A4-0222/97

Proposal for a European Parliament and Council Directive on the legal protection of biotechnological inventions (COM(95)0661 - C4-0063/96 - 95/0350(COD))

The proposal was approved with the following amendments:

(Amendment 1)

Citation 3a (new)

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Having regard to report No 8 by the Group of Advisers on the Ethical Implications of Biotechnology to the European Commission,

(Amendment 2)

Recital 3

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(3) Whereas without effective and harmonised protection throughout the Member States such investments might well not be made;

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(3) Whereas effective and harmonised protection throughout the Member States is essential in order to maintain and encourage investment in the field of biotechnology;

(Amendment 3)

Recital 4

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(4) Whereas following the European Parliament's rejection of the joint text, approved by the Conciliation Committee, for a European Parliament and Council Directive on the legal protection of biotechnological inventions, the European Parliament and the Council have determined that the legal protection of biotechnological inventions cannot be left as it currently stands;

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(4) Whereas following the European Parliament's rejection of the joint text, approved by the Conciliation Committee, for a European Parliament and Council Directive on the legal protection of biotechnological inventions, the European Parliament and the Council have determined that the legal protection of biotechnological inventions requires clarification;

(Amendment 5)

Recital 9

>Original text>

(9) Whereas harmonization of the laws of the Member States is necessary to clarify certain concepts in national laws 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 and 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;

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(9) Whereas in such cases as the exclusion from patentability of plant and animal varieties and of essentially biological processes for the production of plants and animals, certain concepts in national laws based upon international patent and plant variety conventions have created uncertainty regarding the protection of biotechnological and certain microbiological inventions; whereas harmonisation is necessary to clarify the said uncertainty;

(Amendment 6)

Recital 9a (new)

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(9a) Having regard to the potential of the development of biotechnology for the environment and in particular the utility of this 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;

(Amendment 7)

Recital 9b (new)

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(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 world; whereas the patent system should likewise be used to encourage research in these fields; whereas international procedures for the dissemination of such technology in the Third World and to the benefit of the population groups concerned should be promoted;

(Amendment 8)

Recital 9c (new)

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(9c) Whereas the Agreement on Trade-related Aspects of Intellectual Property Rights (TRIPS) signed by the European Community and the Member States is directly applicable law and provides that patent protection shall be guaranteed for products and processes in all areas of technology;

(Amendment 9)

Recital 11

>Original text>

(11) Whereas a patent for invention does not authorize the holder to implement that invention, but merely entitles him to prohibit third parties from exploiting it for industrial and commercial 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 commercialization 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;

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(11) Whereas a patent for invention does not authorize the holder to implement that invention, but merely entitles him to prohibit third parties from exploiting it for industrial and commercial purposes; whereas, consequently, substantive patent law cannot serve to replace or render superfluous national, European or international law which may impose restrictions or prohibitions or which concerns the monitoring of research and of the use or commercialization 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;

(Amendment 10)

Recital 12a (new)

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(12a) Whereas the Council of Europe Convention on Human Rights and Biomedicine (adopted by the Committee of Ministers on 19 November 1996) should be respected;

(Amendment 11)

Recital 13

>Original text>

(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 excluding all ownership of human beings;

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(13) Whereas patent law must respect the fundamental principles safeguarding the dignity and integrity of the person; whereas it is important to assert the principle that the human body, at any stage in its formation or development, its elements, including germ cells, its products and 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;

(Amendment 12)

Recital 14

>Original text>

(14) Whereas significant progress in the treatment of diseases has already been made thanks to medicinal products derived or otherwise produced from elements isolated from the human body, and medicinal products resulting from a technical process aimed at obtaining elements similar in structure to those existing naturally in the human body and whereas, consequently, the patent system should promote research aimed at obtaining such elements;

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(14) Whereas significant progress in the treatment of diseases has already been made thanks to medicinal products derived and/or otherwise produced from elements isolated from the human body, and medicinal products resulting from technical processes aimed at obtaining elements similar in structure to those existing naturally in the human body and whereas, consequently, the patent system should promote research aimed at obtaining and isolating such elements valuable to medicinal production;

(Amendment 13)

