Sea change on stem cell patenting in Europe
A European Union directive banning the patenting of inventions whose commercialization violates public order or "morality" has been used to invalidate a patent involving human embryonic stem cells. Greenpeace was the challenger to a patent held by Dr. Oliver Bruestle of the University of Bonn.
One notes that Greenpeace does NOT oppose research involving human embryonic stem cells, but does oppose the commercialization of the human body. Thus, it was NOT a religious position that "did in" the embryonic stem cell patents in Europe. However, note the Reuters post EU court bars stem cell patents when embryos destroyed, Christians hail ruling , including the text: In March, Advocate General Yves Bot handed down a legal opinion, which the ECJ effectively upheld on Tuesday. [18 Oct 2011]
IPBiz notes that, back in the days of California's Proposition 71, proponents for the stem cell bond issue argued that European scientists were getting the jump on American scientists. The intellectual property landscape is now significantly different. So, embryonic stem cell advocates have moved from "the Europeans are eating our lunch" to "the Europeans aren't helping us make lunch," without wondering if they are at the wrong deli.
From the judgment:
In the light of the foregoing considerations, the answer to the first question is that:
– any human ovum after fertilisation, any non-fertilised human ovum into which the cell nucleus from a mature human cell has been transplanted and any non-fertilised human ovum whose division and further development have been stimulated by parthenogenesis constitute a ‘human embryo’ within the meaning of Article 6(2)(c) of the Directive;
– it is for the referring court to ascertain, in the light of scientific developments, whether a stem cell obtained from a human embryo at the blastocyst stage constitutes a ‘human embryo’ within the meaning of Article 6(2)(c) of the Directive.
The second question
39 By its second question, the referring court asks whether the concept of ‘uses of human embryos for industrial or commercial purposes’ within the meaning of Article 6(2)(c) of the Directive also covers the use of human embryos for purposes of scientific research.
40 In that regard, it must be pointed out that the purpose of the Directive is not to regulate the use of human embryos in the context of scientific research. It is limited to the patentability of biotechnological inventions.
41 With regard, therefore, solely to the determination of whether the exclusion from patentability concerning the use of human embryos for industrial or commercial purposes also covers the use of human embryos for purposes of scientific research or whether scientific research entailing the use of human embryos can access the protection of patent law, clearly the grant of a patent implies, in principle, its industrial or commercial application.
42 That interpretation is supported by recital 14 in the preamble to the Directive. By stating that a patent for invention ‘entitles [its holder] to prohibit third parties from exploiting it for industrial and commercial purposes’, it indicates that the rights attaching to a patent are, in principle, connected with acts of an industrial or commercial nature.
43 Although the aim of scientific research must be distinguished from industrial or commercial purposes, the use of human embryos for the purposes of research which constitutes the subject-matter of a patent application cannot be separated from the patent itself and the rights attaching to it.
44 The clarification in recital 42 in the preamble to the Directive, that the exclusion from patentability set out in Article 6(2)(c) of the Directive ‘does not affect inventions for therapeutic or diagnostic purposes which are applied to the human embryo and are useful to it’ also confirms that the use of human embryos for purposes of scientific research which is the subject-matter of a patent application cannot be distinguished from industrial and commercial use and, thus, avoid exclusion from patentability.
45 That interpretation is, in any event, identical to that adopted by the Enlarged Board of Appeal of the European Patent Office regarding Rule 28(c) of the Implementing Regulations to the CGEP, which uses precisely the same wording as Article 6(2)(c) of the Directive (see decision of 25 November 2008, G 2/06, Official Journal EPO, May 2009, p. 306, paragraphs 25 to 27).
46 The answer to the second question is therefore that the exclusion from patentability concerning the use of human embryos for industrial or commercial purposes in Article 6(2)(c) of the Directive also covers use for purposes of scientific research, only use for therapeutic or diagnostic purposes which are applied to the human embryo and are useful to it being patentable.
The third question
47 By its third question, the referring court asks the Court, in essence, whether an invention is unpatentable even though its purpose is not the use of human embryos, where it concerns a product whose production necessitates the prior destruction of human embryos or a process for which requires a base material obtained by destruction of human embryos.
48 It is raised in a case concerning the patentability of an invention involving the production of neural precursor cells, which presupposes the use of stem cells obtained from a human embryo at the blastocyst stage. It is apparent from the observations presented to the Court that the removal of a stem cell from a human embryo at the blastocyst stage entails the destruction of that embryo.
49 Accordingly, on the same grounds as those set out in paragraphs 32 to 35 above, an invention must be regarded as unpatentable, even if the claims of the patent do not concern the use of human embryos, where the implementation of the invention requires the destruction of human embryos. In that case too, the view must be taken that there is use of human embryos within the meaning of Article 6(2)(c) of the Directive. The fact that destruction may occur at a stage long before the implementation of the invention, as in the case of the production of embryonic stem cells from a lineage of stem cells the mere production of which implied the destruction of human embryos is, in that regard, irrelevant.
50 Not to include in the scope of the exclusion from patentability set out in Article 6(2)(c) of the Directive technical teaching claimed, on the ground that it does not refer to the use, implying their prior destruction, of human embryos would make the provision concerned redundant by allowing a patent applicant to avoid its application by skilful drafting of the claim.
51 Again, the Enlarged Board of Appeal of the European Patent Office reached the same conclusion when asked about the interpretation of Rule 28(c) of the Implementing Regulations to the CGEP, the wording of which is identical to that of Article 6(2)(c) of the Directive (see decision of 25 November 2008, paragraph 22, referred to in paragraph 45 above).
52 The answer to the third question is therefore that Article 6(2)(c) of the Directive excludes an invention from patentability where the technical teaching which is the subject-matter of the patent application requires the prior destruction of human embryos or their use as base material, whatever the stage at which that takes place and even if the description of the technical teaching claimed does not refer to the use of human embryos.
