The role of the patents
Patents confer the right to prevent third parties from making, using or selling the invention without their owners' consent. Patents should not be confused with the other kinds of intellectual property (IP) rights available: utility models (with some national exceptions), copyright, trademark, designs.
In Europe, the European Patent Organisation operates under the European Patent Convention (EPC) and includes the European Patent Office (EPO) as its executive body (comprising an examining division for granting patents, boards of appeal, and the Enlarged Board of Appeal). It is distinct from the European Union (EU) where the Court of Justice of the European Union (CJEU) serves as the primary judicial authority. However, all EU Member States are parties to the EPC, and the European Patent Organisation extends beyond the EU to include nine non-EU Member States. From 1999, the EPC contracting States agreed to incorporate the wording of the EU Directive 98/44/EC on the legal protection of biotechnological inventions into the EPC. They also decided to use this directive as a supplementary tool for interpretation.
The requirements for obtaining a patent. According to the Art. 52 of the EPC, the European patents shall be granted for any inventions in all fields of technology provided they comply with three main requirements. Namely, that inventions are:
(i) New (Art. 54 EPC)
(ii) Involve an inventive step (Art. 56 EPC)
(iii) Are susceptible of industrial applications (Art. 57 EPC)
The European patent application shall disclose the invention in a manner sufficiently clear and complete for it to be carried out by a person skilled in the art (Art. 83 EPC).
An invention can be a product, a process or an apparatus, for example. However, discoveries, scientific theories, mathematical methods, aesthetic creations, schemes, rules and methods for performing mental acts, playing games or doing business, and computer programs and presentations of information are not considered inventions. Also excluded from patentability are plant and animal varieties; inventions contrary to 'ordre public' or morality; methods of treating the human or animal body by surgery or therapy; and diagnostic methods practised on the human or animal body. However, the latter exception does not exclude the patentability of other methods of treating living human beings and animals as long as they are of a technical and not essentially biological character (see G‑II, 5.4.2). European Patent Office (EPO) provides an example stating that an application containing claims directed to the purely cosmetic treatment of a human by administration of a chemical product is considered to be patentable (see T 144/83), whereas a cosmetic treatment involving surgery or therapy would not be patentable (see Link). With relation to patentability of cells and tissues, the EPO states that: “Treatment of body tissues or fluids after they have been removed from the human or animal body, or diagnostic methods applied on them, are not excluded from patentability as long as they are not then returned to the same body. So the treatment of blood for storage in a blood bank or diagnostic testing of blood samples is not excluded, whereas a treatment of blood by dialysis where the blood is returned to the same body would be excluded.”
In essence, the requirement for an invention fulfills a dual function within the framework of European patent law. Firstly, it serves as a mechanism for determining which inventions are eligible for patent protection and which are not. Secondly, it facilitates the designation of patent protection for those inventions that meet the criteria of being new, inventive, susceptible of industrial application, and sufficiently defined.
The patent validity. Patents are valid in individual countries for specified periods. They are generally granted by a national patent office, or a regional one like the European Patent Office (EPO).
Patenting human genes and stem cells
Inventions involving stem cells, including T-cells, as well as other biological materials, are subject to patentability as long as they fulfill patentability requirements of novelty, an inventive step and industrial applicability. As stated in the 16th Opinion of the European Group of Ethics in Science and New Technologies to the European Commission, “(...) the patentability of processes involving human stem cells, whatever their source, there is no specific ethical obstacle, in so far as they fulfill the requirements of patentability.”
However, there are some exceptions. According to Art. 53 (a) of EPC, inventions regarded as contrary to public order or morality are not patentable. The main exclusions under Article 53(a) EPC and Rule 28 EPC concern inventions involving:
- processes for cloning human beings;
- processes for modifying the germ line genetic identity of human beings;
- uses of human embryos for industrial or commercial purposes.
The latter prohibition also extends to the uses of human embryos where their destruction is required (as established by the CJEU’s Brüstle v. Greenpeace decision (C-34/10) and the EPO’s WARF ruling G2/2006).
The Brüstle ruling (C-34/10) was especially significant as it analysed the balance between protection of human dignity and patentability of inventions involving human embryo. The Court held that a “human embryo” includes not just fertilized ova, but also non-fertilized ova (i.e. whose division has been stimulated by parthenogenesis). The Court also ruled that the exclusion from patentability applies not only to industrial or commercial purposes, but also to scientific research, with the exception of therapeutic or diagnostic purposes that benefit the embryo itself. Subsequent to the emergence of new scientific knowledge in the field of stem cell research, the Court was compelled to amend its definition of a human embryo within a period of several years. In the second CJEU’s Brüstle case, i.e. International Stem Cell Corporation case, C-364/13, unfertilized oocytes that had been activated by parthenogenesis were used to manufacture several embryonic stem cell lines. As the life sciences field progressed, the CJEU amended its initial definition. In the initial Brüstle case, the parthenote would be classified as a "human embryo". In the subsequent International Stem Cell Corporation case, a parthenote, despite its capacity to form a blastocyst, was unable to develop into a human being. Consequently, the Court expanded the definition of the "human embryo" by stipulating that "human embryo" should be regarded as such only if it initiates the process of development into a human being, or any process that would result in the development of a human being.
Moreover, excluded from patentability are also publicly available cell lines initially derived from embryo destruction (the Technical Board of Appeal decision in T 2221/10). However, with a progress in a biotechnology field, the current Part. 5.3 of the Guidelines for Examination in the EPO states that an application pertaining to human pluripotent stem cells, including human embryonic stem cells, uses thereof or products derived therefrom cannot be regarded as excluded from patentability under Art. 53(a) and Rule 28(1)(c) (T 0385/14) if (i) the application has an effective date (i.e. a valid priority date or, if no priority is claimed or the priority is not valid, a filing date) on or after 5 June 2003, and (ii) its technical teaching can be put into practice using human embryonic stem cells derived from parthenogenetically activated human oocytes. Moreover, (i) foetal and post-natal human cells as well as (ii) culture media, supports and apparatuses "suitable for" use with human embryonic cells, or even "specifically designed" for this purpose, are not per se excluded from patentability.
With relation to gene or gene editing tools patentability, if embryo destruction is not involved and it is done for therapeutic purposes it is potentially patentable. Natural gene sequences are patentable when they satisfy the fundamental requirements of novelty, inventive step and industrial applicability. However, the EPO has adopted an increasingly stringent stance on industrial applicability, effectively turning it into an 'actual test of usefulness' that poses a significant challenge, particularly in biotechnology. However, modifying the human germline is explicitly excluded from patentability under the EU Biotechnology Directive and the EPO’s Rule 28(1)(b). Germline interventions are also banned or strictly regulated in many national jurisdictions. While Rule 28(1)(b) specifically excludes processes for altering human germline genetic identity, product claims must be assessed individually under the general “ordre public” and morality exception, meaning the EPO’s evaluation partly depends on the type of claim."