Amended proposal for a European Parliament and Council Directive on the legal protection of biotechnological inventions
COMMISSION OF THE EUROPEAN COMMUNITIES Brussels, 29. 08. 1997 COM(97) 446 final 95/ 0350 (COD) Amended proposal for a EUROPEAN PARLIAMENT AND COUNCIL DIRECTIVE on the legal protection of biotechnological inventions (presented by the Commission pursuant to Article 189 a (2) of the EC-Treaty) EXPLANATORY MEMORANDUM GENERAL COMMENTS In February 1996, the Commission presented to European Parliament and the Council a new proposal for a Directive on the legal protection of biotechnological inventions. 1 The Economic and Social Committee adopted its opinion regarding this proposal on 11 July 1996. 2 European Parliament adopted 66 amendments at its first reading of the proposal during its plenary part-session of 14-18 July 1997. 3 These amendments reflect European Parliament's concerns regarding the need (a) to clarify the difference between discoveries and inventions where the patentability of elements of human origin is concerned and (b) to introduce an ethical dimension into the proposal for a Directive. In this respect, this amended proposal takes account of all of European Parliament's amendments. There is only one amendment, amendment 76, which the Commission is unable to accept. This proposed the introduction of an Article 8a. The first paragraph of this amendment required a patent application for an invention consisting of biological material of animal or plant origin to indicate the geographical place of origin of the material in question and to provide evidence that the material had been used in accordance with the legal access and export provisions in force in the place of origin. The second paragraph required that, if the biological material was of human origin, the patent application should publish the name and address of the person of origin or his or her legal representative and also provide evidence that the material had been used and the patent applied for with the agreement of the person of origin or of his or her legal representative. The first paragraph of this amendment goes beyond the international commitments which the Community and its Member States have entered into in approving and ratifying the Convention on Biological Diversity of 5 June 1992. 4 Moreover, the second paragraph does not meet the requirements governing the protection of personal data. 5 1 OJ No C 296, 8. 10. 1996, p. 4. 2 OJ NO C 295, 7. 10. 1996, p. 11. 3 Not yet published. 4 Council Decision of 25 October 1993 concerning the conclusion of the Convention on Biological Diversity, OJNo L 309, 13. 12. 1993, p. 1. 5 Directive 95/46/EC of the European Parliament and of the Council of 24 October 1995 on the protection of individuals with regard to the processing of personal data and on the free movement of such data, OJ No L 281, 23. 11. 1995. COMMENTS ON THE RECITALS From a general point of view The table below indicates the numbers of the recitals into which the amendments adopted by Parliament have been incorporated. Recitals 3 4 8a 9a 9b 9c 11 13 14 14a 14b 15 16 16a-e 16f 16g 17 17a 17b 17c 18 19 19a 19b-c 20 22 23 24 24a 24b 25 30 32 33 34 35 36 37 38 Amendments 2 3 5 6 7 8 9 11 12 13 1 14 15 16 17 99 and 79 18 19 20 21 22 23 24 26 27 80 30 31 new 10 and 33 34 35 new 36 37 38 39 40,41,42,43,68,77 44 From an individual point of view All the amendments to the recitals have been incorporated in full, except as far as the following aspects are concerned: Recital 13 incorporates amendment 11. Its middle section has been slightly reworded in order to align it on the wording of Article 5(1). Recital 14a incorporates amendment 13. The beginning has been slightly reworded in order to take better account of the need to finance research against rare or so-called orphan diseases. Recital 15 incorporates amendment 14. It has been slightly reworded at the end because it is the rights conferred by a patent and not the patent itself which are concerned. Recital 16b incorporates amendment 16b. It has been slightly reworded in order to make it clearer that it is a DNA sequence's lack of biological function which makes it unpatentable. Recital 16f incorporates amendment 17. It has been slightly reworded in order to align it on point 2. 4. of Opinion No 8 of the Group of Advisers on the Ethical Implications of Biotechnology. Recital 16g summarises amendments 79 and 99 in the light of the consequences of Article 28(1 )(a) of the TRIPs Agreement. Recital 17 incorporates amendment 18, with one slight change: the word "practicability" has been replaced by "application". Recital 19 incorporates amendment 23. Its wording has been amended to make it legally more certain. Recital 19c incorporates the second part of amendment 26. The final clause has been left out because there is nothing to prevent the patent on a product, e. g. a medicinal product, whose commercial exploitation has been authorised from being annulled if a judge finds that one of the conditions for its patentability is not met. Annulment of the patent does not involve withdrawal of the authorisation to exploit the product commercially. The two procedures are independent of each other. Recital 22 incorporates amendment 80. The end has been slightly reworded in order to avoid any incorrect scientific interpretation which would be inconsistent with the amendment's purpose. Recital 23 incorporates amendment 30. The wording has been amended following the deletion of recital 21 by amendment 28 because recital 23 is linked to it. Recital 24a is new. It refers to the definition of human reproductive cloning contained in Opinion No 9 of the Group of Advisers on the Ethical Implications of Biotechnology. At the same time, it incorporates what was intended by amendment 55, paragraph 2(bb). This subparagraph better explains why the patentability of human reproductive cloning is to be ruled out. In view of the need for proper drafting, any redundant information should be avoided in the operative part of the Directive and the explanation should be incorporated into the recitals. Recital 24b is a summary of amendments 10 and 33. Recital 32 has been given a new wording. It is aligned on the wording of Article 31(l)(i) of the TRIPs Agreement in view of the fact that amendment 67 expressly introduces a reference to the rights and obligations arising out of that agreement, inter alia, in Article 1 (2) of the proposal for a Directive. Recital 35 incorporates amendment 38. The words "because otherwise patenting would be precluded on the grounds of lack of novelty of the invention" have been left out for the sake of clarity and in order to avoid any incorrect technical interpretation. Recital 37 summarises amendments 40, 41, 42, 43, 68 and 77. Some of these amendments proposed introducing complete quotations of articles from the Convention on Biological Diversity. It would appear more appropriate, in view of the fact that recital 40 states that this Directive does not affect the rights and obligations of Member States arising from international agreements, and that amendment 67, cited above, also refers to this Convention, to refer globally to the Council Decision of 25 October 1993 concerning the conclusion of the Convention on Biological Diversity. COMMENTS ON THE INDIVIDUAL ARTICLES Article 1(2) incorporates amendment 67. Article 2 incorporates amendment 48, paragraphs 2, 4, 5 and 6. Article 3 incorporates amendment 48, paragraphs 1 and 3. Amendment 48 has been divided into two articles for the sake of clarity. Article 4 incorporates amendment 47. Paragraph 2 of this Article has been amended in the same way as recital 17, amended by amendment 18. The word "practicability" is replaced by "application". Article 5 incorporates amendments 100 and 49. It corresponds to the former Article 3 Articles 4, 5, 6, 7 and 8 have been deleted in accordance with amendments 50. 