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

2013

Radoslav M. Milkov

36

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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

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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.