INTRODUCTION
Advancements in the field of biotechnology have enabled innovations across various disciplines such as genetic engineering, biopharmaceuticals, and agricultural biotechnology. Although patent law is regarded as an important tool for protecting and commercializing these innovations, the patenting of biotechnological inventions brings with it various legal and ethical debates. Under Turkish law, the patentability of biotechnological inventions is subject to certain criteria, and there are several limitations, particularly concerning the protection of genetic materials and the consideration of public interest. In this context, the manner in which the boundaries between legal regulations and ethical principles are drawn has become an important topic of discussion.
A. CONCEPTS OF BIOTECHNOLOGICAL INVENTION AND BIOLOGICAL MATERIAL
According to Article 2(1)(a) of Directive 98/44/EC on the Legal Protection of Biotechnological Inventions (“Directive 98/44”), biological material refers to any material containing genetic information and capable of reproducing itself or being reproduced in a suitable biological system. Biotechnological inventions, on the other hand, are defined in Article 27 of the EPC Implementing Regulations, which form the basis of the European Patent Convention (“EPC”), as inventions relating to a product consisting of or containing biological material, or to a process by which biological material is produced, processed, or used.
B. CONDITIONS FOR THE PATENTABILITY OF BIOTECHNOLOGICAL INVENTIONS
For a biotechnological invention to be patentable, it must meet the requirements of novelty, inventive step, and industrial applicability under Article 82 of the Industrial Property Law No. 6769 (“IPL”). However, due to the nature of biotechnological inventions, there is debate as to whether such inventions require specific provisions under national and international regulations.
During the discussion of the draft IPL, although it was proposed to include more detailed provisions regarding biotechnological inventions, the draft specified the boundaries of biotechnological inventions that could not be patented. Therefore, inventions falling outside this scope may benefit from patent protection under the general provisions, provided they meet the requirements of novelty, inventive step, and industrial applicability as required by international regulations. For this reason, it is important to examine these criteria in detail with regard to the patentability of biotechnological inventions.
i. Novelty Requirement
One of the fundamental requirements for the patentability of biotechnological inventions is that they meet the novelty criterion. According to Article 83 of the IPL, an invention is considered new if it differs from the existing state of technical knowledge. The assessment of novelty focuses not on whether the invention occurs for the first time in nature, but on whether it has been disclosed to the public previously. For biotechnological inventions, the main debate concerns how a material that already exists in nature can be considered new. However, in patent law, novelty is measured not by whether an organism or genetic material exists in nature, but by whether it has been made publicly available through human intervention. Any information disclosed or used publicly prior to the patent application is considered part of the state of the art and cannot be patented. While the inventor is not obligated to prove novelty, if it is alleged that the invention is not new, the burden of proof lies with the party making that claim.
ii. Inventive Step Requirement
For an invention to be patentable, it is not sufficient for it to be merely new; it must also involve an inventive step. According to the IPL and Article 56 of the EPC, an inventive step is defined as a novelty that is not obvious to a person skilled in the relevant technical field and that advances the state of the art. For biotechnological inventions, this criterion is directly related to whether the invention provides a technical contribution that differs from existing biological processes or genetic materials.
The European Patent Office (“EPO”)’s ‘problem/solution’ approach is one of the main methods used to assess whether an invention involves an inventive step. This method consists of three stages: (i) identifying the closest prior art, (ii) determining the technical problem to be solved, and (iii) evaluating whether the invention would have been obvious to a person skilled in the relevant technical field.
For patent protection, it is not sufficient to merely discover genetic materials or biological processes; they must be modified through a technical process, endowed with a new function, or applied in a way that solves a specific technical problem.
In this context, the most important consideration when assessing inventive step is whether the technical developments in the relevant field could be easily anticipated by a person skilled in the art. If a new biotechnological method or product is considered merely a simple combination of existing knowledge and techniques, it will not be eligible for patent protection. Therefore, to protect inventions in the field of biotechnology, it is essential to carefully examine how a natural process has been transformed through a technical innovation.
iii. Industrial Applicability Requirement
According to the sixth paragraph of Article 83 of the IPL, an invention is considered industrially applicable if it can be produced or used in any field of industry, including agriculture. This requirement is particularly important for biotechnological inventions, as genetic materials and biological processes are subject to assessment criteria that are more complex and nuanced compared to those applied under the traditional patent system.
One of the most debated issues regarding the industrial applicability of biotechnological inventions is the patentability of genetic materials. According to Article 5(1) of Directive 98/44/EC, genes, partial gene sequences, and other biological elements considered part of the human body cannot be patented solely because they have been discovered. However, if such genetic materials are isolated from the human body or produced through a specific technical process, they cease to be natural elements and are considered technical inventions, making them eligible for patent protection.
The industrial applicability requirement is not limited to the patenting of genetic materials; it also imposes significant restrictions on medical diagnostic and therapeutic methods. According to the EPC, surgical, therapeutic, and diagnostic methods applied to the human or animal body are excluded from patent protection on the grounds that they are not directly susceptible to industrial application. However, if the same drug acquires a different use—for example, if it is found to be usable as a herbicide in agriculture—it can meet the industrial applicability requirement and be eligible for patent protection. This issue is particularly controversial in the pharmaceutical sector, as the inability to patent new medical uses of known drugs has been criticized for negatively affecting the research and development processes of the pharmacology industry.
C. EXCEPTIONS OF THE PATENTABILITY OF BIOTECHNOLOGICAL INVENTIONS
The patentability of biotechnological inventions is subject to certain exceptions under the second and third paragraphs of Article 82 of the IPL. These exceptions are generally divided into two categories: elements that do not constitute an invention and inventions excluded from patent protection for reasons of public order or morality.
Elements that do not constitute an invention are identified solely as matters of discovery. However, a biotechnological invention developed using elements that do not constitute an invention may still be eligible for patent protection.
Cases where patentability is limited for reasons of public order and morality are of particular significance for biotechnological inventions. According to the third paragraph of Article 82 of the IPL, human cloning, the discovery of elements of the human body including gene sequences, the commercial use of human embryos, and genetic interventions that do not provide medical benefits cannot be patented. These restrictions are imposed to protect human health, prevent the commercialization of the human body, and ensure animal welfare.
CONCLUSION
The patenting of biotechnological inventions is a matter that involves both legal and ethical considerations, requiring a balance between promoting scientific progress and safeguarding the public interest. Under the IPL and international regulations, such inventions must meet the requirements of novelty, inventive step, and industrial applicability to be eligible for patent protection. However, certain areas, such as human cloning, the discovery of genetic materials, and inventions contrary to public order, are excluded from patent protection.
Particularly due to the nature of biotechnological inventions, it is crucial to clarify the distinction between discovery and technical innovation, ensure industrial applicability, and define ethical boundaries. In this context, Turkey’s participation in international agreements such as the EPC and TRIPS ensures that the patent regime in the field of biotechnology aligns with global standards.
- EVRİM, N. (2018). Protection of Biotechnological Inventions (Publication No: 531642) [Doctoral dissertation, Dokuz Eylül University]. Council of Higher Education.
- Implementing Regulations to the Convention on the Grant of European Patents https://www.epo.org/en/legal/epc/2020/regulations.html
