sou · GWB320 · 2008-03-14 00:00:00 — A patent claim that protects a product covers all conceivable uses of that product. This means that the patent gives the holder the sole right to use the patented product commercially. protection is not restricted to one specific use and is therefore usually called absolute product protection. A patent for a chemical compound therefore covers all uses of the chemical compound in question. Consequently the protection is not restricted to the use or uses specified in the patent application. Patents that protect gene sequences and microorganisms can also give absolute product protection as in patent law contexts they are treated in the same way as traditional chemical compounds. It is only possible to obtain a patent for a chemical compound with absolute product protection when the invention refers to a previously unknown chemical substance. The idea behind absolute product protection is to create effective patent protection for an invention that entails making a chemical substance available to the general public for the first time. Known chemical substances can be granted product protection for new uses in methods for treatment or in diagnostic methods, but such patents are restricted to these areas of use. In prevailing patent law doctrine, use-bound product patents (also known as purpose-bound product patents) for previously unknown chemical compounds have been regarded as far too easy to circumvent. An actor who for example markets a chemical substance commercially under such circumstances would be able to traverse an alleged patent infringement by saying that the substance in question is only being marketed for other uses than are covered by the patent on the substance in question. absolute product protection implies that all use of a chemical substance falls within the patents scope of protection. However, it is possible to get a patent for an invention involving the use of a known chemical substance for another use than specified by the product patent holder in the patent application. Such patents can also be obtained by someone other than the holder of the product patent for the substance. This is on condition that the new use fulfils the patentability requirements. Utilisation of such an invention, however, requires the consent of the product patent holder. Absolute product protection constitutes a central issue as regards the scope of the patent protection for gene sequences and as regards the fears that protection in this area may be too broad- based and strong. Both the EPO and PRV apply absolute product protection for gene sequences and microorganisms. National patent legislation in , , , and , however, applies restrictions on patenting human or other naturally occurring gene sequences. In its interim report Oinskränkt produktskydd för patent på genteknikområdet (Absolute product protection for patents in the genetic technology area), SOU 2006:70, the Committee has made the assessment that should not at present aim for a tran- sition to use-bound product protection for patents on gene sequences. stated in the interim report that there was no evidence of any adverse trend in the genetic technology area due to absolute product protection. Moreover, the Committee established that it was doubtful whether use-bound product pro- tection for product patents on gene sequences would have any practical advantages over absolute product protection. The Committee considered that weakening protection for inventions in- volving gene sequences under such circumstances was not justified. During the remainder of its work the Committee has continued to follow developments in absolute product protection in the area of genetic technology. In doing this the Committee has studied the consultation responses on its interim report received by the . The continued work of the Committee has not, however, given rise to different assessment as regards the choice of product protection than that made in the interim report. A question with some association to absolute product protec- tion is the possibility of obtaining patents based on indica- tions for a specific chemical substance. In the opinion of the Committee, Section 2, fourth paragraph of the Swedish Patents Act should be clarified to ensure that the possibility of obtaining patents based on the first and the second and the following indications is clearly pointed out in the Patents Act. Ethical considerations in biotechnology Both the EPC and national legislation prohibit the granting of patents on inventions whose commercial exploitation would be contrary to public order or morality. When implementing Directive 98/44/EC on the legal protection of biotechnological inventions a non-exhaustive list of uses that shall always be considered to be contrary to public order or morality was introduced in Section 1 c, third paragraph of the Patents Act. This list includes processes for cloning human beings, processes for modifying the germ line genetic identity of human beings, the use of human embryos for industrial or commercial purposes and processes for modifying the genetic identity of animals which are likely to cause them suffering without any substantial benefit to man or animal. has primarily studied EPO case law regarding the exception from patenting on ethical grounds. Moreover, the Committee has evaluated the effects of the amendments to the Patents Act due to the implementation of Directive 98/44/EC on the legal protection of biotechnological inventions. This evaluation has had in view the protection of fundamental principles of human dignity and integrity. A further question for the Committee in this respect has been whether measures are needed to develop cooperation between the agencies concerned as regards the basis for assessing ethical issues in patent cases referring to biotechnological inventions. Case law from the EPO reflects a restrictive application of the exception from patenting on ethical