Local view for "http://purl.org/linkedpolitics/eu/plenary/2005-10-25-Speech-2-282"
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".
Mr President, I understand Members’ concerns that the biotechnology directive should be applied correctly. This is important, not just for all those in industry who use patents to support the introduction of new products and processes, but also those who benefit from the availability of the results of research and development. These could be researchers, industrial competitors, patients and medical staff and those who administer health systems.
The term ‘therapeutic cloning’ covers a wide range of different possibilities. Research may be permitted in some Member States and not in others. For the Commission, the use of human pluripotent stem cells to cure diseases is not necessarily excluded from patentability. In light of those arguments, a modification of the directive does not, at this stage, seem appropriate.
In conclusion, I would like to recall that biotechnology has enormous potential for good, particularly in medical fields, and patent protection is of great importance to key industrial sectors, which invest heavily in research and development costs. We are working in the context of a global economy, which means our industry and researchers are competing with those in the United States and growing markets such as Asia. Indeed, according to recent reports Chinese companies filed more biotechnology patents in Europe in certain sectors last year than European companies did. As I have said, I understand the concerns that some Members have raised and I shall listen with interest to the debate.
Biotechnology covers a wide range of powerful and sometimes controversial technologies. They can make a vital contribution to the long-term future of industries such as pharmaceuticals, food, agriculture, energy, textiles and chemicals. Biotechnology also creates new opportunities and prospects for developing life-saving drugs and treating diseases. It offers enormous potential for massively improving the quality of life of many citizens. But success in developing biotechnology also depends on finding solutions to the significant ethical, societal, economic and environmental issues it throws up.
Directive 98/44/EC establishes well-balanced principles for the protection of biotechnological inventions through patents. It also takes into account the ethical aspects of this sensitive subject, as well as the legitimate desire of industry and others to establish a clear and effective scope for patent protection in this area of technology.
Let me recall that the purpose of the directive is to establish the legal framework for granting patents, which covers the results of research. It does not in any way replace regulations that govern research in particular areas, including certain ethical rules such as those on human integrity.
The Commission will continue to follow the application of the directive in practice very carefully, with due regard to ethical, moral and cultural considerations, and will not fail to inform the European Parliament, as it has so far done, in the framework of the evaluation reports envisaged in the directive.
In terms of the particular areas identified by Parliament in the motion for a resolution, I make the following remarks. On purpose-bound protection, the issue is whether patents on gene sequences – DNA sequences – should be allowed according to the classical model of patent claim whereby a first inventor can claim an invention that covers possible future uses of that sequence. Or should the patent be restricted so that only the specific use disclosed in the patent application can be claimed, which is purpose-bound protection?
On examination of the technical provisions of the directive, it can be seen that none of these articles explicitly addresses the concept of a restricted scope of protection relating to the specific use identified for the gene sequence concerned. That might be seen as arguing for the usual broad scope of protection rather than a restricted one, since that has always been the traditional approach in patent law.
On the other hand, it might be thought that the Community legislator had intended at least to raise the possibility of a limited scope of protection, covering only the specific industrial application identified in the patent as far as this particular type of invention is concerned. That restrictive interpretation should not be incompatible with the directive.
The Commission will now, in consultation with those involved, consider the consequences of allowing both interpretations of the directive and the best way to achieve a correct application of the directive on human cloning. The directive is clear for the Commission as regards the issue of patentability of reproductive cloning involving the creation of new human beings, which is clearly excluded under Article 6 of the directive."@en4
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"Mr President, I understand Members’ concerns that the biotechnology directive should be applied correctly. This is important, not just for all those in industry who use patents to support the introduction of new products and processes, but also those who benefit from the availability of the results of research and development. These could be researchers, industrial competitors, patients and medical staff and those who administer health systems.
The term ‘therapeutic cloning’ covers a wide range of different possibilities. Research may be permitted in some Member States and not in others. For the Commission, the use of human pluripotent stem cells to cure diseases is not necessarily excluded from patentability. In light of those arguments, a modification of the directive does not, at this stage, seem appropriate.
In conclusion, I would like to recall that biotechnology has enormous potential for good, particularly in medical fields, and patent protection is of great importance to key industrial sectors, which invest heavily in research and development costs. We are working in the context of a global economy, which means our industry and researchers are competing with those in the United States and growing markets such as Asia. Indeed, according to recent reports Chinese companies filed more biotechnology patents in Europe in certain sectors last year than European companies did. As I have said, I understand the concerns that some Members have raised and I shall listen with interest to the debate.
Biotechnology covers a wide range of powerful and sometimes controversial technologies. They can make a vital contribution to the long-term future of industries such as pharmaceuticals, food, agriculture, energy, textiles and chemicals. Biotechnology also creates new opportunities and prospects for developing life-saving drugs and treating diseases. It offers enormous potential for massively improving the quality of life of many citizens. But success in developing biotechnology also depends on finding solutions to the significant ethical, societal, economic and environmental issues it throws up.
Directive 98/44/EC establishes well-balanced principles for the protection of biotechnological inventions through patents. It also takes into account the ethical aspects of this sensitive subject, as well as the legitimate desire of industry and others to establish a clear and effective scope for patent protection in this area of technology.
Let me recall that the purpose of the directive is to establish the legal framework for granting patents, which covers the results of research. It does not in any way replace regulations that govern research in particular areas, including certain ethical rules such as those on human integrity.
The Commission will continue to follow the application of the directive in practice very carefully, with due regard to ethical, moral and cultural considerations, and will not fail to inform the European Parliament, as it has so far done, in the framework of the evaluation reports envisaged in the directive.
In terms of the particular areas identified by Parliament in the motion for a resolution, I make the following remarks. On purpose-bound protection, the issue is whether patents on gene sequences – DNA sequences – should be allowed according to the classical model of patent claim whereby a first inventor can claim an invention that covers possible future uses of that sequence. Or should the patent be restricted so that only the specific use disclosed in the patent application can be claimed, which is purpose-bound protection?
On examination of the technical provisions of the directive, it can be seen that none of these articles explicitly addresses the concept of a restricted scope of protection relating to the specific use identified for the gene sequence concerned. That might be seen as arguing for the usual broad scope of protection rather than a restricted one, since that has always been the traditional approach in patent law.
On the other hand, it might be thought that the Community legislator had intended at least to raise the possibility of a limited scope of protection, covering only the specific industrial application identified in the patent as far as this particular type of invention is concerned. That restrictive interpretation should not be incompatible with the directive.
The Commission will now, in consultation with those involved, consider the consequences of allowing both interpretations of the directive and the best way to achieve a correct application of the directive on human cloning. The directive is clear for the Commission as regards the issue of patentability of reproductive cloning involving the creation of new human beings, which is clearly excluded under Article 6 of the directive."@cs1
"Hr. formand, jeg forstår, at medlemmerne er opmærksomme på, at direktivet om bioteknologi anvendes korrekt. Det er vigtigt, ikke blot for alle dem i industrien, der anvender patenter til støtte for indførelsen af nye produkter og processer, men også for dem, der drager fordel af resultaterne af forskning og udvikling. Det kan være forskere, industrielle konkurrenter, patienter og lægefagligt personale og dem, der administrerer sundhedssystemerne.
Begrebet "terapeutisk kloning" omfatter en lang række forskellige muligheder. Forskning er måske tilladt i nogle medlemsstater og ikke i andre. Efter Kommissionens mening er anvendelsen af pluripotente stamceller fra mennesker ikke nødvendigvis udelukket fra at blive patenteret. I lyset af disse argumenter er en ændring af direktivet ikke på nuværende tidspunkt relevant.
Afslutningsvis vil jeg gerne minde om, at bioteknologien indebærer mange potentielle fordele, navnlig på det medicinske område, og patentbeskyttelse er meget vigtig for centrale industrisektorer, der investerer kraftigt i udgifter til forskning og udvikling. Vi arbejder i en global økonomi, der betyder, at vores industri og vores forskere konkurrerer med forskere i USA og på de voksende markeder i f.eks. Asien. I henhold til de seneste oplysninger indgav kinesiske virksomheder faktisk flere patentansøgninger i Europa inden for visse sektorer sidste år end europæiske virksomheder. Som sagt har jeg forståelse for de bekymringer, som nogle af medlemmerne har givet udtryk for, og jeg vil lytte interesseret til debatten.
Bioteknologi omfatter en lang række kraftfulde og nogle gange kontroversielle teknologier. De kan yde et vigtigt bidrag til den langsigtede udvikling af industrigrene som f.eks. lægemidler, levnedsmidler, landbrug, energi, tekstiler og kemikalier. Bioteknologi skaber også nye muligheder for at udvikle livsvigtig medicin og for at behandle truende sygdomme. Den indebærer et enormt potentiale for forbedring af mange borgeres livskvalitet. En vellykket udvikling af bioteknologien afhænger imidlertid også af, at vi finder frem til løsninger på de betydelige etiske, samfundsmæssige, økonomiske og miljømæssige spørgsmål, den rejser.
Direktiv 98/44/EF opstiller velafbalancerede principper for beskyttelse af bioteknologiske opfindelser gennem patenter. Det tager også hensyn til de etiske aspekter af dette følsomme område samt til industriens og andres legitime ønske om en klar og effektiv afgrænsning af patentbeskyttelsen på dette teknologiske område.
Lad mig minde om, at formålet med direktivet er at fastsætte den retlige ramme for udstedelse af patenter, der omfatter forskningsresultater. Det træder ikke på nogen måde i stedet for forordninger, der regulerer forskning på bestemte områder, herunder visse etiske regler som f.eks. menneskets integritet.
Kommissionen vil fortsat følge anvendelsen af direktivet i praksis meget nøje under behørig hensyntagen til etiske, moralske og kulturelle overvejelser og vil ikke undlade at informere Parlamentet, sådan som den hidtil har gjort, i de evalueringsrapporter, der er omhandlet i direktivet.
Jeg har følgende bemærkninger til de særlige områder, som Parlamentet har identificeret i sit beslutningsforslag. Med hensyn til formålsbestemt beskyttelse er spørgsmålet, om der skal kunne udstedes patent på sekvenser af gener - dna-sekvenser - efter den klassiske model for patentrettigheder, hvor den oprindelige ophavsmand kan gøre krav på en opfindelse, der omfatter mulige fremtidige anvendelser af den pågældende sekvens, eller om patentet bør begrænses, så kravet kun kan omfatte den konkrete anvendelse, der er redegjort for i patentansøgningen, hvilket er formålsbestemt beskyttelse.
En gennemgang af direktivets tekniske bestemmelser viser, at ingen af disse artikler udtrykkeligt nævner en beskyttelse, der er begrænset til den specifikke anvendelse, der er påvist for den pågældende sekvens af gener. Det kan opfattes som et argument til fordel for den sædvanlige brede beskyttelse frem for en begrænset beskyttelse, da det altid har været den traditionelle fremgangsmåde inden for patentlovgivningen.
På den anden side kan det opfattes således, at fællesskabslovgiver har haft til hensigt i det mindste at åbne mulighed for et begrænset beskyttelsesområde, der kun omfatter den konkrete industrielle anvendelse, der er redegjort for i patentansøgningen vedrørende denne bestemte type intervention. En sådan restriktiv fortolkning skulle ikke være uforenelig med direktivet.
