In a landmark decision on October 18, 2011, the highest court of the European Union—the Court of Justice—decided on the patentability of stem-cell-related inventions (case number C-34/10). The dispute arose around the definition of the term "human embryo" in the European Biotechnology Directive. Based upon this decision, the Court will now apply a very broad definition, which will result in nonpatentability and invalidity of many stem-cell-related inventions in Europe. The impact on biotechnology and life sciences innovator companies will be significant.
Introduction
The patentability of inventions on "life" has long
been subject of a heated debate. Over time, European patent laws
have been amended to clarify that the use of human embryos for
industrial and commercial purposes shall not be patentable.
However, the definition of the term "human embryo"
remained unclear. In particular, questions arose as to whether and
to what extent human stem cells are covered by the term as well,
and how inventions merely using human stem cells shall be treated
with respect to patentability.
In its landmark decision, the Court of Justice has applied a broad
definition to the term "human embryo."
According to the Court, the definition shall include the fertilized
human ovum. Reaching even further, the term shall also include
artificial cell types including the ones obtained by cell nucleus
transfer from a mature human cell into a nonfertilized human ovum.
This technology was used to obtain the clone sheep
"Dolly," for instance.
The Court of Justice further ruled that not only is any
such—broadly defined—human embryo unpatentable,
but also that every invention that requires the prior destruction
of a human embryo shall not be the subject of a patent. This also
applies to inventions using stem cell lines that resulted from the
destruction of a human embryo long before the cell line was
employed for the invention.
This ruling will have a major impact on companies dealing with the
development of biomedical products and therapies based on embryonic
stem cells. It might also affect companies working with cells not
derived from the human embryo, but with a developmental potential
close to that of embryonic stem cells.
The Facts of the Underlying Case
In December 1997, the neurobiologist Prof. Oliver Brüstle
filed a patent application with the German Patent and Trademark
Office, and subsequently a patent was granted (DE 197 56 864.5).
The claims of the patent are directed to isolated and purified
precursor cells derived from embryonic stem cells with the
potential to develop into neuronal cells to be used to cure severe
diseases like Parkinson's.
With the intention to prevent life from commercialization,
Greenpeace e.V. opposed Mr. Brüstle's patent. The German
Federal Patent Court ("GFPC"), concerned with the
respective nullity suit, declared Mr. Brüstle's patent
invalid insofar as it related to procedures allowing precursor
cells to be obtained from human embryonic stem cells. The GFPC came
to the conclusion that in this regard, the patent violated Section
2(2) item 3 of the German Patent Act ("GPA"), which
stipulates that the use of human embryos for industrial or
commercial purposes is contrary to ordre public and
morality and thus shall be unpatentable.
Section 2 GPA finds its basis in Art. 6 of the European
Biotechnology Directive 98/44/EC (the "Directive"). Since
the interpretation of the German provision also required
interpretation of the underlying Directive, the German Federal
Court of Justice ("GFCJ"), to which Mr. Brüstle had
appealed, decided to stay proceedings and referred three main
questions to the Court of Justice in order to obtain a ruling on
the proper interpretation of the Directive that ensures unified
application of the Directive in all EU member states.
The Ruling of the Court of Justice
First, the Court of Justice was asked to interpret the term
"human embryo," since the Directive does not contain any
definition thereof. In its decision, the Court of Justice largely
followed the foregoing opinion of the advocate general, applying a
broad interpretation of the term "human embryo." In
particular, the Court decided that any human ovum after
fertilization, any nonfertilized human ovum into which the cell
nucleus from a mature human cell has been transplanted, and any
nonfertilized human ovum whose division and further development
have been stimulated by parthenogenesis constitute a "human
embryo."
According to the Court of Justice's interpretation, a
"human embryo" is to be assumed at "day one" of
fertilization and even includes artificial cell types, which have
not been fertilized at all. In this regard, the Court considered it
as decisive that the respective cell is capable of commencing the
process of development of a human being, and this capability
already exists from the moment of fertilization.
