A.

The Myriad Genetic Case

1. Myriad Genetics spearheaded the discovery of the accurate location and sequence of
the BRCA1 and BRCA2 genes. Mutations of these genes greatly contribute to higher
risk of breast and ovarian cancer. Not only the company was able to isolate the genes,
but also create a complementary DNA, which allowed them to conduct tests in
assessing the cancer risks of patients. Myriad Genetics secured approved patents and
for 20 years, the company had exclusive rights and control of the technology. At
another time, it came to the attention of the company that the patented BRCA testing
was also being done by the Genetic Diagnostic Laboratory (GLD) of University of
Pennsylvania. So, patent infringement was filed by Myriad Genetics, which halted the
operations of GDL. Later on, Dr. Harry Ostrer, as well as other doctors and patients,
filed a case, which invalidates the patents, against Myriad Genetics.

2. a. “The DNA code that tells a cell to produce the string of BRCA1 amino acids set
forth in SEQ ID NO:2 [which identifies 1,864 amino acids found in a typical BRCA1
gene sequence].”

b. “An isolated DNA having at least 15 nucleotides of the DNA of” the above claim.
c. “The cDNA nucleotide sequence listed in SEQ ID No:1, which codes for the
typical BRCA1 gene.”
d. Isolated cDNA having at least 15 nucleotides of the cDNA sequence in the above
claim.

3. Segmented DNA cannot be considered patentable simply because, it is naturally

occurring, which is against the rules on patenting. Moreover, the segments contain
relevant sequence of nucleotides, not a specific molecule with a certain chemical
composition.

4. cDNA is considered patentable because it is not naturally occurring in which the

noncoding regions are removed, making it a technological and at the same time, a
synthetic creation.

5. The “method patent” cannot be granted to Myriad Genetics for the very reason that
the process of BRCA isolation is already widely used in the scientific world. It means
that there is nothing novel to the technology being done so a patent is not approvable.

6. The Federal District Court gave its judgement invalidating the patents of Myriad
Genetics for using products of nature. Nevertheless, US Supreme Court had given
patents to the cDNAs for BRCA 1 and BRCA2 genes for being synthetically created
DNAs.
B. Mayer Paper
1. Tissue Culture was easily adopted in developing countries because, it is a low-cost
technology that has a quick return on investment due to its direct impact on
production.

2. Genetic engineering involves practices of incorporating foreign genes to different

varieties of a species or into various species. It plays a vital role in the patenting of
plant varieties. There are issues that came up regarding the concern in EPO where
patents that produce multiple genetically modified varieties were allowed. But it was
concluded by the EPO that the said patents can be allowed if and only if they are not
limited to a single variety.

3. Yes, it is possible, but a permission from PBR must be considered before registering
since, it does not make a new variety if it is only an introduced gene.

4. Material Transfer Agreements, MTA, is a mechanism for the transferring of tangible

property in countries with inappropriate IPR. The main purpose of MTA is that, it is
used by international centers, for example, to secure permits in utilizing technologies.
Commercialization of new technology developed using the “borrowed” technology is
accepted but it depends on what the agreement is.

5. No. The lack of proper funding of technological use in research is sounder to be

consider the culprit. In addition, other novel and useful technologies are readily
accessible using internet.

6. Freedom to Operate, FTO, involves determining whether a particular action, such as

testing or commercializing a product, can be done without infringing valid intellectual
property rights of others. It dictates different jurisdictions of where you want to
operate. For instance, you acquire a novel variety of watermelon seed, which you
want to commercialize in your region. You should consider first if there are
established patents and plant variety rights, trademarks or other IP rights covering the
seed, the process used to make it or the way you wish to market it. Luckily, if there
are none, you have the complete freedom to operate.

7. The IP regime can hinder the use of agricultural biotechnologies since they can
monopolize the technologies which will later cause higher cost. This will be a
problem for the farmers because it will be difficult for them to pay high priced
technologies or simply it will become unaffordable. On the other hand, researchers do
not hinder the use of agricultural biotechnologies since, they are the ones looking for
more ways on how the farmers can use and utilize the product of biotechnology in
low cost. They are the ones doing researchers and projects that helps the farmers in
producing higher yields.
 C. Ethical Framework Assessment
Stakeholder Respect for

Well-being Autonomy/ Justice

independence/ freedom

Treated organism  Inserted genes NA NA

have no negative
contribution to the
organism and its
well-being

Producers a. a. a.
a) Farmers  Increases farmer’s  Engages farmers  Presence of weak
income to the dilemma policies and laws
 Requires less labor of using GM in trading which
 Minimizes corn or the is the root of
chemicals used conventional injustice
one
b. b.
b) Technolog b.
y owners  Works in a  Protected by PVP
controlled  NA laws
environment

Consumers  undergoes food  Provides choice  Scientific

safety tests whether buy researches which
GM corn or the presents the
conventional safety of the GM
one corn
 Offers lower
value

Biota/environment  Credible sources  Provides and  Sustains biotic

stating no evident maintains population
harm to the biodiversity
environment
 Requires less land
area
 Improves shelf-life
 The land used is
chemical free

Conclusion: Yes, GM corn is ethically acceptable but with reservations. This may be due to the
fact that it is a GMO and other products of biotechnology are still in the deliberations and
assessment. Nevertheless, farmers are already planting it and they can clearly experience and
testify to its potential in terms of cost, income, economic capacity, and return of investment.