Recital 14a (new)

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(14a) Whereas the patent system does not make it possible to finance research into and production of biotechnological medicines which are needed to combat rare or 'orphan' diseases; whereas the Community and the Member States have a duty to respond adequately to this problem;

(Amendment 14)

Recital 15

>Original text>

(15) Whereas, therefore, it should be made clear that an invention 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 identical to that of a natural element, since no patent may be interpreted as covering an element of the human body in its natural environment forming the basic subject of the intervention;

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(15) Whereas, therefore, 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 is capable of industrial application, is not excluded from patentability, even where the structure of that element is identical to that of a natural element, while the patent cannot cover an element of the human body in its natural environment forming the basic subject of the intervention;

(Amendment 15)

Recital 16

>Original text>

(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 process 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;

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(16) Whereas such an element isolated from the human body or otherwise produced is not excluded from patentability as it is 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 putting into practice and which Nature is incapable of accomplishing by itself;

(Amendment 16)

Recitals 16a to 16e (new)

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(16a) Whereas the discussion on the patentability of sequences or partial sequences of genes is controversial; whereas, according to this 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;

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(16b) Whereas a mere sequence of DNA segments does not contain a technical teaching and is therefore not a patentable invention;

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(16c) 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;

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(16d) Whereas for the criterion of industrial application the first requirement is that the reading frame of the sequence or partial sequence is determined and thus also the protein for which a DNA sequence codes; whereas for sequences which overlap, each sequence will be considered as an independent sequence in patent law terms;

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(16e) Whereas the requirements for disclosure of the industrial application of the sequences or partial sequences do not differ from those in other areas of technology; whereas at least an industrial application must be actually disclosed in the patent application;

(Amendment 99)

Recital 16f (new)

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(16f) Whereas this Directive in no way affects the basis of current patent law applicable to biotechnological inventions, according to which a patent may be granted for any new application of an invention relating to a gene or a partial sequence already protected by patent;

(Amendment 17)

Recital 16g (new)

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(16g) 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;

(Amendment 18)

Recital 17

>Original text>

(17) Whereas, in order to determine the extent to which plant and animal varieties are to be excluded from patentability, it should be specified that the exclusion concerns those varieties as such and that, 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;

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(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 patentable provided that the practicability of the invention is not technically confined to a single plant or animal variety;

(Amendment 19)

Recital 17a (new)

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(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;

(Amendment 20)

Recital 17b (new)

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(17b) Whereas a plant totality which is characterized by a particular gene (and not its whole genome) is not covered by the protection of new varieties and is therefore not excluded from patentability even if it comprises plant varieties;

(Amendment 21)

Recital 17c (new)

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(17c) Whereas, however, if an invention consists only in genetically modifying a particular plant variety and producing a new variety from it, the new variety shall be excluded from patentability even if the genetic modification is the result not of breeding but of a genetic engineering procedure;

(Amendment 22)

Recital 18

>Original text>

(18) Whereas, for the purposes of determining whether or not it is possible to patent essentially biological processes for obtaining plants or animals, human intervention and the effects of that intervention on the result obtained must be taken into account;

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(18) Whereas a procedure for the 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);

(Amendment 23)

Recital 19

>Original text>

(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 in respect of inventions whose publication or exploitation would be contrary to public policy or morality;

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(19) Whereas this Directive shall be without prejudice to concepts of invention and discovery, as developed by national patent laws, the practice of patent offices and case law, as well as concepts laid down in international agreements and the European Patent Convention;

(Amendment 24)

Recital 19a (new)

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(19a) Whereas this Directive shall be without prejudice to the provisions of national patent law whereby surgical or therapeutic treatment 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;

(Amendment 79)

Recital 19b (new)

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(19b) 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 product already protected by patent;

(Amendment 26)

Recitals 19c and 19d (new)

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(19c) Whereas the TRIPS Agreement provides for the possibility that parties may exclude from patentability inventions whose commercial exploitation within their territory must be prevented in order to protect public policy or morality, including to protect human, animal or plant life or health or to prevent serious harm to the environment, provided that such an exclusion is not undertaken solely because exploitation is prohibited by the law of the specific state party to the Agreement (Article 27(2));