With regard to stem cells obtained from a human embryo at the
blastocyst stage (as in Mr. Brüstle's patent), the GFCJ
decided that it is for the referring court to ascertain, in the
light of scientific developments, whether they are capable of
commencing the process of development of a human being and,
therefore, are included within the concept of "human
embryo."
For the second question posed by the GFCJ, the Court had to examine
whether the concept of "uses of human embryos for industrial
or commercial purposes" as set out in Art. 6(2)(c) of the
Directive also covers the use of human embryos for purposes of
scientific research. In this regard, the Court outlined that the
use of human embryos for scientific research purposes is also a
form of industrial and commercial application and, therefore, falls
under the exclusion from patentability. However, the Court found
that the intention of the Directive was not to exclude the use of a
human embryo for industrial or commercial purposes where it
concerns the use for therapeutic or diagnostic purposes that are
applied to the human embryo itself and that are useful to it, for
example to correct a malformation and improve the chances of
life.
Finally, the Court of Justice dealt with the third question posed
by the GFCJ: whether an invention is unpatentable even if the use
of human embryos does not form part of the claimed invention, but
where such use is a prerequisite for practicing the invention.
Continuing to apply a strict ruling, the Court of Justice decided
that even if the claims of a patent do not recite the use of human
embryos, as long as the implementation of the invention requires
the destruction of human embryos, a patent shall not be
granted.
The fact that an invention can be based on cells that have been
obtained through the destruction of a human embryo at a stage long
before the invention was actually made (as in the case of the
Brüstle patent) was considered irrelevant. The mere fact that
the invention required an embryo to be destroyed was considered by
the Court of Justice as sufficient to deny patentability.
Resulting Consequences for Stem Cell Patents and Patent Applications
Binding for EU Member States.
The ruling of the Court of Justice is binding for the member
states of the European Union. As a result, national
stem-cell-related patent applications in the member states of the
European Union that fulfill the above-mentioned criteria will be
refused, and already granted patents may be revoked as expected for
the Brüstle patent when the German Federal Supreme Court
applies these criteria.
Nonbinding for the EPO and Non-EU Member States. Interesting
follow-up questions arise from the fact that the Court of
Justice's decision is not binding for the European Patent
Organization ("EPO") itself, since it is a supranational
organization and not formally part of the EU. It is binding only
for the member states of the European Union. Notably, not all
member states of the European Patent Convention ("EPC")
are members of the European Union (for example, Switzerland,
Norway, and Serbia). Thus, the consequences of the judgment do not
automatically apply to all states for which a European patent can
be sought.
However, even though not immediately and formally bound by the
Court of Justice's decision, it is anticipated that the EPO
examiners will follow the ruling laid down by the Court of Justice,
with effect for all countries for which patents can be applied
under the EPC. The introduction of the corresponding provision to
the EPC, i.e., Rule 28(2)(c) EPC, was done with the intent
to align the EPC rules with the Biotechnology Directive
98/44/EC.
Moreover, the EPO already had come to similar conclusions in its
Enlarged Board of Appeal decision G 2/06, in which the board had to
decide at least in part on comparable questions. In G 2/06, the EPO
decided that claims directed to products that, as described in the
application, at the filing date could be prepared exclusively by a
method necessarily involving the destruction of the human embryos
from which the said products are derived, even if that method is
not part of the claims, shall not be allowable. The Court of
Justice's decision could thus be seen as complementing and
further developing tendencies for which foundations had already
been laid by EPO case law.
Another Incentive for a Unified Patent System in
Europe. The Court of Justice's decision also
underlines that the patent system in Europe is not yet fully
harmonized. In its decision G 2/06, the Enlarged Board of Appeal on
the one hand confirmed that the EPO has no possibility to refer
legal questions to the Court of Justice of the European Union, but
on the other hand, it based its ruling on the interpretation of the
European Directive, which is the Court of Justice's primary
task to ensure a unified application of European Directives
throughout Europe.
This incongruent situation again demonstrates the advantages that a
unitary European patent system would offer, including a European
patent court and the possibility to refer legal questions to the
Court of Justice. This is of particular importance, as exemplified
by the above-referenced case wherein the Court of Justice could
have decided contrary to the EPO. This would have led to the
awkward situation of two different interpretations of similar legal
provisions within the European territory. To prevent such
situations in the future, a unified European patent system would be
desirable.
