Legal Protection Of Biotechnological Inventions Research Articles

LEGAL PROTECTION OF BIOTECHNOLOGICAL INVENTIONS: FOREIGN EXPERIENCE

The article discusses approaches to the legal protection of biotechnological inventions on the example of the EAEU member states, EU member states, the USA and Australia. As part of the study, judicial practices were considered and the main trends in the field of legal protection of biotechnological inventions were identified. The article focuses on approaches to determining industrial applicability, inventive step and novelty in the previously listed countries. The main legal acts of the respective states on the legal protection of inventions are considered and analyzed. Based on the study, the main trends and features of the legal protection of biotechnological inventions abroad were identified.

Legal Protection of Genetic Research

The article discusses the patentability of the results of genetic research, in particular the sequence of genes in the molecular structure of deoxyribonucleic acid. The main approaches established in the American, European and national legal system regarding the protection of genetic inventions are presented. The main points in a decision of the Court of Justice of the EU are analysed. Both the criteria for patentability of an element of the human body and the hypotheses referring to the exceptions to patentability corresponding to the provisions of Directive 98/44/EC on the legal protection of biotechnological inventions, the Convention on Human Rights and Biomedicine of Oviedo, the European Patent Convention and the TRIPS Agreement. The connection between the importance of genetic research and the development of the innovative economy based on the patents for these inventions is substantiated.

Protection of intellectual property rights in the field of biotechnology

Keywords: intellectual property rights, biotechnologies, patenting, legal protection,legislation
 Current trends of globalization and the process of European integrationof Ukraine necessitate the creation of an effective mechanism of legal regulationof intellectual property rights in the field of biotechnology, due to the constitutionalprovisions according to which human life and health are the highest value inthe state. The purpose of the study was to determine the legal regulation of protection
 of intellectual property rights in the field of biotechnology. Empirical and theoreticalmethods of scientific cognition are used for comprehensive consideration of the topicof the article. It has been found that modern biotechnological advances require inventorsnot only to secure monopoly rights to use them, but also to comply with the moraland ethical criteria for the perception of inventions created by genetic engineeringand living matter. It is determined that the legal system of intellectual property protectionin the field of biotechnology is based on the provisions of the Constitution ofUkraine, the Civil Code of Ukraine, regulations in the field of health and agriculture,international treaties and special legislation in the field of intellectual property. It isestablished that the system of legal protection of biotechnological inventions consistsof the acquisition of intellectual property rights to these inventions (establishment ofthe object of patenting and compliance with patentability, state registration of inventions)and the use and disposal of intellectual property rights to such inventions. Alegislative support of legal protection of biotechnological inventions is seen in furtherempirical research and theoretical and methodological substantiation in order to determinethe legal mechanisms of their practical implementation.

THE PATENTABILITY OF BIOTECHNOLOGICAL INVENTIONS IN THE EU: AN IMPACT ON THERAPEUTIC PRACTICE

The aim: To identify the spheres in which it is forbidden to patent the results of medical researches and as a consequence there is no legal protection of biotechnological inventions. Materials and methods: The research material is a modern European regulatory framework that establishes the basic principles for patentability of biotechnological inventions. The methods of information retrieval, analysis, systematization, and generalization were used in this article. Conclusions: The Court of Justice has categorically stated that inventions that use human embryonic cells cannot be used for industrial or commercial purposes and therefore cannot be patented. In connection with this prohibition, the Court of Justice provided a unified definition of "embryo" and determined that it could be considered a dividing human egg, but only if it had a real ability to develop into a human. That is, the determining factor is not the beginning of the process of cell proliferation, but their real ability to become human. These decisions have become crucial for the development of research and the use of their results in therapeutic activities in the EU.

