2 1 century, the rapid development of biotechnology in the world has also triggered a series of new legal issues. Is the analysis of microorganisms and their genes an invention in the sense of patent law or a scientific discovery? It is of great significance to discuss whether it meets the requirements of patent law protection and understand the international practice of strengthening biotechnology patent protection in developed countries for China's biotechnology patent protection.
In recent years, the development of biotechnology has made amazing progress, which has triggered great changes in a series of fields such as agriculture, medicine, chemical industry and environmental protection. Scientists predict that 2 1 century will be the century of biotechnology. However, the backward development of non-technical fields makes the advanced nature of biotechnology not fully exerted. Great changes have taken place in the institutional environment of the original political, economic, medical, ethical and legal systems due to the development of biotechnology, but the original theoretical system and operational system cannot achieve the fission, transformation and upgrading of the system as quickly as the development of biotechnology. Biotechnology is like a double-edged sword, which not only brings people infinite surprises, but also brings people infinite distress.
In the field of law, biotechnology and its patentability have always been a big problem that puzzles scholars. The description of life and DNA double helix structure claims patent right, which has also triggered a series of heated debates. The discussion on this issue has involved a series of deep-seated problems such as the nature of patent system, the definition of invention and scientific discovery, science and technology and ethics.
Disputes over patent protection of microorganisms and their genes
According to the viewpoint of traditional patent law, the key to solve the problem of whether to claim patent rights for microorganisms and genes lies in whether microorganisms and genes are inventions in patent law or scientific discoveries. Generally speaking, discovery reveals the essential laws of natural phenomena, and invention is the concrete application of these essential laws. Although scientific discovery may contribute more to society than invention, it does not have the practicability required by patent law for patent protection, and it cannot directly produce unprecedented products or directly use them as methods. Therefore, it is not an invention in the sense of patent law and cannot be granted a patent right. In other words, an important scientific discovery may have a far-reaching impact on mankind, and may win the Nobel Prize, but it will not become an invention in patent law and be protected by patents.
The different answers to whether the research results of microorganisms and genes are inventions or scientific discoveries have formed two different views on whether microorganisms and genes can be patented.
One view, which we can call negative, is that microorganisms and genes exist objectively in nature, and people's research results are like Mendeleev's periodic table of elements based on his profound insight into the periodic period of elements, or medical researchers' anatomical drawings of human bodies based on their subtle research on the human body. Of course, they have paid hard mental work, but they still belong to the category of scientific discovery, because scientific discovery itself determines that it is impossible to draw obvious conclusions. Therefore, anyone can draw conclusions about microorganisms and genes themselves. The unique method of purification, purification and extraction belongs to the protection scope of patent law and can be patented.
Another viewpoint, which we can call affirmative, is the microorganism and gene advocated by the inventor, because the purification, purification and drawing activities of the inventor have changed their original natural state. Because of the close relationship between biotechnology and social life, the study of microorganisms and genes is not only a revelation of their objective laws, but also a step away from their objective application. Moreover, genetic research is special, high-risk, high-investment, and its commercial application prospect is immeasurable. No matter from the angle of intellectual labor or commercial return, we should recognize its intellectual property rights and grant patents, otherwise the development of biotechnology as a new industry will be greatly affected.
The author thinks that scientific discovery and invention are in the process of forming research results of microorganisms and genes, and should be treated differently.
First of all, it is undeniable that microorganisms and genes exist objectively in nature, which does not depend on how much we know about them. Observing their existence for the first time should be a revelation of objective things and a scientific discovery. Of course, this discovery does not meet the industrial practicability standards required by patent law protection. Therefore, even if researchers spend their whole lives on it, they can't claim the patent right, just as researchers can't claim the patent right and collect patent fees by observing and measuring the objective existence of a cosmic celestial body.
Secondly, if the research goes further, the researchers carry out a series of separation, purification and purification of microorganisms and genes, change their natural existence mode and state in nature, so that they can be controlled by manpower and find their social use value, then we have no reason to refuse to provide patent protection for them.
In fact, in scientific and technological research, scientific discovery and invention are closely combined. Any scientific and technological invention must be based on the original scientific discovery, and no invention is created out of thin air. Only by mastering the objective things and laws in this field can we talk about invention and innovation. Of course, the same is true in the field of biotechnology research, but because biotechnology research and development itself is highly professional and persistent.
