One of the most important and complex patent cases has just come to an end. The US Supreme Court, the highest court in the States, recently heard an extremely difficult biotech case: Assoc. for Molecular Pathology v. Myriad Genetics, Inc., No. 12-398, June 13, 2013 (hereafter 'Op.'). It's ruling is expected to have broad implications, not only in the U.S. but worldwide. The central question is: whether human genes could be patented? Put in a simple way: how genes, the basis for hereditary traits in living organisms, could become a company’s intellectual property; and who owns the gene?

1. Is There a Line Of Demarcation Between Natural And
Invented DNA? The U.S Supreme Court Decided That
Human Genes May Not Be Patented.
By Thomas Dubuisson, LL.M., J.D., LL.B
http://www.d-is-freshinteresting.blogspot.nl/
tom.dubuisson@gmail.com - @tdubuisson
One of the most important and complex patent cases has just come to an end.
The U.S Supreme Court, the highest court in the States, recently heard an extremely
difficult biotech case: Assoc. for Molecular Pathology v. Myriad Genetics, Inc., No.
12-398, June 13, 2013 (hereafter 'Op.'). It's ruling is expected to have broad
implications, not only in the U.S. but worldwide. The central question is: whether
human genes could be patented? Put in a simple way: how genes, the basis for
hereditary traits in living organisms, could become a company’s intellectual property;
and who owns the gene?
In particular in the field of medicine, modern biotechnology is one of the key
technologies of the 21st century, a major source of innovation and a global driver of
economic growth. With annual net sales exceeding $90 billion, it's easy to understand
the paramount importance of biopharmaceuticals to the pharmaceutical industry today.
With all these new technologies, scientists have developed processes to modify the
genetic composition of living organisms, better known as "human genetic engineering
(HGE)". In other words, it is "a process by which scientists and medical professionals
alter the genetic makeup, or DNA, in a living human cell"1
.
As clearly explained on the World Intellectual Property Organization
(WIPO 2
) website 3
, biotech may also concern "the application of cellular and
molecular biology to human needs and the use of cells and biological molecules to
solve problems or make useful products (for instance, fix defective genes that cause
diseases and other genetic complications). It includes scientific and industrial
disciplines directed to understanding and manipulating living or biologically active
material at the molecular level. Often it refers to recombinant deoxyribonucleic acid
(DNA) techniques and analysis of genetic information".
1
http://www.redorbit.com/news/science/1112819269/human-genetic-engineering-a-very-brief-
introduction/ (last visited on July 18, 2013).
2
The WIPO is the United Nations agency dedicated to the use of intellectual property (patents,
copyright, trademarks, designs, etc.) as a means of stimulating innovation and creativity
3
http://www.wipo.int/export/sites/www/about-ip/en/iprm/pdf/ch7.pdf (last visited on July 18, 2013).

2. Myriad Genetic Laboratories, Inc., a small Utah-
based biotechnology company, created a 'monopoly'
in the U.S when its co-founder became the first
scientist to isolate, sequence and patent two human
genes, mutations (BRCA1 and BRCA2) of which
can substantially increase the risks of breast and
ovarian cancer4
. Simply put, Myriad has exclusive
rights for all clinical use of the BRCA mutations.
Even though scientists knew that heredity played a
role in establishing a woman's risk of developing breast and ovarian cancer, Myriad
identified the exact location of the BRCA1 and BRCA2 genes (on chromosome 17
that has approximately 80 million nucleotides and chromosome 13 that has 114
million).
The plaintiff, the Association for Molecular
Pathology, sued Myriad, seeking invalidation of
the contested claims. The Association "asserted
that the claims covered products of nature, laws
of nature, natural phenomena, abstract ideas or
basic human knowledge, disputing the subject
matter's patentability, in light of 35 U.S.C. §101.
Further, it argued that the patents hindered
scientific research and innovation, prevented
competition and threatened patients' rights"5
. Moreover, the Association relied on the
arguments of scientists who have said that such isolated fragments of DNA do indeed
occur through natural processes in the human body.
In sum, the main issue is the patentability of isolated DNA sequences in relation to
diagnostic and drug screening claims.
Before developing the subject into details, it is important to remind ourselves of
the genetics basics:
"The human genome consists of approximately 22,000 genes packed into 23 pairs of
chromosomes. Each human gene is encoded as deoxyribonucleic acid (DNA), which
takes the shape of the familiar “double helix.” Each “cross-bar” in the DNA helix
consists of two chemically joined nucleotides. The possible nucleotides are adenine
(A), thymine (T), cytosine (C), and guanine (G), each of which binds naturally with
another nucleotide: A pairs with T; C pairs with G. The nucleotide cross-bars are
chemically connected to a sugar-phosphate backbone that forms the outside
framework of the DNA helix. Sequences of DNA nucleotides contain the information
necessary to create strings of amino acids used to build proteins in the body. The
nucleotides that code for amino acids are “exons,” and those that do not are “introns.”
Scientists can extract DNA from cells to isolate specific segments for study. They can
also synthetically create exons-only strands of nucleotides known as composite DNA
(cDNA). cDNA contains only the exons that occur in DNA, omitting the intervening
4
For a detailed explanation of the facts, see: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3037261/
(last visited on July 18, 2013).
5
http://ipkitten.blogspot.nl/2013/04/patentability-of-dna-sequences-debate.html (last visited on July 18,
2013).