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(19d) Whereas other prohibitions on exploitation under national law are not sufficient to exclude patentability; whereas such an exclusion presupposes that the commercial exploitation of the invention is prohibited in the Member State in question; whereas an invention, the commercial exploitation of which is permitted, may not be excluded from patentability;

(Amendment 27)

Recital 20

>Original text>

(20) Whereas such a reference to public policy and morality should be included in the operative part of this Directive in order to bring out the fact that some applications of biotechnological inventions, by virtue of some of their consequences or effects are capable of offending against them;

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(20) Whereas the principle whereby inventions must be excluded from patentability where their publication or exploitation offends against public policy or morality must also be stressed in this Directive;

(Amendment 28)

Recital 21

>Original text>

(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 from the invention, on the one hand, is weighed against any risks associated therewith, and any objections based on fundamental principles of law, on the other hand;

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Deleted

(Amendment 80)

Recital 22

>Original text>

(22) Whereas the operative part of this Directive should also include an illustrative list of 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;

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(22) Whereas the operative part of this Directive should also include an illustrative list of 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 obviously cannot presume to be exhaustive; whereas processes the use of which offend against human dignity, such as processes to produce chimeras from germ cells or totipotent cells of humans and animals, are obviously also excluded from patentability;

(Amendment 30)

Recital 23

>Original text>

(23) Whereas such moral considerations must be given greater weight in appraising the patentability of biotechnological inventions, both on account of the subject- matter of this branch of science, namely living matter, and because of the often far- reaching implications of the inventions 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 inventions are required to undergo from the start of their development or at the marketing stage, particularly with regard to safety;

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(23) Whereas such moral considerations must be carefully weighed in appraising the patentability of biotechnological inventions due to the inherent relationship to living matter and the potentially far-reaching implications; and whereas such moral considerations may only supplement the standard legal checks of patent law regardless of category;

(Amendment 31)

Recital 24

>Original text>

(24) Whereas, in view of the importance and the controversial nature of the unprecedented questions raised by germ line gene therapy, it is important to exclude unequivocally from patentability any methods of treatment of human beings based on it;

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(24) Whereas in the European Union there is a consensus that 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 for cloning human beings;

(Amendment 33)

Recital 24a (new)

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(24a) Whereas this Directive does not affect the application of the Convention on Human Rights and Fundamental Freedoms of 4 November 1950, the Convention for the protection of human rights and the dignity of the human person with respect 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 which the Member States have cooperated or to which they have acceded;

(Amendment 34)

Recital 25

>Original text>

(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 be excluded from patentability insofar as the suffering or physical handicaps inflicted on the animals concerned are out of proportion to the objective pursued;

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(25) Whereas processes for modifying the genetic identity of animals which are likely to cause them suffering or physical handicaps without any substantial medical (diagnostic or therapeutic) benefit to man or animal, and also animals resulting from such processes must be excluded from patentability;

(Amendment 35)

Recital 30

>Original text>

(30) Whereas a second derogation from the rights of the holder of the patent must authorise the farmer to use the protected livestock for breeding purposes on his own farm, in order to replenish their numbers;

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(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;

(Amendment 36)

Recital 33

>Original text>

(33) Whereas, in the field of the use of new plant characteristics resulting from new plant varieties in genetic engineering, guaranteed access against a fee must be granted in the form of a compulsory licence where public interest demands the exploitation of the invention for which the licence is requested and where the invention represents significant technical progress,

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(33) Whereas, in the field of the use of new plant characteristics resulting from new plant varieties in genetic engineering, guaranteed access against a fee must be granted in the form of a compulsory licence where the invention represents significant technical progress,

(Amendment 37)

Recital 33a (new)

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(33a) Whereas the TRIPS Agreement contains detailed provisions on the burden of proof (Article 34) which are binding on all Member States; whereas, therefore, a provision in this Directive is not necessary;

(Amendment 38)

Recital 33b (new)

