The substantive provisions (among them those relating to patentability) of the Hungarian Law No. XXXIII of 1995 on the Protection of Inventions By Patents (hereinafter: Patent Act) are fully compatible with the substantive provisions of the European Patent Convention (EPC). Accordingly - as it is prescribed in Article 53(b) of the EPC - essentially biological processes are not patentable in Hungary. There is, however, not an explicit provision of the law to this effect. Such processes are not patentable under Article 1 of the Patent Act. According to Article 1:
"(1) Patents shall be granted for any inventions which are new, involve an inventive activity and are susceptible of industrial application.
"(2) The following in particular shall not be regarded as inventions within the meaning of paragraph (1):
(a) discoveries, scientific theories and mathematical methods;
(b) aesthetic creations;
(c) schemes, rules and methods for performing mental acts, playing games or doing business, and programs for computers;
(d) presentations of information.
"(3) Patentability of the subject-matters referred to in paragraph (2) shall be excluded only to the extent to which a patent application or the patent relates to such subject-matter as such."
The essentially biological processes are considered to be the same category as the discoveries and consequently they are not patentable.
In the context of patentability of the subject-matters described in Article 27.3 of the TRIPS Agreement, the following provisions of the Patent Act have to be cited as well.
Under Article 5(2):
"Methods for treatment of the human or animal body by surgery or therapy and diagnostic methods practised on the human or animal body shall, in particular, not be regarded as susceptible of industrial application. This provision shall not apply, however, to products, in particular substances (compounds) or compositions, for use in such methods."
Under Article 6(2):
"No patent protection may be granted for an invention if the publication or exploitation thereof would be contrary to public policy or morality; exploitation may not be regarded as contrary to public policy merely because it is prohibited by law or regulation."
The notion of public policy and morality encompasses the fundamental institutions and principles of our legal system which express the decisive values of our social and legal order. Practically, the same legal provisions are included in this range which also belong here in the international practice. However, concrete judicial decisions have not yet been made in these issues (e.g. in connection with the patentability of animals).
Inventions relating to biotechnological processes are eligible for patent protection or not eligible for protection in Hungary according to the following categories:
(a) Under Article 5(2) of the Patent Act, methods of treatment of the human or animal body by surgery are not patentable as not susceptible of industrial application;
(b) Under Article 5(2) of the Patent Act, methods of treatment of the human or animal body by therapy are not patentable as not susceptible of industrial application, including, in particular:
- germ line gene therapy,
- somatic cell gene therapy,
- method of treatment by therapy based on the use of biopharmaceutical or other agents that indirectly effect genetic modifications;
(c) Under Article 5(2) of the Patent Act, diagnostic methods practised on the human or animal body are not patentable as not susceptible of industrial application;
(d) Eligible to be patented are methods involving gene manipulation of animals practised not for the purposes of therapy or diagnosis, e.g. animal experimentation or tests for research purposes, unless the method used is contrary to morality by Article 6(2). Under Article 6(2) of the Patent Act all methods involving gene manipulation of humans are excluded from patentability;
(e) Under Article 1 of the Patent Act, essentially biological processes carried out by natural crossing are not patentable. Patentable are, however, processes in which there is technical intervention by man if such intervention plays a part in achieving the desired result and if the process may be characterized by at least one essential technical step.
It is part of the official examination to decide whether the subject-matter of the application is an essentially biological process. In this regard the totality of human intervention in the process and its impact on the result achieved has to be taken into account. If the human activity does not represent any contribution - apart from a trivial activity - to the process and to its result, the process is deemed to be an essentially biological process.
Furthermore, it has to be stated that animals per se and animal organs are patentable in Hungary. Animals and parts of animals produced by not essentially biological processes, including gene manipulation, are eligible to be patented under the general provisions relating to industrial inventions. Under Article 6(2) of the Patent Act, animals produced by the modification of their genetic identity and as a result of processes that would probably cause pain or physical harms to the animals without ensuring a proportionate advantage for humans or animals are not patentable on the basis of moral considerations. New animal breeds are patentable, the relevant provisions are included in a special chapter of the Patent Act.
By Article 6(2) of the Patent Act, humans, human body are not patentable; parts of the human body, thus human organs are not patentable either in their natural form. Eligible to be patented are, however, parts and products isolated from the human body, including cell lines, genes and nucleic or amino acid sequences, if they meet the general criteria of patentability.
Microorganisms and microbiological processes are patentable under the general criteria of the protection.