51. 52. 5"* and 54 respectively. This is basically because they have been incorporated into Article 2, 3 and 4 of the amended proposal. Article 6 incorporates amendment 55. It corresponds to the former Article 9. It should be noted that the word "publication" bus not been included in paragraph 1. The paragraph is thus consistent with Article 27(2) of the TRIPs Agreement. Paragraph 2(bb) of the amendment is not incorporated as such into Article 6. See the explanation given regarding the new recital 24a. Article 7 incorporates amendment 78. As the Commission announced during the plenary debate, it considers that, in the context of the request for proposals to be formulated on the composition and terms of reference of an ethics committee before the Directive enters into force, its Group of Advisers on the Ethical Implications of Biotechnology should be In so doing, the Commission will take account of Parliaments made competent. Resolution B4-0484/97 of 13 June 1997 on the terms of reference of the Group of Advisers on the Ethical Implications of Biotechnology. Article 8(1) is unchanged. It corresponds to the former Article 10. Article 8(2) incorporates amendment 57. It corresponds to the former Article 11. Article 9 is inspired by amendment 58. However, the reference in this amendment to Article 2a(l) (i. e. Article 4(1) of the amended proposal) is technically and legally incomprehensible in the light of Article 11 of the proposal, which introduces a derogation for farmers, and Article 12, which provides for a system of compulsory cross-licensing where a patent dominates a plant variety. It would therefore not be appropriate to include this reference because, in practice, this would limit the scope of protection conferred by a patent in such a way as to go against current practice under patent law. Article 10 is unchanged. It corresponds to the former Article 12. Article 11 incorporates amendment 59. It corresponds to the former Article 13. It should be noted that amendment 95, which aimed to amend paragraph 2 of this Article, gives rise to a number of practical difficulties. The reference to Article 14(1) and (3) of Regulation No 2100/94 is incomplete. Those two paragraphs cannot function without paragraph 2 because it that would render meaningless the idea that the derogation provided for in Article 11 is in accordance with the provisions on plant varieties. Moreover, farmers might be confronted with different legal situations. This would not be desirable. The final sentence of amendment 95 repeats the final sentence of amendment 59. However, this applies to plants what is specifically laid down for animals, which would not be appropriate. Article 12(1) and (2) remain unchanged. They correspond to the former Article 14. Article 12(3)(b) incorporates amendment 60, in accordance with Article 31(l)(i) of the TRIPs Agreement. Article 12(4) incorporates amendment 61. Article 13 is unchanged. It corresponds to the former Article Î5. Article 14 is unchanged. It corresponds to the former Article 16. Article 17 of the initial proposal is deleted in accordance with amendment 62. Article 15(1) incorporates amendment 63. It corresponds to the former Article 18. Article 16 is new. It corresponds to amendment 64. Articles 17 and 18 are unchanged. They correspond to the former Articles 19 and 20 respectively. Amended proposal for a EUROPEAN PARLIAMENT AND COUNCIL DIRECTIVE on the legal protection of biotcchnological inventions THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION, Initial proposal Amended proposal Having regard to the Treaty establishing Unchanged the European Community, and in particular Article 100a thereof, Having regard to the proposal from the Unchanged Commission,1 Having regard Economic and Social Committee,2 to the Opinion of the Unchanged Acting in accordance with the procedure Unchanged laid down in Article 189b of the Treaty,3 (1) Unchanged (2) Unchanged arc (1) Whereas biotechnology and genetic an playing engineering increasingly important role in a broad range of industries and the protection biotechnological inventions will certainly be of fundamental the industrial Community's development; importance for of research (2) Whereas the investments required in development, and particularly for genetic engineering, are especially high and especially of risky recouping that investment can only be guaranteed effectively through adequate legal protection; possibility and the and (3) Whereas without effective throughout harmonised protection such Member States the investments might well not be made; (3) 1 OJ No C 296, 8. 10. 1996, p. 4. 2 OJ No C 295, 7. 10. 1996, p. 11. 3 European Parliament Opinion of Whereas effective and harmonised protection throughout the Member to States maintain and encourage investment in the field of biotechnology; is essential in order Initial proposal Amended proposal (4) Whereas following a for the European Parliament's rejection of the joint text, approved by the Conciliation Committee, European Parliament and Council Directive of legal the on the biotechnological European Parliament the Council have determined that the legal protection of biotechnological inventions cannot be left as it currently stands; protection inventions,1 and (4. ) a for Whereas following the European Parliament's rejection of the joint text, approved by the Conciliation Committee, European Parliament and Council Directive on of the the biotechnological European the Parliament Council have determined that the legal protection of biotechnological inventions requires clarification: protection inventions, and Êegai (5) Unchanged (5) Whereas differences exist in the legal protection of biotechnological inventions offered by the laws and the Member States; practices of whereas such differences could create barriers to trade and to the creation and proper functioning of the internal market; (6) Unchanged (7) Unchanged (6) Whereas such differences in legal could well become protection greater as Member States adopt new and and administrative practices, or as national case-law interpreting such legislation develops differently; legislation different (7) Whereas the legal protection uncoordinated development of national laws on the of biotechnological inventions in the the Community could result creation of new disincentives to trade, the industrial development of such smooth inventions and of operation of the internal market; the detriment of the in to OJ No C 68, 20. 3. 