Italy Italie Italien. Report Q 150

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1 Italy Italie Italien Report Q 150 in the name of the Italian Group by R. SGARBI, O. CAPASSO, A. COPPO, F. MACCHETTA, G. MATTEUCCI, G. ORLANDO, R. PISTOLESI Patentability Requirements and Scope of Protection of Expressed Sequence Tags (ESTs), single Nucleotide Polymorphism (SNPs) and Entire Genomes This report expressing the opinion of the Italian Group on the above question is drawn up by making reference to the specific paragraphs of the working guidelines published in AIPPI yearbook 1999/1 1. and 2. Introduction and Legal Position This Group feels that the question should be examined on the light of the fact that, at least for the European Union countries, the Directive 98/44/EC on the legal protection of biotechnology inventions defines a framework which shall bind both the national patent offices and the national courts. Even the European Patent Office, although not directly obliged to respect the provisions of the Directive, for political reasons and for the control exerted on it by the EPC member States through the Administrative Council, will conform its procedures and jurisprudence to the Directive. Therefore, this report shall mainly consider those aspects of the question which have not been directly addressed or clearly identified and legally defined by the Directive. In this respect, it is considered that a problem that does not deserves expressing a specific position of this Group is the one regarding the patentability of nucleotide sequences or whole genes in all cases where the requisites of Article 5 in combination with recitals 22, 23 and 24 of the Directive are fully met. Said Article and recitals, in fact, establish basic cryteria for patentability of nucleotide sequences, and exclude from patentability those human body elements which are not isolated from the human body or sequences for which an industrial application is not disclosed. A space will remain open for discussion regarding the interpretation of certain terms of said Article such as "industrial application" or "technical process" to the extent that it may 1

2 lead to exclude or not from patentability certain sequences or partial sequences, for which compliance with the relative provisions is a key element. 3. Issues for patentability 3.1. Public Policy The issue of patentability of DNA sequences has recently received some consideration in Italy by both the patent authorities and the courts. The question regarding public policy that has concerned the EPO in several instances, has been faced also by the Ufficio Italiano Brevetti e Marchi (UIBM) in connection with the first patent application filed in this country for a transgenic mammalian in which an activated human oncogene sequence under the control of a liver-specific inducible promoter was inserted. On November 1992 the UIBM had requested the Commissione dei Ricorsi (Board of Appeal) to issue an opinion under the provision of paragraph 3 of Article 71 of the Italian Patent Law. The question was focussed on the provisions of Article 13, which corresponds to Article 53 EPC. The opinion of the Commissione dei Ricorsi was favourable to patentability, based essentially on the same reasons that are backing Article 6(d) of the Directive 98/44/EC. The patent was granted with No Moreover, the Court of Milan, in an order of February 10, 1997 granting a preliminary injunction held a viral DNA sequence for which an industrial application was clearly disclosed as an object of a valid patent (Il Diritto Industriale, 1997, 4,285). 3.1(a) With respect to the specific point whether patenting of ESTs, SNPs and genomes may be contrary to the "ordre public", the opinion of this group is that there is no reason for concerns that patentability of such materials may have a particular impact on the general public policy issue which may overcome the arguments developed by the EPO in the "Relaxin" case (OJEPO, 1995, 388). However, the question may be considered from some different aspects. A first one is concerning the private property issue connected with the element(s) isolated from the human body and regards specifically the person(s) from whom said element(s) is/are derived. This Group feels that this aspect may not justify raising concerns that morality or "ordre public" limits are violated, once informed consensus is obtained from the person(s) from whom the element(s) is(are) taken, according to recital 26 of the Directive 98/44/EC. 2

