Decades, progress and the birth of gene recombination technology is poured a lot of vitality to the biological development, to bring the value of gene recombination technology also huge economic benefits and scientific research, many countries and a large amount of manpower investment of financial power, we have developed a gene recombination technology. However, gene recombination technology products, especially genetically modified animals animal protection, may result in dispute, such as a biological logic, also legal provisions and practices operation for the correlation field is different for some countries, genetically modified animals patent rights The question of whether to be protected by has become now a big topic.
1, Japan, the gene in the United States and Europe recombinant provisions relating to animal
Developed countries in general are taking the attitude that authorized or deliberate authorized for transgenic animals. On the other hand, many developing countries including China, usually, is taking an attitude of not awarded patent rights. First become genetically engineered animal patent in the world well-known that the United States Patent and Trademark Office in 1988 was awarded "Harvard mouse" is a patent. This is a milestone in genetic recombination patent protection development. Japan in 1993, was defined to grant the patent to genetically modified animals.
Europe is taking a relatively cautious attitude. When hearing the patent application of the Harvard mouse, the European Patent Office finally awarded the patent in 1992, in 1998 it has passed through the command of the No. EU98 / 44. If you still plant and animal varieties in the directive 4, paragraph 1 and is defined to be not awarded the patent rights, but the Ka line of "invention technology is not limited to a particular plant or animal varieties in Section 2, the plant or animal invention and is defined as "having patentable. Therefore, EU Patent Office restrictively to the naturally occurring the "animal variety" in the directive to be interpreted as a "animal varieties", the genetically modified animals are distinguished from the animal breed of authorized not, be authorized.
2, provisions relating to genetically modified animals in China
Many developing countries including China are taking the attitude that is not authorized in transgenic animals. In China Patent Law Article 25 1 (4) of this section it has been defined as "the animal and plant varieties not awarded the patent rights." If the "patent examination teaching" two-part Chapter 10 is an animal or plant that was obtained by recombinant DNA techniques such as biology method of "transgenic animals or plants gene process, that itself is still this part Chapter 1 Section 4.4 in defined "animal variety" or to enter the category of "plant varieties", pursuant to the provisions of the Patent Law Article 25 Clause 1 4 Subsection, it can not be awarded the patent rights. " Also still the contents of whether it is possible to authorized genetically modified animals in "patent law amendment draft (opinion conscripted draft)" of 2015 has not been written.
But at the same time, China for the "Patent Prosecution teaching" two-part Chapter 1 production method of "animal or plant varieties in, can be awarded the patent rights. However, the production method as referred to here is a method of non-biological and in refers, the methods of the main biologically Upon the production of animal or plant is defined as not including ", a further exclusion behind to define the meaning of" How to mainly biology ", ie," the method is determined to about human intervention "," when a person of the technology intervention happens to request purpose and main governing action or decisive action to the effect that of the method, not the method 'mainly biological methods' " .
As separate from this, under the present Patent Law system in China, transgenic animals are not able to grant the patent, a method of generating transgenic animals can be authorized.
3, PCT , such as the revision and protection is narrower rights request after entering China of problem
America, Europe, after the PCT application of Japan of transgenic animals has entered the China national stage, right request of genetically modified animal products should replace the rights request of transgenic animals generating method.
For example the rights required in PCT application "in animals modified by gene recombination of a type, .... animal containing X gene has said," in this Chinese national stage, through "type of recombinant modifications A method of producing an animal, the method that is said must be remedied and ...... "as to include an X genes by modifying the animal.
Such revision methods may be overcome situations that can not be authorized to Chinese transgenic animals, but leads to a big problem at the same time. It is, when changing from the product right request to the way right request, is a fear that leads to the narrowness of the scope of protection.
According to the provisions of the Chinese Patent Law Article 11, for the purpose of "production management, manufacturing for its patented product, use, license sales, sales, and should not be subjected to import, or use the patented process and the patent Use the product obtained directly by the method, license sales, sale, shall not be subjected to import ". Therefore, with respect to the product right request, patents directly protect the product, the protective power is strong, and is usually referred to as "absolute protection". To methods rights request, patent protects the product obtained directly from the method, and the method, the protective power is weak, and are usually referred to as "relative protection". If there is infringement for a method right request, there are many difficulties in terms of contrast, etc. of collection and methods of evidence of the right holder, it is not advantageous to the protection of the rights of patent holders.
Therefore, when changing the rights request transgenic animal products to the rights request transgenic animals generation method, narrows the scope of protection of the patent, it may compromise the future.
HFG proposal to customers
In fact operational, transgenic animals are produced from the study for a specific gene or gene product which had been often, so transgenic animals are subordinate to the normal gene product. Products upper which is also produced from the gene itself and of a gene product, for example, siRNA, mRNA, protein or the like.
According to the provisions China "patent examination teaching" two parts Chapter 10, "microorganism becomes pure culture are separated, and only when provided with a certain industrial applications, the microorganism itself corresponds to the object that provides patent protection ", and" A first gene or DNA is separated by or extracted from nature, utilizing the nucleotide sequence has not been described in the prior art, and suitably can be characterized, moreover on Industrial If it has value, both of the gene or DNA fragment itself and how to obtain it, corresponding to the object to provide patent protection ".
Therefore, taken together the correlation provisions of the current Chinese patent law, genes, genetic carriers, genetic generation method, a gene product, the gene product generation method, a gene of a microorganism or a fused cell, and a method such as transgenic animals produce even authorized It is a customer pair.
As separate from this, in the case of constructing a full protection against gene or gene product that a customer like builds a patent family, each of the upper genes (products right request), the gene carriers (product rights request ), gene generation method (Method rights request), the gene product (product rights request), gene product generation method (Method rights request), of gene microorganism or fused cells (product rights request), and the lower of transgenic animals generation of how to protect the (way right request), also aligned as much as possible many of the generation method, to prevent the infringement that may occur in the future.
On the other hand, when viewed from another aspect, if it is customers like competitor has already protected a method of generating transgenic animals which are the patent application, if the gene itself is not protected, the customer-like and of the patent and seriously studied the production methods of transgenic animals, to the gene recombination with a particular animal, by other methods different from the patented process produces a self-required transgenic animal patents competitors Avoid the protection scope, it can be avoided from having to infringe.
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