Особливості правової охорони медичних винаходів: сучасність і перспективи

The modern legal doctrine of intellectual property practically does not investigate the terms of legal protection of inventions in medical practice. Aim. Therefore, the purpose of the article is to clarify the features of the legal protection of medical inventions, the prospects for its improvement. Materials and methods . The study of the peculiarities of the legal protection of inventions in medical practice is based on a systematic approach, in particular, a critical analysis of the state of modern patent law in Ukraine and the prospects for its improvement through the implementation of European legislation in the field of medical inventions. Through comparative legal method the analysis of the Specialized Database of Ukrpatent “Inventions (Utility Models) in Ukraine” concerning the identification of patents for medical discoveries has been carried out. Results . Inventions within medical practice have a specific feature that is manifested in their industrial suitability (sphere of application – medicine) and possibility of fair use only after examination, in particular, medical and biological or clinical trials (experiments) involving human being. Types of inventions in medical practice are: methods of human treatment, devices for the treatment and diagnosis of a person, medicines, strains of microorganisms used to diagnose a person’s disease or for treatment, biotechnological inventions. Conclusions . The peculiarity of medical inventions is as follows: they have their own distinctive division due to the scope of invention’s application (the method of treatment, diagnosis, etc.); must undergo medical and biological or clinical trials (experiments); they must meet ethical requirements. It is established that it requires legislative consolidation at the level of the Law of Ukraine “On Protection of Rights to Inventions and Utility Models”: Ethical Requirements Regarding Biotechnological Inventions; balance of interests, rights of patients and patent holders; the grounds and conditions for granting a compulsory license for medical inventions; the implementation of Directive 98/44/EC of the European Parliament and Council of 07/06/1998 on the legal protection of biotechnological inventions.

Patent Ethics: The Misalignment of Views Between the Patent System and the Wider Society.

Concerns have been voiced about the ethical implications of patenting practices in the field of biotechnology. Some of these have also been incorporated into regulation, such as the European Commission Directive 98/44 on the legal protection of biotechnological inventions. However, the incorporation of ethically based restrictions into patent legislation has not had the effect of satisfying all concerns. In this article, we will systematically compare the richness of ethical concerns surrounding biotech patenting, with the limited scope of ethical concerns actually addressed in the patent system. As sources of our analyses we will use literature and document studies and a survey with important stakeholders and experts related to Norwegian patenting in the aquacultural biotechnology sector. We will structure the analyses with an ethical matrix, developed for this purpose. Showing the misalignment of the discussions within and outside the patent system, we suggest that an important reason for the ethical controversy still surrounding patenting is that ethical questions keep being framed in a narrow way within the system. Until a richer set of ethical considerations is addressed head-on within the patent system, the patent system will continue to evoke academic and interest group criticism, potentially contributing to a legitimacy crisis of the whole system.

Some Problems Related to the “Human Embryo” in the European Union Law

Abstract The following article is dedicated to the topic of human dignity - the human embryos and the legal framework they are regulated by in the EU: The Charter of Fundamental Rights of European Union and the EU Court practice. For the purpose, the authors look first and foremost at the EU Directive 98/44, regulating the legal protection of biotechnological inventions which aim at balancing the human beings' dignity and integrity with the need to preserve the social function of patents as a vector for the competiveness of the European biotech industry. Two key EU Court cases are analyzed, both of which reflecting the evolution of the Court of Justice on the European Union's Case Law on Stem Cell Patents, namely Case C-34/10 Oliver Brüstle v Greenpeace е. V. and Case C-364/13 International Stem Cell Corporation. The article looks then at the European Citizens’ Initiative “One of us”, which aims at securing Juridical protection of the dignity, the right to life, as well as to the integrity of every human being from conception in those areas of EU competence where such protection has a particular importance.

Status embrionów ludzkich na tle zdolności patentowej wynalazków biotechnologicznych

This article presents an overview of the issues surrounding the patenting of inventions concerning the use of the human body, the status of the human embryo and the admissibility of patenting human embryos. In his analysis, the author refers to the provisions of directive 98/44/EC of the European Parliament and of the Council from the 6th July 1998 on the legal protection of biotechnological inventions, which is the main European Union legal act on patenting biological material. Issues discussed in this article refer to article 5 of the above-mentioned directive, according to which the human body, at the various stages of its formation and development, cannot constitute a patentableinvention.

Purpose-bound protection for DNA sequences: in through the back door?