Kommissionen vil nu i samråd med de involverede parter overveje følgerne af at tillade begge fortolkninger af direktivet og den bedste måde, hvorpå man kan nå frem til en korrekt anvendelse af direktivet, når det gælder kloning af mennesker. Direktivet er efter Kommissionens mening klart vedrørende spørgsmålet om patentering af reproduktiv kloning, der indebærer skabelse af nye mennesker, som helt klart udelukkes i direktivets artikel 6."@da2
".
Herr Präsident! Ich verstehe, dass den Abgeordneten sehr an einer ordnungsgemäßen Anwendung der Biotechnologie-Richtlinie liegt. Das ist nicht nur für all jene Vertreter der Branche von Bedeutung, die mithilfe von Patenten die Einführung neuer Produkte und Prozesse unterstützen, sondern auch für diejenigen, die von der Verfügbarkeit der Ergebnisse von Forschung und Entwicklung profitieren. Das können Wissenschaftler sein, Wettbewerber aus der Industrie, Patienten und medizinisches Personal sowie jene, die die Gesundheitssysteme verwalten.
Der Begriff des „therapeutischen Klonens“ erstreckt sich auf eine Vielzahl unterschiedlicher Möglichkeiten. In einigen Mitgliedstaaten ist die Forschung auf diesem Gebiet gestattet, in anderen nicht. Nach Ansicht der Kommission ist der Einsatz pluripotenter Stammzellen zur Heilung von Krankheiten nicht notwendigerweise von der Patentierbarkeit ausgeschlossen. Ausgehend von diesen Argumenten erscheint zum jetzigen Zeitpunkt eine Abänderung der Richtlinie nicht angebracht.
Ich möchte abschließend nochmals darauf verweisen, dass die Biotechnologie vor allem im Bereich der Medizin enorme Möglichkeiten zum Wohle des Menschen bietet und dass der Patentschutz für Schlüsselsektoren der Wirtschaft, die hohe Beträge in die Forschung und Entwicklung investieren, von sehr großer Bedeutung ist. Wir operieren vor dem Hintergrund einer globalen Wirtschaft. Das bedeutet, dass sich unsere Wirtschaft und unsere Wissenschaftler gegen die USA und auf im Wachstum begriffenen Märkten wie beispielsweise dem asiatischen behaupten müssen. So haben chinesische Unternehmen jüngsten Berichten zufolge im vergangenen Jahr in bestimmten Sektoren mehr Biotechnologiepatente in Europa angemeldet als europäische Unternehmen. Wie ich schon sagte, ich verstehe die Bedenken, die einige Abgeordnete angemeldet haben, und werde die Aussprache mit Interesse verfolgen.
Die Biotechnologie umfasst eine Vielzahl leistungsfähiger und bisweilen kontroverser Technologien, die einen entscheidenden Beitrag zur langfristigen Zukunft von Sektoren wie die Pharmaindustrie, die Lebensmittelindustrie, die Landwirtschaft, die Energiewirtschaft, die Textilindustrie und die chemische Industrie leisten. Die Biotechnologie eröffnet ferner ungeheure Möglichkeiten und Aussichten für die Entwicklung lebensrettender Arzneimittel und die Behandlung von Krankheiten. Wie kaum ein anderer Bereich kann sie zu einer massiven Verbesserung der Lebensqualität vieler Bürger beitragen. Doch der Erfolg der biotechnologischen Entwicklung hängt auch davon ab, ob für die damit verbundenen schwer wiegenden ethischen, gesellschaftlichen, ökonomischen und ökologischen Probleme Lösungen gefunden werden können.
Die Richtlinie 98/44/EG stellt ausgewogene Grundsätze für den Patentschutz von biotechnologischen Erfindungen auf. Dabei trägt sie den ethischen Aspekten dieser heiklen Thematik ebenso Rechnung wie dem legitimen Wunsch der Industrie und anderer nach Schaffung eines klaren und effektiven Rahmens für den Patentschutz in diesem Bereich der Technologie.
Ich möchte daran erinnern, dass das Ziel der Richtlinie darin besteht, einen rechtlichen Rahmen für die Erteilung von Patenten zu schaffen, der sich auf Forschungsergebnisse erstreckt. Sie soll in keiner Weise Rechtsvorschriften ablösen, die die Forschung in bestimmten Bereichen regeln, einschließlich ethischer Vorschriften wie jener zur menschlichen Integrität.
Die Kommission wird die Anwendung der Richtlinie in der Praxis auch künftig sehr aufmerksam und unter Berücksichtigung der damit verbunden ethischen, moralischen und kulturellen Aspekte verfolgen und das Parlament wie bisher im Rahmen der in der Richtlinie vorgesehenen Evaluierungsberichte informieren.
Zu den konkreten vom Parlament im Entschließungsantrag herausgestellten Bereichen möchte ich Folgendes sagen. Hinsichtlich des zweckgebundenen Schutzes stellt sich die Frage, ob Patente auf Gensequenzen (DNA-Sequenzen) nach dem klassischen Modell des Patentanspruchs zugelassen werden sollten, wonach der Ersterfinder eine Erfindung beanspruchen kann, die auch potenzielle künftige Verwendungen dieser Sequenz umfasst, oder ob das Patent eingeschränkt werden sollte, damit nur die Rechte auf die konkrete, im Patentantrag dargelegte Verwendung beansprucht werden können, das wäre dann der zweckgebundene Schutz.
Schaut man sich die technischen Bestimmungen der Richtlinie genauer an, so wird man feststellen, dass es in keinem dieser Artikel ausdrücklich um einen eingeschränkten Schutz geht, der sich ausdrücklich auf die konkrete Verwendung für die jeweilige Gensequenz bezieht. Das könnte als Argument für den üblichen umfassenden Schutz im Gegensatz zum eingeschränkten Schutz verstanden werden, der im Patentrecht traditionell stets den Vorrang hatte.
Andererseits könnte man meinen, dass es die Absicht des gemeinschaftlichen Gesetzgebers war, was diese spezielle Form der Erfindung betrifft, zumindest auf die Möglichkeit eines eingeschränkten Schutzes zu verweisen, der sich nur auf die konkrete gewerbliche Anwendung bezieht, die im Patent ausgewiesen wurde. Diese restriktive Auslegung dürfte sich nicht im Widerspruch zu dieser Richtlinie befinden.
In Absprache mit allen Beteiligten wird die Kommission nun prüfen, welche Konsequenzen die Zulassung beider Auslegungen der Richtlinie hätte und wie am besten die korrekte Anwendung der Richtlinie auf das Klonen von Menschen gewährleistet werden kann. Aus Sicht der Kommission sieht die Richtlinie klare Regelungen bezüglich der Patentierbarkeit von Verfahren zum Klonen von menschlichen Lebewesen vor, die nach Artikel 6 der Richtlinie eindeutig von der Patentierbarkeit ausgeschlossen sind."@de9
"Κύριε Πρόεδρε, κατανοώ τις ανησυχίες των βουλευτών ότι η οδηγία σχετικά με τη βιοτεχνολογία πρέπει να εφαρμόζεται ορθώς. Αυτό είναι σημαντικό, όχι μόνο για όλους τους εμπλεκόμενους στον κλάδο που χρησιμοποιούν διπλώματα ευρεσιτεχνίας προκειμένου να υποστηρίξουν την εισαγωγή νέων προϊόντων και διαδικασιών, αλλά και για όσους επωφελούνται από τη διαθεσιμότητα των αποτελεσμάτων της έρευνας και της ανάπτυξης. Αυτοί μπορεί να είναι ερευνητές, ανταγωνιστικές βιομηχανίες, ασθενείς και ιατρικό προσωπικό, καθώς και το προσωπικό που είναι επιφορτισμένο με τη διαχείριση των συστημάτων υγείας.
Ο όρος «θεραπευτική κλωνοποίηση» καλύπτει ένα ευρύ φάσμα διαφορετικών δυνατοτήτων. Η έρευνα μπορεί να επιτρέπεται σε ορισμένα κράτη μέλη και όχι σε άλλα. Για την Επιτροπή, η χρήση αρχέγονων πολυδύναμων κύτταρων για τη θεραπεία ασθενειών δεν αποκλείεται απαραίτητα από τη δυνατότητα χορήγησης διπλώματος ευρεσιτεχνίας. Υπό το πρίσμα αυτών των επιχειρημάτων, δεν φαίνεται σκόπιμο, σε αυτό το στάδιο, να τροποποιηθεί η οδηγία.
Εν κατακλείδι, θα ήθελα να υπενθυμίσω ότι η βιοτεχνολογία έχει τεράστιες δυνατότητες για την επίτευξη καλών σκοπών, ιδίως σε ιατρικούς τομείς, και η προστασία των διπλωμάτων ευρεσιτεχνίας είναι μεγάλης σημασίας στους βασικούς βιομηχανικούς τομείς, που επενδύουν μεγάλα ποσά στην έρευνα και στο αναπτυξιακό κόστος. Εργαζόμαστε στο πλαίσιο της παγκόσμιας οικονομίας, γεγονός το οποίο σημαίνει ότι η βιομηχανία και οι ερευνητές μας ανταγωνίζονται τις Ηνωμένες Πολιτείες και αναπτυσσόμενες αγορές όπως η Ασία. Πράγματι, σύμφωνα με πρόσφατες εκθέσεις, οι κινεζικές εταιρείες υπέβαλαν πέρυσι περισσότερες αιτήσεις κατοχύρωσης διπλωμάτων ευρεσιτεχνίας για τη βιοτεχνολογία στην Ευρώπη σε συγκεκριμένους τομείς από ό,τι οι ευρωπαϊκές εταιρείες. Όπως είπα, κατανοώ τις ανησυχίες που ήγειραν ορισμένοι βουλευτές και θα ακούσω με ενδιαφέρον τη συζήτηση.
Η βιοτεχνολογία καλύπτει ένα ευρύ φάσμα ισχυρών και συχνά αμφιλεγόμενων τεχνολογιών. Μπορούν να συμβάλουν δραστικά στο μακροπρόθεσμο μέλλον των βιομηχανιών φαρμακευτικών προϊόντων, τροφίμων, γεωργίας, ενέργειας, κλωστοϋφαντουργικών ειδών και χημικών. Η βιοτεχνολογία δημιουργεί επίσης νέες ευκαιρίες και προοπτικές για την ανάπτυξη σωτήριων φαρμάκων και τη θεραπεία ασθενειών. Προσφέρει τεράστιες δυνατότητες για τη ριζική βελτίωση της ποιότητας ζωής πολλών πολιτών. Αλλά η επιτυχία στην ανάπτυξη της βιοτεχνολογίας εξαρτάται επίσης από την ανεύρεση λύσεων στα σημαντικά ηθικά, κοινωνικά, οικονομικά και περιβαλλοντικά θέματα που φέρνει στο προσκήνιο.
Η οδηγία 98/44/ΕΚ καθιερώνει συνετές αρχές για την προστασία των βιοτεχνολογικών εφευρέσεων μέσω διπλωμάτων ευρεσιτεχνίας. Λαμβάνει επίσης υπόψη τις ηθικές πτυχές του ευαίσθητου αυτού θέματος, καθώς και τη θεμιτή προσδοκία της βιομηχανίας και άλλων να θεσπίσουν ένα σαφές και αποτελεσματικό πλαίσιο για την προστασία των διπλωμάτων ευρεσιτεχνίας στον τομέα της τεχνολογίας.