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(33b) Whereas the Commission will investigate whether, in the field of basic genetic engineering research, free and unimpeded scientific exchanges are hampered because publications containing information eligible for patent protection are delayed or not undertaken, because otherwise patenting would be precluded on the grounds of lack of novelty of the invention; whereas the Commission will carry out a comparison with the patent law of the USA and Japan in this respect and report to the Council and the European Parliament two years after the entry into force of this Directive;

(Amendment 39)

Recital 33c (new)

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(33c) Whereas the Commission will report annually to the European Parliament on the development of patent law in the field of biotechnology and genetic engineering;

(Amendment 40)

Recital 33d (new)

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(33d) Whereas the rights and obligations of the Member States derived from international agreements are not affected by this Directive;

(Amendment 41)

Recital 33e (new)

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(33e) Whereas the principles of the Convention on Biological Diversity are that 'States have, in accordance with the Charter of the United Nations and the principles of international law, the sovereign right to exploit their own resources pursuant to their own environmental policies, and the responsibility to ensure that activities within their jurisdiction or control do not cause damage to the environment' (Article 3);

(Amendment 42)

Recital 33f (new)

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(33f) Whereas Article 16(2), second sentence, of this Convention (Access to and transfer of technology) states that 'In the case of technology subject to patents and other intellectual property rights, such access and transfer shall be provided on terms which recognize and are consistent with the adequate and effective protection of intellectual property rights.';

(Amendment 77)

Recital 33g (new)

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(33g) Whereas Article 8(j) of this Convention (In-situ conservation) states that 'Each contracting party shall, as far as possible and as appropriate, subject to its national legislation, respect, preserve and maintain knowledge, innovations and practices of indigenous and local communities embodying traditional lifestyles relevant for the conservation and sustainable use of biological diversity and promote their wider application with the approval and involvement of the holders of such knowledge, innovations and practices and encourage the equitable sharing of the benefits arising from the utilization of such knowledge, innovations and practices;'

(Amendment 43)

Recital 33h (new)

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(33h) Whereas Article 16(5) of this Convention states that 'The Contracting Parties, recognizing that patents and other intellectual property rights may have an influence on the implementation of this Convention, shall cooperate in this regard subject to national legislation and international law in order to ensure that such rights are supportive and do not run counter to its objectives.';

(Amendment 44)

Recital 33i (new)

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(33i) Whereas the Third Conference of the Parties of the Biodiversity Convention , which took place in November 1996, noted in Decision III/17 that 'further work is required to help develop a common appreciation of the relationship between intellectual property rights and the relevant provisions of the TRIPS Agreement and the Convention on Biological 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, including the protection of knowledge, innovations and practices of indigenous and local communities embodying traditional lifestyles relevant for the conservation and sustainable use of biological diversity';

(Amendment 68)

Recital 33j (new)

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(33j) Whereas the responsibilities and commitments undertaken by Member States through the Convention on Biological Diversity, including the aforementioned principles, shall be recognised and reflected in the application of this Directive and subsequent biotechnological patent law;

(Amendment 67)

Article 1(2)

>Original text>

2. This Directive shall be without prejudice to national and Community laws on the monitoring of research and of the use or commercialization of its results.

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2. This Directive shall be without prejudice to the rights and obligations of the Member States pursuant to international agreements, and in particular the Convention on Biological Diversity and the TRIPS Agreement.

(Amendment 48)

Article 2

>Original text>

For the purposes of this Directive:

1. Biological material means any material containing genetic information and capable of self- reproduction or of being reproduced in a biological system;

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1. Inventions which are novel, based on inventive activity and 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.

>Original text>

2. Microbiological process means any process involving or performed on or resulting in microbiological material; a process consisting of a succession of steps shall be treated as a microbiological process if at least one essential step of the process is microbiological;

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2. 'Biological material' means any material containing genetic information and capable of reproducing itself or being reproduced in a biological system.

>Original text>

3. 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.

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3. 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.

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3a. 'Microbiological process' means any process involving or performed upon or resulting in microbiological material.

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3b. A procedure for the breeding of plants or animals shall be defined as essentially biological if it is based on crossing and selection.

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3c. The concept 'plant variety' shall be defined by the law protecting new varieties.