The European Parliament adopted Directive 98/44 on the legal protection of biotechnological inventions (‘Biopatent Directive’) in 1998 after more than 10 years’ discussion. The Directive allows patents for plants, animals, and DNA sequences, solves certain protection problems inherent for material which can self-replicate, and provides for harmonization with plant variety protection law in certain areas such as the ‘farmer’s privilege’. Since 2006, a biotechnology patent dispute has arisen in several European countries. With a referral to the Court of Justice (‘ECJ’), the case now approaches the final shoot-out, being the first time the ECJ must interpret the Biopatent Directive’s infringement provisions. This dispute concerns the shipment of soya meal from Argentina to the EU. The soya meal was obtained from genetically modified soya tolerant to the herbicide glyphosate (Roundup Ready) due to the presence of a specific gene encoding the enzyme 5-enol-pyruvylshikimate-3-phosphate synthase (EPSPS). It is undisputed that the Roundup Ready tolerant soybean (‘RR soybean’) was originally made by Monsanto, which developed it, obtaining government approval for cultivation in Argentina and importation for the purposes of food and feed into the EU. Soybeans, one of the most widely planted crops, are primarily used as a protein-source for livestock production. In Argentina, the production of RR soybean occupies half the cultivated land and is its most important export product. Argentina exports 14 m tonnes of soya meal annually—more than half of its annual production—into the EU, which depends heavily on their importation for meat production. While in Argentina the gene is not patent protected and RR soybeans are thus legally planted without permission from Monsanto, in several EU countries the

Synthetic biology and patents

The patent system has evolved over many centuries and is considered, by and large, to have successfully promoted innovation. Patents help to stimulate investment in research and development through the provision of a limited monopoly to the inventor, while ensuring full disclosure of the invention to the public. One of the reasons for the long‐lasting success of the patent system is its non‐discriminatory character. The same basic patentability criteria apply to all fields of technology: novelty, inventive step and industrial application. This provides legal certainty to the applicant and third parties because the criteria applied during examination at the patent office—and in courts—are largely independent of the nature of the invention. The World Trade Organization (WTO; Geneva, Switzerland) Agreement on Trade Related Aspects of Intellectual Property Rights (TRIPS), which was negotiated in 1994, includes a provision that underlines this technology‐neutral character of patents: Article 27(1) states that “[…] patents shall be available for any inventions, whether products or processes, in all fields of technology, provided that they are new, involve an inventive step and are capable of industrial application”. Nevertheless, the emergence of new technologies regularly raises the question of whether the patent system, which was historically designed to protect mechanical inventions, and was only later extended to chemical products and processes, is suitable to protect inventions in fields as new as synthetic biology. Perhaps more importantly, it also raises the issue of whether the patent system is, or has been, able to promote the advancement of these new technologies. Similar questions were also raised some years ago, as the patenting of biotechnology and computer‐implemented inventions—that is, software—gathered momentum. The European Parliament (Strasbourg, France), after a 10‐year debate, concluded Directive 98/44/EC on the legal protection of biotechnological inventions; this was later implemented in the regulations of the European Patent Convention …

Commentary: Is Totipotency of a Human Cell a Sufficient Reason to Exclude Its Patentability Under the European Law?

This article argues that totipotent character of human totipotent cells--defined as the capacity of a cell "to differentiate into all somatic lineages (ectoderm, mesoderm, endoderm), the germ line and extra-embryonic tissues such as the placenta"--is not a sufficient reason to exclude their patentability on the basis of Article 5(1) of the Directive 98/44/EC on the Legal Protection of Biotechnological Inventions (Biopatent Directive), which maintains that "the human body, at the various stages of its formation and development, [...] cannot constitute patentable inventions." Since human totipotent cells have both the potential to generate an entire new organism or to generate only different tissues or organs of an organism, they simultaneously fit the definition of the unpatentable human body at the earliest stage of its formation as well as of an element of the human body, which "may constitute a patentable invention" pursuant to Article 5(2) of the Biopatent Directive, whether that element is isolated from the human body or otherwise produced by means of a technical process. Therefore, this article suggests that, when evaluating patentability of human totipotent cells, they should be further evaluated according to their location and their method of derivation (i.e., whether human totipotent cells are located in the human body, whether they are isolated from the human body, or whether they are produced otherwise by means of a technical process). Disclosure of potential conflicts of interest is found at the end of this article.

