad makes the uncontested point that
since its BRCA patents were issued, 18,000 researchers have
conducted studies involving those genes, published over 8,000
scientific papers, and conducted over 130 clinical trials. That’s a
lot of progress, and the evidence that the patents have prevented
still more progress from occurring is slim. In a recent,
comprehensive analysis,
Christopher Holman, a professor at the University of
Missouri–Kansas City Law School, deflates the claim that 20 percent
of human genes are patented and that this constitutes a roadblock
to newer genetic technologies, such as testing based on whole
genome sequencing.
The claim that 20 percent of human genes are patented comes from
a single
article in Science magazine in 2005. The
Science authors assumed that the mention of a gene’s DNA
sequence in patent claim was equivalent to patenting the gene, but
in most cases that actually isn’t so. What’s more, sequencing a
whole genome does not require the use of isolated genes. It
involves running a person’s DNA through a detection device to
determine the specific order of DNA base pairs; these data are then
compared with publicly available studies describing the various
effects of the identified sequences on an individual’s health and
well-being. In very few instances would preexisting patents prevent
this.
Holman concludes that “there is no empirical support for the
widespread notion that 20 percent of human genes are patented in
manner that would be inevitably infringed” by modern genetic
testing technologies. In fact, whole genome sequencing will soon be
cheaper than diagnostic tests, such as Myriad’s, that depend on
patented genes.
In the meantime, declaring human gene patents invalid would
likely slow progress in the creation of new medical treatments. As
Holman notes, the “biotechnology industry has invested heavily in
life-saving products based on the expectation that effective patent
protections are available for innovations in this field.” During
oral arguments, Justice Antonin Scalia asked the highly relevant
question of the ACLU attorney: “Why would a company incur massive
investment if it—if it cannot patent?” The lawyer lamely responded
that scientists might do such work “because they’re curious,”
“because they want a Nobel Prize,” and because they would “get
enormous recognition.” Scalia drily replied, “Well, that’s lovely.”
Scalia asked the right question; for the sake of future patients’
well-being, let’s hope a majority of the court comes up with the
right answer.
Disclosure: I am still a card-carrying member of the
ACLU. … Read More