(Amendment 47)

Article 2a (new)

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Article 2a

1. The following shall not be patentable:

(a) plant and animal varieties,

(b) essentially biological procedures for the breeding of plants and animals.

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2. Inventions which concern plants or animals may be patented if the practicability of the invention is not technically confined to a particular plant or animal variety.

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3. Paragraph 1(b) shall 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.

(Amendments 100 and 49)

Article 3

>Original text>

1. The human body and its elements in their natural state shall not be considered patentable inventions.

>Text following EP vote>

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.

>Original text>

2. Notwithstanding paragraph 1, the subject of an invention capable of 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.

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2. An element isolated from the human body or otherwise produced by means of a technical process including the structure or partial structure of a gene may constitute a patentable invention, even if the structure of that element is identical to that of a natural element.

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2a. The industrial application of a sequence or a partial sequence of a human gene must be disclosed in the patent application.

(Amendment 50)

Article 4

>Original text>

Article 4

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.

>Text following EP vote>

Deleted

>Original text>

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 as such, shall be patentable.

(Amendment 51)

Article 5

>Original text>

Article 5

Microbiological processes and products obtained by means of such processes shall be patentable.

>Text following EP vote>

Deleted

(Amendment 52)

Article 6

>Original text>

Article 6

Essentially biological processes for the production of plants or animals shall not be patentable.

>Text following EP vote>

Deleted

(Amendment 53)

Article 7

>Original text>

Article 7

Uses of plant or animal varieties and processes for their production, other than essentially biological processes for the production of plants or animals, shall be patentable.

>Text following EP vote>

Deleted

(Amendment 54)

Article 8

>Original text>

Article 8

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.

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Deleted

(Amendment 76/rev.)

Article 8a (new)

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Article 8a

1. If the object of an invention consists of biological material of plant or animal origin or if it uses such material, a patent on this invention shall be granted only if the patent specification publishes the geographical place of origin of the material and the applicant for the patent provides evidence to the patent authorities that the material was used in accordance with the legal access and export provisions in force in the place of origin.

>Text following EP vote>

2. If the object of an invention consists of biological material of human origin or if it uses such material, a patent on this invention shall be granted only if the patent application publishes the name and address of the person of origin, or his or her legal representative or relatives, and if the applicant for the patent provides evidence to the patent authorities that the material has been used and the patent applied for with the voluntary and informed agreement of the person of origin, or his or her legal representative or relatives. The names and addresses of the person of origin, the legal representative and the relatives shall not be published by the patent authorities.

(Amendment 55)

Article 9

>Original text>

1. Inventions shall be considered 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.

>Text following EP vote>

1. Inventions shall be considered unpatentable where exploitation or publication 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.

>Original text>

2. On the basis of paragraph 1, the following shall be considered unpatentable:

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2. On the basis of paragraph 1, the following shall be considered unpatentable:

>Original text>

(a) methods of human treatment involving germ line gene therapy;

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(a) procedures for human reproductive cloning;

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(aa) processes for modifying the germ line genetic identity of human beings;

>Original text>

(b) 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, whenever the suffering or physical handicaps inflicted on the animals concerned are disproportionate to the objective pursued.

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(b) processes for modifying the genetic identity of animals which are likely to cause them suffering or physical handicaps without any substantial medical benefit to man or animal and also animals resulting from such processes;

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(ba) methods in which human embryos are used;

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(bb) methods for the artificial production of human embryos containing the same genetic information as another human being or a dead person (human cloning).

(Amendment 78)

Article 9a (new)

>Text following EP vote>

Article 9a

An Ethics Committee shall be set up to assess all ethical aspects of biotechnology and its utilization, in particular with regard to patents. The Commission shall submit proposals for the composition and terms of reference of the committee before this Directive comes into force.

(Amendment 57)

Article 10(2)

>Original text>

2. The protection conferred by a patent on a process that enables a biological material to be produced possessing specific 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 directly obtained through multiplication or propagation in an identical or divergent form and possessing those same characteristics. That protection shall not affect the exclusion from patentability of plant and animal varieties as such, pursuant to Article 4(2).

>Text following EP vote>

2. The protection conferred by a patent on a process that enables a biological material to be produced possessing specific 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 directly obtained through multiplication or propagation in an identical or divergent form and possessing those same characteristics.