1995, p. 26. Initial proposal Amended proposal (8) Whereas the legal protection of biotechnological inventions does not necessitate the creation of a separate body of law in place of the rules of national patent law; whereas the rules of national patent law remain the essential basis for the of biotechnological inventions; whereas, however, they must be in certain adapted or added specific respects in order to take full technological of developments involving biological material which also the fulfil requirements for patentability; protection account legal to (8) Unchanged the in such cases as (8a) Whereas exclusion from patentability of plant and animal varieties and of essentially biological processes for and the production of plants concepts certain animals, in upon national based laws plant patent international variety conventions have created uncertainty regarding the protection of biotechnological and certain inventions; microbiological whereas harmonisation is necessary to clarify the said uncertainty; and Initial proposai Amended proposal in national concepts (9) Whereas harmonisation of the laws of the Member States is necessary to clarify laws certain originating in certain international patent and plant variety conventions which have led to some uncertainty as to the possibility of protecting biotechnological inventions concerning plant matter certain microbiological inventions, concepts such as the exclusion from patentability of plant and animal varieties and of essentially biological processes for the production of plants and animals; and (9) Deleted (9a) and of Having regard to the potential of the development of biotechnology environment for in the this utility the particular technology for the development of methods of cultivation which are less polluting and more economical in their use of land; whereas the patent system should be used to encourage research into, and the application of, such procedures; 10 Initial proposal Amended proposal (9b) Having regard to the importance of the development of biotechnology to developing countries, both in the field of health and combating major epidemics and endemic diseases and in that of combating hunger in the patent the world; whereas system should likewise be used to encourage research in these fields; whereas international procedures such the dissemination of for technology in the Third World and to the benefit of the population be groups promoted; concerned should (9c) Whereas the TRIPs Agreement signed by the European Community and the Member States has entered into force and provides that patent protection shall be guaranteed for products and processes in all areas of technology; 11 Initial proposal Amended proposal (10) Whereas to the Community's legal framework for the protection of biotechnological inventions can be laying down certain limited principles as they apply to the patentability of biological material as such - such principles being intended, in particular, to determine the difference between inventions and discoveries with regard to the patentability of certain elements of human origin - and can be further limited to defining the scope of the protection accorded by a patent on a biotechnological invention, to the right to use a deposit mechanism in addition to written descriptions, to a reversal of the burden of proof and to obtaining non-exclusive compulsory licences interdependence in between and varieties inventions; respect of plant option the of the that from authorise exploiting (11) Whereas a patent for invention does holder to not implement invention, but merely entitles him to prohibit third parties for it industrial commercial and purposes; whereas, consequently, substantive patent law cannot serve to call into question national and Community law on the monitoring of research and of the use or commercialisation of its results, notably from the point of view of the requirements of public health, safety, environmental protection, animal welfare, the preservation of genetic diversity and compliance with certain ethical standards; (10) Unchanged the that from authorise exploiting (11) Whereas a patent for invention does to holder not implement invention, but merely entities him to prohibit third it parties for industrial commercial and puiposes; whereas, consequently, substantive patent law cannot serve to replace or render superfluous nationals European or international law which may impose restrictions or prohibitions or which concerns the monitoring of research and of the use or commercialisation of its results, notably from the point of view of the requirements of public health, safety, animal welfare, the preservation of genetic diversity and compliance with certain ethical standards; 12 (12) (13) (14) Initial proposal Amended proposal (12) Unchanged no Whereas exclusion exists European patent Convention) which a priori biological matter; prohibition or in national or (Munich precludes of patentability law the (13) Whereas it should be specified that knowledge relating to the human body and to its elements in their natural state falls within the realm of scientific discovery and may not, therefore, be regarded as patentable inventions; whereas it follows from this that substantive patent law is not capable of prejudicing the basic ethical principle all ownership of human beings; excluding or dignity fundamental Whereas patent law must respect principles the safeguarding and the integrity of the person; whereas it is important to assert the principle that the human body, at any stage in its formation development, including germ cells, and the simple discovery of one of its elements or one of its products, including the sequence or partial sequence of a human gene, cannot be patented: whereas these principles are in line with the criteria of patentability proper to patent law, whereby a mere discovery cannot be patented; the body, Whereas significant progress in the treatment of diseases has already been made thanks to medicinal products derived and/or otherwise isolated produced from elements from and human medicinal products resulting from at processes technical obtaining in elements structure to those existing naturally in the human body and whereas, consequently, the patent system should promote research aimed at such obtaining elements valuable to medicinal production; aimed similar isolating and the body, Whereas significant progress in the treatment of diseases has already to medicinal thanks been made products derived or otherwise isolated produced from elements from and human medicinal products resulting from a at process technical obtaining in elements structure to those existing naturally in the human body and whereas, consequently, the patent system should promote research aimed at obtaining such elements; aimed similar (14) 13 Initial proposal Amended proposal (14a) Whereas, since the patent system provides insufficient incentive for and research financing into biotechnological production of medicines which are needed to combat rare or 'orphan' diseases, the Community and the Member States have a duty to respond adequately to this problem; (14b) Having regard to Opinion No 8 by the of the European the Group of Advisers on Ethical Biotechnology Commission; Implications to (15) Whereas, therefore, is capable of it should be made clear that an invention based on an element isolated from the human body or otherwise produced by means of a technical process, which industrial application, is not excluded from patentability, the structure of that element is identical to that of a natural element, while the rights conferred by the patent do not extend to the human body and their natural in elements its environment; even where that an it should be (15) Whereas, therefore, invention made clear capable of industrial application and based on an element isolated from the human body or otherwise produced by means of a technical process is patentable, even where the structure of that element is that of a natural identical element, since no patent may be interpreted as covering an element of the human body in its natural environment the basic forming subject of the invention. to 14 Initial proposal Amended proposal (16) (16) Whereas such an element isolated from the human body or otherwise produced may not be regarded as unpatentable in the same way as an element of the human body in its natural state, that is to say, may not. be equated with a discovery, since the element isolated is the result of the technical processes used to identify, purify and classify it and to reproduce it outside the human body, techniques which human beings alone are capable of putting into practice and which Nature is incapable of accomplishing by itself; Whereas such an element isolated from the human body or otherwise produced is not excluded from patentability as it is, for example, the result of the technical process used to identify, purify and classify it and to reproduce it outside the human body, techniques which human beings alone are capable of into practice and which putting of is Nature accomplishing by itself; incapable (16a) (16b) (16c) the discussion on the Whereas patentability of sequences or partial sequences of genes is controversial; whereas, this according Directive, the granting of a patent for inventions which concern such sequences or partial sequences require the same criteria to be applied as in all other areas of technology; to Whereas a mere sequence of DNA segments without indication of a biological function does not contain a technical teaching and is therefore not a patentable invention; Whereas a sequence or partial sequence can be the subject of a patentable invention when all the necessary conditions for a patent are satisfied: novelty, level of invention and industrial application; 15 Initial proposal Amended proposal to for the criterion of (16d) Whereas industrial be application complied with, the genetic sequence or partial sequence and thus also the protein for which a DNA sequence codes must be determined; whereas for sequences which overlap, each sequence will be considered as an independent sequence in patent law terms; (16e) Whereas of the the requirements for disclosure industrial application of the sequences or partial sequences do not differ from those in other areas of technology; industrial whereas at application must actually disclosed in the patent application; least an be (16f) Whereas the free and informed consent of the person from whose body material is taken is required in order for an application to be made for a patent in respect of the use of that material; (16g) Whereas this Directive in no way affects the basis of current patent law, according to which a patent may be granted for any new application of a patented product; 16 Initial proposal Amended proposal (17) Whereas, in order to determine the extent to which piant and animr. 1 varieties are to be excluded from patentability, it should be specified those the exclusion concerns that varieties that, and consequently, it does not prejudice the patentability of plants or animals obtained by means of a process at least one stage of which is essentially microbiological, irrespective of the basic biological material to which that process is applied; such as (17) Whereas this Directive shall be without prejudice to the exclusion of plant and animal varieties from patentability; whereas on the other hand inventions which concern plants or animals are in general ppovided the patentable application of the invention is not technically confined to a single plant or animal variety; that (17a) Whereas the concept 'plant variety' is defined by the law protecting new varieties, pursuant to which a variety is defined by its whole genome and therefore possesses individuality; whereas it is clearly distinguishable from other varieties; (17b) Whereas a plant totality which is characterised by a particular gene (and not its whole genome) is not covered by the protection of new therefore not is varieties and excluded from patentability even if it comprises plant varieties; 17 Initial proposa! Amended proposal (17c) in only shall Whereas, however, if an invention consists genetically modifying a particular plant variety, it from if the genetic patentability even is the result not of modification genetic a breeding engineering procedure; excluded but be of (18) for the Whereas a procedure breeding of plants and animals is essentially biological if it is based on crossing whole genomes (with subsequent selection and perhaps further crossing of whole genomes); (19) Whereas this Directive shall be without prejudice to concepts of invention as developed by national, European or international patent laws; discovery, and (18) Whereas, to for patent the purposes of is it determining whether or not essentially possible biological processes for obtaining plants or animals, human intervention and the effects of that intervention on the result obtained must be taken into account; (19) Whereas national patent laws for inventions contain provisions as to the criteria for allowing or excluding patentability, including provisions to the effect that a patent may not be granted inventions respect of whose publication or exploitation would be contrary to public policy or morality; in (19a) Whereas this Directive shall be without prejudice to the provisions of national patent law whereby treatment surgical or therapeutic procedures applicable to the human body or the bodies of animals and diagnostic procedures which are carried out on the human body or the bodies of animals are excluded from patentability; 18 Initial proposal Amended proposal (19b) Whereas the TRIPs Agreement the possibility that provides for the World Trade members of from Organisation may exclude inventions whose patentability commercial exploitation within their territory must be prevented in order to protect public policy or morality, to protect human or animal life or health, to preserve plants or to prevent serious harm to the environment, provided is not that such an exclusion because undertaken exploitation is prohibited by their legislation; including solely (19c) Whereas other prohibitions on exploitation under national law are exclude not to sufficient patentability; whereas an such the that exclusion presupposes the commercial exploitation of invention the in is prohibited Member State in question; (20) Whereas such a reference to public policy should be and morality included in the operative part of this Directive in order to bring out the fact that of biotechnological inventions, by virtue of some of their consequences or effects, are capable of offending against them; applications some (20) W7hereas the principle whereby inventions must be excluded from their patentability commercial offends against public policy or morality must also be stressed this Directive; where exploitation in 19 Initial proposai Amended proposal (21) Deleted (21) Whereas it must be determined whether applications offend against public policy and morality in each specific case, by means of an appraisal of the values