Επιτρέψτε μου να υπενθυμίσω ότι σκοπός της οδηγίας είναι να θεσπίσει το νομικό πλαίσιο για τη χορήγηση των διπλωμάτων ευρεσιτεχνίας, το οποίο καλύπτει τα αποτελέσματα της έρευνας. Δεν αντικαθιστά κατ’ ουδένα τρόπο κανονισμούς που διέπουν την έρευνα σε συγκεκριμένους τομείς, συμπεριλαμβανομένων ορισμένων ηθικών κανόνων, όπως οι κανόνες για την ακεραιότητα του ανθρώπινου όντος.
Η Επιτροπή θα συνεχίσει να παρακολουθεί την εφαρμογή της οδηγίας στην πράξη πολύ προσεκτικά, αποδίδοντας τη δέουσα προσοχή στη δεοντολογική, ηθική και πολιτιστική αντιμετώπιση, και δεν θα παραλείψει να ενημερώνει το Ευρωπαϊκό Κοινοβούλιο, όπως έχει πράξει έως τώρα, στο πλαίσιο των εκθέσεων αξιολόγησης που εξετάζονται στην οδηγία.
Όσον αφορά τους συγκεκριμένους τομείς που επισημαίνονται από το Κοινοβούλιο στην πρόταση ψηφίσματος, θα ήθελα να κάνω τις ακόλουθες παρατηρήσεις. Σχετικά με την ειδική προστασία, το θέμα είναι κατά πόσον τα διπλώματα ευρεσιτεχνίας για τις γονιδιακές αλληλουχίες –αλληλουχίες DNA– πρέπει να επιτρέπονται σύμφωνα με το κλασικό πρότυπο του δικαιώματος στην ευρεσιτεχνία, σύμφωνα με το οποίο ο πρώτος εφευρέτης μπορεί να διεκδικήσει μια εφεύρεση που καλύπτει πιθανές μελλοντικές χρήσεις αυτής της αλληλουχίας. Αν, όμως, το δίπλωμα ευρεσιτεχνίας πρέπει να περιορίζεται ούτως ώστε μόνο η συγκεκριμένη χρήση που αποκαλύπτεται στην εφαρμογή του διπλώματος ευρεσιτεχνίας να μπορεί να διεκδικηθεί, τότε τι αποτελεί ειδική προστασία;
Κατά την εξέταση των τεχνικών διατάξεων της οδηγίας, μπορεί να διαπιστωθεί ότι κανένα από αυτά τα άρθρα δεν αντιμετωπίζει συγκεκριμένα την ιδέα ενός περιορισμένου βαθμού προστασίας συνδεόμενου με τη συγκεκριμένη χρήση που καθορίζεται για την ενεχόμενη γονιδιακή αλληλουχία. Αυτό μπορεί να θεωρηθεί ενδεχομένως ως επιχείρημα υπέρ του συνήθους ευρέος φάσματος προστασίας και όχι του περιορισμένου, εφόσον αυτή υπήρξε ανέκαθεν η παραδοσιακή προσέγγιση στη νομοθεσία για τα διπλώματα ευρεσιτεχνίας.
Αφετέρου, μπορεί ενδεχομένως να θεωρηθεί ότι ο κοινοτικός νομοθέτης είχε ως πρόθεση τουλάχιστον να θεσπίσει τη δυνατότητα ενός περιορισμένου φάσματος προστασίας, αποκλειστικά για τη συγκεκριμένη βιομηχανική εφαρμογή που καθορίζεται στο δίπλωμα ευρεσιτεχνίας όσον αφορά τον συγκεκριμένο τύπο εφεύρεσης. Αυτή η περιοριστική ερμηνεία δεν πρέπει να είναι ασύμβατη με την οδηγία.
Η Επιτροπή θα εξετάσει τώρα, σε διαβούλευση με τους εμπλεκόμενους, τις συνέπειες της αναγνώρισης και των δύο ερμηνειών της οδηγίας και του καλύτερου τρόπου επίτευξης της ορθής εφαρμογής της οδηγίας για την ανθρώπινη κλωνοποίηση. Η οδηγία είναι σαφής για την Επιτροπή όσον αφορά το θέμα της δυνατότητας ευρεσιτεχνιακής κατοχύρωσης της αναπαραγωγικής κλωνοποίησης που περιλαμβάνει τη δημιουργία νέων ανθρωπίνων όντων, η οποία αποκλείεται ρητώς σύμφωνα με το άρθρο 6 της οδηγίας."@el10
"Señor Presidente, entiendo la preocupación de sus Señorías de que la Directiva sobre biotecnología se aplique correctamente. Es importante, no solo para quienes en el sector utilizan patentes para apoyar la introducción de nuevos productos y procesos, sino también para quienes se benefician de la disponibilidad de los resultados de la investigación y el desarrollo. Pueden ser investigadores, competidores industriales, pacientes y personal médico, y quienes administran los sistemas de salud.
El término «clonación terapéutica» abarca una amplia gama de posibilidades distintas. La investigación puede estar permitida en algunos Estados miembros y prohibida en otros. Para la Comisión, el uso de células madre humanas pluripotentes para curar enfermedades no queda necesariamente excluido de la patentabilidad. A la luz de esos argumentos, no parece apropiada una modificación de la Directiva en estos momentos.
En resumen, quisiera recordar que la biotecnología tiene un enorme potencial beneficioso, sobre todo en el terreno médico, y la protección de patentes es de gran importancia para los principales sectores industriales, que invierten muchísimo en investigación y desarrollo. Trabajamos en el contexto de una economía mundial, lo que significa que nuestra industria y nuestros investigadores compiten con los de los Estados Unidos y de mercados en crecimiento como Asia. De hecho, según informes recientes, las empresas chinas presentaron el año pasado más patentes de biotecnología en Europa en determinados sectores que las empresas europeas. Como he dicho, entiendo la preocupación que han expresado algunos diputados y escucharé el debate con interés.
La biotecnología abarca una amplia gama de tecnologías poderosas y a veces controvertidas. Pueden realizar una aportación vital para el futuro a largo plazo de industrias como la farmacéutica, alimentaria, agrícola, energética, textil y química. La biotecnología también crea nuevas oportunidades y perspectivas para desarrollar fármacos que salven vidas y curen enfermedades. Ofrece un enorme potencial para mejorar en gran manera la calidad de vida de muchos ciudadanos. Pero el éxito del desarrollo de la biotecnología también depende de que se encuentren soluciones para las principales cuestiones éticas, sociales, económicas y medioambientales que plantea.
La Directiva 98/44/CE establece unos principios bien equilibrados para la protección de las invenciones biotecnológicas mediante patentes. También tiene en cuenta los aspectos éticos de este tema tan delicado, así como el deseo legítimo del sector, y otros, de delimitar una esfera clara y eficaz para la protección de patentes en este ámbito de la tecnología.
Permítanme recordar que el objetivo de esta Directiva es establecer el marco legal para la concesión de patentes, lo que incluye los resultados de la investigación. No sustituye en modo alguno los reglamentos que rigen la investigación en determinados ámbitos, incluidas determinadas normas éticas sobre la integridad humana.
La Comisión seguirá controlando muy detenidamente la puesta en práctica de esta Directiva, con la debida consideración por las cuestiones éticas, morales y culturales, y no dejará de informar al Parlamento Europeo, como ha hecho hasta ahora, en el marco de los informes de evaluación previstos en la Directiva.
En cuanto a los ámbitos particulares identificados por el Parlamento en la propuesta de resolución, quiero realizar las siguientes observaciones. Sobre la protección en función del objetivo, la cuestión es si las patentes sobre secuencias de genes –secuencias de ADN– deberían concederse según el modelo clásico de reivindicación de patente que permite a un primer inventor reivindicar una invención que abarca posibles futuros usos de dicha secuencia. ¿O bien debería limitarse la patente de modo que solo se pudiera reivindicar el uso específico revelado en la solicitud de la patente, que es la protección en función del objetivo?
Al examinar las disposiciones técnicas de la Directiva, se puede observar que ninguno de esos artículos aborda explícitamente el concepto de un ámbito restringido de protección en cuanto al uso específico identificado para la secuencia de genes en cuestión. Se podría considerar un argumento a favor del amplio alcance habitual de la protección, más que del restringido, dado que siempre ha sido ese el planteamiento tradicional del Derecho de patentes.
Por otro lado, se podría pensar que el legislador comunitario intentó al menos plantear la posibilidad de un ámbito limitado de protección, que abarque solo la aplicación industrial específica identificada en la patente en lo que se refiere a dicho tipo concreto de invención. Esta interpretación restrictiva no sería incompatible con la Directiva.
Ahora la Comisión, en consulta con las partes implicadas, considerará las consecuencias de permitir ambas interpretaciones de la Directiva y la mejor forma de conseguir una aplicación correcta de la Directiva sobre clonación humana. La Directiva es clara para la Comisión en cuanto al tema de la patentabilidad de la clonación reproductora con creación de nuevos seres humanos, que queda claramente excluida en el artículo 6 de la misma."@es20
"Mr President, I understand Members’ concerns that the biotechnology directive should be applied correctly. This is important, not just for all those in industry who use patents to support the introduction of new products and processes, but also those who benefit from the availability of the results of research and development. These could be researchers, industrial competitors, patients and medical staff and those who administer health systems.
The term ‘therapeutic cloning’ covers a wide range of different possibilities. Research may be permitted in some Member States and not in others. For the Commission, the use of human pluripotent stem cells to cure diseases is not necessarily excluded from patentability. In light of those arguments, a modification of the directive does not, at this stage, seem appropriate.
In conclusion, I would like to recall that biotechnology has enormous potential for good, particularly in medical fields, and patent protection is of great importance to key industrial sectors, which invest heavily in research and development costs. We are working in the context of a global economy, which means our industry and researchers are competing with those in the United States and growing markets such as Asia. Indeed, according to recent reports Chinese companies filed more biotechnology patents in Europe in certain sectors last year than European companies did. As I have said, I understand the concerns that some Members have raised and I shall listen with interest to the debate.
Biotechnology covers a wide range of powerful and sometimes controversial technologies. They can make a vital contribution to the long-term future of industries such as pharmaceuticals, food, agriculture, energy, textiles and chemicals. Biotechnology also creates new opportunities and prospects for developing life-saving drugs and treating diseases. It offers enormous potential for massively improving the quality of life of many citizens. But success in developing biotechnology also depends on finding solutions to the significant ethical, societal, economic and environmental issues it throws up.
Directive 98/44/EC establishes well-balanced principles for the protection of biotechnological inventions through patents. It also takes into account the ethical aspects of this sensitive subject, as well as the legitimate desire of industry and others to establish a clear and effective scope for patent protection in this area of technology.
Let me recall that the purpose of the directive is to establish the legal framework for granting patents, which covers the results of research. It does not in any way replace regulations that govern research in particular areas, including certain ethical rules such as those on human integrity.
The Commission will continue to follow the application of the directive in practice very carefully, with due regard to ethical, moral and cultural considerations, and will not fail to inform the European Parliament, as it has so far done, in the framework of the evaluation reports envisaged in the directive.
In terms of the particular areas identified by Parliament in the motion for a resolution, I make the following remarks. On purpose-bound protection, the issue is whether patents on gene sequences – DNA sequences – should be allowed according to the classical model of patent claim whereby a first inventor can claim an invention that covers possible future uses of that sequence. Or should the patent be restricted so that only the specific use disclosed in the patent application can be claimed, which is purpose-bound protection?