One notes that Greenpeace does NOT oppose research involving human embryonic stem cells, but does oppose the commercialization of the human body. Thus, it was NOT a religious position that "did in" the embryonic stem cell patents in Europe. However, note the Reuters post EU court bars stem cell patents when embryos destroyed, Christians hail ruling , including the text: In March, Advocate General Yves Bot handed down a legal opinion, which the ECJ effectively upheld on Tuesday. [18 Oct 2011]
IPBiz notes that, back in the days of California's Proposition 71, proponents for the stem cell bond issue argued that European scientists were getting the jump on American scientists. The intellectual property landscape is now significantly different. So, embryonic stem cell advocates have moved from "the Europeans are eating our lunch" to "the Europeans aren't helping us make lunch," without wondering if they are at the wrong deli.
From the judgment:
In the light of the foregoing considerations, the answer to the first question is that:
– any human ovum after fertilisation, any non-fertilised human ovum into which the cell nucleus from a mature human cell has been transplanted and any non-fertilised human ovum whose division and further development have been stimulated by parthenogenesis constitute a ‘human embryo’ within the meaning of Article 6(2)(c) of the Directive;
– it is for the referring court to ascertain, in the light of scientific developments, whether a stem cell obtained from a human embryo at the blastocyst stage constitutes a ‘human embryo’ within the meaning of Article 6(2)(c) of the Directive.
The second question
39 By its second question, the referring court asks whether the concept of ‘uses of human embryos for industrial or commercial purposes’ within the meaning of Article 6(2)(c) of the Directive also covers the use of human embryos for purposes of scientific research.
40 In that regard, it must be pointed out that the purpose of the Directive is not to regulate the use of human embryos in the context of scientific research. It is limited to the patentability of biotechnological inventions.
41 With regard, therefore, solely to the determination of whether the exclusion from patentability concerning the use of human embryos for industrial or commercial purposes also covers the use of human embryos for purposes of scientific research or whether scientific research entailing the use of human embryos can access the protection of patent law, clearly the grant of a patent implies, in principle, its industrial or commercial application.
42 That interpretation is supported by recital 14 in the preamble to the Directive. By stating that a patent for invention ‘entitles [its holder] to prohibit third parties from exploiting it for industrial and commercial purposes’, it indicates that the rights attaching to a patent are, in principle, connected with acts of an industrial or commercial nature.
43 Although the aim of scientific research must be distinguished from industrial or commercial purposes, the use of human embryos for the purposes of research which constitutes the subject-matter of a patent application cannot be separated from the patent itself and the rights attaching to it.
44 The clarification in recital 42 in the preamble to the Directive, that the exclusion from patentability set out in Article 6(2)(c) of the Directive ‘does not affect inventions for therapeutic or diagnostic purposes which are applied to the human embryo and are useful to it’ also confirms that the use of human embryos for purposes of scientific research which is the subject-matter of a patent application cannot be distinguished from industrial and commercial use and, thus, avoid exclusion from patentability.
45 That interpretation is, in any event, identical to that adopted by the Enlarged Board of Appeal of the European Patent Office regarding Rule 28(c) of the Implementing Regulations to the CGEP, which uses precisely the same wording as Article 6(2)(c) of the Directive (see decision of 25 November 2008, G 2/06, Official Journal EPO, May 2009, p. 306, paragraphs 25 to 27).
46 The answer to the second question is therefore that the exclusion from patentability concerning the use of human embryos for industrial or commercial purposes in Article 6(2)(c) of the Directive also covers use for purposes of scientific research, only use for therapeutic or diagnostic purposes which are applied to the human embryo and are useful to it being patentable.
The third question
47 By its third question, the referring court asks the Court, in essence, whether an invention is unpatentable even though its purpose is not the use of human embryos, where it concerns a product whose production necessitates the prior destruction of human embryos or a process for which requires a base material obtained by destruction of human embryos.
48 It is raised in a case concerning the patentability of an invention involving the production of neural precursor cells, which presupposes the use of stem cells obtained from a human embryo at the blastocyst stage. It is apparent from the observations presented to the Court that the removal of a stem cell from a human embryo at the blastocyst stage entails the destruction of that embryo.
49 Accordingly, on the same grounds as those set out in paragraphs 32 to 35 above, an invention must be regarded as unpatentable, even if the claims of the patent do not concern the use of human embryos, where the implementation of the invention requires the destruction of human embryos. In that case too, the view must be taken that there is use of human embryos within the meaning of Article 6(2)(c) of the Directive. The fact that destruction may occur at a stage long before the implementation of the invention, as in the case of the production of embryonic stem cells from a lineage of stem cells the mere production of which implied the destruction of human embryos is, in that regard, irrelevant.
50 Not to include in the scope of the exclusion from patentability set out in Article 6(2)(c) of the Directive technical teaching claimed, on the ground that it does not refer to the use, implying their prior destruction, of human embryos would make the provision concerned redundant by allowing a patent applicant to avoid its application by skilful drafting of the claim.
51 Again, the Enlarged Board of Appeal of the European Patent Office reached the same conclusion when asked about the interpretation of Rule 28(c) of the Implementing Regulations to the CGEP, the wording of which is identical to that of Article 6(2)(c) of the Directive (see decision of 25 November 2008, paragraph 22, referred to in paragraph 45 above).
52 The answer to the third question is therefore that Article 6(2)(c) of the Directive excludes an invention from patentability where the technical teaching which is the subject-matter of the patent application requires the prior destruction of human embryos or their use as base material, whatever the stage at which that takes place and even if the description of the technical teaching claimed does not refer to the use of human embryos.
posted by Lawrence B. Ebert at 4:24 AM
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