grounds, which is in line with the intentions behind this exception from patenting. Develop- ments in biotechnology in recent years have, however, meant new challenges with regard to assessing whether an invention for which a patent has been applied is contrary to public order or morality. Inventions involving chimera and hybrid technology may raise complicated ethical issues in this context. The same applies to inventions involving human embryonic stem cells (for more on this, please see below). As regards the EPOs examination of patent applications with respect to the exception from patenting on ethical grounds, the EPO must ascertain what constitutes an over- all European concept of morality. As far as inventions involving human embryonic stem cells are concerned, this assessment is complicated by the fact that the EPC states have different opinions on what is ethically acceptable in patenting such inventions. The EPOs handling of an ongoing patent case concerning embryonic stem cells should therefore be monitored by the Government. The same applies to the EUs work on biotechnology involving chimeras and hybrids within the framework of the Chimbrids project. As regards the clarifications in the Patents Act resulting from the implementation of Directive 98/44/EC on the legal protection of biotechnological inventions, the Committee notes that the provisions in Section 1 b and 1 c of the Patents Act mean that the definitions for patents on inventions involving human biological material have been made clearer. The clear statement in Section 1 b of the Patents Act that the human body in its various stages of formation cannot constitute a patentable invention implies a con- crete expression of the principle of human dignity. notes, however, that patents on inventions in- volving biological material are still an ethically sensitive issue for many people. One factor that makes dealing with ethical issues concerning patenting biotechnological inventions difficult is that these inventions are very complicated to understand for non- experts in biotechnology. Additionally, patent legislation is not the easiest of things for to understand. Therefore the Committee sees a need for information to the public on biotechnology in general and the implications of the patent system. Such informa- tion creates conditions for better understanding of the pros and cons of the patent system as regards biotechnological inventions, something that is central to public confidence in the patent system. Regarding the relationship of the patent system to the principle of human dignity, there is concern that biotechnological patents give their holders over-comprehensive protection to the detriment of both the individual and society in general. In the opinion of the Committee, however, strict adherence to the fundamental patent- ability requirements is a precondition for a granted patent being compatible with the contribution of knowledge to society that the invention expresses. The development of case law shows that the EPO now applies patentability criteria to biotechnological inven- tions in an appropriate way. According to the Committee, current EPO practice, which is characterised by restrictiveness, creates the conditions for patents with a balanced scope of protection. Regarding the relationship of the patent system to respect for personal integrity, the Committee believes that the patent system constitutes only a part of a greater complex around both biotech- nological research and development and the use of biotechnological inventions, which may imply an attack on personal integrity. does not deem it appropriate or even practically possible to take measures within the framework of the patent system to prevent the risk of violations of integrity within this complex. Even though the patent system is not ethically neutral, it offers a blunt and inexpedient tool in ethical questions. A patent does not constitute a right to practise an invention. Instead a patent con- stitutes a time-limited right to prevent others from commercially using the patented invention. A decision of a patent authority to reject the patent application for a certain invention does not con- stitute a prohibition against or obstacle to commercial exploitation of the said invention. Patents on inventions that involve stem cells A stem cell is an immature cell that can be developed (differen- tiated) into a certain form of body cell, such as liver cells, bone cells, heart cells etc. The development potential of a stem cell varies. One form of stem cells, adult stem cells, occur in the human body as a store of immature cells intended to replace body cells that have been lost as a consequence of different kinds of wear and tear. These adult stem cells can develop into a limited number of body cell types. For example, there are blood stem cells that can be differentiated into all types of blood cells but not into any other type of cell, such as liver cells. Another form of stem cell is the embryonic stem cell. These stem cells have a greater development potential than adult stem cells and can be differentiated into more or less all forms of body cells. Embryonic stem cells are taken from a blastocyst, i.e. a fertilised egg cell that has been dividing for about a week. The great development potential of embryonic stem cells has made them interesting for research and there are hopes that with the help of therapies based on such stem cells it will be possible in the future to cure or alleviate serious diseases and con- ditions that are incurable today. However, the use of human embryonic stem cells raises difficult ethical questions, for example regard for human dignity. The production of such stem cells ultimately assumes the destruction of a blastocyst, which some people see as ethically unacceptable. These people have the view that, in the right circumstances, the blastocyst could have developed into a human being. At present it is mainly fertilised