On examination of the technical provisions of the directive, it can be seen that none of these articles explicitly addresses the concept of a restricted scope of protection relating to the specific use identified for the gene sequence concerned. That might be seen as arguing for the usual broad scope of protection rather than a restricted one, since that has always been the traditional approach in patent law.
On the other hand, it might be thought that the Community legislator had intended at least to raise the possibility of a limited scope of protection, covering only the specific industrial application identified in the patent as far as this particular type of invention is concerned. That restrictive interpretation should not be incompatible with the directive.
The Commission will now, in consultation with those involved, consider the consequences of allowing both interpretations of the directive and the best way to achieve a correct application of the directive on human cloning. The directive is clear for the Commission as regards the issue of patentability of reproductive cloning involving the creation of new human beings, which is clearly excluded under Article 6 of the directive."@et5
"Arvoisa puhemies, ymmärrän, että parlamentin jäsenet ovat huolissaan bioteknologiadirektiivin moitteettomasta soveltamisesta. Moitteeton soveltaminen on tärkeää teollisuudessa kaikille niille, jotka käyttävät patentteja tukeakseen uusien tuotteiden ja prosessien käyttöönottoa, mutta myös niille, jotka hyötyvät tutkimus- ja kehittämistoiminnan tulosten saatavuudesta. Tällaisia henkilöitä voivat olla esimerkiksi tutkijat, kilpailevat teollisuusyritykset, potilaat ja lääkintähenkilöstö sekä terveydenhuoltojärjestelmiä hallinnoivat virkamiehet.
Ilmaus "terapeuttinen kloonaus" kattaa koko joukon erilaisia mahdollisuuksia. Sitä koskeva tutkimus saattaa olla joissakin jäsenvaltioissa sallittua ja toisissa ei. Komission mielestä ihmisen pluripotenttien kantasolujen käyttämistä sairauksien parantamiseen ei pidä välttämättä sulkea patentoitavuuden ulkopuolelle. Tällaisten väitteiden valossa direktiivin muuttaminen ei näytä tässä vaiheessa tarkoituksenmukaiselta.
Lopuksi haluan muistuttaa, että bioteknologia avaa huimat mahdollisuudet tehdä hyvää, varsinkin lääketieteen aloilla, ja patenttisuoja on erittäin tärkeä keskeisille teollisuudenaloille, jotka investoivat voimakkaasti tutkimus- ja kehittämismenoihin. Työskentelemme maailmanlaajuisessa taloudessa, mikä merkitsee, että teollisuutemme ja tutkijamme kilpailevat Yhdysvaltojen teollisuuden ja tutkijoiden kanssa sekä Aasian kaltaisten kasvavien markkinoiden kanssa. Viimeaikaiset selvitykset osoittavatkin, että kiinalaisyritykset tekivät Euroopassa tietyillä aloilla enemmän bioteknologian patenttihakemuksia kuin eurooppalaiset yritykset. Kuten olen jo todennut, ymmärrän eräiden jäsenten esittämät huolenaiheet ja kuuntelen mielenkiinnolla aiheesta käytävää keskustelua.
Bioteknologiaan kuuluu suuri määrä tehokkaita ja toisinaan kiistanalaisiakin tekniikoita. Niillä voidaan myötävaikuttaa ratkaisevasti esimerkiksi lääke- ja elintarviketeollisuuden, maatalouden sekä energia-, tekstiili- ja kemianteollisuuden kaltaisten tuotannonalojen tulevaisuuteen pitkällä aikavälillä. Bioteknologia luo myös uusia tilaisuuksia ja näkymiä elintärkeiden lääkkeiden ja sairaanhoidon kehittämiselle. Se tarjoaa valtavia mahdollisuuksia parantaa merkittävästi monien kansalaisten elämänlaatua. Onnistuminen bioteknologian kehittämistyössä riippuu kuitenkin myös siitä, löydetäänkö sen synnyttämiin merkittäviin eettisiin, yhteiskunnallisiin, taloudellisiin ja ympäristöpoliittisiin kysymyksiin ratkaisuja.
Direktiivillä 98/44/EY luodaan sopusointuiset periaatteet bioteknologian keksintöjen suojaamiseksi patentein. Siinä otetaan myös huomioon tämän arkaluontoisen aiheen eettiset näkökulmat sekä teollisuuden ja muiden tahojen oikeutettu toive selkeän ja tehokkaan suojan saamiseksi tämän teknologia-alan patenteille.
Haluan muistuttaa, että direktiivin tarkoituksena on luoda patenttien myöntämiselle lainsäädännölliset puitteet, jotka kattavat myös tutkimustulokset. Se ei mitenkään korvaa erityisalojen tutkimusta säänteleviä asetuksia eikä tiettyjä eettisiä sääntöjä, joita on annettu muun muassa ihmisten koskemattomuudesta.
Komissio seuraa jatkossakin erittäin tarkasti direktiivin soveltamista käytäntöön ja ottaa eettiset, moraaliset ja kulttuuriset näkökohdat asianmukaisesti huomioon. Se ei myöskään unohda – kuten ei ole tähänkään mennessä unohtanut – tiedottaa asiasta Euroopan parlamentille direktiivin mukaisilla arviointikertomuksilla.
Esitän parlamentin päätöslauselmaesityksessään yksilöimien erikoisalojen osalta seuraavat huomiot. Käyttötarkoituksiin sidotun suojan osalta kyse on siitä, voidaanko geenin sekvenssiä – DNA-sekvenssiä – koskeva patenttisuoja hyväksyä perinteisen patenttisuojajärjestelmän mukaisesti, jolloin keksinnön ensimmäisenä tuottanut taho voi esittää keksinnön osalta vaatimuksen, joka kattaa kyseisen sekvenssin mahdolliset myöhemmät käyttötarkoitukset. Vai pitäisikö patenttisuojaa rajoittaa niin, että tällainen vaatimus voi kattaa ainoastaan tietyn käyttötarkoituksen, joka on esitetty havainnollisesti patenttihakemuksessa, mikä tarkoittaa käyttötarkoitukseen sidottua suojaa?
Tarkasteltaessa direktiivin teknisiä säännöksiä voidaan havaita, että yhdessäkään niitä koskevista artikloista ei säädetä nimenomaisesti suojan laajuuden rajoittamisesta asianomaisen geeniketjun tiettyyn käyttötarkoitukseen. Tämän pohjalta voitaisiin ennemminkin kannattaa tavanomaista laajaa kuin rajoitettua suojaa, koska se on aina ollut perinteinen lähestymistapa patenttioikeudessa.
Toisaalta on aihetta olettaa, että yhteisön lainsäätäjä oli aikonut vähintäänkin tuoda esiin mahdollisuuden rajoitetusta suojasta, joka kattaisi – siinä määrin kuin se koskee asianomaista keksintöä – ainoastaan tietyn teollisen käytön, joka on esitetty havainnollisesti patentissa. Tällaisen rajoitetun tulkinnan ei pitäisi olla direktiivin vastaista.
Komissio aikookin nyt tutkia yhteistyössä asianomaisten osapuolten kanssa, mitä seurauksia direktiivin molempien tulkintojen hyväksymisellä voisi olla ja mikä on paras tapa varmistaa ihmisten kloonausta koskevan direktiivin moitteeton soveltaminen. Komissio katsoo, että direktiivi on uusien ihmisten luomista koskevan lisääntymistavoitteisen kloonauksen osalta selkeä, sillä se kielletään selvästi direktiivin 6 artiklan nojalla."@fi7
"Monsieur le Président, je comprends le souhait des députés européens de voir la directive sur les biotechnologies appliquée correctement. Il s’agit d’un point important, non seulement pour tous les industriels qui ont recours aux brevets pour appuyer l’introduction de nouveaux produits et procédés, mais également pour ceux qui bénéficient de la disponibilité des résultats dans le domaine de la recherche et du développement, à savoir les chercheurs, les concurrents industriels, les patients, le personnel médical, ainsi que les gestionnaires des systèmes de soins de santé.
L’expression «clonage thérapeutique» englobe nombre de possibilités diverses. Seuls quelques États membres pourraient autoriser la recherche dans ce domaine. Aux yeux de la Commission, l’utilisation de cellules souches humaines pluripotentes dans une optique thérapeutique n’est pas nécessairement exclue de la brevetabilité. À la lumière de ces arguments, il ne semble pas approprié, à ce stade, de modifier la directive.
En conclusion, je voudrais rappeler que les biotechnologies peuvent avoir d’énormes répercussions positives, en particulier dans le domaine médical, et que la protection par le brevet est cruciale pour les grands secteurs industriels, qui investissent massivement dans la recherche et le développement. Notre travail s’inscrit dans le cadre d’une économie mondiale, ce qui signifie que notre industrie et nos chercheurs sont en concurrence avec leurs homologues américains, ainsi qu’avec ceux issus des marchés en plein essor, comme l’Asie. En effet, selon de récents rapports, les entreprises chinoises ont déposé l’année dernière, dans certains secteurs d’activité européens, davantage de brevets de biotechnologie que les entreprises européennes. Comme je l’ai dit, je comprends les inquiétudes exprimées par quelques députés, et c’est avec beaucoup d’attention que je suivrai le débat.
Les biotechnologies englobent un large éventail de technologies puissantes et parfois controversées. Elles peuvent apporter une contribution essentielle aux perspectives à long terme d’industries, telles que l’industrie pharmaceutique, l’industrie de l’alimentation, de l’agriculture, de l’énergie, du textile et des produits chimiques. Elles créent également de nouvelles possibilités et perspectives en matière de développement de médicaments aptes à sauver des vies et à traiter des maladies. Elles offrent un potentiel énorme pour ce qui est de l’amélioration massive de la qualité de vie de nombreux citoyens. Mais leur développement fructueux dépend également des solutions à apporter aux grandes questions qu’elles posent dans les domaines de l’éthique, de la société, de l’économie et de l’environnement.
La directive 98/44/CE pose des principes équilibrés pour la protection des inventions biotechnologiques au moyen de brevets. Elle tient également compte des aspects éthiques qui entourent ce sujet sensible, ainsi que du souhait exprimé avec raison par l’industrie, entre autres, de laisser à la protection conférée par les brevets dans ce domaine technologique une marge de manœuvre efficace et bien délimitée.
Laissez-moi vous rappeler l’objet de cette directive: l’établissement du cadre juridique pour l’octroi de brevets, qui couvre les résultats de la recherche. Elle ne se substitue en aucun cas aux règlements qui organisent la recherche dans certains domaines, y compris certaines règles éthiques telles que celles sur l’intégrité de la personne.
La Commission continuera de suivre de très près la mise en œuvre de cette directive dans la pratique, en tenant dûment compte des aspects éthiques, moraux et culturels, et veillera à en informer le Parlement européen, comme elle l’a fait jusqu’à présent, dans le cadre des rapports d’évaluation prévus par la directive.
Concernant les points spécifiques que le Parlement a relevés dans la proposition de résolution, je ferai les remarques suivantes. Pour ce qui est de la protection fondée sur les fonctions, la question qui se pose est la suivante: les brevets sur les séquences de gène - séquences ADN - devraient-ils être autorisés conformément au modèle classique de la revendication de brevet par laquelle un premier inventeur peut revendiquer une invention couvrant des éventuelles utilisations futures de cette séquence? Ou bien le brevet devrait-il être limité afin que seul l’usage spécifique révélé dans la demande de brevet puisse être revendiqué, comme le veut la protection fondée sur les fonctions?