involved, whereby the benefit to be derived the invention, on the one from is weighed and evaluated hand, against associated therewith, and any objections based on fundamental principles of law, on the other hand; risks any list (22) Whereas the operative part of this Directive should also include an illustrative inventions excluded from patentability so as to provide national courts and patent offices with a general guide to inteqsreting the reference to public policy or morality; of of list (22) Whereas the operative part of this Directive should also include an illustrative inventions excluded from patentability so as to provide national courts and patent offices with a general guide to interpreting the reference to public policy and morality; whereas this list be exhaustive; whereas processes the use of which offend against human to dignity, produce chimeras from a mixture of human and animal genomes, are also excluded from patentability; such as processes presume cannot to 20 Initial proposal Amended proposal Whereas morality represents the ethical or moral principles generally in a Member State or observed the scientific or accepted by professional concerned; circles whereas it is particularly important that these principles be respected in the field of biotechnology in view of the potential scope of inventions in this field and inherent living matter; relationship whereas such ethical or moral principles supplement the standard law of legal regardless of the technical field of the invention; checks patent their to a is consensus Whereas in the European Union that there interventions in the human germ line and the cloning of human beings offends against public policy and morality; whereas it is therefore important to exclude unequivocally from patentability methods for intervention in the germ line of human beings and processes for cloning human beings; (23) (24) inventions (23) Whereas such moral considerations must be given greater weight in appraising the patentability of inventions, both biotechnological on account of the subject-matter of this branch of science, namely living matter, and because of the often far-reaching implications of the to be examined; whereas these considerations do not, however, change the nature of patent law as a primarily technical body of law and are no substitute for the other legal checks which biotechnological are required to undergo from the start of the their development or at marketing stage, particularly with regard to safety; inventions (24) Whereas, in view of the importance and the controversial nature of the unprecedented questions raised by germ is important to exclude unequivocally from patentability methods of treatment of human beings based on it; line gene therapy, it 21 Initial proposal Amended proposai is consensus (24a) Whereas in the European Union there that a interventions in the human germ line and the cloning of human beings offends against public policy and morality; whereas it is therefore important to exclude unequivocally from patentability methods for intervention in the germ line of human beings and processes for cloning human beings; 22 Initial proposal Amended proposal of the Freedoms application of (24b) Whereas this Directive does not affect the Convention on Human Rights and 4 Fundamental November 1950, the Convention for the protection of human rights and the dignity of the human person with to applications of biology and medicine: Convention on human rights and biomedicine of 19 November 1996, or any other international instrument concerning the protection of human rights on the Member States have which cooperated or to which they have acceded; respect (25) Whereas processes for modifying the genetic identity of animals which are likely to cause them suffering or physical handicaps without any substantial benefit to man or animal, and also animals resulting from such processes must from patentability be excluded insofar as the suffering or physical handicaps inflicted on the animals concerned are out of proportion to the objective pursued; (25) Whereas processes for modifying the genetic identity of animals which are likely to cause them suffering without any substantial medical (diagnostic or therapeutic) benefit to man or animal, and also animals such processes, must be excluded from patentability; resulting from 23 Initial proposal Amended proposal (26) Unchanged (27) Unchanged an exclusive and (26) Whereas, in view of the fact that the function of a patent is to reward the inventor for his creative efforts by but granting time-bound thereby right, encourage inventive activities, the holder of the patent should be entitled the use of patented self-reproducible material in situations analogous to those where it would be permitted to prohibit such use of patented, non-self-reproducible products, namely in respect of the production of the patented product itself; to prohibit (27) Whereas it is necessary to provide for a first derogation from the rights of the holder of the patent when the propagating material incorporating the protected invention is sold to a farmer for farming purposes by the holder of the patent or with his initial consent; whereas derogation must the farmer to use the product of his harvest for further multiplication or farm; propagation on his own whereas the conditions of that derogation must be limited in accordance with the extent and conditions set out in Council (EC) No 2100/94;i that authorise Regulation extent and the (28) Whereas only the fee envisaged under Community plant variety rights as a condition for applying the derogation from Community plant variety rights can be required of the farmer; (28) Unchanged OJNoL227, 1. 9. 1994, p. 1. 24 Initial proposal Amended proposal Unchanged (29) Whereas, however, the holder of the (29) patent may defend his rights against a farmer abusing the derogation or the breeder who has against variety developed plant incorporating protected invention if the latter fails to adhere to his commitments; the the (30) Whereas a second derogation from the rights of the holder of the patent must authorise the farmer to use the protected for breeding purposes on his own farm, in order to replenish their numbers; livestock (30) Whereas a second derogation from the rights of the holder of the patent must authorise the farmer to use the protected livestock for agricultural purposes; (31 ) Unchanged (31) Whereas of the and extent that the second conditions derogation may be determined by and national practices, no Community legislation on animal variety rights; regulations is there laws, since new plant access must, Whereas, in the field of exploitation of characteristics resulting from genetic engineering, guaranteed on payment of a fee, be granted in the form of a compulsory licence where, in relation to the genus or species concerned, the plant variety technical significant represents progress of considerable economic interest compared to the invention claimed in the patent; (32) new plant access must, (32) Whereas, in the field of exploitation of characteristics resulting from genetic engineering, guaranteed on payment of a fee, be granted in a Member State in the form of a compulsory in relation to the genus or species concerned, public interest demands the exploitation of the plant variety for which the licence is requested and the plant variety