eggs left over from IVF treatment, i.e. artificial insemination of childless couples, that are used in research into embryonic stem cells. These eggs, which are donated to research by the man and woman, would otherwise have been destroyed. Other people, therefore, have no major objections to using donated fertilised eggs left over from IVF treatments in stem cell research in order, if possible, to develop new methods of treatment for currently incurable diseases. As far as the patent system is concerned, the question arises of how to treat patent applications for inventions involving, in some way, human embryonic stem cells. Patents may not be granted for inventions the commercial exploitation of which would be contrary to public order or morality. A particular example of inventions that shall always be regarded as contrary to public order and morality is the use of embryos for industrial or commercial purposes. notes that at European level there is at present uncertainty as to how the term use of embryos for industrial or commercial purposes is to be interpreted. All EU and EPC states are probably in agreement that inventions that require direct access to blastocysts cannot be patented due to the exception from patenting on ethical grounds. However, as a rule the inventions for which patent applications are made do not require any direct access to blastocysts, only to embryonic stem cells as such, i.e. the stem cells that the invention requires a supply of can be taken from an existing stem cell line. Some countries, among them , are of the opinion that inventions involving embryonic stem cells can be patented, if these stem cells can be taken from cell lines already existing in companies or hospitals. Other countries do not see any difference between an invention that requires a direct supply of blastocysts and inventions that are based on existing cultures of embryonic stem cells. These latter countries believe that what is crucial is that a blastocyst must unavoidably be destroyed at some earlier point in order to be able to establish the cultures of embryonic stem cells that are to supply the necessary embryonic stem cells. In its work the Committee has followed the ethical discussions concerning embryonic stem cell technology and the patent law developments in this area. A case is currently pending before , G 2/06, which takes into account the issues just mentioned. The opinion of in this case will be of major significance for future possibilities of patenting inventions involving human embryonic stem cells. According to information from the EPO a decision is expected some time during 2008. The Government should monitor the outcome of this case and thereafter come to a decision on whether there is reason to make adjustments in Swedish patent legislation. In this respect, the Committee draws the Governments attention to the fact that in the future embryonic stem cells may be extracted in other ways than at present. Alternative methods may be somatic nuclear transfer of unfertilised eggs, chimera technology, partheno- genesis technology or reprogramming of somatic cells. The experimental use exemption in patent law and patents on research tools In most European countries a patent does not hinder anyone in- vestigating or experimenting on a patented invention. This is evident from the experimental use exemption in patent law. The purpose of this exemption is to enable researchers to understand the structure of an invention and to carry out experiments aimed at ascertaining whether the invention can be improved or used in a way other than it was patented for. The experimental use exemption thus facilitates research and further development of science and technology. Research tools are inventions that are used as tools or aids in various experiments or research measures. In biotechnology, various proteins, cell lines, experimental animals etc may constitute im- portant research tools. These inventions can be patented in the same way as other inventions. The predominant view in Europe is that patented research tools must be treated in the same way as other types of inventions when applying the experimental use exemption, i.e. experiments on a patented research tool are allowed. On the other hand experiments with a patented research tool are not allowed if the use is covered by the patent. One important exception is the Belgian patent law, where the experimental use exemption covers actions both on and with a patented research tool. A fear that has been expressed in the debate on patented research tools is that the holders of such patents may prevent researchers from gaining access to research tools that are important for biotechnological, particularly biomedical, research. This could lead to serious delays in research and development of new and improved medicines, for example. At the same time the patent system is an important incentive for those who specialise in developing new and improved research tools. Without the possibility of patents it is highly likely that considerably fewer research tools would have become available to researchers. has examined whether the present formulation of the experimental use exemption constitutes a suitable balance between public and private interests and whether there is any distortion of this balance as regards patented research tools. As regards the experimental use exemption the Committee notes that the present formulation is satisfactory. Measures on but not with a patented invention is an appropriate restriction that creates conditions for continued research on the patented product while protecting justified interests, for example those of actors who develop new and improved research tools. Infringement proceedings due to alleged breaches of the pro- visions regulating the experimental use exemption in patent law are rare. The same applies to situations where someone is refused access to a patented research tool. On the basis of the studies