Après examen des dispositions techniques de la directive, on constate qu’aucun de ces articles n’aborde explicitement le concept d’étendue limitée de la protection concernant l’usage spécifique identifié pour la séquence de gène concernée, ce qui pourrait être considéré comme un argument non pas en faveur d’une protection limitée, mais en faveur de la protection élargie habituelle, vu qu’il s’agit de l’approche traditionnellement adoptée dans le domaine du droit des brevets.
D’autre part, on pourrait penser que le législateur européen avait au moins tenté de rendre possible la protection limitée, ne couvrant que l’application industrielle spécifique identifiée dans le brevet, pour autant que ce soit ce type particulier d’invention qui soit concerné. Cette interprétation restrictive devrait pouvoir être conciliée avec la directive.
La Commission va maintenant se pencher, en concertation avec les différents acteurs, sur les conséquences de cette double interprétation potentielle de la directive et la meilleure façon de parvenir à une application correcte de la directive sur le clonage humain. La Commission estime que la directive est sans ambiguïté pour ce qui est de la question de la brevetabilité du clonage reproductif impliquant la création de nouveaux êtres humains, lequel est clairement exclu à l’article 6 de la directive."@fr8
"Mr President, I understand Members’ concerns that the biotechnology directive should be applied correctly. This is important, not just for all those in industry who use patents to support the introduction of new products and processes, but also those who benefit from the availability of the results of research and development. These could be researchers, industrial competitors, patients and medical staff and those who administer health systems.
The term ‘therapeutic cloning’ covers a wide range of different possibilities. Research may be permitted in some Member States and not in others. For the Commission, the use of human pluripotent stem cells to cure diseases is not necessarily excluded from patentability. In light of those arguments, a modification of the directive does not, at this stage, seem appropriate.
In conclusion, I would like to recall that biotechnology has enormous potential for good, particularly in medical fields, and patent protection is of great importance to key industrial sectors, which invest heavily in research and development costs. We are working in the context of a global economy, which means our industry and researchers are competing with those in the United States and growing markets such as Asia. Indeed, according to recent reports Chinese companies filed more biotechnology patents in Europe in certain sectors last year than European companies did. As I have said, I understand the concerns that some Members have raised and I shall listen with interest to the debate.
Biotechnology covers a wide range of powerful and sometimes controversial technologies. They can make a vital contribution to the long-term future of industries such as pharmaceuticals, food, agriculture, energy, textiles and chemicals. Biotechnology also creates new opportunities and prospects for developing life-saving drugs and treating diseases. It offers enormous potential for massively improving the quality of life of many citizens. But success in developing biotechnology also depends on finding solutions to the significant ethical, societal, economic and environmental issues it throws up.
Directive 98/44/EC establishes well-balanced principles for the protection of biotechnological inventions through patents. It also takes into account the ethical aspects of this sensitive subject, as well as the legitimate desire of industry and others to establish a clear and effective scope for patent protection in this area of technology.
Let me recall that the purpose of the directive is to establish the legal framework for granting patents, which covers the results of research. It does not in any way replace regulations that govern research in particular areas, including certain ethical rules such as those on human integrity.
The Commission will continue to follow the application of the directive in practice very carefully, with due regard to ethical, moral and cultural considerations, and will not fail to inform the European Parliament, as it has so far done, in the framework of the evaluation reports envisaged in the directive.
In terms of the particular areas identified by Parliament in the motion for a resolution, I make the following remarks. On purpose-bound protection, the issue is whether patents on gene sequences – DNA sequences – should be allowed according to the classical model of patent claim whereby a first inventor can claim an invention that covers possible future uses of that sequence. Or should the patent be restricted so that only the specific use disclosed in the patent application can be claimed, which is purpose-bound protection?
On examination of the technical provisions of the directive, it can be seen that none of these articles explicitly addresses the concept of a restricted scope of protection relating to the specific use identified for the gene sequence concerned. That might be seen as arguing for the usual broad scope of protection rather than a restricted one, since that has always been the traditional approach in patent law.
On the other hand, it might be thought that the Community legislator had intended at least to raise the possibility of a limited scope of protection, covering only the specific industrial application identified in the patent as far as this particular type of invention is concerned. That restrictive interpretation should not be incompatible with the directive.
The Commission will now, in consultation with those involved, consider the consequences of allowing both interpretations of the directive and the best way to achieve a correct application of the directive on human cloning. The directive is clear for the Commission as regards the issue of patentability of reproductive cloning involving the creation of new human beings, which is clearly excluded under Article 6 of the directive."@hu11
".
Signor Presidente, comprendo le preoccupazioni degli onorevoli parlamentari, che auspicano una corretta applicazione della direttiva sulle biotecnologie. E’ una questione importante, non soltanto per coloro che, all’interno del settore, usano i brevetti per sostenere l’introduzione di nuovi prodotti e processi, ma anche per coloro che traggono vantaggio dalla disponibilità dei risultati della ricerca e dello sviluppo, siano essi ricercatori, concorrenti industriali, pazienti, personale medico o amministratori sanitari.
Il termine “clonazione terapeutica” contempla un’ampia gamma di possibilità di diversa natura. La ricerca potrebbe essere consentita in alcuni Stati membri e non in altri. Per la Commissione, l’uso delle cellule staminali pluripotenti a fini di cura delle malattie non è necessariamente escluso dalla brevettabilità. Alla luce di queste considerazioni, non pare necessario procedere, in questa fase, a una modifica della direttiva.
In conclusione, desidero ricordare che la biotecnologia ha enormi potenzialità positive, in particolare nel settore medico, e che la protezione dei brevetti riveste enorme importanza per i principali settori industriali, che investono ingenti somme per finanziare la ricerca e lo sviluppo. Operiamo nel contesto dell’economia globale, per cui le nostre realtà produttive e i nostri ricercatori competono con i loro omologhi negli Stati Uniti e nei mercati emergenti, come quelli asiatici. In effetti, secondo recenti relazioni, in alcuni settori l’anno scorso le società cinesi hanno registrato più brevetti nel settore delle biotecnologie, in alcuni ambiti, di quanto non abbiano fatto le imprese europee. Come ho detto, comprendo le preoccupazioni espresse da alcuni onorevoli parlamentari e seguirò con interesse il dibattito.
La biotecnologia comprende un’ampia gamma di tecnologie importanti e talvolta controverse, che possono offrire un contributo essenziale al futuro a lungo termine di ambiti quali: settore farmaceutico, alimentazione, agricoltura, energia, tessile e chimica. La biotecnologia crea altresì nuove opportunità e prospettive per lo sviluppo di farmaci salvavita e per la cura delle malattie. Rappresenta un enorme potenziale ai fini del radicale miglioramento della qualità della vita di molti cittadini. Tuttavia, il successo dello sviluppo della biotecnologia dipende anche dalla capacità di trovare soluzioni alle importanti questioni etiche, societarie, economiche e ambientali che solleva.
La direttiva 98/44/CE stabilisce obiettivi bilanciati di tutela delle invenzioni biotecnologiche tramite brevetto, tenendo altresì conto degli aspetti etici di questo tema delicato e del legittimo auspicio del settore e di altre parti di stabilire un campo di applicazione chiaro ed efficace per la protezione dei brevetti in questo settore tecnologico.
Consentitemi di ricordare che l’obiettivo di questa direttiva è la fissazione del quadro normativo per la concessione di brevetti sui risultati della ricerca. Questa direttiva non sostituisce affatto i regolamenti che disciplinano la ricerca in determinati settori, i quali includono alcune regole etiche come quelle in materia di integrità umana.
La Commissione continuerà a seguire da vicino l’applicazione pratica della direttiva, tenendo debitamente conto degli aspetti etici, morali e culturali, e non mancherà di informare il Parlamento europeo, come ha fatto sinora, nel quadro delle relazioni di valutazione previste dalla direttiva.
Per quanto attiene alle aree specifiche identificate dal Parlamento nella proposta di risoluzione, desidero presentare le seguenti osservazioni. Per quanto attiene alla protezione in funzione dello scopo, ci si chiede se i brevetti sulle sequenze genetiche – sequenze di DNA – debbano essere concessi in base al modello classico, secondo cui il primo inventore può rivendicare un’invenzione che copre i futuri usi possibili di tale sequenza, o se si debba prevedere invece la restrizione del brevetto all’uso specifico definito nella richiesta di brevetto, ossia una copertura in funzione dello scopo.
L’esame delle disposizioni tecniche della direttiva rivela che nessuno di questi articoli tratta esplicitamente il concetto di campo di applicazione restrittivo della protezione, limitato all’uso specifico identificato per la sequenza genetica in oggetto. Si potrebbe sostenere che ciò deponga a favore di un campo di applicazione ampio, e non restrittivo, in termini di protezione, visto che questo è sempre stato l’approccio tradizionale nel diritto in materia di brevetti.
D’altro lato, si potrebbe ritenere che il legislatore comunitario abbia quanto meno voluto consentire la possibilità di un ambito di protezione limitato, che copra soltanto l’applicazione industriale specifica identificata nel brevetto per quanto attiene a questo tipo particolare di invenzione. Questa interpretazione restrittiva probabilmente non sarebbe incompatibile con la direttiva.
Ora la Commissione, in consultazione con le parti interessate, esaminerà le conseguenze che deriverebbero dal consentire ciascuna delle due interpretazioni della direttiva, e studierà il modo migliore per assicurare una corretta applicazione della direttiva nell’ambito della clonazione umana. Per la Commissione, la direttiva è chiara quanto alla questione della brevettabilità della clonazione riproduttiva, che comporta la creazione di nuovi esseri viventi, esclusa esplicitamente all’articolo 6 della direttiva."@it12
"Mr President, I understand Members’ concerns that the biotechnology directive should be applied correctly. This is important, not just for all those in industry who use patents to support the introduction of new products and processes, but also those who benefit from the availability of the results of research and development. These could be researchers, industrial competitors, patients and medical staff and those who administer health systems.
The term ‘therapeutic cloning’ covers a wide range of different possibilities. Research may be permitted in some Member States and not in others. For the Commission, the use of human pluripotent stem cells to cure diseases is not necessarily excluded from patentability. In light of those arguments, a modification of the directive does not, at this stage, seem appropriate.
In conclusion, I would like to recall that biotechnology has enormous potential for good, particularly in medical fields, and patent protection is of great importance to key industrial sectors, which invest heavily in research and development costs. We are working in the context of a global economy, which means our industry and researchers are competing with those in the United States and growing markets such as Asia. Indeed, according to recent reports Chinese companies filed more biotechnology patents in Europe in certain sectors last year than European companies did. As I have said, I understand the concerns that some Members have raised and I shall listen with interest to the debate.
Biotechnology covers a wide range of powerful and sometimes controversial technologies. They can make a vital contribution to the long-term future of industries such as pharmaceuticals, food, agriculture, energy, textiles and chemicals. Biotechnology also creates new opportunities and prospects for developing life-saving drugs and treating diseases. It offers enormous potential for massively improving the quality of life of many citizens. But success in developing biotechnology also depends on finding solutions to the significant ethical, societal, economic and environmental issues it throws up.