3 A further aspect should regard the risk that the monopoly granted to the patentee on a sequence or partial sequence of genomic DNA may determine unsustainable disadvantages or obstacles to the interest of the public. In this respect, it is observed that the Italian Patent Law, as well as the laws of many other European countries, contain provisions such as compulsory licenses and/or expropriation for public interest reasons which may constitute a safeguard against the above mentioned risk. A third aspect would regard the issue whether patentability cryteria should involve the general concepts of morality or ethics according to the customs, the religious belief, and usages of a certain country or community. The position of this Group on this issue is expressed in the following paragraph. 3.1(b) The opinion of this Group is that the patent law should not be the correct system to control that human activities, in particular, researches, do not point to targets which can be held immoral or contrary to the "ordre public". This control should be left to other legislation which may be more specific, could avail of resources that the patent offices currently do not have and could be more appropriate and apt to evaluate the effects on the "ordre public" of activities, which, inter alia, may not necessarily lead to patents. Nevertheless, it is observed that the present status of patent laws in Europe, including the provisions of the EPC and of the Directive, implies that a patent office takes into account morality and "ordre public" aspects when granting patents. Therefore, the patent offices are, in first instance, assigned the task to determine these questions. This Group is of the opinion that, when said questions are to be faced by the patent offices, they should refrain to come to a decision denying patentability, unless the question has been first submitted to a higher authority that is given the task of examining the question with a wider and more reliable knowledge and experience on social, legal, and economical issues and can perform a more complete evaluation of the specific aspects of the invention and their impact and consequences on customs and usages of the country or group of countries where it might be put into practice. 3.2 Utility With regard to the requirement of "utility", the opinion of this Group is that the requirement of industrial application of Article 5 of the Directive 98/44/EC (and, possibly, its transposition into the national law of the Community member States, either by legislation or interpretation by the judicial system) should imply that it is taken as a synonymous of utility. 3

4 This would lead to the conclusion that the mere fact that the object of the invention may be manufactured in any industry is not a sufficient reason to justify the patentability of an invention. Rather, the patent application should contain sufficient data and elements to put the expert of the field, to whom the description of the invention is directed, in the condition to reproduce and utilize the invention without undue burden. Normally, generic statements of utility, or putative uses based on theoretical speculations, or computer abstractions should not be considered as sufficient tools to comply with "utility" requirements. For instance, when for a certain nucleotide sequence it is alleged a utility (or industrial application) as probe to isolate certain genic sequences, or functional part thereof, or as encoding certain proteins or functional part thereof, said statements should be supported by enabling description, demonstrating the biological effects of such utility and identifying the function of the isolated gene or codified protein or functional part thereof. In the absence of such enabling description, the granting of a patent would represent an obstacle to research and technical development rather than a means to promote progress and scientific knowledge. 3.3 Invention ESTs or SNPs, as usually identified (i.e. DNA sequences without any factual disclosure of an industrial application) do not respond to the utility cryteria expressed above. Therefore, they should not be regarded as patentable inventions. 3.4 Novelty Most patent legislation hold an invention as novel if it is not, as such, part of the state of the art. In this respect, ESTs, SNPs or genomes, even if they are not complying with other patentability requirements, such as industrial application, may be considered to be novel, provided sufficient information is given with regard to their identification and process of obtainment. 3.4(c) To answer the question whether a prior published nucleotide sequence of a EST or SNP or a genome sequence whose function is not specified, constitutes anticipatory prior art with respect to the subsequent identification of the full length gene sequence and relative function, it may be considered that, in pure chemical terms, the full gene is a different molecular entity with respect to a partial sequence of the same gene that may have been previously disclosed. The conclusion would be that the full gene responds to the concept of novelty adopted by the EPO. It may depend on the relevance that the previously disclosed nucleotide sequence may have with respect to the specific function or utility (industrial application) of the full length gene sequence whether the full gene may respond also to the inventive step requirements. 4

