FACTS OF THE CASE

Myriad Genetics, Inc. is a Utah based American Molecular diagnostic company. In the year 1994, the
company discovered precise location and sequence of the BRCA1 and BRCA2 genes,also synthetically
created BRCA cDNA and methods of diagnosis and systems detecting mutations,it was subsequently
granted a patent over them by the US PTO.These genes were instrumental in diagnosing breast and
ovarian cancer among women as women possessing these genetic mutations were more susceptible of
having breast cancer (nearly 50-80%) and ovarian cancer (nearly 20-50%) later in their lives.3

Myriad threatened to sue any lab which was offering tests for BRCA or related genes. The company took
complete advantage of the exclusive rights that the patent has vested on it. It charged humongous costs
for the diagnostic tests. The actual price accrued was not even a fraction of the amount that was
charged. Gradually, it stopped sharing data with the international scientific community. The most
bothersome issue was that for several years, it denied to upgrade the lists. These lists included the
subsidiary and ancillary mutations. Themajor drawback of not upgrading the lists was that several
women who have taken the test within this time frame received the wrong result.4 As a result of the
gene monopoly, no other lab was in a capacity to provide for the tests, prompting the suffering of
numerous women with no fault of theirs.

Subsequently in the year 2010, a case was filed against Myriad Genetics by a group of several experts,
physicians, geneticists, patients, advocacy and scientific research groupschallenging the validity of
patents granted over the BRCA1 and BRCA2 genes

the District Court granted summary judgment to petitioners, concluding that Myriad’s claims were
invalid because they covered products of nature. The Federal Circuit initially reversed, but on remand in
light of Mayo Collaborative Services v. Prometheus Laboratories, which had established that items or
processes are not patentable unless they are themselves inventive or do not exist or occur without
artificial modification [13].

The federal circuit court issued a new opinion, with two out of three of the judges concluding, for
different reasons, that isolated DNA segments are eligible for patenting [14]. reason was that the
isolation process involved severing covalent bonds at both ends of a DNA segment, which technically
formed molecules that do not occur naturally

PATENTING PRODUCTS OF NATURE

The Association for Molecular Pathology ("AMP") points to the Supreme Court’s decision in Diamond v.
Chakrabarty for the proposition that a composition of matter must have “markedly different
characteristics” from a thing found in nature to qualify as patent-eligible subject matter. . The
Association for Molecular Pathology ("AMP") argues that DNA molecules that have been isolated in the
lab are not substantially different from DNA as it is found in nature, and therefore they may not be
patented. Myriad counters that the action of isolating DNA molecules rendered them in a form not
known in nature and with different properties, making it appropriate subject matter for a patent. AMP
cites the danger in allowing a patentee, such as Myriad, to control a property of nature and a general
body of knowledge, while Myriad contends that its patent claims at issue in this case are limited to
distinct physical compositions

Analysis

By statute, only four categories of invention are eligible for patents: processes, machines, manufactures,
and compositions of matter. Courts have further restricted the reach of patent law by carving out three
exceptions to these categories, stating that laws of nature, natural phenomena, and abstract ideas may
not be patented. In this case, the Supreme Court will determine whether a patent may be granted for a
human gene. The parties dispute the nature of Myriad’s claimed invention and the effects of allowing
such patents.

CONCLUSION:

The U.S. Supreme Court unanimously held that a naturally occurring DNA segment was a product of
nature and not patent eligible under 35 U.S.C.S. § 101 merely because it was isolated, but cDNA was
patent eligible because it was not naturally occurring. In isolating the genes, the laboratory found
important and useful genes but did not create or alter either the genetic information encoded in the
genes or the genetic structure of the DNA, and the location and order of the genetic sequences existed
in nature before the laboratory isolated them. However, cDNA which removed codes for anything other
than amino acids was not a product of nature and was patent eligible since the removal of the unwanted
codes unquestionably created something new.