Directive 98/44/EC establishes well-balanced principles for the protection of biotechnological inventions through patents. It also takes into account the ethical aspects of this sensitive subject, as well as the legitimate desire of industry and others to establish a clear and effective scope for patent protection in this area of technology.
Let me recall that the purpose of the directive is to establish the legal framework for granting patents, which covers the results of research. It does not in any way replace regulations that govern research in particular areas, including certain ethical rules such as those on human integrity.
The Commission will continue to follow the application of the directive in practice very carefully, with due regard to ethical, moral and cultural considerations, and will not fail to inform the European Parliament, as it has so far done, in the framework of the evaluation reports envisaged in the directive.
In terms of the particular areas identified by Parliament in the motion for a resolution, I make the following remarks. On purpose-bound protection, the issue is whether patents on gene sequences – DNA sequences – should be allowed according to the classical model of patent claim whereby a first inventor can claim an invention that covers possible future uses of that sequence. Or should the patent be restricted so that only the specific use disclosed in the patent application can be claimed, which is purpose-bound protection?
On examination of the technical provisions of the directive, it can be seen that none of these articles explicitly addresses the concept of a restricted scope of protection relating to the specific use identified for the gene sequence concerned. That might be seen as arguing for the usual broad scope of protection rather than a restricted one, since that has always been the traditional approach in patent law.
On the other hand, it might be thought that the Community legislator had intended at least to raise the possibility of a limited scope of protection, covering only the specific industrial application identified in the patent as far as this particular type of invention is concerned. That restrictive interpretation should not be incompatible with the directive.
The Commission will now, in consultation with those involved, consider the consequences of allowing both interpretations of the directive and the best way to achieve a correct application of the directive on human cloning. The directive is clear for the Commission as regards the issue of patentability of reproductive cloning involving the creation of new human beings, which is clearly excluded under Article 6 of the directive."@lt14
"Mr President, I understand Members’ concerns that the biotechnology directive should be applied correctly. This is important, not just for all those in industry who use patents to support the introduction of new products and processes, but also those who benefit from the availability of the results of research and development. These could be researchers, industrial competitors, patients and medical staff and those who administer health systems.
The term ‘therapeutic cloning’ covers a wide range of different possibilities. Research may be permitted in some Member States and not in others. For the Commission, the use of human pluripotent stem cells to cure diseases is not necessarily excluded from patentability. In light of those arguments, a modification of the directive does not, at this stage, seem appropriate.
In conclusion, I would like to recall that biotechnology has enormous potential for good, particularly in medical fields, and patent protection is of great importance to key industrial sectors, which invest heavily in research and development costs. We are working in the context of a global economy, which means our industry and researchers are competing with those in the United States and growing markets such as Asia. Indeed, according to recent reports Chinese companies filed more biotechnology patents in Europe in certain sectors last year than European companies did. As I have said, I understand the concerns that some Members have raised and I shall listen with interest to the debate.
Biotechnology covers a wide range of powerful and sometimes controversial technologies. They can make a vital contribution to the long-term future of industries such as pharmaceuticals, food, agriculture, energy, textiles and chemicals. Biotechnology also creates new opportunities and prospects for developing life-saving drugs and treating diseases. It offers enormous potential for massively improving the quality of life of many citizens. But success in developing biotechnology also depends on finding solutions to the significant ethical, societal, economic and environmental issues it throws up.
Directive 98/44/EC establishes well-balanced principles for the protection of biotechnological inventions through patents. It also takes into account the ethical aspects of this sensitive subject, as well as the legitimate desire of industry and others to establish a clear and effective scope for patent protection in this area of technology.
Let me recall that the purpose of the directive is to establish the legal framework for granting patents, which covers the results of research. It does not in any way replace regulations that govern research in particular areas, including certain ethical rules such as those on human integrity.
The Commission will continue to follow the application of the directive in practice very carefully, with due regard to ethical, moral and cultural considerations, and will not fail to inform the European Parliament, as it has so far done, in the framework of the evaluation reports envisaged in the directive.
In terms of the particular areas identified by Parliament in the motion for a resolution, I make the following remarks. On purpose-bound protection, the issue is whether patents on gene sequences – DNA sequences – should be allowed according to the classical model of patent claim whereby a first inventor can claim an invention that covers possible future uses of that sequence. Or should the patent be restricted so that only the specific use disclosed in the patent application can be claimed, which is purpose-bound protection?
On examination of the technical provisions of the directive, it can be seen that none of these articles explicitly addresses the concept of a restricted scope of protection relating to the specific use identified for the gene sequence concerned. That might be seen as arguing for the usual broad scope of protection rather than a restricted one, since that has always been the traditional approach in patent law.
On the other hand, it might be thought that the Community legislator had intended at least to raise the possibility of a limited scope of protection, covering only the specific industrial application identified in the patent as far as this particular type of invention is concerned. That restrictive interpretation should not be incompatible with the directive.
The Commission will now, in consultation with those involved, consider the consequences of allowing both interpretations of the directive and the best way to achieve a correct application of the directive on human cloning. The directive is clear for the Commission as regards the issue of patentability of reproductive cloning involving the creation of new human beings, which is clearly excluded under Article 6 of the directive."@lv13
"Mr President, I understand Members’ concerns that the biotechnology directive should be applied correctly. This is important, not just for all those in industry who use patents to support the introduction of new products and processes, but also those who benefit from the availability of the results of research and development. These could be researchers, industrial competitors, patients and medical staff and those who administer health systems.
The term ‘therapeutic cloning’ covers a wide range of different possibilities. Research may be permitted in some Member States and not in others. For the Commission, the use of human pluripotent stem cells to cure diseases is not necessarily excluded from patentability. In light of those arguments, a modification of the directive does not, at this stage, seem appropriate.
In conclusion, I would like to recall that biotechnology has enormous potential for good, particularly in medical fields, and patent protection is of great importance to key industrial sectors, which invest heavily in research and development costs. We are working in the context of a global economy, which means our industry and researchers are competing with those in the United States and growing markets such as Asia. Indeed, according to recent reports Chinese companies filed more biotechnology patents in Europe in certain sectors last year than European companies did. As I have said, I understand the concerns that some Members have raised and I shall listen with interest to the debate.
Biotechnology covers a wide range of powerful and sometimes controversial technologies. They can make a vital contribution to the long-term future of industries such as pharmaceuticals, food, agriculture, energy, textiles and chemicals. Biotechnology also creates new opportunities and prospects for developing life-saving drugs and treating diseases. It offers enormous potential for massively improving the quality of life of many citizens. But success in developing biotechnology also depends on finding solutions to the significant ethical, societal, economic and environmental issues it throws up.
Directive 98/44/EC establishes well-balanced principles for the protection of biotechnological inventions through patents. It also takes into account the ethical aspects of this sensitive subject, as well as the legitimate desire of industry and others to establish a clear and effective scope for patent protection in this area of technology.
Let me recall that the purpose of the directive is to establish the legal framework for granting patents, which covers the results of research. It does not in any way replace regulations that govern research in particular areas, including certain ethical rules such as those on human integrity.
The Commission will continue to follow the application of the directive in practice very carefully, with due regard to ethical, moral and cultural considerations, and will not fail to inform the European Parliament, as it has so far done, in the framework of the evaluation reports envisaged in the directive.
In terms of the particular areas identified by Parliament in the motion for a resolution, I make the following remarks. On purpose-bound protection, the issue is whether patents on gene sequences – DNA sequences – should be allowed according to the classical model of patent claim whereby a first inventor can claim an invention that covers possible future uses of that sequence. Or should the patent be restricted so that only the specific use disclosed in the patent application can be claimed, which is purpose-bound protection?
On examination of the technical provisions of the directive, it can be seen that none of these articles explicitly addresses the concept of a restricted scope of protection relating to the specific use identified for the gene sequence concerned. That might be seen as arguing for the usual broad scope of protection rather than a restricted one, since that has always been the traditional approach in patent law.
On the other hand, it might be thought that the Community legislator had intended at least to raise the possibility of a limited scope of protection, covering only the specific industrial application identified in the patent as far as this particular type of invention is concerned. That restrictive interpretation should not be incompatible with the directive.
The Commission will now, in consultation with those involved, consider the consequences of allowing both interpretations of the directive and the best way to achieve a correct application of the directive on human cloning. The directive is clear for the Commission as regards the issue of patentability of reproductive cloning involving the creation of new human beings, which is clearly excluded under Article 6 of the directive."@mt15
".
Mijnheer de Voorzitter, ik begrijp dat leden bezorgd zijn over de correcte toepassing van de richtlijn voor biotechnologie. Dit is van belang, niet alleen voor al degenen in de sector die gebruik maken van octrooien ter ondersteuning van de invoering van nieuwe producten en processen, maar ook voor degenen die profiteren van de beschikbaarheid van de resultaten van onderzoek en ontwikkeling. Dit kunnen onderzoekers zijn, concurrenten in de sector, patiënten en medisch personeel en degenen die de gezondheidsstelsels beheren.
De term “therapeutisch klonen” dekt een breed scala aan verschillende mogelijkheden. Onderzoek is mogelijk toegestaan in een aantal lidstaten en in andere weer niet. Voor de Commissie is het gebruik van menselijke pluripotente stamcellen voor het genezen van ziekten niet noodzakelijk uitgesloten van octrooieerbaarheid. In het licht van deze argumenten lijkt wijziging van de richtlijn in dit stadium niet gepast.
Tot besluit zou ik eraan willen herinneren dat de biotechnologie enorme mogelijkheden biedt voor het goede, vooral op medisch terrein, en octrooibescherming is van groot belang voor de belangrijkste industriesectoren, die zwaar investeren in uitgaven aan onderzoek en ontwikkeling. Wij werken binnen de context van een mondiale economie, wat betekent dat onze industrie en onze onderzoekers concurreren met hun tegenhangers in de Verenigde Staten en groeimarkten als Azië. Volgens recente berichten zijn er afgelopen jaar door Chinese bedrijven in bepaalde sectoren meer octrooien op het vlak van biotechnologie aangevraagd dan door Europese. Zoals ik al zei, begrijp ik de bezorgdheid waarvan sommige leden blijk gaven en ik zal met belangstelling luisteren naar het debat.
Biotechnologie omvat een breed terrein van krachtige en soms controversiële technologieën. Deze kunnen een essentiële bijdrage leveren aan de toekomst op de lange termijn van sectoren als farmaceutica, levensmiddelen, landbouw, energie, textiel en chemicaliën. Biotechnologie creëert ook nieuwe mogelijkheden en vooruitzichten voor de ontwikkeling van levensreddende geneesmiddelen en de behandeling van ziekten. Zij biedt enorme mogelijkheden voor een massale verbetering van de levenskwaliteit van vele burgers. Maar succes in de ontwikkeling van de biotechnologie hangt ook af van het al dan niet vinden van oplossingen voor de belangrijke ethische, maatschappelijke, economische en ecologische vraagstukken die zij opwerpt.
In Richtlijn 98/44/EG worden evenwichtige beginselen vastgelegd voor de bescherming van biotechnologische uitvindingen middels octrooien. De richtlijn houdt ook rekening met de ethische aspecten van dit gevoelige onderwerp, alsmede met de gerechtvaardigde wens van de sector en van anderen om de draagwijdte van de octrooibescherming op dit terrein van de technologie duidelijk en doeltreffend af te bakenen.