5 If it is proved that the essential functional features of the full length gene sequence are not shared by or plainly derived from the prior disclosed EST, or SNP or genome sequence (i.e. the anticipatory sequence does not have a functional relevance with regard to the utility of the full gene) then, the full length gene sequence successively identified may be considered as novel and inventive. In a reverse situation where the full sequence has been previously described and a partial sequence endowed with particular characteristics is successively individuated and specifically claimed, an approach consistent with the basic principles which govern the patentability of selection inventions may be followed. 3.4(d) In this connection, it is felt that the patent offices should refrain from granting to new nucleotide sequences being part of a not yet identified full gene claims worded as "a DNA comprising the following sequence..." or equivalent language. Such claims would have a an unduly broad literal scope producing a potential overlapping with a later claim to the full gene sequence. Said formal overlapping could, in many instances, turn to be prejudicial to the patentability of the full gene sequence accompanied by an effective disclosure of its real function. In the opinion of this Group, a claim to a nucleotide sequence should be expressed and interpreted as a claim directed to a specific chemical product and, if the case may be, to its biologically equivalent derivatives and variants. The fact that the main technical effect of said nucleotide sequence is to be referred to the information content that is inherent to its chemical structure could be acknowledged by fairly applying the concept of equivalency when the real scope of the claim addressed to its chemical structure is evaluated. 3.5(a) and (b) Obviousness The standard for the appreciation of inventive step of DNA sequences such as ESTs, SNPs and genomes should respond to the same cryteria usually applied for chemical compounds. In this field, because of the limited number of the nucleotide bases, the structural originality of the molecule is even less significative than in the general field of the organic natural or synthetic substances. Therefore, originality should mainly reside in the inventivity of the utility or industrial application of the isolated sequence. For this reson, the approach followed by the EPO in the decision T939/92 (AGREVO/Triazoles, OJEPO 1996,309) should be a valid rule. Actually, the acknowledgement of inventive step of a DNA sequence would essentially depend on the characteristic functions that are connected to its chemical structure. These features should be concretely defined and represented in the patent through biological parameters and results. 5

6 A problem can be posed by the question whether such characteristics should be originally disclosed in the application or they may be added during the examination of the same or, ultimately, they may be proved even during an opposition or revocation procedure. It appears that, if the monopoly granted on a DNA sequence as a chemical entity should enjoy absolute protection, as a reward, the public should receive from the granted patent an explicit and clear indication enabling the direct evaluation of the merits of the patent and it should not become aware of the real technical features which justify the inventive step only when the patent is challenged before an opposition division or a court. Moreover, even if the stated biological effects of the invention claimed may be corroborated during the examination (or opposition/revocation) procedure by presenting further technical evidence of the inventive utility, the application, as originally filed, should contain an enabling disclosure for the identification and verification of the alleged technical effects on which the inventive step is relying (see Article 5(3) of the Directive 98/44/EC). In the field of the DNA sequences as well as in any other technological field, allowing the applicant to introduce new originally undisclosed inventive effects or to substantiate inventive utility originally asserted only in generic terms by presenting factual biological evidence at a later stage of the procedure, e.g. during the examination, this would make the filing of the original application a sort of booking the protection of an invention when it is not yet completed. This approach would not justify the absolute monopoly granted by the patent on any use of the sequence and the broad scope of protection of a patent on biological material as conferred by Article 8 and 9 of the Directive 98/44/EC. 3.6 Sufficiency There should not be a special standard for the sufficiency requirements of patents concerning ESTs, SNA and genomic DNA. The cryteria adopted for evaluating the compliance of this requirement by chemical inventions should be followed also here. The governing principle should be that the description of an invention made in a patent application should put the skilled person in the position to reproduce without undue effort all matter and technical results that are embraced by the claim(s). 3.7 Documenting DNA inventions This Group does not agree that there should be any special provision for the written description and claims directed to DNA sequences in general, including ESTs, SNPs and genomic DNA. The principles codified in Article 82 and Rule 30 of the EPC are applicable for the unity of invention and should rely on structural homology, functional and utility relationships among a plurality of the inventions claimed in the same patent application, provided the common features are clearly expressed or may be readily determined from the description. 6

