each state in which the patent was granted and for each patent granted for inven-
tions involving embryonic stem cells.
In addition to prescribing that the human body in various stages of its formation
and development cannot constitute a patentable invention, Article 5 paragraph 1 of
the Directive also prescribes that a simple discovery of one of its elements,
including the sequence or partial sequence of a gene, cannot constitute a patentable
invention. What is and what is not to be considered a simple discovery of one of the
elements of the human body according to the Directive is much clearer when
paragraph 1 is read in conjunction with paragraph 2 of Article 5, which prescribes
as follows:
An element isolated from the human body or otherwise produced by means of a technical
process, including the sequence or partial sequence of a gene, may constitute a patentable
invention, even if the structure of that element is identical to that of a natural element.^26
The simple discovery of an element of the human body, therefore, concerns only
its existence within the body as its natural environment, and it cannot be protected
by a patent.^27 However, once the element is isolated or otherwise produced by
means of a technical process, so as to exist outside of the human body, it cannot
anymore be considered a discovery but an invention eligible for patent protection. It
becomes patentable because it is a result of a technical process used to identify it,
purify it, and classify it, as well as to reproduce it outside of the human body, which
cannot be achieved in nature without human,i.e.technical, intervention.^28 The
Directive, therefore, adopted the so-called isolation of natural products theory to
distinguish between inventions and discoveries in the field of human biotechnol-
ogy.^29 Several recitals of the Directive lead to the conclusion that such approach,
which is certainly less demanding for potential patent applicants, was adopted with
the objective to give a strong incentive to research related to the application of
products of human origin in medicinal treatments.^30 On the other hand, the adoption
of such an approach was expected since it only codifies the long practice of the
European Patent Office, which would in principle grant patents for elements of
human origin isolated from their natural environment or otherwise produced by a
technical process, provided they satisfied the patentability requirements.
Article 5 paragraph 1 essentially allows the patenting of embryonic stem cells.
By applying the provision, it follows that for embryonic stem cells to be patentable
(^26) This provision is related to Article 3 paragraph 2 of the Directive, which reads: “Biological
material which is isolated from its natural environment or produced by means of a technical
process may be the subject of an invention even if it previously occurred in nature.”
(^27) See recital no. 20 of the Directive on Patents in Biotechnology.
(^28) See recital no. 20 of the Directive on Patents in Biotechnology.
(^29) Recital 34 of the Directive, however, prescribes that the Directive shall be without prejudice to
concepts of invention and discovery, as developed by national, European, or international patent
law. About the theories concerning the distinction between inventions and discoveries in the field
of human biotechnology, see Mutabžija ( 2014 ), pp. 31–41.
(^30) See recitals 17 and 18 of the Directive on Patents in Biotechnology.
62 J. Mutabžija