WORKING SESSION
Exclusions from patentability with special focus on the medical field
Peter MEIER-BECK - Presiding judge at the Bundesgerichtshof (Federal Court of Justice) - Non-patentability, in particular in the medical field
I. Under Article 53 of the European Patent Convention (EPC), European patents may not be granted for:
(a) inventions the commercial exploitation of which would be contrary to "ordre public" or morality;
(b) plant or animal varieties or essentially biological processes for the production of plants or animals;
(c) methods for treatment of the human or animal body by surgery or therapy, and diagnostic methods practised on the human or animal body.
All three of these exceptions to patentability are themselves limited in scope: Article 53(a) EPC states that exploitation is not deemed contrary merely because it is prohibited by law or regulation in some or all of the contracting states. The exception in Article 53(b) EPC does not apply to microbiological processes or the products thereof, while Article 53(c) EPC is not applicable to products, in particular substances or compositions, for use in surgical or therapeutic methods. This alone shows that it is not always easy to draw a distinction between what can and cannot be patented under Article 53 EPC. I will now go on to look in more detail at two of the exceptions, namely those governed in paragraphs (a) and (c):
II. The Bundesgerichtshof (Federal Court of Justice; BGH) was faced with the question of the scope of the exception to patentability under Article 53(a) EPC in revocation proceedings brought by Greenpeace against a patent granted to a Professor Brüstle (Xa ZR 58/07, GRUR Int. 2010, 236 – neural progenitor cells). The patent claims were directed to isolated, purified progenitor cells with neuronal or glial properties of embryonic stem cells obtained in stages of cultivation, proliferation and isolation described in more detail in the claims.
An exception to patentability reflecting that in Article 53(a) EPC is laid down in Section 2(1) of the German Patent Law (PatG) applicable in this case. The subject-matter covered is defined more specifically in Section 2(2) PatG, according to which patents may not be granted, inter alia, for:
1. processes for cloning the human being
2. processes for modifying the germ line genetic identity of human beings
3. uses of human embryos for industrial or commercial purposes.
The wording of these provisions is identical to that used in Article 6(2)(a) to (c) of the Biotech Directive, which was likewise incorporated verbatim into Rule 28(a) to (c) of the Implementing Regulations to the EPC 2000. The Bundespatentgericht (Federal Patents Court), which ruled on the case at first instance, had taken the view that the neuronal progenitor cells according to the invention were non-patentable under these provisions because human embryos had to be "consumed" to obtain them and the invention therefore concerned the use of human embryos for industrial or commercial purposes.
The BGH doubts the safety of this ruling and has therefore referred a number of questions relating to the interpretation of Article 6(2)(c) of the Biotech Directive to the European Court of Justice (ECJ) for a preliminary ruling:
(i) An invention is excluded from patentability under Article 6(2)(c) of the Directive only if it concerns human embryos.
If – as is unlikely to be the case – embryonic stem cells cannot themselves be regarded as embryos, the question arises whether blastocysts, from which such stem cells are derived and which in practice are destroyed on removal, are human embryos within the meaning of the Directive. The decisive issue is whether "embryo" covers all stages of the development of human life from fertilisation of the ovum onwards, as found by the Bundespatentgericht and also by the Enlarged Board of Appeal (EBA) of the European Patent Office in its decision G 2/06 of 25 November 2008, or whether a fertilised ovum can only be regarded as an embryo within the meaning of the Directive from a later stage of development, and if so, from which one. An argument in favour of such a temporal restriction may be that Article 6(2) of the Directive gives four examples of methods and uses which are non-patentable because commercial use of the invention would be contrary to "ordre public" or morality (ECJ judgment in Case C- 377/98 Netherlands v Parliament and Council ECR [2001] I-7079 = GRUR Int. 2001, 1043, paragraph 39). Given, however, that the time from which embryos enjoy statutory protection differs from member state to member state, there may be no shared firm legal view that the fertilised egg cell is already to be regarded as a human embryo and must therefore be protected. An argument against a restriction of the exception is that there is nothing in the Directive to support the specification of a later point in time as the beginning of embryo protection. Rather, recital 16 emphasises the need to safeguard human dignity and integrity, albeit in a different context, declaring it important therefore to reaffirm the principle that the human body is non-patentable at all stages of its formation and development.
(ii) The next question is whether the use of embryos or stem cells in scientific research constitutes use "for industrial or commercial purposes" within the meaning of Article 6(2)(c) of the Directive.
Unlike the other three examples of excluded uses given in Article 6(2) of the Directive, indent (c) excludes only uses for those purposes from patentability. It cannot be inferred unequivocally from the wording whether the provision is intended merely to reiterate the principle, referred to in recital 14 to the Directive and also reflected in Article 6(1), that a patent only confers rights in respect of industrial and commercial activity, or whether the range of activities excluded from patentability under Article 6(2)(c) is narrower still. Irrespective of the wording, the legislative history indicates that the exception to patentability under Article 6(2)(c) is not intended to exclude all uses of human embryos which would be patentable under the generally applicable rules. Whilst an earlier draft provided for the non-patentability of "methods in which human embryos are used" (proposal of 29.8.1997, COM/97/0446 final, OJ 1997 C 311, p. 12), this was amended in later proposals to prescribe an exclusion of uses of human embryos for industrial or commercial purposes (Common Position (EC) No. 19/98 of 26.2.1998, OJ 1998 C 110, p. 17). At the same time, recital 42 was inserted to show that the exception to patentability was by no means intended to apply to inventions for therapeutic or diagnostic purposes which are applied to the human embryo and are useful to it. However, not even this gives a clear answer to the question whether only the use of human embryos for therapeutic and diagnostic applications is patentable - which, given the non-patentability of methods for treatment of the human body and of diagnostic methods practised on the human body, applicable to both German and European patents (Section 2a(1) No. 2 PatG; Article 53(c) EPC), would in any event have little practical effect - or whether a patent may also be granted for the use of an invention for the purposes of scientific research. It may therefore be significant that not all member states prohibit the obtaining of embryonic stem cells for research where this entails the destruction of "superfluous" embryos, i.e. those generated by extracorporeal fertilisation but not required for pregnancy, as contrary to "ordre public". The words "for industrial or commercial purposes" may therefore be intended to leave scope for these different ethical viewpoints and so restrict the exception in Article 6(2)(c) of the Directive in a stricter sense to inventions the use of which goes hand in hand with trading or an industrial use of human embryos, acts considered morally reprehensible in accordance with a firm legal view generally held in Europe.