Patents as Credence Goods

The view of patents as well defined property rights is as simplistic as it is ubiquitous. This paper argues that in newly arising or immature technologies, patents are subject to intrinsic and extrinsic uncertainty that make them very opaque representations of the underlying inventions. The opacity is a result of unsettled legal doctrine and scientific terminology, uncertain commercial and technological prognosis, and leads to considerable ambiguity in property parameters. Patents in immature technologies do not solve Arrow’s information paradox of non-rivalrous goods because they do not represent the sharp exclusive right that is central to his thesis. In such cases patents ought to be reclassified in terms of their perceived and actual function as credence goods. The difficulty in discovering the value of these patents necessitates credence verifiers, further increasing the transaction costs of encouraging innovation. The theoretical and empirical implications of credence explored in this paper are based primarily on the Anglo-American legal protection of biotechnological inventions, but may equally be relevant to patents in other newly arising technologies.

Die Biopatentrichtlinie in der Praxis Kritische Anmerkungen aus der Sicht von Wirtschaft und Forschung

This article critically evaluates the Directive on the legal protection of biotechnological inventions from an economic and a research perspective. In the first part of his article, the author briefly describes the origins of the Directive and defines and explains the different areas of modern biotechnology (red, green, white and grey biotechnology). By giving facts and figures on the development of the biotech industry in recent years, the author demonstrates the enormous market potential of the various branches of biotechnology, especially red biotechnology. The second part of his article discusses the findings on the biotech industry in connection with the Directive. The author takes the view that legal protection of biotechnological inventions is a precondition for medical progress and profitability. In order to exploit the full potential of the growing biotech market, the implementation of the Directive will have to lead to further harmonisation. Lack of harmonisation would lead to a distortion of competition and malfunctioning of the internal market. As a consequence, implementation must strictly adhere to the wording of the Directive. Only restricted implementation can create a positive climate for innovation and investment in Europe. In particular, no new conditions for, or limits to, the patenting of biotechnological inventions such as purpose-bound protection, ethical limits, donor consent or proof of origin should be added to the terms of the present Directive. The author concludes that a revision of the Directive is neither necessary nor useful.

Die Patentierung biotechnologischer Erfindungen Aktuelle Debatte und Perspektiven: Ein Tagungsbericht

This is a report on the seminar “Patenting Biotechnological Inventions: Debates and Perspectives” which ERA organised in cooperation with the Austrian Federal Chancellery and the Austrian Patent Office under the auspices of the 2006 Austrian presidency of the European Union. The purpose of the seminar was to take stock of the current status of the implementation of Directive 98/44/EC on the legal protection of biotechnological inventions and its practical application in the Member States. The report first deals with the presentations made to the plenary on the first day of the conference, with a focus on practical experience with the Directive. The origins of the Directive are explained and the Directive is analysed from an economic, ethical and practical point of view. The second part of the report sums up the discussions and conclusions of the three different working groups which met on the second day of the seminar. One working group dealt with “Patenting of Genes and Gene Sequences”, another examined the problems of “Licensing” and the third looked at the “Transposition [of the Directive] into National Law”. The report closes with a resume of some conclusions on the subject.

Ethische Aspekte der Biopatentierung

The article deals with the ethical aspects of patenting biotechnological inventions. The author illustrates the current debate by discussing three different hypotheses. The first hypothesis is that patenting parts of the human body (e.g. genes or gene sequences) involves commercialisation of the human body and, as the object of the patent is part of the human body, this contravenes human dignity. The author does not draw this conclusion in general, but he believes that for similar ethical reasons certain patents should not be granted.-The second hypothesis postulates that using the term “invention” for elements of “life” is not appropriate. Article 3(2) of the Directive on the legal protection of biotechnological inventions allows for biological material that has been isolated to be considered an invention, even if it already existed in nature. This use of the term “invention” is criticised because it does not reflect the everyday use of the term.-The third hypothesis assumes that particularly patents on genes and gene sequences (“Stoffpatente”) might hamper medical research. An important characteristic of a gene is its multi-functionality, it can have several varying effects and can therefore be used in a variety of ways. The “Stoffpatent” includes all these different effects and allows the owner of the patent to make exclusive use of them. Despite the fact that even patented inventions may be accessed freely for research purposes by the scientific community (cf. section 11 of the German law on patents), the author sees a danger for medical research because “free access” does not mean “use for free”, e.g. in the context of research. Medical research in certain fields could thus be hampered if researchers are not willing or able to pay royalties. The author’s conclusion is that patenting biotechnological inventions can lead to conflicts of interests and that certain patents should not be granted for ethical reasons. It would seem necessary to create a sui generis patent system to reward the achievement of isolating a gene and identifying its structure and functions, where the current patent system does not seem appropriate.