represents significant technical progress; licence where, 25 Initial proposal Amended proposal guaranteed (33) Whereas, in the field of the use of new plant characteristics resulting from new plant varieties in genetic engineering, access against a fee must be granted in the form of a compulsory licence where the public exploitation of the invention for which the licence is requested and represents invention where significant technical progress, demands interest the (33) Whereas, in the field of the use of new plant characteristics resulting from new plant varieties in genetic engineering, access against a fee must be granted in the form of a compulsory licence where the invention represents significant technical progress of considerable economic interest; guaranteed (34) Whereas the TRIPs Agreement contains detailed provisions on the burden of proof which are binding on all Member States; whereas, therefore, a provision this Directive is not necessary; in (35) Whereas the Commission will investigate whether, in the field of basic genetic engineering research, scientific free and unimpeded exchanges are hampered because publications containing information which might be patentable are delayed or not undertaken, as a result of which patentability would be excluded because of the lack of novelty on the part of the inventor; whereas the Commission will carry out a comparison with the patent law of the United States and Japan in this respect and report to the European Parliament the Council two years after the entry into force of this Directive; and 26 Initial proposal Amended proposal (36) Whereas the Commission will report [annually] to the European Parliament on the development of field of patent biotechnology genetic engineering; the and law in (37) Whereas the rights and obligations of the Member States derived from international agreements, particularly further to the Council Decision of 25 October 1993 on the conclusion of the Convention on Biological Diversity,1 and Articles 3, 8(j), 16(2), second sentence, and on 16(5) of Biological of 5 June 1992, are not affected by this Directive; the Convention Diversity 1 OJ No L 309,13. 12. 1993, p. 1. 27 Initial proposal Amended proposal a the develop (38) Whereas the Third Conference of the Parties of the Biodiversity Convention , which took place in November 1996, noted in Decision HI/17 that 'further work is required to help common relationship appreciation of between intellectual property rights and the relevant provisions of the the TRIPs Agreement and Convention Biological on Diversity, in particular on issues relating to technology transfer and conservation and sustainable use of biological diversity and the fair and equitable sharing of benefits arising out of the use of genetic resources, of including knowledge, and practices of indigenous and local communities embodying traditional lifestyles the relevant conservation and sustainable use of biological diversity'; protection innovations the for 28 Initial proposal Amended proposal HAVE ADOPTED THIS DIRECTIVE: HAVE ADOPTED THIS DIRECTIVE: CHAPTER I Patentability Article 1 shall 1. Member States protect biotechnological inventions under national patent if necessary, adjust their national patent law to take account of the provisions of this Directive. law. Member States shall, CHAPTER I Patentability Article 1 1. Unchanged 2. This Directive shall be without prejudice to national and Community laws on the monitoring of research and of the use or commercialisation of its results. 2. This Directive shall be without prejudice to the obligations of the Member States pursuant to international agreements, and in particular the Convention on Biological Diversity and the TRIPs Agreement. Article 2 Article 2 For the purposes of this Directive, 1. For the purposes of this Directive, Biological material means any genetic containing material of information and self-reproduction being reproduced in a biological system; capable of or Microbiological process means any process involving or performed upon or resulting in microbiological material; a process consisting of a succession of steps shall be treated as a microbiological process if at the least one essential step of process is microbiological; (a) (b) Biological material means any genetic containing material and information of reproducing being itself reproduced in a biological system; capable or Microbiological process means any process involving or performed upon or resulting in microbiological material. 29 Initial proposai Amended proposa! Essentially biological process for the production of plants or animals means any process which, taken as a whole, exists in nature or is not more than a natural plant-breeding or animal-breeding process. 2. A procedure for the breeding of plants or animals shall be defined as essentially biological if it is based on crossing and selection. 3. The concept plant variety is defined by Article 5 of Regulation (EC) No 2100/94. Article 3 the purposes of are this Directive, 1. For imply novel, inventions which inventive activity and are capable of industrial application shall be patentable even if they concern a product consisting of or containing biological material or a procedure by means of which biological material is produced, processed or used. 2. Biological material which is isolated from its natural environment or processed by means of a technical process may be the subject of an invention even if it already occurred in nature. Article 4 1. The following shall not be patentable: (a) (b) plant and animal varieties, essentially biological procedures for the breeding of plants and animals. 2. Inventions which concern plants or animals may be patented if the application of the invention is not technically confined to a particular plant or animal variety. 30 Initial proposal Amended proposal 1(b) shall 3. Paragraph be without prejudice to the patentability of inventions which concern a microbiological or other technical procedure or a product obtained by means of such a procedure. 31 Initial proposal Amended proposal Article 3 Article 5 I. The human body and its elements in their natural state shall not be considered patentable inventions. invention capable of 2. Notwithstanding paragraph 1, the subject of an industrial application which relates to an element isolated from the human body or otherwise produced by means of a technical process shall be patentable, even if the structure of that element is identical to that of a natural element. 1. The human body, at the various stages of its formation and development, and the simple discovery of one of its elements including the sequence or partial sequence of a gene, cannot constitute patentable inventions. 2. An element isolated from the human body or otherwise produced by means of a technical process including the sequence or partial sequence of a gene may constitute a patentable invention, even if the structure of that element is identical to that of a element natural 3. The function of a sequence or a partial sequence of a gene must be disclosed in the patent application. Article 4 Deleted 1. The subject of an invention shall not be considered unpatentable merely on the grounds that it is composed of, uses, or is applied to biological material. 