(iii) Finally, the question arises whether there is a use of human embryos within the meaning of Article 6(2)(c) of the Directive even where the use of embryos is not part of the technical teaching claimed in the patent, but merely a prerequisite for its application.
The EBA has held that Rule 28(c) EPC also prohibits the patenting of claims directed to products which, at the time the application was filed, could only be prepared by a method necessarily involving the destruction of the human embryos used to obtain the products, even if that method is not included in the claims.
In contrast to the case ruled on by the EBA, the Brüstle patent entails a series of additional steps between the destruction of embryos and application of the claimed teaching, because the patent does not claim embryonic stem cells but rather progenitor cells derived from them and two methods of deriving them. This raises the question whether such an indirect connection is sufficient to find that human embryos are used within the meaning of Article 6(2)(c) of the Directive.
An argument against such an interpretation of Article 6(2)(c) of the Directive may be that it would ultimately widen the scope of the exception to patentability applying to the use of human embryos for industrial or commercial purposes to include the use of embryonic stem cells, with the result that inventions whose exploitation is not deemed contrary to "ordre public" and so is permitted under the law of one or more member states would be rendered non-patentable. Although the use of embryonic stem cells presupposes the prior use of embryos to obtain stem cell lines, a different legal and ethical view may be taken of each stage. Indeed, such differing views can be found in the German law on the protection of embryos (ESchG) and the German law on stem cells: whilst section 2(1) ESchG prohibits and criminalises the use of human embryos created extracorporeally for a purpose not serving their preservation, and so for the purpose of obtaining stem cells as such, the law on stem cells nevertheless permits the use of stem cell lines created in this way (outside Germany and before the statutory deadline) for authorised research purposes in certain, narrowly-defined circumstances. Similar distinctions presumably exist in other member states' legislation. Similarly, the Commission has found research projects whereby human embryos are destroyed with a view to obtaining stem cells to be ineligible for subsidies, but not excluded subsequent research using human embryo stem cells from Community funding. The law makes similar distinctions in various areas, where it differentiates between prohibited acts and use of the "fruit of the forbidden tree".
III. The purpose of Article 53(c) EPC is to protect doctors' freedom of therapy. Doctors treating the human or animal body are not to be impeded by patents in pursuing the appropriate treatment indicated by their diagnosis. However, given the possibility of substance protection, which was already permitted under Article 52(4), second sentence, EPC 1973, there are limits to this freedom. The scope of substance protection has been widened by Article 54(5) EPC, according to which paragraphs (2) and (3) do not exclude the patentability of any substance or composition referred to in paragraph (4) for any specific use in a method referred to in Article 53(c) EPC, provided such use is not comprised in the state of the art.
This raises the question how "specific use" is to be construed for the purposes of Article 54(5) EPC; or in other words: how far does the exception to patentability for therapeutic methods reach, given that patents may be granted for substances and compositions for specific use in methods referred to in Article 53(c) EPC? Does this mean that any therapeutic method can be patented as long as it encompasses a substance which can be used as a pharmaceutical and the claim is worded as a product claim limited to a specific purpose of the active agent used, or is patentability restricted to a new indication - however that term is to be defined?
An important starting point in answering this question may be that the contracting states chose to guarantee the patentability of second medical indications in the form of purpose-limited substance protection. Where a substance is to be patented for specific use in a therapeutic method, a fiction is created that it is novel. The very recourse to a legal fiction shows that this fictional aspect need not actually reflect reality. Nevertheless, such a fiction becomes less plausible the further the fictional aspect is removed from the typical reality of the situation concerned. The protection of the first medical indication is thus a good illustration of an appropriate fiction: although the substance being used in therapy for the first time is not in itself novel, the strict requirements to be met in pharmacology, medicine and law by such first use of a substance as a medicinal product justify treating it in the same way as subject-matter unknown in the state of the art. A fiction of novelty is not so self-evident, but nonetheless plausible, where the active agent is described for the first time as a medicinal product for treating a disease never before treated by that means. Then too, the active agent can be deemed a substance of a particular make-up which is unknown in the state of the art and characterised as a substance by its suitability for treating a specific disease. However, the more its use becomes lost in the specifics of the therapy and/or dosage, the more implausible any legal fiction that it is novel will become.
There is nothing apparent in the legislative history of the EPC revision to suggest that the contracting states wished to create an "unlimited fiction of novelty". They wished to make it possible to obtain patent protection for second (and subsequent) medical indications, but not for new uses of known medical substances generally. Irrespective of whether they were justified, the EBA's misgivings in decision G 1/83 as to use claims of German origin are likewise incompatible with an all too broad interpretation of the term "specific use", given that the concerns were raised precisely against the grant of use patents based on merely reworded method claims.
The wording and the legislative history therefore support the view that "specific use" is to be understood to mean a new medical indication. It is beyond the scope of this paper to examine how "indication" must be defined in this context, and no such definition will be attempted here. However, there appears to be a need to discuss whether really any change in the dosage of a medicament is sufficient to establish a new indication.