Exclusion by Inclusion? On Difficulties with Regard to an Effective Ethical Assessment of Patenting in the Field of Agricultural Bio-Technology

In order to take ethical considerations of patenting biological material into account, the so-called “ordre public or morality clause” was implemented as Article 6 in the EC directive on the legal protection of biotechnological inventions, 98/44/EC. At first glance, this seems to provide a significant advantage to the European patent system with respect to ethics. The thesis of this paper argues that the ordre public or morality clause does not provide sufficient protection against ethically problematic uses of the patent system within the area of life. On the contrary, there are worrisome obstacles to any effective and comprehensive critical analysis of the ethical aspects of bio-patenting, especially in the field of agriculture. These obstacles can be seen as indirect consequences of the implementation of ethical considerations in form of the ordre public and morality clause in the EC Directive. Therefore, Article 6 of the EC Directive on the legal protection of biotechnological inventions seems to ultimately weaken the position of ethics in the debate concerning bio-patenting because the ordre public and morality clause is usually interpreted in an exclusively bio-ethical way in the sense of an “intrinsic ethics,” which is primarily interested in questions regarding the moral status of particular entities. It is argued that an important cause of this phenomenon is that the decisive reasons against bio-patenting are concerns of social ethics, and not bio-ethics.

Patents on Human Gene Sequences in Germany: On Bad Lawmaking and Ways to Deal With It

Whether patents should be granted on human genes or gene sequences is highly controversial, both ethically and politically; not only in Germany but throughout Europe and in most parts of the world. Proof of this has been the attention created by US biotechnology company Myriad Genetics, which, in 2001, obtained European patents for human gene sequences indicating an increased risk of certain types of cancer. In Germany the Bundestag has recently addressed the issue: the core of a newly introduced provision of the German Patent Statute (PatG) is Paragraph 1a Sec. 4 PatG, which limits the scope of patent protection available for human gene sequences or parts thereof. If the subject of an invention is a human gene sequence, Paragraph 1a Sec. 4 PatG requires disclosure of not only the sequence but also at least one application. Without such disclosure a human gene sequence is not patentable under German Patent Law. This is remarkable, because under the Directive of the European Parliament and the Council on the Legal Protection of Biotechnological Inventions, the so-called Biotechnology Directive of 1998, a piece of European Union legislation, the situation is different.

Act Implementing the Directive on the Legal Protection of Biotechnological Inventions in Germany (BioPatG)

Act Implementing the Directive on the Legal Protection of Biotechnological Inventions in Germany (BioPatG)

Ethics and patentability in biotechnology

The systems of patent rights in force in Europe today, both at the level of national law and on the regional level, contain general clauses prohibiting the patenting of inventions whose publication and exploitation would be contrary to "ordre public" or morality. Recent years have brought frequent discussion about limiting the possibility of patent protection for biotechnological inventions for ethical reasons. This is undoubtedly a result of the dynamic development in this field in the last several years. Human genome sequencing, the first successful cloning of mammals, and the progress in human stem cell research present humanity with many new questions of an ethical nature. Directive 98/44 of the European Parliament and of the Council of July 6, 1998, on the Legal Protection of Biotechnological Inventions created a new basis for patent protection in this field of technology. Based on the European experience to now, however, it must be said that patent law is not the right place to legislate the consequences of the morality of an invention.

Development and Implications of Patent Law

AbstractIntroductionThis is the second report pursuant to Article 16c of the Directive 98/44/EC of the European Parliament and of the Council of 6 July 1998 on the legal protection of biotechnological inventions and bears the title “Developments and implications of patent law in the field of biotechnology and genetic engineering” (hereinafter the “second 16c Report”).Its purpose is to set out the key events which have occurred since publication of the first 16c Report, and to comment on two issues identified in the latter: the scope of patents on sequences or partial sequences of genes which have been isolated from the human body; and the patentability of human stem cells and cell lines obtained from them. The Commission’s analysis is based on the Commission staff working paper SEC(2005)943.