carried out in both Europe and the the Committee can state that this is partly because the licensing system seems to work well and partly because patent holders often have no interest in taking action against infringements on the part of researchers at univer- sities and other higher education institutions. As regards the latter circumstance, researchers at universities and other higher education institutions seem to a great extent to be unaware of the content of patent law. The use of patented inventions that may be doubtful from the point of view of patent law thus seldom takes place knowingly. Patent holders are usually keen to have good relations with researchers at universities and other higher education institu- tions, and therefore they seldom have cause to intervene against these researchers use of patented inventions so long as the research is not transformed into a product that can be commercialised. One area, however, where there seems to be some lack of clarity as to whether the experimental use exemption of patent law is applicable is clinical trials with patented chemical substances. concretely, the issue concerns whether human trials using a patented chemical substance constitute an experiment on or with the sub- stance in question. In the opinion of the Committee it is important that this question is discussed and clarified at European level. Thus the Committee has not been able to establish any concrete signs that biotechnological patents are an obstacle to important basic research at universities and other higher education institu- tions. Unawareness of the patent system among researchers at universities and other higher education institutions, however, is something that should be addressed. Ignorance of the novelty requirement in patent law may mean that a researcher cannot patent a potentially valuable invention, if the researcher has published the invention in a scientific journal, for example. As far as is concerned the Committee believes that it is important that univer- sities and other higher education institutions involve intellectual property law, especially patent law, in the context of postgraduate higher education to a greater extent than today. As regards patented research tools, the Committee has not been able to find indications that researchers are denied access to such tools in such a way that the balance between private and public interests risks being upset. There are, however, fears for the future regarding whether the patent system offers effective measures to restrain abuse of patents on research tools. In the view of the Committee, certain forms of abuse can probably be prevented with the help of competition law. In certain circumstances patent law affords the possibility of applying to a court for a compulsory licence. is doubtful to what extent these provisions could be used by a researcher refused access to a patented research tool and has therefore considered proposing certain extensions to the compulsory licence provisions. However, the Committees remit only covers the biotechnology area and an extension of the compulsory licence provisions should not be made without first examining the effects of such an extension on other areas of tech- nology. The question of which situations would merit the granting of a compulsory licence should therefore preferably be dealt with as part of a wider review of patent law or as part of the framing of a Community patent system. Access to patented biotechnological inventions in research Even if the patent fundamentally implies a possibility to prevent others from exploiting an invention commercially, it is in the interest of most patent holders to grant others the right to use the inven- tion. In this context it is important that the transaction costs of granting and acquiring rights to patented biotechnological inven- tions are kept to a minimum. Otherwise the existence of a patent threatens to make continued research and development in the bio- technological area more difficult. The main instrument for granting rights to others to use a patented invention is a patent licence. Apart from this, the Committee has analysed the existence of patent pools and clearing houses in the biotechnological area. Moreover, the Committee has examined how material transfer agreements are used when transferring bio- logical material. As regards the licensing system the Committee notes that overall this works well in the biotechnological area. In 2006 the drew up guidelines for how licensing agreements in the areas of research and health and care should be drawn up with regard to genetic inventions. In the opinion of the Committee, these guidelines constitute a valuable aid, not least for universities and higher education institutions and the health care sector. As regards patent pools and clearing houses, these solutions for facilitating access to patented inventions have not as yet had much impact in the biotechnological area. This is largely because these arrangements are more complicated to use than the licensing system. Patent pools and clearing houses may also be questionable from a competition law perspective. However, it cannot be ruled out that these arrangements may come to have a greater significance in the future, since biomedical research is showing a tendency to become more complicated. In this context the Committee has noted an increased tendency among biotechnological actors to create open sources, i.e. databases with genetic information accessible to every- one, instead of patenting individual genes. This trend is probably linked to a realisation on the part of these actors that in the future biotechnology will be a matter of studying genetic networks rather than studying individual genes. As regards abuse of the exclusive right a patent confers, the Committee recalls that competition law constitutes an important control mechanism and an important complement to the com- pulsory licence provisions of patent law.