Can microbes be patented?

With the rapid development of biotechnology, the number of patents for the invention of microorganisms is increasing. So can microbes be patented?

At first, the granting of patents for microorganisms themselves was restricted in many countries, but in the 1970 s, things began to take a turning point, and this milestone turning point was the "Chakrabarty case" in the United States. Scientists Chakrabarty through the intercellular bonding., Obtaining super cells that can degrade different petroleum components at the same time, but the patent protection for the bacteria itself was rejected by the Patent Office. After a year of legal controversy, the patent was granted, and since then the restrictions on the granting of patents for microorganisms have gradually been broken.

In China, since the implementation of the second revision of the Patent Law on January 1, 1993, the patent rights of microorganisms have also begun to be recognized by law. The key to judge whether a microbe can claim a patent right itself is to judge whether it has the novelty, originality and practicality required by the patent law to grant patent protection. Among them, practicality is the most controversial point on the issue of granting patents to microorganisms themselves.

So what can be called a microbe? A detailed explanation is given in the review guide.

"The so-called microbial invention refers to the use of various bacteria, fungi, viruses and other microorganisms to produce a chemical substance (such as antibiotics) or decomposition of a substance of the invention. Microorganisms include bacteria, actinomycetes, fungi, viruses, protozoa, algae, etc.

However, microorganisms that exist in nature without any technical treatment by humans cannot be patented because they are scientific discoveries. Only when the microorganism is separated into a pure culture and has a specific industrial use, the microorganism itself is an object that can be granted patent protection."

Specifically:

"A microorganism that is significantly different from the taxonomic characteristics of a known species (I. e., a new species) is inventive if the taxonomic characteristics of the microorganism to which the invention relates are not substantially different from those of the known species, but the microorganism produces a technical effect that would not be expected by those skilled in the art."

"In the case of an invention for the use of a microorganism, if the microorganism used in the invention is of a known species and belongs to the same genus as another microorganism known to be used for the same purpose, then the invention for the use of a microorganism is not inventive. However, if the application of the microorganism produces an unexpected technical effect compared with the application of another known microorganism belonging to the same genus, then the invention of the application of the microorganism is inventive."

"If the microorganism used in the invention has significantly different taxonomic characteristics from the known species of microorganism (that is, the microorganism used in the invention is a new species), then the invention of the application of the microorganism is inventive even if the use is the same."

However, regarding the method of screening specific microorganisms from nature, "this type of method is limited by objective conditions and has great randomness, so it cannot be reproduced in most cases. For example, a specific microorganism is isolated and screened from the soil of a certain county in a certain province. Due to the uncertainty of its geographical location and the continuous changes of natural and man-made environment, as well as the contingency of the existence of specific microorganisms in the same soil, it is impossible to reproduce the same genus and the same biochemical and genetic properties within 20 years of the validity of the patent. Therefore, the method of screening specific microorganisms from nature is generally not industrially applicable. Unless the applicant can give sufficient evidence to prove that this method can be repeated, this method cannot be patented."

At present, the most common method is to produce new microorganisms by artificial mutagenesis through physical and chemical methods. "This type of method mainly relies on random mutations produced by microorganisms under mutagenic conditions. This mutation is actually a DNA replication process. One or several base changes in China, and then a strain with certain characteristics is screened out. Since the base changes are random, even if the mutagenesis conditions are clearly described, it is difficult to obtain exactly the same results by repeating the mutagenesis conditions. This method does not comply with the provisions of Article 22, paragraph 4, of the Patent Law in the vast majority of cases, unless the applicant can give sufficient evidence to prove that mutagenesis under certain mutagenesis conditions will inevitably result in microorganisms with the desired characteristics, Otherwise, this type of method cannot be patented."