3. introns" (See Assoc. for Molecular Pathology v. Myriad Genetics, Inc., No. 12-398,
June 13, 2013, p. 1-2.)
In Europe, under the European Patent Convention (EPC), biological material isolated
from its natural environment is considered patentable. This includes inanimate
biogically active material such as genes and DNA and RNA sequences and animate
matter, such as microorganisms. In other words, as it is explicitly explained in Rule
29 (2) and (3) EPC, if the biotechnological inventions meet the basic criteria of
patentability (Articles 54, 56, 57, 83 and 84 EPC), there is no bar to the patentability
of genes or DNA sequences:
An element isolated from the human body or otherwise produced by means of a
technical process, including the sequence or partial sequence of a gene, may
constitute a patentable invention, even if the structure of that element is identical to
that of a natural element - rule - 2
The industrial application (i.e. the function) of a sequence or a partial sequence of a
gene must be disclosed in the patent application - rule 3
In the U.S, the United States Patent and Trademark Office (USPTO) has
already granted thousands of patents on DNA sequences (like BRCA mutations) since
1982. Recently, the Court of Appeal for the Federal Circuit (on July 29, 2011) held
four important principles:
 cDNA (complementary DNA) is patentable.
For non-scientists, a cDNA is "a single-stranded DNA that is complementary to a
certain sequence of messenger RNA (A type of RNA - molecule - that carries the
code or chemical blueprint for a specific protein). It is usually formed in a laboratory
by the action of the enzyme reverse transcriptase on a messenger RNA template.
Complimentary DNA is a popular tool for molecular hybridization or cloning
studies"6
.
In other words, it is essentially synthetic (designed by humans) and used for medical
or agricultural purposes. A Washington Lawyer gave an easier interpretation: "the
cDNA has the same genetic information as our natural gene, but it's in a user-friendly
form. If you think of a human gene as gold still in a gold mine, then cDNA is the gold
after it's been mined and polished".
 Isolated human DNA is patentable.
 Method for comparing and analysing human genes is NOT patentable (lacks
any transformative step):
"We conclude that Myriad’s claims to “comparing” or “analyzing” two gene
sequences fall outside the scope of § 101 because they claim only abstract mental
processes. See Benson, 409 U.S. at 67 (“Phenomena of nature, . . . mental processes,
and abstract intellectual concepts are not patentable, as they are the basic tools of
6
For more information, see: http://www.answers.com/topic/cdna#ixzz2VX3hH1Tk (last visited on July
18, 2013).

4. scientific and technological work.”). The claims recite, for example, a “method for
screening a tumor sample,” by “comparing” a first BRCA1 sequence from a tumor
sample and a second BRCA1 sequence from a non-tumor sample, wherein a
difference in sequence indicates an alteration in the tumor sample. ’001 patent claim 1.
This claim thus recites nothing more than the abstract mental steps necessary to
compare two different nucleotide sequences: look at the first position in a first
sequence; determine the nucleotide sequence at that first position; look at the first
position in a second sequence; determine the nucleotide sequence at that first position;
determine if the nucleotide at the first position in the first sequence and the first
position in the second sequence are the same or different, wherein the latter indicates
an alternation; and repeat for the next position" (See Appeal from the United States
District Court for the Southern District of New York in Case No. 09-CV-4515, Senior
Judge Robert W. Sweet. p. 49-50).
 Method for screening potential cancer therapeutics is patentable.
In this case, both parties appealed to the Supreme Court. The Highest Court reverted
back to the Court of Appeal on March 26, 2012 (in other words, to re-hear the entire
case again) in view of Prometheus vs. Mayo Decision, 566 U.S. ___ 132 S.Ct. 1289
(where the Court ruled that certain kinds of claims in medical diagnostics patents,
including natural phenomena, were not patentable). On Appeal, on August 16, 2012,
the Court overturned the District Court Decision, ruling again in a 2–1 decision in
favor of Myriad. Then, a second petition for certiorari was filed with the Supreme
Court in September 2012. Oral arguments were heard before the Supreme Court on
April 15, 2013 which may be summarized in three questions:
- Is the isolation or extraction of natural products patentable?
- Are there sufficient incentives for genetic research, if genes are non-patentable?
- What are the differences between DNA and cDNA? Which of them can be the
subject of a patent?
These questions have already been answered by the U.S Court of Appeal for the
Federal Circuit in 2011. Based on the comments and questions heard in Court
on April 15th, 2013, the Judges of the Supreme Court seemed sceptical about
whether these kinds of genes should continue to be patented; and therefore to decide
to invalidate the main patents of Myriad and, perhaps, the thousands of patents
already issued.
On June 13, 2013, the U.S
Supreme Court ruled unanimously
(9-0 decision written by Justice
Clarence Thomas) that human
genes cannot be patented, is not
eligible subject matter under 35
U.S.C. § 101:
"Whoever invents or discovers
any new and useful (...)

