Patentability and Scope of Protection for DNA Sequence-related Inventions from Perspective of the United States of America and Europe

Author:Radoslav M. Milkov
Position:LL.B. Candidate at The Hague University of Applied Sciences (The Hague, The Netherlands)
Pages:36-52
SUMMARY

Since the mapping of the human genome and the technical innovations in the field of biotechnology, patent law has gone through great controversies. Protection is required for an investor to make an investment but how broad should the given protection be? Whether the invention is a micro-organism capable of dissolving crude oil, or the gene of a soya plant, the genetic engineering required for... (see full summary)

 
FREE EXCERPT
2013
Radoslav M. Milkov
36
4
Abstract: Since the mapping of the human
genome and the technical innovations in the field of
biotechnology, patent law has gone through great
controversies. Protection is required for an investor
to make an investment but how broad should the
given protection be? Whether the invention is a mi-
cro-organism capable of dissolving crude oil, or the
gene of a soya plant, the genetic engineering required
for their production entails vast amounts of capi-
tal. The policy in that respect is tailored by legislative
acts and judicial decisions, ensuring a fair balance be-
tween the interests of patent right holders and third
parties. However, the policy differs from jurisdiction
to jurisdiction, thus creating inconsistencies with re-
gards to the given protection to the same invention,
and as a result this could deter innovation and pro-
mote stagnation.
The most active actors shaping the patent policy on
an international level are the patent offices of the
United States of America, Japan and the European
Patent Organization. These three patent offices have
set up a cooperation programme in order to promote
and improve efficiency with regards to their patent
policies on a global scale. However, recent judicial de-
velopments have shown that the policy in respect to
the field of biotechnology differs between the patent
regimes of the United States of America and the two-
layer system of the European Patent Organisation/
the European Union.
Patentability and Scope of Protection for
DNA Sequence-Related Inventions
from the Perspective of the United
States of America and Europe
by Radoslav M. Milkov*
LL.B. Candidate at The Hague University of Applied Sciences (The Hague, The Netherlands)
© 2013 Radoslav M. Milkov
Everybody may disseminate this ar ticle by electroni c means and make it available for downlo ad under the terms and
conditions of the Digita l Peer Publishing Licence (DPPL). A copy of the license text may be obtaine d at http://nbn-resolving.
de/urn:nbn:de:00 09-dppl-v3-en8.
Recommended citation: Radoslav M. Mi lkov, Patentablility and Scope of Pr otection for DNA Sequen ce-Related Inventions
from the Perspecti ve of the United States of America and Europe, 4 (2013) JIPITEC 3 6, para. 1.
Keywords: Patent; DNA Biotechnology; Patentability Requirements; Scope of Protection; US Patent Regime; Eu-
ropean Patent Regime
A. Introduction
1
The debate regarding patents for biological material
    
in high publicity and wide media coverage in the
  1 The term biotechnology,
for the purposes of this Research Paper, should be
understood to mean “any technological application
that uses biological systems, living organisms, or
derivatives thereof, to make or modify products or
2 Moreover, biotechnology
is not a newly developed concept, but it is one of
3 The high
publicity and media coverage mentioned above
 
a wide public awareness of experimentation and
testing carried on living organisms in the name of
technological development and medical progress.
Patentability and Scope of Protection for DNA Sequence-Related Inventions
2013
37
4
2
Furthermore, this technological development and
medical progress has been facilitated through patent
systems. The “primary purpose of the patent system
is to provide incentives for the disclosure of valuable
inventions that might otherwise be kept secret. [The
society] offers a bargain: a limited period of statutory
exclusivity for the claimed invention in exchange for
full disclosure of the invention.”4
3 Additionally, without the negative monopoly rights
for industrial exploitation provided by a patent,
the majority of investors would hardly devote
any resources if there is no guarantee that their
investment would be secured in the end. This being
said, then the research and development within
     
biotechnology, would become stagnant if there was
no adequate protection.
4
Thus, these ownership rights sparked the debate
forty years ago concerning patents upon biological
material. The debate was concentrated around the
questions of whether or not “life” could be owned
or whether these negative monopoly rights could
amount to a modern form of slavery.
5
In that regard,
“many advocates have … declared deoxyribonucleic
acid [hereinafter “DNA”] to be common to the global
human heritage.”
6
However, currently it is widely
accepted that biological patents are vital for the
development of modern medicine and bioresearch,
leading to the debate’s development. “The debate
today has seen a shift in focus, from questioning the
possibility to patent … DNA-related inventions … [to
questioning] the strength of the patents and the type
of protection those inventions receive.”7
5 The purpose of this descriptive Research Paper is to
examine the patentability and scope of protection
for DNA sequence-related inventions from the
perspectives of the United States of America and
Europe. Moreover, it should be noted that the
“DNA is considered to be a chemical substance,
and consequently, the basic patent law principles
applicable to chemical inventions will equally be
applicable to DNA inventions.”8
6
In Part B of this Research Paper, the author will
examine the bio-patent policy from an international
perspective. This will be followed by a discussion
in Part C on the patent systems of both the United
States and Europe, with an emphasis upon their
respective jurisprudences concerning the patenting
of DNA material.
7 Afterwards, this Research Paper will turn in Part D

to the patentability of DNA sequences. First, it will
   
biotechnology could be categorized as inventions,
or non-patentable discoveries. This will be followed
by a discussion on the criterion of novelty in respect
to DNA sequence innovations. Afterwards, it will be
considered whether the DNA sequence patents could
inventive step/non-obviousness.
At the end of Part D, an examination on the industrial
applicability/utility for DNA sequence inventions will
be offered.
8
In Part E of this Research Paper, the author will
turn to the issue of the scope of protection for
DNA sequence-related patents and will elaborate
upon the four main types of patents: product based
patents, process based patents, use based patents
and purpose-based patents.
9
In Part F of this Research Paper, the author will
present a conclusion in light of the analysis that
has been given.
B. Introductory remarks of the
bio-patent policy from an
international perspective
10 The validity and scope of a patent depends on the
jurisdiction that grants it. This means that a patent
granted by the United States Patent and Trademark
     
within the jurisdiction of the United States. This
could have a negative impact upon the decision of an
inventor to disclose his or her invention if protection
is not provided in other jurisdictions as well.
11
 
(hereinafter “EPO”) or the World Intellectual
Property Organisation (hereinafter “WIPO”) give a
solution to this problem, through the administration
of the European Patent Convention9 (hereinafter
“EPC”) and the Patent Cooperation Treaty10,
respectively.
12 They provide the possibility to an inventor to apply
for multiple patents within the jurisdictions of their
respective Member States using a single application
form. It should be noted that these organisations
do not grant a single patent with unitary effect, but
rather a bundle of domestic patents for which the
inventor has applied.
13 There has been a discussion11 for many years about
the creation of a unitary patent for the European
Union similar to the truly regional patent of
the African Intellectual Property Organization
(hereinafter “OAPI”).12 The negotiations in that
regard culminated with the adoption of two
Regulations through enhanced cooperation,
13
and
 
Court (hereinafter “the Agreement”).
14
The ambition
behind these pivotal steps is to make the internal
market of the European Union more competitive on
the global technology scale.

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