2. Biological material, including plants and animals, as well as elements of plants and animals obtained by means of a process not essentially biological, except plant and animal varieties shall be as patentable. such, Article 5 Deleted Microbiological processes and products obtained by means of such processes shall be patentable. 32 Initial proposal Amended proposal Article 6 Deleted Essentially biological processes for the production of plants or animals shall not be patentable. Article 7 Deleted Uses of plant or animal varieties and processes for their production, other than the essentially biological processes for production of plants or animals, shall be patentable. Article 8 Deleted The subject of an invention concerning a biological material shall not be considered a discovery or lacking in novelty merely on the grounds that it already formed part of the natural world. Article 9 Article 6 be shall 1. Inventions considered unpatentable where exploitation would be contrary to public policy or morality; however, exploitation shall not be deemed contrary merely because it is prohibited by law or regulation. be their considered 1. Inventions shall commercial unpatentable where exploitation would be contrary to public policy or morality; however, exploitation shall not be deemed to be so contrary merely because it is prohibited by law or regulation. the basis of paragraph 1, the 2. On following shall be considered unpatentable: the basis of paragraph 1, the 2. On following shall be considered unpatentable: (a) methods involving germ line gene therapy; human treatment of (a) procedures for human reproductive cloning; 33 Initial proposal Amended proposal (b) processes for modifying the genetic identity of animals which arc likely to them suffering or physical cause handicaps without any substantial benefit to man or animal, and also such animals processes, whenever the suffering or physical handicaps inflicted on the animals are the objective disproportionate pursued. concerned resulting from to (b) processes for modifying the germ line genetic identity of human beings; (c) (d) methods in which human embryos are used; processes for modifying the genetic identity of animals which are likely to cause them suffering without any substantial medical benefit to man or animal and also animals resulting from such processes; Article 7 The Commission's Group of Advisers on the Ethical Implications of Biotechnology shall aspects of assess biotechnology. ethical all 34 Initial proposal CHAPTER II Scope of protection Article 10 Amended proposal CHAPTER II Scope of protection Article 8 1. Unchanged 1. The protection conferred by a patent on a biological material possessing specific characteristics as a result of the invention shall extend to any biological material that biological material derived through multiplication or propagation in an identical or divergent form and possessing those same characteristics. from produced possessing 2. The protection conferred by a patent on a process that enables a biological material to specific be characteristics as a result of the invention shall extend to biological material directly obtained using that process and to any other biological material derived from the biological material obtained through multiplication or propagation in an identical or divergent form and possessing those same characteristics. That protection shall not affect from patentability of plant and animal varieties as such, pursuant to Article 4(2). the exclusion directly produced possessing 2. The protection conferred by a patent on a process that enables a biological material to specific be characteristics as a result of the invention shall extend to biological material directly obtained through that process and to any other biological material derived from the biological material obtained through multiplication or propagation in an identical or divergent form and possessing those same characteristics. directly Article 11 Article 9 The protection conferred by a patent on a product containing or consisting of genetic information shall extend to all material, save as provided in Article 3(1), in which the product is incorporated and in which the genetic information is contained and expressed. The protection conferred by a patent on a product containing or consisting of genetic information shall extend to all material, save as provided in Article 5(1), in which the product is incorporated and in which the genetic information is contained and expressed. 35 Initial proposal Article 12 Amended proposal Article 10 The protection referred to in Articles 10 and 11 shall not extend to biological material obtained from the multiplication or propagation of biological material marketed in the territory of a Member State by the holder of the patent or with his consent, or propagation necessarily results from the application the biological material was marketed, provided that the obtained material is not subsequently used for other multiplication or propagation. the multiplication for which if of from The protection referred to in Articles 8 and 9 shall not extend to biological material the multiplication or obtained propagation biological material marketed in the territory of a Member State by the holder of the patent or with his or consent, the multiplication the propagation necessarily results from application the biological for which material was marketed, provided that the obtained material is not subsequently used for other multiplication or propagation. if Article 13 Article 11 1. By way of derogation from Articles 10 and 11, the sale of propagating material to a farmer by the holder of the patent or with his consent for agricultural use implies authorisation for the farmer to use the product of his harvest for reproduction or propagation by him on his own farm, the scope of and procedure for this derogation corresponding to those under Article 14 of Regulation (EC) No 2100/94. 1. By way of derogation from Articles 8 and 9, the sale of propagating material to a farmer by the holder of the patent or with his consent for agricultural use implies authorisation for the farmer to use the product of his harvest for reproduction or propagation by him on his own farm. , the scope of and procedure for this derogation coiTesponding to those under Article 4 of Regulation (EC) No 2100/94. 2. By way of derogation from Articles 10 and 11, the sale of breeding stock to a farmer by the holder of the patent or with his consent implies authorisation for the farmer to use the protected livestock for breeding purposes on his own farm, in order to replenish their numbers. 2. By way of derogation from Articles 8 and 9, the sale of breeding stock or other reproductive material to a farmer by the holder of the patent or with his consent implies authorisation for the farmer to use the protected livestock for an agricultural purpose. This includes the sate for the purposes of pursuing agricultural activities but not the sale within the framework, or for the purpose of a commercial breeding activity. 