Progress in biotechnology is accelerated by the patent system: research and development costs are often high and would frequently be unaffordable were it not possible to legally protect the end-product. Some end-products in the field are, however, not eligible for patent protection.
For an invention to be granted a patent, there are two distinct requirements that the subject matter of the invention must satisfy. The first requirement is intended to establish that that the proposed invention is an invention at all, and ? in most legal jurisdictions ? this is judged to be the case if the proposed invention is novel, inventive, and capable of industrial application. The second requirement is intended to ensure that the invention is suitable for patent protection, and this is judged to be the case if the invention does not relate to a subject matter that is considered unpatentable.
There are a number of different reasons why a particular subject matter may be considered unpatentable. In Europe, for example, subject matter is deemed unpatentable if it is judged to be contrary to the ?ordre public? or unethical. It is therefore unsurprising that many developments in biotechnology ? the science of manipulating living matter and life processes ? cannot be patented, and that many contentious questions relating to patentability in the area continue to be asked.
In Europe, ?Directive 98/44/EC on the legal protection of biotechnological inventions? was introduced in July 1998 with the intention of clarifying what subject matter should and should not be considered prima facie patentable in biotechnology. The interpretation of European Patent Law thus evolved, and has needed to evolve in order to keep pace with the rapid progress being made in biotechnology. Since the introduction of the Directive, case law has continued to modify the way in which the law is interpreted, and below are provided some interesting points relating to subject matter patentability in biotechnology.
Firstly, plant varieties, animal varieties, and essentially biological processes cannot be patented. Inventions relating to plants or animals are patentable, however, if the invention is technically feasible for a higher taxonomic group of plant or animal, such as a species or a genus. It should also be noted that, although biological processes are considered unpatentable, an exception is made for micro-biological processes.
Secondly, the human body or any element thereof ? including whole or partial gene sequences ? cannot be patented. An element of the human body can be patented, however, if isolated or produced by a non-biological technical process, even if the element is identical to the element that exists in Nature. Interestingly, this means that isolated whole or partial human genes are patentable ? although it is important to note that there must be an industrial application for the particular sequence of As, Ts, Cs and Gs.
Thirdly, the genetic identity of human beings is treated sensitively: processes for cloning human beings, processes for modifying the germ-line genetic identity of human beings, and the uses of human embryos will not be considered for patent protection. (The patentability of human embryos and stem cells has been the subject of lots of case law in recent years, and the reader should visit our website for more information.) In addition to human beings, the morality of certain actions towards animals is considered in the law: processes for modifying the genetic identity of animals are not patentable if they cause undue animal suffering ? that is, animal suffering without sufficient compensatory benefit to man or animal.
And finally, therapeutic, surgical, and diagnostic methods are not patentable, the rationale being that human beings or animals should not be denied access to these methods because of legal ownership.
There is much to European Patent Law, in addition to the foregoing, relating to patentability in biotechnology. Clearly, there are some types of invention that consequently can not be patented. It is very important to note, however, that patent protection can still be obtained for an idea that at first sight may appear unpatentable: it is simply a case of skilfully drafting the patent application and carefully choosing the form of the invention ? it could be a product, process, or use, for example ? when applying for patent protection.
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