Laat mij in herinnering roepen dat het doel van deze richtlijn erin bestaat een rechtskader voor de toekenning van octrooien vast te stellen dat de resultaten van onderzoek omvat. De richtlijn dient geenszins ter vervanging van reglementen die het onderzoek op bepaalde terreinen regelen, waaronder bepaalde ethische regels zoals die in verband met de menselijke integriteit.
De Commissie zal de toepassing van de richtlijn in de praktijk zeer zorgvuldig blijven volgen en passende aandacht schenken aan ethische, morele en culturele overwegingen, en zij zal niet nalaten het Europees Parlement te informeren, zoals zij tot dusverre al heeft gedaan, in het kader van de evaluatieverslagen zoals die in de richtlijn zijn voorzien.
Wat betreft de bijzondere terreinen die door het Parlement in de ontwerpresolutie worden benoemd, wil ik de volgende opmerkingen maken. Bij doelgebonden bescherming gaat het erom of octrooien op gensequenties – DNA-sequenties – moeten worden toegestaan volgens het klassieke model van de octrooiaanvraag waarbij de eerste uitvinder een octrooi kan krijgen dat ook mogelijke toekomstige toepassingen van de sequentie omvat. Of moet het octrooi worden beperkt tot het specifieke, in de octrooiaanvraag vermelde gebruik, waarbij we het hebben over doelgebonden bescherming?
Bij bestudering van de technische bepalingen van de richtlijn kan men zien dat in geen van de artikelen uitdrukkelijk aandacht wordt besteed aan het concept van beperkte draagwijdte van de bescherming in verband met het specifiek gebruik dat voor de betreffende gensequentie is vastgesteld. Dit zou gezien kunnen worden als een pleidooi voor de gebruikelijke grote draagwijdte van de bescherming in plaats van een beperkte, aangezien de eerste optie altijd de traditionele benadering is geweest in het octrooirecht.
Anderzijds zou men kunnen denken dat de communautaire wetgever in ieder geval de bedoeling heeft gehad om de mogelijkheid van een beperkte draagwijdte voor de bescherming aan de orde te stellen, waarbij alleen de specifieke industriële toepassing zoals in het octrooi staat vermeld wordt gedekt voorzover het dit specifieke type uitvinding betreft. Die restrictieve interpretatie zou niet onverenigbaar moeten zijn met de richtlijn.
De Commissie zal nu, in samenspraak met de betrokkenen, bestuderen wat de gevolgen zijn wanneer beide interpretaties van de richtlijn worden toegelaten en wat de beste manier is om een correcte toepassing van de richtlijn over menselijk klonen te bewerkstelligen. De richtlijn is duidelijk voor de Commissie voor wat betreft het onderwerp van octrooieerbaarheid van het reproductief klonen waarbij nieuwe menselijke wezens geschapen worden, hetgeen duidelijk wordt uitgesloten krachtens artikel 6 van de richtlijn."@nl3
"Mr President, I understand Members’ concerns that the biotechnology directive should be applied correctly. This is important, not just for all those in industry who use patents to support the introduction of new products and processes, but also those who benefit from the availability of the results of research and development. These could be researchers, industrial competitors, patients and medical staff and those who administer health systems.
The term ‘therapeutic cloning’ covers a wide range of different possibilities. Research may be permitted in some Member States and not in others. For the Commission, the use of human pluripotent stem cells to cure diseases is not necessarily excluded from patentability. In light of those arguments, a modification of the directive does not, at this stage, seem appropriate.
In conclusion, I would like to recall that biotechnology has enormous potential for good, particularly in medical fields, and patent protection is of great importance to key industrial sectors, which invest heavily in research and development costs. We are working in the context of a global economy, which means our industry and researchers are competing with those in the United States and growing markets such as Asia. Indeed, according to recent reports Chinese companies filed more biotechnology patents in Europe in certain sectors last year than European companies did. As I have said, I understand the concerns that some Members have raised and I shall listen with interest to the debate.
Biotechnology covers a wide range of powerful and sometimes controversial technologies. They can make a vital contribution to the long-term future of industries such as pharmaceuticals, food, agriculture, energy, textiles and chemicals. Biotechnology also creates new opportunities and prospects for developing life-saving drugs and treating diseases. It offers enormous potential for massively improving the quality of life of many citizens. But success in developing biotechnology also depends on finding solutions to the significant ethical, societal, economic and environmental issues it throws up.
Directive 98/44/EC establishes well-balanced principles for the protection of biotechnological inventions through patents. It also takes into account the ethical aspects of this sensitive subject, as well as the legitimate desire of industry and others to establish a clear and effective scope for patent protection in this area of technology.
Let me recall that the purpose of the directive is to establish the legal framework for granting patents, which covers the results of research. It does not in any way replace regulations that govern research in particular areas, including certain ethical rules such as those on human integrity.
The Commission will continue to follow the application of the directive in practice very carefully, with due regard to ethical, moral and cultural considerations, and will not fail to inform the European Parliament, as it has so far done, in the framework of the evaluation reports envisaged in the directive.
In terms of the particular areas identified by Parliament in the motion for a resolution, I make the following remarks. On purpose-bound protection, the issue is whether patents on gene sequences – DNA sequences – should be allowed according to the classical model of patent claim whereby a first inventor can claim an invention that covers possible future uses of that sequence. Or should the patent be restricted so that only the specific use disclosed in the patent application can be claimed, which is purpose-bound protection?
On examination of the technical provisions of the directive, it can be seen that none of these articles explicitly addresses the concept of a restricted scope of protection relating to the specific use identified for the gene sequence concerned. That might be seen as arguing for the usual broad scope of protection rather than a restricted one, since that has always been the traditional approach in patent law.
On the other hand, it might be thought that the Community legislator had intended at least to raise the possibility of a limited scope of protection, covering only the specific industrial application identified in the patent as far as this particular type of invention is concerned. That restrictive interpretation should not be incompatible with the directive.
The Commission will now, in consultation with those involved, consider the consequences of allowing both interpretations of the directive and the best way to achieve a correct application of the directive on human cloning. The directive is clear for the Commission as regards the issue of patentability of reproductive cloning involving the creation of new human beings, which is clearly excluded under Article 6 of the directive."@pl16
"Senhor Presidente, compreendo a preocupação dos senhores deputados em certificar-se da correcta aplicação da directiva relativa às biotecnologias. Isso é importante não apenas para todos quantos, na indústria, recorrem ao registo de patentes como meio para a introdução de novos produtos e processos, mas também para todos os que beneficiam da disponibilidade dos frutos da investigação e do desenvolvimento. No número destes últimos contam-se investigadores, produtores industriais para o mercado concorrencial, doentes e pessoal médico e administradores de sistemas de saúde.
O termo "clonagem terapêutica" abarca um vasto e diversificado leque de possibilidades. A investigação pode ser permitida nalguns Estados-Membros e interdita noutros. Para a Comissão, o diploma não exclui necessariamente a patenteabilidade da utilização de células germinais ou pluripotentes humanas para curar doenças. À luz destas considerações, não se nos afigura apropriada, na presente fase do processo, uma modificação da directiva.
Concluindo, gostaria de recordar que as biotecnologias têm um enorme potencial para o bem, particularmente no campo da medicina, e a protecção por meio de patente assume grande relevância para sectores industriais estratégicos, que investem fortemente em investigação e desenvolvimento. Estamos a trabalhar no contexto de uma economia global, o que significa que a nossa indústria e os nossos investigadores competem com os dos Estados Unidos e de mercados em crescimento como os da Ásia. Na realidade, segundo dados recentes, o ano passado, em certos sectores das biotecnologias, o número de patentes registadas na Europa por empresas chinesas ultrapassou o das empresas europeias. Como já disse, compreendo as preocupações manifestadas por alguns senhores deputados e seguirei o debate com interesse.
A biotecnologia abarca um amplo leque de tecnologias poderosas e, por vezes, controversas. Elas podem dar um contributo vital para o futuro a longo prazo de sectores económicos como os da indústria farmacêutica, alimentar, agricultura, energia, têxtil e químico. As biotecnologias geram também novas oportunidades e perspectivas de desenvolvimento de drogas capazes de salvar vidas e tratar doenças. Encerram um enorme potencial em matéria de elevação da qualidade de vida de muitos cidadãos. Mas o sucesso no desenvolvimento das biotecnologias depende também da descoberta de soluções para as relevantes questões de ordem ética, social, económica e ambiental que suscita.
A Directiva n.º 98/44/CE estabelece um conjunto de princípios equilibrado no campo da protecção jurídica das invenções biotecnológicas por meio de patente. Toma igualmente em conta os aspectos éticos deste melindroso tema e o legítimo desejo da indústria e outros de que se defina de forma clara e efectiva o âmbito da protecção por meio de patente nesta área da tecnologia.
Permitam-me que recorde que o propósito da directiva é estabelecer um enquadramento legal para a concessão de patentes que cubra os resultados de actividades de investigação. Não substitui de modo algum os regulamentos que disciplinam a investigação em áreas específicas, incluindo determinadas normas éticas como as atinentes à integridade da pessoa humana.
A Comissão continuará a seguir escrupulosamente a aplicação prática da directiva, dando a devida atenção às considerações éticas, morais e culturais, e não deixará de informar o Parlamento Europeu, como até aqui, no quadro dos relatórios de avaliação previstos na directiva.
No que toca às áreas particulares que o Parlamento identifica na sua proposta de resolução, tenho a observar o seguinte. Quanto à protecção em função do objectivo, a questão consiste em saber se deve ser autorizada a concessão de patentes de sequências genéticas – sequências de ADN – de acordo com o modelo clássico de pedido de patente, nos termos do qual um inventor pode reivindicar uma invenção que abranja as possíveis utilizações futuras dessa sequência. Ou deve antes restringir-se o âmbito da patente, de forma a abarcar apenas a utilização específica indicada no pedido da patente, solução que constitui a chamada protecção em função do objectivo?
Examinando as disposições técnicas da directiva, verificamos que nenhum dos artigos em questão menciona explicitamente o conceito de âmbito de protecção restrito em função do uso específico indicado para a sequência genética em causa. Isso pode ser tomado como um indício de que se pretendeu consagrar o habitual âmbito de protecção alargado, em detrimento de um âmbito restrito, já que essa é a abordagem tradicional, que sempre prevaleceu no direito de patentes.
Por outro lado, poderá entender-se que o legislador comunitário teve a intenção de, pelo menos, aventar a possibilidade de um âmbito de protecção limitado, que cobrisse exclusivamente a aplicação industrial específica identificada na patente, no que a este tipo particular de invenção diz respeito. Uma tal interpretação restritiva não deverá ser tida por incompatível com a directiva.
A Comissão irá agora, em consulta com as partes envolvidas, ponderar as consequências de permitir ambas as interpretações da directiva e o melhor modo de garantir uma aplicação correcta da directiva relativa à clonagem de seres humanos. Para a Comissão, a directiva é clara no que toca à questão da patenteabilidade da clonagem reprodutiva que envolva a criação de novos seres humanos, que é excluída de modo claro pelo artigo 6º da directiva."@pt17
"Mr President, I understand Members’ concerns that the biotechnology directive should be applied correctly. This is important, not just for all those in industry who use patents to support the introduction of new products and processes, but also those who benefit from the availability of the results of research and development. These could be researchers, industrial competitors, patients and medical staff and those who administer health systems.