36 Initial proposal Amended proposal 3. The extent and the conditions of the 3. Unchanged derogation provided for in paragraph 2 shall be determined by national laws, regulations and practices. CHAPTER III CHAPTER III Compulsory cross-licensing Compulsory cross-licensing Article 14 Article 12 1. Unchanged 2. Unchanged 1. Where a breeder cannot acquire or exploit a plant variety right without infringing a prior patent, he may apply for a compulsory licence for non-exclusive use of the invention protected by the patent inasmuch as the licence is necessary for the exploitation of the plant variety to be to payment of an protected, appropriate royalty. Member States shall provide is granted, the holder of the patent will be entitled to a cross-licence on reasonable terms to use the protected variety. that where such a licence subject 2. Where the holder of a patent on a biotechnological invention cannot exploit it without infringing a prior plant variety right, he may apply for a compulsory licence for non-exclusive use of the plant variety protected by that right, subject to payment of royalty. Member States shall provide that where such a licence is granted, the holder of the variety to a right will be entitled cross-licence on reasonable terms to use the protected invention. appropriate an 37 Initial proposal Amended proposal 3. Applicants for the licences referred to in paragraphs above must demonstrate that: and 1 2 (a) (b) they have applied unsuccessfully to the holder of the patent or of the plant variety right to obtain a contractual licence; exploitation of the plant variety or the invention for which the licence is requested the public interest and the plant variety constitutes invention or significant technical progress. is dictated by the 4. Each Member State shall designate the authority or authorities responsible for granting the licence. The licence shall be granted principally for the supply of the the Member State domestic market of which has granted the licence. 3. Unchanged (a) Unchanged (b) the plant variety or the invention constitutes technical significant progress of considerable economic interest. 4. Each Member State shall designate the authority or authorities responsible for granting the licence. CHAPTER IV CHAPTER IV Deposit, access and re-deposit of a biological material Deposit, access and re-deposit of a biological material Article 15 Article 13 1. Unchanged 1. Where an invention involves the use of or concerns a biological material which is not available to the public and which cannot be described in a patent application in such a manner as to enable the invention to be reproduced by a person skilled in the art, the description shall be considered inadequate for the purposes of patent law unless: 38 Initial proposal Amended proposal international (a) the biological material has been deposited, no later than the date on which the patent application was filed, with a recognised institution. At least depositary the depositary authorities which acquired this status by virtue of Article 7 of of the 2SAprill977 the International Recognition of the deposit of micro-organisms for the purposes of patent procedure, the hereinafter referred shall be "Budapest Treaty", recognised; Treaty on Budapest to as (b) the application as filed contains such relevant information as is available to the applicant on the characteristics of the biological material deposited; (c) the patent application states the depository the accession name institution and number. the of to the deposited biological 2. Unchanged 2. Access material shall be provided through the supply of a sample: (a) up to the first publication of the patent application, only to those persons who are authorised under national patent law; (b) between the first publication of the application and the granting of anyone requesting it or, if the applicant so an requests, independent expert; patent, only the to to (c) after the patent has been granted, and notwithstanding revocation or cancellation of the patent, to anyone requesting it. 39 Initia! proposal Amended proposal 3. The sample shall be supplied only if the person requesting it undertakes, for the term during which the patent is in force: 3. Unchanged (a) not to make it or any matter derived from it available to third parties and (b) not to use from derived experimental purposes, it or any matter for it except the unless or patent applicant, as applicable, expressly waives such an undertaking. holder 4. At the applicant's request, where an 4. Unchanged application is refused or withdrawn, access to the deposited material shall be limited to an independent expert for twenty years the patent from application was that case, paragraph 3 shall apply. the date on which In filed. 5. The applicant's requests referred to in 5. Unchanged point (b) of paragraph 2 and in paragraph 4 may only be made up to the date on which the technical preparations for publishing the patent application are deemed to have been completed. Article 16 Article 14 1. If the biological material deposited in 1. Unchanged accordance with Article 15 ceases to be available from the recognised depositary institutions, a new deposit of the material shall be permitted on the same terms as those laid down in the Budapest Treaty. 40 Initial proposal Amended proposal 2. Any new deposit shall be accompanied by a statement signed by the applicant deposited certifying biological material is the same as that originally deposited. the newly that Unchanged CHAPTER V Deleted Burden of proof Article 17 l. If the subject-matter of a patent is a process for obtaining a new product, then, when the same product is produced by any other party, it shall, in the absence of proof to the contrary, be deemed to have been obtained by the patented process. 2. In the adduction of proof to the contrary, the legitimate interests of the defendant in protecting his manufacturing and business secrets shall be taken into account. CHAPTER VI Final provisions Article 18 CHAPTER VI Final provisions Article 15 and regulations 1. Member States shall bring into force the laws, administrative provisions necessary to comply with this Directive not later than 1 January 2000. They the immediately shall Commission thereof inform and regulations 1. Member States shall bring into force the laws, administrative provisions necessary to comply with this Directive not later than 1 January 1999. They the immediately shall Commission thereof. inform 41 Initial proposal Amended proposal Unchanged adopt When Member States these measures, these shall contain a reference to this Directive or shall be accompanied by such reference at the time of their official The procedure for such publication. by reference Member States. adopted shall be 2. Member States shall communicate to the 2. Unchanged the main Commission provisions of national law which they adopt in the field covered by this Directive. text of the Article 16 a report on the Commission Every five years after the transposition of shall this Directive publish any problems encountered with regard to the relationship between this Directive and international agreements on the protection of human rights to which the Member States have acceded or on which they have cooperated. The report shall be forwarded to European Parliament and the Council. Article 19 Article 17 This Directive shall enter into force on the Unchanged 20th day following that of its publication in the Official the European Journal of Communities. Article 20 Article 18 This Directive Member States. is addressed to the Unchanged 42 ISSN 0254-1475 COM(97) 446 final DOCUMENTS EN 05 06 08 15 Catalogue number : CB-CO-97-455-EN-C ISBN 92-78-24376-0 Office for Official Publications of the European Communities L-2985 Luxembourg 43