Severe Difficulties are Foreseeable in Practical
Application of the Ruling. On the scientific side, it
follows from the decision that two restrictive criteria will have
to be met for stem cell patents and patent applications. First, the
claimed invention shall not be directed to a human embryo, which
appears to be broadly defined in the Court of Justice decision by
the capability of the respective cell type to commence the process
of development of a human being. Second, an invention is excluded
from patentability where the technical teaching that is the subject
matter of the patent application requires the prior destruction of
human embryos.
Several follow-up questions could be likely to arise in the
practical application of these criteria. For example, how should an
invention be treated that is directed to cells (or their use),
wherein the cells were obtained from the human embryo at a
multi-cell stage without actually killing the embryo?
The Court of Justice came to the conclusion that for the technical
teaching of the Brüstle patent, where stem cells are taken
from the human embryo at the blastocyst stage, the embryos
necessarily have to be destroyed. However, new technologies
(developed after the filing date of the Brüstle patent) might
allow obtaining and propagating cells from the human embryo without
actually killing the embryo. Unfortunately, the Court of Justice
(and also the EPO in G 2/06) did not address this issue in detail.
However, for applications employing such
"life-sustaining" technologies, patentability should come
down to the question whether the derived cells are capable of
commencing the process of development of a human being. This core
question was not decided by the Court of Justice but was left for
the national courts to decide. Hence, the question whether a cell
derived from a human embryo that was not killed in obtaining the
cell can commence the process of development of a human being,
i.e., is a totipotent cell, has to be decided on a
case-by-case basis by a national authority.
Even if a patent application relates to stem cells obtained from
sources other than the human embryo, a similar reasoning may be
applied: As the Court of Justice has laid down a very broad
interpretation of the human embryo, including artificial cell
types, each totipotent cell, even if not derived from the human
embryo, appears to be excluded from patentability as it falls under
the broad definition of the Court of Justice. Again, according to
the Court of Justice the question whether a stem cell is in fact
totipotent shall be decided by a national court.
The fact finding and evidence will lead to difficulties;
ultimately, this would require experimental proof that a claimed
stem cell in fact develops into a human being. Thus, it may
eventually be the burden of the applicant to demonstrate that the
claimed cells are not totipotent, but only pluripotent,
i.e., only have the capability to develop into a limited
number of cell types and not into a complete human being. It
remains open how such evidence may be conclusively collected
without again compromising the fundamental principles relating to
human life upon which the Court of Justice's decision is
based.
Practical Advice for Stem Cell Patent Applicants.
As stem cell research in general aims to obtain cells that have the
capability to develop into as many different cell types as
possible, the differentiation between a totipotent cell,
i.e., a human embryo according to the Court of Justice
definition, and a pluripotent cell might become difficult. For
instance, continued progress of genetic reprogramming of cells to
more and more pluripotent cells in the case of the so-called
induced pluripotent stem cells (iPSCs) might result in totipotent
cells capable of commencing the process of development of a human
being. Also in these instances, national courts would have to
decide about the developmental potential of the claimed cells, and
in case of doubts, the burden of proof that the claimed cells do
not fall under the definition of a human embryo would be with the
applicant.
Thus, it is advisable when drafting a patent application concerning
human stem cells to include statements and maybe even experimental
data showing that the cells involved in the invention are not
capable of commencing the process of development of a human
being.
In this regard, care should be taken when drafting an inventive
step argument based on an "increased totipotency" as a
beneficial effect. This line of argument might bring the claimed
cells into or at least close to the definition of the human embryo
and thus toward unpatentable subject matter.
For inventions based on stem cells that can also be obtained from
the human embryo without ultimately destroying the embryo, it might
be problematic that the "life-sustaining" production
method is not displayed by the generated cells, as they are most
likely not distinguishable from cells obtained by a method that
requires destruction of the embryo. However, a patent might still
be obtained when the "life-sustaining" production method
is included in the claims or at least in the specification.
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.