Researchers have observed and measured the objective existence of a cosmic celestial body, but they cannot claim patent rights and collect patent fees.
Secondly, if the research goes further, the researchers carry out a series of separation, purification and purification of microorganisms and genes, change their natural existence mode and state in nature, so that they can be controlled by manpower and find their social use value, then we have no reason to refuse to provide patent protection for them.
In fact, in scientific and technological research, scientific discovery and invention are closely combined. Any scientific and technological invention must be based on the original scientific discovery, and no invention is created out of thin air. Only by mastering the objective things and laws in this field can we talk about invention and innovation. Of course, the same is true in the field of biotechnology research, but because of the high professionalism and continuity of biotechnology research and development itself, the earliest discoverers of microorganisms and genes and deep R&D users are often the same research subject. This development makes inventions and scientific discoveries merge, interweave and interact with each other, and it is difficult to distinguish between true and false. Simply put, there can be no related inventions of biotechnology without revealing objective laws or the first discovery of microorganisms and genes. However, it is not enough to request the protection of patent law only through objective disclosure and first discovery. Among them, what researchers need to do is to combine the two and make achievements in the invention of biotechnology. What we need to do is to separate the two and give them different legal attitudes. The present situation and countermeasures of biotechnology patent protection in China: China's patent protection for biotechnology started later than that of developed countries abroad, and there is no legal provision for biotechnology patent protection in the current patent law. However, in the detailed rules for the implementation of the patent law, there are specific requirements for the sample submission and classified preservation of biomaterials. In the review guide, there are also criteria for judging whether a type of microorganism has the conditions for patent protection: "Microorganisms that exist in nature without any technical treatment by human beings are scientific discoveries and have no industrial applicability, so patents are not granted. Only when microorganisms are separated into pure cultures and have specific industrial uses, microorganisms themselves are the subject of patent grant. "
It should be said that China's legislation on biotechnology patent protection is consistent with the related protection concept of TRIPS, which provides a legal basis for whether the staff should be granted biotechnology patent protection in actual operation and has positive practical significance for the development of biotechnology in China.
It is not difficult to find that in the legal protection of biotechnology in China, the debate about the attribution of microorganisms and genes in inventions and scientific discoveries and whether to grant patent protection is of little significance. Biotechnology in developed countries has developed rapidly under the relaxed legal environment and strong government support. As the birthplace of biotechnology, the United States now has more than two-thirds of biotechnology companies in the world, including 225 large biopharmaceutical companies, with an industrial investment of $35 billion. It can be said that the loose legal support for biotechnology has created and will continue to create great wealth for the United States. With the growing gap between developing countries and developed countries in biotechnology, there will be more and more "biopiracy" that uses biotechnology monopoly to plunder the limited biotechnology resources in the world. When developed countries are scrambling to land in the field of biotechnology and establish patent barriers to replace the gradually dismantled tariff barriers, what developing China countries can do is not to immerse themselves in the academic debate on whether to protect them, but to keep up with their own interests in scientific research strength and legal protection, keep up with the pace of international intellectual property protection, and really learn to use intellectual property weapons to safeguard their legitimate interests and avoid being "maliciously infringed" by other countries. No matter from public health and commercial interests, or from scientific and technological progress and social development, patent protection of biotechnology is imperative.
At present, it is urgent to make full use of the existing advantages, speed up the process of international protection of biotechnology patents, make full use of the foreign priority system in international treaties in international patent applications, and seize the international opportunities as soon as possible.
1967 The revised Paris Convention for the Protection of Industrial Property stipulates: "An applicant or other right successor who has formally filed an invention patent, utility model, industrial product model or registered trademark in a member country of the Union shall enjoy priority when filing the same application in other member countries of the Union within the following prescribed time limit." The above priority period is 12 months for invention patents and utility models, and 6 months for industrial products and trademarks. To put it simply, as far as the patent protection of microorganisms and genes is concerned, within 12 months, the date when the patent applicant filed a patent application in other countries of the Paris Convention is the time standard for judging novelty. The acquisition of this priority should be based on the declaration made by the applicant within the latest time limit stipulated by the state as a formal requirement.