court decision this week may at last spell the end to companies'
rights to claim ownership of your genes. However, the story
started long ago in the biotechnology industry's nascent days in the
year 1980.The 1980 U.S. Supreme Court Decision Diamond v.
Chakrabarty was among the most important legal precedents of the last
two decades of the previous millennia. While it will never
enjoy the instant recognition of a case like Roe
v Wade or Brown
v Board of Education,
the case was among the most important commercial and medical
decisions in modern history.It ruled that "organisms"
made from human DNA were patentable if they were "man-made"
-- produced by human processes. This was interpreted, over
time, to mean that genes of organisms could be patented, granting the
holder exclusive ownership of that gene.That may sound
incredible, given that most patent systems worldwide, including that
of the U.S., disallow patents based on nature, and genes were
developed by nature, not man. Still, the U.S. Patent and
Trademark Office has received over 3 million patent applications to
date on genomes, according
to the Human Genome Project. Many of those patents
were granted.Today, according to experts speaking
over 20 percent of the genes in the human genome are patented.
Companies that own these patents can block other companies or
research institutions from developing tests for these genes or
developing certain medical treatments. The criteria to receive
a genome patent today has become slightly stricter, but they today
are granted if the inventors can:
a novel gene
the gene's sequence
how the gene functions in nature
the gene using bioengineering techniques
its use in medicine
that definition, companies are perfectly entitled to "own"
rights to genes that your body likely contains, and own the rights to
genetic tests on those genes.However, that may be coming to
an end, with what may come to be considered one of the most important
federal court rulings of the new century.In the case
Association for Molecular Pathology v. United States Patent and
Trademark Office, better known as ACLU
v. Myriad Genetics, ACLU lawyers challenged a big biotech firm's
ownership of two breast cancer genes, BRCA1 and BRCA2. Myriad
Genetics had extracted the genes, unaltered, using standard
techniques, then patented them. It proceeded to sell expensive
test kits for breast cancer. It blocked competitors from using
the genes, essentially disallowing patients the chance at a second
opinion. It also blocked university cancer researchers from
studying the gene in some cases.On Monday, Judge Robert W.
Sweet of the United States District Court for the Southern District
of New York ruled against Myriad Genetics in a precedent setting
case.He writes in his decision [PDF]:
sum, the clear line of Supreme Court precedent and accompanying lower
court authorities, stretching from American Wood-Paper through to
Chakrabarty, establishes that purification of a product of nature,
without more, cannot transform it into patentable subject matter.
Rather, the purified product must possess “markedly different
characteristics” in order to satisfy the requirements of § 101.
decision essentially rules patents on unaltered genes of humans and
other organisms dead, unless the decision is appealed or overturned
in this case or another by another federal court or the Supreme
Court. There will be ample opportunity for that to occur -- the
ruling is expected to lead to many genome patent holders to be taken
to court in an effort to revoke their ownership of genes of humans
and other creatures.Advocates of reform are cheering the
decision. Despite being heralded by critics as a "liberal"
ruling, among the strongest opponents of gene patents was
conservative late science-fiction author Michael
Crichton. Crichton published an
op-ed in The
New York Times in
2007 attacking the BRCA patents, writing:
or someone you love, may die because of a gene patent that should
never have been granted in the first place. Sound far-fetched?
Unfortunately, it’s only too real.Gene patents are now used
to halt research, prevent medical testing and keep vital information
from you and your doctor. Gene patents slow the pace of medical
advance on deadly diseases. And they raise costs exorbitantly: a test
for breast cancer that could be done for $1,000 now costs $3,000.
critics, though, the decision is infuriating. Gene Quinn,
Patent Attorney and founder of the IPWatchdog blog calls Judge Sweet
a "88 year old liberal jurist" and comments:
founding fathers seemed to have done quite well with this “American
experiment” and one thing is certain, they knew a thing or two
about incentivizing people in the face of long odds. They also felt
it necessary to mention intellectual property, specifically patents,
in the Constitution, which is an almost unbelievably short document
that does little more than announce fundamental principles. For those
who have trouble keeping up, this means the US patent system was
considered of FUNDAMENTAL IMPORTANCE by the likes of Jefferson,
Madison, Washington and all the others in the starting a thriving and
sustaining democracy Hall of Fame!...It isn’t just a
passing craze. Hakuna matada, its just a matter of time before the
United States Court of Appeals for the Federal Circuit reverses Judge
Sweet, because word on the street is Myriad WILL appeal (surprise
it or not, the claim that a company can "own" a human gene
has been dealt a serious body blow by the U.S. federal court system
and stands a few more blows away from a knockout. The U.S.
leads the world in biotechnology and genetics research -- so whatever
legal precedent is set in the U.S. will likely have a profound affect
on the law in Japan, China, India, the EU, and elsewhere.
quote: Methods for detecting BRCA1 mutations are provided. The methods include the steps of determining the amount of the BRCA1 polypeptide contained in a sample of the subject, and correlating the amount of BRCA1 to the presence of the BRCA1 gene mutation in the subject, wherein the amount below a predetermined cutoff value is an indication of the presence of the mutation in the BRCA1 gene of the subject. The methods of the present invention are well suited for use to determine a condition associated with BRCA1 mutation, such as a predisposition to breast cancer, ovarian cancer, colorectal, and prostate cancers, and the presence or prognosis of breast cancer, ovarian cancer, colorectal, and prostate cancers.