Angela Foster, PhD, Esq.
Law Offices of Angela Foster
Where Science,
Law &
Ethics Meet
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For over 30 years, many scientist opposed the granting of
gene patents:
◦ Restricts Research
◦
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Restricts Access to Genetic Testing
Biotechnology Industry argues that such patents are needed
to encourage investments in genetic research.
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Delay in Disseminating Information
◦ Researchers waiting for patent approval are less likely to share
information until the patent is granted.
◦ Scientists are unlikely to share material or information to ensure they
would be entitled to the patent rights as well as gain the financial
rewards.
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Contrast
◦ Gene patents provide incentive to develop and research new
inventions.
◦ Because of patent term expiration, the information is ultimately
disseminated to the public
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Submarine patents
◦ Researchers waiting for patent approval are less likely to
share information until the patent is granted.
◦ Scientists are unlikely to share material or information to
ensure they would be entitled to the patent rights as well as
gain the financial rewards.
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Hinders development of new diagnostic tests and medications
◦ Patent exclusivity rights prevent other organizations from
testing for a patented gene.
◦ Experimental Use Exception
 limited to research strictly for philosophical inquiry,
curiosity or amusement with no commercial use
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Compromise of autonomy and confidentiality
◦ Patients are potential "treasure troves" for researching
lucrative genes.
◦ Struggle with balancing the need for patent protection to
encourage the necessary research for advancements in
medical technology, while maintaining patient integrity.
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Patent holders are granted exclusive rights to
make, use, and sell their invention to the exclusion
of others in exchange for disseminating the
information in the public domain.
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An invention must be a machine, manufacture, process, or
composition of matter, or an improvement thereof, in order
to be eligible for patenting.
An invention cannot be an abstract idea, physical phenomena,
or product of nature.
◦ Mathematical formulas, laws of nature, or natural phenomena such as a
mineral or plant organism, even if newly discovered.
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However, methods and products utilizing abstract ideas,
natural phenomena, and laws of nature to perform a realworld function may be patentable
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Supreme Court in Diamond v. Chakrabarty held that a living
organism—genetically engineered bacteria capable of
breaking down crude oil—is patentable subject matter.
Living organisms were considered to be “products of nature,”
specifically excluded from the definition of patentable subject
matter under section 101 of the Patent Act.
Because a bacterium such as that described by Chakrabarty is
not found anywhere in nature, its creation constitutes a
patentable “manufacture” or “composition of matter” under
section 101.
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Parke-Davis v. H.K. Mulford Co. – exception
◦ Because the purified adrenaline was extracted from the
suprarenal gland and purified in a form that was more
stable and concentrated, it could be considered more
valuable both therapeutically and commercially.
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Funk Brothers Seed Co. v. Kalo Inoculant Co., ◦ Each species of bacteria in the mixture could benefit certain specific plant
species it might infect by extracting nitrogen from the air and rendering it
available for the infected plants to use.
◦ No single species could infect the roots of all types of plants.
◦ Rather, each species could infect only a particular plant group, and
different bacteria species could exhibit mutually inhibiting effects when
applied to plants in combination.
◦ The patentee had created a mixture of bacteria capable of inoculating the
seeds of plants belonging to several groups.
◦ Patents cannot issue for the discovery of the phenomena of nature.
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Merck & Co. v. Olin Mathieson Chemical Corp –
◦ Isolated a vitamin B12 substance from microorganisms that was
identical to the vitamin B12 found in the calf ’s liver.
◦ Because the active substance was unidentified and unknown,
no one had produced a “comparable” product to the calf ’s
liver.
◦ Compound was far more than simply a purified version of the
natural substance.
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Amgen, Inc. v. Chugai Pharmaceutical –
◦ A purified and isolated DNA sequence encoding the protein,
human erythropoietin (EPO), which stimulates the production of
red blood cells.
◦ Amgen invention did not claim “DNA sequences encoding the
erythropoietin” as previously known, but rather, “a purified and
isolated DNA sequence consisting essentially of a DNA sequence
encoding the erythropoietin.”
◦ The claimed invention was a “purified and isolated” DNA clone
versus actual DNA sequences
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A patent claim directed to an isolated and purified DNA molecule could
cover a gene excised from a natural chromosome or a synthesized DNA
molecule.
◦ An “isolated and purified” DNA molecule that has the same sequence
as a naturally occurring gene is eligible for a patent because either:
 An excised gene is eligible for a patent as a composition of matter
or as an article of manufacture because that DNA molecule does not
occur in that isolated form in nature or
 Synthetic DNA preparations are eligible for patents because their
purified state is different from the naturally occurring compound.
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Prometheus Labs., Inc. v. Mayo Collaborative Services
◦ A method for determining the most effective dosage of a drug, thiopurine,
intended to treat Crohn’s disease, an immune mediated gastrointestinal disorder.