5. composition of matter, (...) may obtain a patent therefor, subject to the conditions and
requirements of this title"; but “laws of nature, natural phenomena, and abstract
ideas”‘are basic tools of scientific and technological work’ ” that lie beyond the
domain of patent protection (Mayo Collaborative Services v. Prometheus
Laboratories, Inc., 566 U. S).
This decisions appears as a victory for ACLU (the plaintiff) and a split decision for
Myriad. Explanations.
Justice Thomas wrote:
'Myriad did not create anything (underline added). To be sure, it found an important
and useful gene, but separating that gene from its surrounding genetic material is not
an act of invention. Groundbreaking, innovative, or even brilliant discovery does not
by itself satisfy the §101 inquiry (...).Myriad found the location of the BRCA1 and
BRCA2 genes, but that discovery, by itself, does not render the BRCA genes “new . . .
composition[s] of matter,” §101, that are patent eligible'. (See Op. p. 12-13).
This passage clearly demonstrates the victory for the American Civil Liberties Union
(ACLU). The isolation of the DNA molecule resulting in a physical change in the
molecule (as it is chemically removed from its intracellular environment) does not
render it patentable.
On the other hand, Justice Thomas explained that cDNA molecules are eligible for
patent protection. That part is where Myriad focused on:
The petitioners argue that 'that cDNA is not patent eligible because “[t]he nucleotide
sequence of cDNA is dictated by nature, not by the lab technician.” Id., at 51. That
may be so, but the lab technician unquestionably creates something new when cDNA
is made (underline added). cDNA retains the naturally occurring exons of DNA, but it
is distinct from the DNA from which it was derived. As a result, cDNA is not a
“product of nature” and is patent eligible under §101 (underline added), except
insofar as very short series of DNA may have no intervening introns to remove when
creating cDNA. In that situation, a short strand of cDNA may be indistinguishable
from natural DNA' (See Op. p. 16-17).
Based on the fact that the average American woman has a 12- to 13-percent risk of
developing breast cancer (See Op. p.2), this patent lawsuit was not only important for
companies (medical innovation), but also for patient care.
However, the court's opinion did not settle the question about whether or not it is
possible to patent a method or process of working with a gene (a method claim).
Moreover, the decision does not involve patents on new applications of knowledge
about the BRCA1 and BRCA2 genes, and the patentability of DNA in which the order
of the naturally occurring nucleotides has been altered.
Patent protection always strikes a delicate balance between creating
“incentives that lead to creation, invention, and discovery and “imped[ing]the flow of
information that might permit, indeed spur, invention.” (See Op. p. 2). Regarding the

6. facts, it can be concluded that cDNA is patentable because it is not naturally
occurring BUT a naturally occurring DNA segment is a product of nature and
not patent eligible merely because it has been isolated.
In other words, the U.S Supreme Court decided that human genes - a part of the
human body - may not be patented and, as a consequence, held 'hostage' by a private
company.
[UPDATE: Very recently (on July 14, 2013), winning Noble prize Joseph E. Stiglitz
wrote a very interesting article about this case and how Intellectual Property (IP)
reinforces inequality.
For him, it's the American intellectual property regime that contributes needlessly to
the gravest form of inequality7
; the U.S IP regime is poorly designed and the result is
that there is actually less innovation and more inequality8
. And added that "genetic
researchers have argued that the patent actually prevented the development of better
tests, and so interfered with the advancement of science. All knowledge is based on
prior knowledge, and by making prior knowledge less available, innovation is
impeded (emphasis added). Myriad’s own discovery — like any in science — used
technologies and ideas that were developed by others. Had that prior knowledge not
been publicly available, Myriad could not have done what it did"9
.
He also encouraged people to use alternatives - as you know the patent system is not
the only way - and strongly concluded that "Myriad’s effort to patent human DNA
was one of the worst manifestations of the inequality in access to health, which in turn
is one of the worst manifestations of the country’s economic inequality (emphasis
added)".]
7
J o s e p h E . S t i g l i t z , " H o w I n t e l l e c t u a l P r o p e r t y R e i n f o r c e s I n e q u a l i t y",
http://opinionator.blogs.nytimes.com/2013/07/14/how-intellectual-property-reinforces-
inequality/?gwh=CF9A0808F712E326DEE9B8D985326C68 (last visited on July 18, 2013).
8
Id.
9
Id.