7 Inventive step, sufficiency of description and unity of invention should rely on a common basic feature of the description of a patent application which is the explicit and concrete disclosure of the nature of the invention claimed and how to obtain and to use it. 3.8 Scope of protection 3.8(a) The fact that DNA inventions have a wide use as research tools does not justify any special ruling about the scope of protection of the relative claims. The experimental use exception provided by most patent laws or case law would safeguard fair experimental uses but, in no way, it should restrict the effect of the patent even if the protected invention serves exclusively for conducting research work. Therefore, in those cases where ESTs, SNPs or genomic DNA may respond to the patentability requisites, the scope of protection of the relative claims should be the same as for any other invention, in particular, chemical inventions. Equivalency concept should play an important role for the interpretation of such claims in the evaluation of alleged infringements. 3.8(b) As a consequence of the opinion given above, the protection of a new DNA sequence or a fragment thereof should be without any restriction to the specific use(s) disclosed in the patent, if this interpretation (as, indeed, it is in most countries) is the one prevailing in all cases of claims directed to chemical substances per se. New inventive industrial applications of patented DNA sequences may form the object of patents whose actual working may infringe the earlier patent. However, the working of the later patents, if representing valuable technical progress, should not be prevented by the unwillingness of the proprietor of the dominant patent to grant licenses thereon. In said cases, the compulsory licenses system for dependent patents (see, for instance Art. 54(2)(b) of the Italian Patent Law)or, even, in particularly severe cases (irrespectively of any existence of a dependent patent)where the public interest should require so, the expropriation of the right attached to the patent in a measure to meet said public interest (see, for instance, Article 60 of the above cited Italian Patent Law) may warrant against the risk that the absolute monopoly granted on a new DNA sequence turn into disadvantage for the public community. Summary Patenting of DNA sequences in the countries members of the European Union shall have the EC Directive 98/44 as a general reference framework. The report, therefore, mainly deals with those aspects of the question which are not directly addressed or clearly defined by the Directive, or which would require an interpretation of its provisions. 7

8 The interpretation of the concepts of industrial application or technical process may be, for example, still open to discussion and, therefore, difference of opinions before the national patent offices and courts might arise. Among the issues of patentability, there should not be any particular concern regarding patentability of DNA sequences isolated form the human body, in view of the provisions of the Directive. If concerns are raised in connection with the fact that the monopoly granted to the patentee on DNA sequences might determine unsustainable disadvantages or obstacles to the interest the public, this risk may be tempered by the possibility given to governments or administrative or judicial bodies to grant compulsory licences or other similar measures in those cases where said measures may be justified. The patent law is not the correct system for controlling that human activities do not pass over the limits of the ethics and affect the "ordre public". However, the present status of the patent legislation in Europe, because of the harmonization with the EPC, implies that the patent offices take into account morality and "ordre public" aspects when examining patent applications. In performing such task the patent offices should not take decisions negative to patentability unless they have received a more reliable opinion from a higher authority to which the question should be referred for a more complete and exhaustive evaluation. With regard to the industrial application requirement, it should be taken as a synonymous of utility. Accordingly, a patent on a DNA sequence should contain an enabling description on how and for which purposes the claimed invention may be used, supported by a demonstration of its biological effects. In view of this primary requirement, it is felt that ESTs or SNPs, in their usually accepted meanings, should not be patentable. To evaluate novelty of DNA sequences, the general cryteria applicable to chemical substances should be utilized. In general, a full sequence should not be denied novelty because of a prior disclosure of a part thereof. Acknowledgement of inventive step may depend on the relevance that the previously disclosed partial sequence may have with respect to the specific function or utility of the full sequence. In a reverse situation where the full sequence has been disclosed first, the patentability of a specific partial sequence endowed with particular characteristics should be evaluated by analogy with the principles which apply to selection inventions. 8

9 As the originality of a DNA sequence or fragments thereof mainly resides into their utility or industrial application, the features that define such characteristics should be concretely expressed in the patent. Even if such features may be corroborated by the filing of further experimental data during the examination of the patent application, the application as originally filed should already contain an enabling disclosure which put the expert in the field in the condition to identify and verify the alleged technical effect on which the inventivity is based. Sufficiency of disclosure and documentation of the inventions regarding DNA sequences do not deserve special treatment with respect to that applied to patenting of common chemical substances. Reproducibility of the invention within the whole extent embraced by the claims should be the governing rule. The scope of protection of claims directed to DNA sequences should be without any restriction to the use specifically disclosed in the patent if absolute protection is the one prevailing for claims directed to chemical substances. In case of new inventive industrial application(s) of DNA sequences previously claimed, the new application(s) could form the object of a dependent patent. The compulsory licences system could help in those cases where the proprietor of the dominant patent is unwilling to grant a licence at reasonable conditions and this refusal would deprive the public of the beneficial effect of the working of the dependent invention. 9