The protection
legalization of genetic sequences under patent is one of the most
controversial and problematic today.
legalization of genetic sequences under patent is one of the most
controversial and problematic today.
From the outset, the
drafting the possible patent application requires special attention,
since specific requirements are necessary in the application, such as
sequence listings, the identification and preparation of which are not immediate
for any expert in another technical field.
drafting the possible patent application requires special attention,
since specific requirements are necessary in the application, such as
sequence listings, the identification and preparation of which are not immediate
for any expert in another technical field.
In addition, the
of the patent application that defines what is to be protected, the
claims, must be drafted with exquisite care to be acceptable
by the different Patent Offices. And, unfortunately, the regulations
comply with in each country and, what is worse, the legislation that determines what
may or may not be protected under patent, differs significantly between the different
countries
of the patent application that defines what is to be protected, the
claims, must be drafted with exquisite care to be acceptable
by the different Patent Offices. And, unfortunately, the regulations
comply with in each country and, what is worse, the legislation that determines what
may or may not be protected under patent, differs significantly between the different
countries
In Europe, The
approval of the Biotechnology Directive (Directive 98/44 EEC) it seemed
solve many doubts. It established that the total or partial sequence
of a gene, isolated from the human body or obtained in another way, could
considered a patentable invention, even if its structure
(sequence) was identical to that of a natural element (gene), as long as
the patent application explicitly mentions an industrial application
for the total or partial sequence of said gene. In this way, it seemed
equate the patentability of gene sequences and the scope of
protection conferred with those of any other chemical product, and may
protected under patent as long as they met the general requirements of
Patentability: novelty, inventive activity and industrial application. At the same time, it avoided the possible
patentability of the mere sequence of a gene before its function or
usefulness, and efforts were made not to block research on them.
approval of the Biotechnology Directive (Directive 98/44 EEC) it seemed
solve many doubts. It established that the total or partial sequence
of a gene, isolated from the human body or obtained in another way, could
considered a patentable invention, even if its structure
(sequence) was identical to that of a natural element (gene), as long as
the patent application explicitly mentions an industrial application
for the total or partial sequence of said gene. In this way, it seemed
equate the patentability of gene sequences and the scope of
protection conferred with those of any other chemical product, and may
protected under patent as long as they met the general requirements of
Patentability: novelty, inventive activity and industrial application. At the same time, it avoided the possible
patentability of the mere sequence of a gene before its function or
usefulness, and efforts were made not to block research on them.
However, the
transposition of said Directive in the different countries of the European Union does not
It turned out to be very homogeneous. In some countries, for example, legislation requires
mention the application of the gene in the corresponding claim, do not
simply in the descriptive part of the request, which seemed to limit the
scope of protection granted for that gene sequence to the application
specific mentioned in the claim, without being extended to any other
possible application, as can be considered to happen with other products
protected under patent.
transposition of said Directive in the different countries of the European Union does not
It turned out to be very homogeneous. In some countries, for example, legislation requires
mention the application of the gene in the corresponding claim, do not
simply in the descriptive part of the request, which seemed to limit the
scope of protection granted for that gene sequence to the application
specific mentioned in the claim, without being extended to any other
possible application, as can be considered to happen with other products
protected under patent.
And indeed,
the interpretation in the European courts of the protection conferred by
patents based on the protection of gene sequences proved not to be
simple. In fact, she ended up being referred to the Luxembourg Court of Justice
for interpretation, who ruled that those non-biological materials
that incorporate genetic information protected by a patent, but in the
which genetic information does not perform the function described in the patent, it does not
infringe the patent. With this sentences, there are those who consider that, in Europe,
gene sequences do not really have protection equivalent to that of
any other product, but, in reality, the protection granted is limited
to a specific application: the one described in the patent application.
the interpretation in the European courts of the protection conferred by
patents based on the protection of gene sequences proved not to be
simple. In fact, she ended up being referred to the Luxembourg Court of Justice
for interpretation, who ruled that those non-biological materials
that incorporate genetic information protected by a patent, but in the
which genetic information does not perform the function described in the patent, it does not
infringe the patent. With this sentences, there are those who consider that, in Europe,
gene sequences do not really have protection equivalent to that of
any other product, but, in reality, the protection granted is limited
to a specific application: the one described in the patent application.
The situation in
USA. It is also not completely clear at present. Until not long ago,
It was considered that "isolated" natural gene sequences
(a term that had to be mentioned in the corresponding claim), and with a
utility, were patentable. However the Myriad Genetics case,
related to a breast cancer diagnostic test that supported its exclusivity
in a patent on the genes analyzed in the trial, BRCA1 and BRCA2, has
caused not only a certain insecurity about the scope of protection
conferred in the US by patents based on gene sequences but,
In addition, a strong social upheaval, with extensive rejection of patents
biotechnologies in general and on gene sequences in particular. That
Social unrest has been echoed in other countries, and has led to a rethinking of
legislation on biotechnology patents in some of them.
USA. It is also not completely clear at present. Until not long ago,
It was considered that "isolated" natural gene sequences
(a term that had to be mentioned in the corresponding claim), and with a
utility, were patentable. However the Myriad Genetics case,
related to a breast cancer diagnostic test that supported its exclusivity
in a patent on the genes analyzed in the trial, BRCA1 and BRCA2, has
caused not only a certain insecurity about the scope of protection
conferred in the US by patents based on gene sequences but,
In addition, a strong social upheaval, with extensive rejection of patents
biotechnologies in general and on gene sequences in particular. That
Social unrest has been echoed in other countries, and has led to a rethinking of
legislation on biotechnology patents in some of them.
Thus, it must
mention the lack of uniformity regarding the patentability of the elements
isolated from living beings between different countries, there being cases of
particularly strict legislation, such as those of many countries
Latin Americans, where such elements are not patentable and not even
those that can be produced by technological means, if they can be identical
to elements present in nature.
mention the lack of uniformity regarding the patentability of the elements
isolated from living beings between different countries, there being cases of
particularly strict legislation, such as those of many countries
Latin Americans, where such elements are not patentable and not even
those that can be produced by technological means, if they can be identical
to elements present in nature.
Therefore, the
lack of uniformity in legislation and difficulties in its interpretation
show that expert support is especially important when
aims to address the possible patent protection of gene sequences. A
initial advice, which allows identifying the patentability of said
sequence in the different countries that may have commercial interest for the
applicant, and constant support to meet all the requirements of a
possible application, including language that provides the broadest protection
possible in the greatest number of countries, are critical points for the future
patent holder can obtain it and obtain the performance
appropriate of it. And, once granted, adequate legal support, which
orient your defense correctly, it can be vital to maintaining it
against possible offenders who try to cause its nullity and, even, so that
the judge involved in the case can issue a fair ruling having
correctly interpreted the case before him.
lack of uniformity in legislation and difficulties in its interpretation
show that expert support is especially important when
aims to address the possible patent protection of gene sequences. A
initial advice, which allows identifying the patentability of said
sequence in the different countries that may have commercial interest for the
applicant, and constant support to meet all the requirements of a
possible application, including language that provides the broadest protection
possible in the greatest number of countries, are critical points for the future
patent holder can obtain it and obtain the performance
appropriate of it. And, once granted, adequate legal support, which
orient your defense correctly, it can be vital to maintaining it
against possible offenders who try to cause its nullity and, even, so that
the judge involved in the case can issue a fair ruling having
correctly interpreted the case before him.