 Determine metabolite levels of thiopurine in clinical samples taken from
patients.
◦ District Court held unpatentable because correlating drug metabolite levels with
therapeutic efficacy and toxicity was a natural body process and merely involved
necessary data-gathering steps.
◦ Federal Circuit disagreed:
 determining metabolite levels” was “transformative” because the “levels cannot
be determined by mere inspection.
 The step included growing cells.
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Myriad patent covered mutations to the BRCA1 and BRCA2
genes; use of these mutations for diagnosis and prognosis
for breast and ovarian cancer; screening for cancer
predisposition; and development of therapeutic cancer
treatments.
The plaintiffs argued that the isolated DNA and sequence for
BRCA1 and BRCA2 are “products of nature” and unpatentable
subject matter.
District Court agreed:
◦ In order to be patentable under section 101, “isolated” DNA must be
“markedly different” from naturally occurring DNA.
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District Court agreed:
◦ In order to be patentable under section 101, “isolated” DNA must be
“markedly different” from naturally occurring DNA.
◦ Because isolated DNA containing naturally occurring sequences is not
“markedly different” from the native DNA, it fell within the “product of
nature” exception to patentable subject matter under section 101.
◦ Because the “fundamental quality” of DNA consists of the physical
embodiment of biological information, the isolated DNA and naturally
occurring DNA possess the same “fundamental quality” and therefore are
not markedly different.
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Myriad method claim:
◦ comparing or analyzing gene sequences to identify the
presence of mutations corresponding to a predisposition to
breast or ovarian cancer.
District Court rejected method claims based on “machine or
transformation” test.
◦ A claimed process or method must be tied to a particular
machine or apparatus, or it transforms a particular article into
a different state or thing.
◦ Myriad method claims also did not qualify for patentability
subject matter under section 101 because claims comprising
comparisons of the BRCA sequences to determine whether a
mutation is present refer only to an “abstract mental process.”
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Federal Circuit reverses District Court:
◦ Claims covering isolated breast cancer DNA sequences are patentable
because the isolated DNA molecules are chemically cleaved from the
native DNA – markedly different characteristic.
◦ Claims covering involving comparing or analyzing gene sequences were
unpatentable because they were abstract mental processes without any
transformation steps.
◦ Court held Myriad’s for screening potential cancer therapeutics via
changes in cell growth rates of transformed cells is patentable.
◦
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Supreme Court reverses the Federal Circuit
◦ Method for comparing the relationship between the
concentration of blood metabolites and optimal dosages of
a therapeutic drug:
 Unpatentable – mere recitation of laws of nature
Supreme issues 3-step Inquiry:
◦ Is the claim drawn to a process? If yes:
◦ Does the claim focus on a natural principle? If yes:
◦ Is the claim more than a recitation of the natural principle
and instructions to “apply it”?
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On appeal, Myriad challenged the grant of standing to the 20
plaintiffs in the case:
◦ Public interest groups
◦ Patients
◦ Health insurance plaintiffs
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Declaratory Judgment
◦ Alleged or potential infringer ask the court to rule they are not liable for
patent infringement because:
 Do not infringe
 Patent is invalid or unenforceable.
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A court has jurisdiction to hear an action for declaratory
judgment only if at the time the action is filed there is an
actual controversy.
Historically, this meant that a plaintiff must have a reasonable
belief that it would be sued by a patent owner for
infringement based on actions of the plaintiff.
When multiple plaintiffs are present, the court must find at
least one plaintiff-defendant relationship that meets this
standard.
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No standing
◦ Vacation of Southern District of New York’s decision that Myriad BRCA
genes are not patentable.
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Standing
◦ Courts could face a significantly higher risk of declaratory judgment
actions by plaintiffs who have had little or no contact with the patentee
but who claim a right to invalidate the patent.
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Federal Circuit ruled that only the research of one scientist
was hampered by Myriad's patent.
Other organizations lacked standing
◦ Simply disagreeing with the existence of a patent on isolated DNA
sequences or even suffering an attenuated, non-proximate, effect from
the existence of a patent does not meet the declaratory judgment
standard
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Other parties had made no preparation to undertake
potentially infringing activities.
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The question of whether human genes and the information
they convey are patentable is of paramount importance to
the future of patent law, the advancement of medical
science and the health of patients.
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Patents on “isolated” DNA are invalid under section 101.
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The method claim upheld is inconsistent with the decision
in Mayo.
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Holding that petitioners lacked standing unless they were
personally threatened by Myriad imposed a rigid standing
requirement contrary to the Supreme Court
QUESTIONS
THANK YOU!
Angela Foster, PhD, Esq.
Law Offices of Angela Foster
2906 Birchwood Court
North Brunswick, New Jersey 08902
Telephone: 732-821-9363
Fax: 732-821-4692
fosteratlaw@aol.com