The term ‘therapeutic cloning’ covers a wide range of different possibilities. Research may be permitted in some Member States and not in others. For the Commission, the use of human pluripotent stem cells to cure diseases is not necessarily excluded from patentability. In light of those arguments, a modification of the directive does not, at this stage, seem appropriate.
In conclusion, I would like to recall that biotechnology has enormous potential for good, particularly in medical fields, and patent protection is of great importance to key industrial sectors, which invest heavily in research and development costs. We are working in the context of a global economy, which means our industry and researchers are competing with those in the United States and growing markets such as Asia. Indeed, according to recent reports Chinese companies filed more biotechnology patents in Europe in certain sectors last year than European companies did. As I have said, I understand the concerns that some Members have raised and I shall listen with interest to the debate.
Biotechnology covers a wide range of powerful and sometimes controversial technologies. They can make a vital contribution to the long-term future of industries such as pharmaceuticals, food, agriculture, energy, textiles and chemicals. Biotechnology also creates new opportunities and prospects for developing life-saving drugs and treating diseases. It offers enormous potential for massively improving the quality of life of many citizens. But success in developing biotechnology also depends on finding solutions to the significant ethical, societal, economic and environmental issues it throws up.
Directive 98/44/EC establishes well-balanced principles for the protection of biotechnological inventions through patents. It also takes into account the ethical aspects of this sensitive subject, as well as the legitimate desire of industry and others to establish a clear and effective scope for patent protection in this area of technology.
Let me recall that the purpose of the directive is to establish the legal framework for granting patents, which covers the results of research. It does not in any way replace regulations that govern research in particular areas, including certain ethical rules such as those on human integrity.
The Commission will continue to follow the application of the directive in practice very carefully, with due regard to ethical, moral and cultural considerations, and will not fail to inform the European Parliament, as it has so far done, in the framework of the evaluation reports envisaged in the directive.
In terms of the particular areas identified by Parliament in the motion for a resolution, I make the following remarks. On purpose-bound protection, the issue is whether patents on gene sequences – DNA sequences – should be allowed according to the classical model of patent claim whereby a first inventor can claim an invention that covers possible future uses of that sequence. Or should the patent be restricted so that only the specific use disclosed in the patent application can be claimed, which is purpose-bound protection?
On examination of the technical provisions of the directive, it can be seen that none of these articles explicitly addresses the concept of a restricted scope of protection relating to the specific use identified for the gene sequence concerned. That might be seen as arguing for the usual broad scope of protection rather than a restricted one, since that has always been the traditional approach in patent law.
On the other hand, it might be thought that the Community legislator had intended at least to raise the possibility of a limited scope of protection, covering only the specific industrial application identified in the patent as far as this particular type of invention is concerned. That restrictive interpretation should not be incompatible with the directive.
The Commission will now, in consultation with those involved, consider the consequences of allowing both interpretations of the directive and the best way to achieve a correct application of the directive on human cloning. The directive is clear for the Commission as regards the issue of patentability of reproductive cloning involving the creation of new human beings, which is clearly excluded under Article 6 of the directive."@sk18
"Mr President, I understand Members’ concerns that the biotechnology directive should be applied correctly. This is important, not just for all those in industry who use patents to support the introduction of new products and processes, but also those who benefit from the availability of the results of research and development. These could be researchers, industrial competitors, patients and medical staff and those who administer health systems.
The term ‘therapeutic cloning’ covers a wide range of different possibilities. Research may be permitted in some Member States and not in others. For the Commission, the use of human pluripotent stem cells to cure diseases is not necessarily excluded from patentability. In light of those arguments, a modification of the directive does not, at this stage, seem appropriate.
In conclusion, I would like to recall that biotechnology has enormous potential for good, particularly in medical fields, and patent protection is of great importance to key industrial sectors, which invest heavily in research and development costs. We are working in the context of a global economy, which means our industry and researchers are competing with those in the United States and growing markets such as Asia. Indeed, according to recent reports Chinese companies filed more biotechnology patents in Europe in certain sectors last year than European companies did. As I have said, I understand the concerns that some Members have raised and I shall listen with interest to the debate.
Biotechnology covers a wide range of powerful and sometimes controversial technologies. They can make a vital contribution to the long-term future of industries such as pharmaceuticals, food, agriculture, energy, textiles and chemicals. Biotechnology also creates new opportunities and prospects for developing life-saving drugs and treating diseases. It offers enormous potential for massively improving the quality of life of many citizens. But success in developing biotechnology also depends on finding solutions to the significant ethical, societal, economic and environmental issues it throws up.
Directive 98/44/EC establishes well-balanced principles for the protection of biotechnological inventions through patents. It also takes into account the ethical aspects of this sensitive subject, as well as the legitimate desire of industry and others to establish a clear and effective scope for patent protection in this area of technology.
Let me recall that the purpose of the directive is to establish the legal framework for granting patents, which covers the results of research. It does not in any way replace regulations that govern research in particular areas, including certain ethical rules such as those on human integrity.
The Commission will continue to follow the application of the directive in practice very carefully, with due regard to ethical, moral and cultural considerations, and will not fail to inform the European Parliament, as it has so far done, in the framework of the evaluation reports envisaged in the directive.
In terms of the particular areas identified by Parliament in the motion for a resolution, I make the following remarks. On purpose-bound protection, the issue is whether patents on gene sequences – DNA sequences – should be allowed according to the classical model of patent claim whereby a first inventor can claim an invention that covers possible future uses of that sequence. Or should the patent be restricted so that only the specific use disclosed in the patent application can be claimed, which is purpose-bound protection?
On examination of the technical provisions of the directive, it can be seen that none of these articles explicitly addresses the concept of a restricted scope of protection relating to the specific use identified for the gene sequence concerned. That might be seen as arguing for the usual broad scope of protection rather than a restricted one, since that has always been the traditional approach in patent law.
On the other hand, it might be thought that the Community legislator had intended at least to raise the possibility of a limited scope of protection, covering only the specific industrial application identified in the patent as far as this particular type of invention is concerned. That restrictive interpretation should not be incompatible with the directive.
The Commission will now, in consultation with those involved, consider the consequences of allowing both interpretations of the directive and the best way to achieve a correct application of the directive on human cloning. The directive is clear for the Commission as regards the issue of patentability of reproductive cloning involving the creation of new human beings, which is clearly excluded under Article 6 of the directive."@sl19
".
Herr talman! Jag förstår ledamöternas oro över att bioteknikdirektivet bör tillämpas på rätt sätt. Detta är viktigt, inte bara för alla dem inom industrin som använder patent för att stödja lanserandet av nya produkter och processer, utan även för dem som drar nytta av tillgången till forsknings- och utvecklingsresultaten. Det kan handla om forskare, konkurrenter inom industrin, patienter och sjukvårdspersonal och de som administrerar sjukvårdssystemen.
Termen ”terapeutisk kloning” täcker ett stort antal olika möjligheter. Forskning kan tillåtas i vissa medlemsstater men inte i andra. Kommissionen anser inte att användandet av mänskliga stamceller med flertalet potentialer för att bota sjukdomar nödvändigtvis måste uteslutas ur patenterbarheten. Med tanke på dessa argument verkar det inte lämpligt med en modifiering av direktivet i detta läge.
Sammanfattningsvis vill jag påminna om att biotekniken har en enorm potential för det goda, särskilt inom de medicinska områdena, och patentskydd är ytterst viktigt för de huvudsakliga industrisektorerna, som gör tunga investeringar i forskning och utveckling. Vi arbetar i en global ekonomi, vilket betyder att vår industri och våra forskare konkurrerar med dem i Förenta staterna och med växande marknader som Asien. Enligt färska rapporter registrerade kinesiska företag fler bioteknikpatent i Europa inom vissa sektorer förra året än vad europeiska företag gjorde. Som jag har sagt förstår jag de bekymmer som vissa ledamöter har tagit upp, och jag ska lyssna med intresse på debatten.
Bioteknik täcker ett stort urval av mäktiga och ibland kontroversiella tekniker. De kan ge ett mycket viktigt bidrag till den långsiktiga framtiden för industrier som läkemedel, livsmedel, jordbruk, energi, textilier och kemikalier. Biotekniken skapar också nya möjligheter och utsikter för utvecklandet av livsavgörande mediciner och behandlingen av sjukdomar. Den erbjuder en enorm möjlighet att massivt förbättra många medborgares livskvalitet. Men framgången inom utvecklandet av bioteknik är även beroende av att man hittar lösningar på de betydande etiska, samhälleliga, ekonomiska och miljömässiga problem den framkallar.
Genom direktiv 98/44/EG etableras väl avvägda principer för skyddet av biotekniska uppfinningar genom patent. I det tas också hänsyn till detta känsliga ämnes etiska aspekter liksom industrins och andras berättigade önskan att upprätta ett tydligt och effektivt utrymme för patentskydd inom detta teknikområde.
Låt mig få påminna om att syftet med detta direktiv är att upprätta den rättsliga ramen för att bevilja patent, som täcker forskningsresultaten. Den ersätter inte på något sätt de förordningar som gäller för forskning inom särskilda områden, inklusive vissa etiska regler såsom dem om mänsklig okränkbarhet.
Kommissionen kommer att fortsätta att följa direktivets tillämpning i praktiken mycket noggrant med tillbörlig hänsyn till etiska, moraliska och kulturella beaktanden, och man kommer inte att underlåta att informera Europaparlamentet, precis som man hittills har gjort, inom ramen för de utvärderingsrapporter som föreskrivs i direktivet.
Om de särskilda områden som parlamentet har identifierat i förslaget till resolution gör jag följande anmärkningar. När det gäller ändamålsbestämt skydd är frågan om patent på gensekvenser – DNA-sekvenser – bör tillåtas enligt den klassiska modellen för patentbegäran där den första uppfinnaren kan begära patent för en uppfinning som täcker möjliga framtida användningar av denna sekvens. Eller bör patentet begränsas så att endast den speciella användning som står på patentansökan kan begäras, vilket är ändamålsbestämt skydd?
När man granskar de tekniska bestämmelserna i direktivet kan man se att ingen av dessa artiklar uttryckligen tar upp konceptet om ett begränsat utrymme för skydd relaterat till det specifika användande som identifierats för gensekvensen i fråga. Det skulle kunna ses som att man argumenterar för det vanliga stora utrymmet för skydd snarare än ett begränsat sådant eftersom detta alltid har varit den traditionella strategin inom patentlagstiftningen.
Å andra sidan kan man tänka sig att gemenskapslagstiftaren hade för avsikt att åtminstone väcka möjligheten för ett begränsat utrymme för skydd som endast täcker den specifika industriella tillämpning som fastställs i patentet beträffande denna särskilda uppfinning. Denna restriktiva tolkning bör inte vara oförenlig med direktivet.
Kommissionen kommer nu, i samråd med de inblandade, att överväga konsekvenserna av att tillåta båda tolkningarna av direktivet och det bästa sättet att uppnå en korrekt tillämpning av direktivet om kloning av människor. Kommissionen anser att direktivet är tydligt när det gäller frågan om patenterbarhet för reproduktiv kloning som inkluderar skapandet av nytt människoliv, något som är tydligt uteslutet enligt artikel 6 i direktivet."@sv21
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