(Amendment 58)

Article 11

>Original text>

The protection conferred by a patent on a product containing or consisting of genetic information shall extend to all material, save as provided for in Article 3(1), in which the product is incorporated and in which the genetic information is contained and expressed.

>Text following EP vote>

The protection conferred by a patent on a product containing or consisting of genetic information shall extend, save as provided for in Article 2a(1) and Article 3(1), to all material in which the product is incorporated and in which the genetic information is contained and expressed.

(Amendment 95)

Article 13(1)

>Original text>

1. By way of derogation from Articles 10 and 11, the sale of propagating material to a farmer by the holder of a patent or with his consent for agricultural use implies authorization 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.

>Text following EP vote>

1. By way of derogation from Articles 10 and 11, the sale of propagating material to a farmer by the holder of a patent or with his consent for agricultural use implies authorization 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(1) and (3) of Regulation (EC) No 2100/94. Furthermore, the sale implies authorization for the farmer to use the protected propagating material for an agricultural purpose, including the resale for agricultural use but not the sale within the framework or for the purpose of a commercial plant breeding activity.

(Amendment 59)

Article 13(2)

>Original text>

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 authorization for the farmer to use the protected livestock for breeding purposes on his own farm, in order to replenish their numbers.

>Text following EP vote>

2. By way of derogation from Articles 10 and 11, the sale of breeding stock or other reproductive material to a farmer by the holder of the patent or with his consent implies authorization for the farmer to use the protected livestock for an agricultural purpose. This authorization includes the resale for agricultural use but not the sale within the framework or for the purpose of a commercial breeding activity.

(Amendment 60)

Article 14(3)(b)

>Original text>

(b) exploitation of the plant variety or the invention for which the licence is requested is dictated by the public interest and the plant variety or the invention constitutes significant technical progress.

>Text following EP vote>

(b) the plant variety or the invention constitutes significant technical progress.

(Amendment 61)

Article 14(4)

>Original text>

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 domestic market of the Member State which has granted the licence.

>Text following EP vote>

4. Each Member State shall designate the authority responsible for granting the licence.

(Amendment 62)

Article 17

>Original text>

Article 17

1. 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.

>Text following EP vote>

Deleted

>Original text>

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.

(Amendment 63)

Article 18(1), 1st subparagraph, 1st sentence

>Original text>

1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive not later than 1 January 2000.

>Text following EP vote>

1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive not later than 1 January 1999.

(Amendment 64)

Article 18a (new)

>Text following EP vote>

Article 18a

Every five years after the transposition of this Directive the Commission shall publish a report on 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 Parliament and the Council.

Legislative resolution embodying Parliament's opinion on the proposal for a European Parliament and Council Directive on the legal protection of biotechnological inventions (COM(95)0661 - C4-0063/96 - 95/0350(COD))

(Codecision procedure: first reading)

The European Parliament,

- having regard to the Commission proposal to Parliament and the Council, COM(95)0661 - 95/0350(COD) ((OJ C 296, 8.10.1996, p. 4.)),

- having regard to Article 189b(2) of the EC Treaty and Article 100a of the EC Treaty, pursuant to which the Commission submitted the proposal (C4-0063/96),

- having regard to Rule 58 of its Rules of Procedure,

- having regard to the report of the Committee on Legal Affairs and Citizens' Rights and the opinions of the Committee on Agriculture and Rural Development, the Committee on the Environment, Public Health and Consumer Protection, the Committee on Economic and Monetary Affairs and Industrial Policy and the Committee on Development and Cooperation (A4-0222/97),

1. Approves the Commission proposal, subject to Parliament's amendments;

2. Calls on the Commission to alter its proposal accordingly, pursuant to Article 189a(2) of the EC Treaty;

3. Calls on the Council to incorporate Parliament's amendments in the common position that it adopts pursuant to Article 189b(2) of the EC Treaty;

4. Points out that the Commission is required to submit to Parliament any modification it may intend to make to its proposal as amended by Parliament;

5. Instructs its President to forward this opinion to the Council and Commission.