Ahmad Fazmi Bin Zainuddin

300198177


What is patent? It can be describe as permission that is given to its owner the
authorization to protect the invention from taken or copied by others in a period of time [1].
Usually the invention patent will be protected for 20 years from the day it was file for
patented [1]. Besides that, a patent is a reward given by the government in exchange for
their agreement to teach the public or share the details of their inventions to other people.
It is always believe that patent is the same as trade secrets [2]. However, the difference is,
patented invention should be taught to other people around the world on how to create and
use new creation, which will give the creator with a benefit in financial aspect from his or
her commercialisation of invention [2]. There are patent agencies such as European patent
Office, US Patent, Trademark Office is agencies which examine and awarded the patents to
the applicants. They ensure the inventions fulfil the standards for patentability. An owner for
the invention that has been patent is protected by negative right which in other words the
person who is the owner will have the authorization to prevent those who trying to take
advantage on the claimed invention without approval [1]. He or she can use authorities to
prevent those who taking advantage on the invention and may get harm from the people
who violate it [1]. In spite of that, patent is just like any other property right, which it may
be sold, licensed, mortgaged, assigned or transferred, given away, or simply abandoned[1].

So, how about gene patent? Can we patent gene? It is a misnomer to call gene
patent as gene in the body cannot be patented. Natural genes cannot be patents as it does
not provide the owner the rights on our genes [3]. Yet, artificial preparations of DNA
molecules are. This is because the DNA molecules have been altered. Human genes
undergoes sequenced and taken out from human bodies. The genes then carefully isolated
and altered to have new functions. Currently, human gene patents are product from the
cloning and differentiation of the sequence of a gene, the role or function of which is easily
accepted. Since 1980s, as a result of cloning and sequencing capabilities developed, there is
growing number in gene patent [4].

Should genes patentable? Latest on the news, Federal Court of Australia has decided
that Myriad Genetics Inc has the right to claim patent related to BRCA1 gene [5]. This is the
first case handle by the Australian court on the patentability of isolated DNA or RNA
sequences. In US, Europe and several other countries, the gene patenting is allowed if meet
the relevant legal criteria [4]. Still, legal and moral justification is not similar. Eventhough it is
legal precedent and procedure, it is still possible for a legal decision to be immoral. It is
argued that the human gene patentable is immoral as it is similar to own other rights. Thus,
patenting the gene seems to be a very controversial issue. We have already noted that one
of the benefits for patenting the invention is that knowledge and idea of the new inventions
should be shared with the other people [1]. This will give others to developed further
inventions and more new ideas to improve the current invention. As we can see, most of the
inventions are possible to create a new invention that may have similar functions, yet it is
portrayed in a different way. This is called inventing around [6].

For a gene patenting, the concept of inventing around is hard to apply as it may have
no other alternatives to the naturally-occurring DNA sequences. For an example, if you are
going to do a diagnostic test, any of the test that is associated with a disease, you will still
need the sequence of the normal gene to compare the mutation that cause the disease.
Besides that, if patented gene has link it with the product produce from the gene, any of the
test done by others, need to have licence from the owner of the patent [6]. This creates a
monopoly by the patent holder. Patenting of gene which claims along with the diagnostic
test, causing restriction to others to use the same diagnostic test or nearly same test on the
gene at least for few years [6,7] . It has been found, few research in US has been inhibited as
a result of patent of genes. This causing inhibition of innovation for new cure rather than
stimulate a new invention [4,6,7,]. Besides that, patent owner also has the exclusive right to
all the subsequence effect of the gene if they patent on the test for the gene. For an
example, if the gene were found to link with cancer, kidney disease, heart disease, the right
of the owner would extend to the entire diagnostic test for the patented gene [6]. Besides,
when gene is patented, there may be an increasing the cost of research, as we have to pay
royalty or more licences required before research can be conducted [6] . In addition, it will
be a slow process for researches to start on their research as they have to negotiate or ask
permission to do research on patented genes. This causes the owner of the gene patented to
gain maximum financial benefits as he may become demand for it [6, 7]. Such restriction can
increase patient burden and costs. On what had happen latest, a biotech firm name Myriad
Genome has been granted to patents the BRCA1 and BRCA2 genes which those genes are
linked to ovarian cancer [8, 9]. Myriad has used this patent to legally blocking other
companies from deploying similar tests [8]. Thus it can be said that there are many cons if
gene is patented. They may inhibit innovation and development.

On the other hand, although it is always thought that gene patent has many negative
values, lets look on the positive side. Gene patent which specific on the diagnostic tests
actually is one way of government shows their appreciation and rewarding the inventors [1].
As return, they provide new ideas for the others to develop the alternative tests. Besides, it
is one way to motivate other people to invent new things. Other than that, when patent of
the gene is protected, research will greatly supported by the investor as they are more
trusted. More funds can be achieved to use on the research by the owner of the gene
patented [9].

Thus, there are many pros and cons on gene patent. Should genes be patentable?
Lots of consideration should be taken before taking any decision. Wise judgement on long
term effect and short term effect must be considered. I personally think that the relevant
bodies that responsible to give the right for patenting, should monitor the impact of the
Guidelines on the examination of patents. This is to ensure that the criterion for utility is
applied. Other than that, give consideration to limit the scope for the product patented.
Besides, any product patents from the gene patented should seldom be permissible. If
permissible, it should be narrowly defined only to the product described. In other words, the
relevant bodies limit the scope of gene patent, where it concerns only the sequences, and
not the derivation of the sequence itself.
References
1. ^ WIPO Intellectual Property Handbook: Policy, Law and Use. Chapter 2: Fields of
Intellectual Property Protection WIPO 2008
2. Article 27.1. of the TRIPs Agreement.
3. http://www.biotech-now.org/public-policy/patently-biotech/2011/06/debunking-
the-myth-your-genes-are-patented#
4. http://www.actionbioscience.org/genomic/crg.html
5. http://www.bloomberg.com/news/2013-03-04/myriad-genetics-win-on-gene-
patent-ownership-is-appealed.html
6. http://www.nuffieldbioethics.org/patenting-dna
7. http://clinicalgenetics.blogspot.com/2011/07/gene-patents-pros-and-cons-
again.html
8. http://www.nature.com/news/the-great-gene-patent-debate-1.11044
9. http://www.dailytech.com/Twenty+Percent+of+Human+Genome+is+Patented+ACLU
+Battle+to+Determine+Legality/article17489.htm