The term “microorganism” encompasses entities across the taxonomic classes including bacteria, actinomycetes, fungi, viruses, protozoa, and algae. According to current Chinese patent rules, a microorganism is neither an animal nor a plant.
Microorganisms and microbial processes are both patentable subject matter. Microorganism inventions are those relating to the production of a chemical substance (such as antibiotics) or the decomposition of a substance through application of the microorganism.
Please note that obtaining a microorganism existing in nature without the involvement of any technical intervention is a scientific discovery and thus unpatentable. Microorganisms constitute patentable subject matter per se only when isolated in pure culture with a particular industrial use.
1. Requirements for microorganism patent applications
Chinese Patent Law requires “biological materials which are not available to the public” to be deposited at a depository institution including materials whose creation process cannot be repeated by a person of ordinary skill in the art - such as new microorganisms that were created through novel mutation and screening. These biological materials must be deposited according to relevant provisions.
The depositary institutions are designated by the China National Intellectual Property Administration(CNIPA) and include the international depository institutions for biological material samples acknowledged by the Budapest Treaty and the Center for General Microorganism Administration Committee consisting of the China Microbiological Culture Collection (CGMCC) in Beijing, the China Center for Type Culture Collection (CCTCC) in Wuhan, and the Guangdong Microbial Culture Collection Center (GDMCC).
A claim involving a microorganism must include a description of the microorganism consistent with its microbiological taxonomic denomination in both Latin (in brackets where it is first mentioned) and in Chinese (if applicable).
If the microorganism has been deposited in a depository recognized by the CNIPA then the claim must also reflect the microorganism’s access number and depository abbreviation (e.g., Staphylococcus Aureus CCTCC8605).
When the microorganism involved is a novel species, its taxonomy must be described in detail as well as justification for classification as a new species must be given and relevant documentation must be provided.
If a specific mutant strain of a microorganism is not mentioned in the description, it must be mentioned in the embodiment or no claim to the mutant strain will be permitted.
If the taxonomic characteristics of a microorganism are remarkably different from that of the known species (new species), then it embodies an inventive step. If there is no substantive difference in the taxonomy of the microorganism and the known species, then the microorganism must produce technical effects that are not known or predictable to a person of ordinary skill in the art to satisfy the inventive step.
2. Patent requirements for the screening and production of microorganisms
The process for screening a microorganism from its natural environment is typically not repeatable as the objective condition is limiting and random. This screening process thus does not possess any practical applicability. Unless the applicant can supply evidence to prove the repeatability of the process, the process is unpatentable.
The process of producing new microorganisms through physical and chemical mutagenesis depends on the random mutation of the microorganism through one or more base changes during DNA replication and screening out strains with specified characteristics. Because the base mutations are random, the result is difficult to replicate even if the mutagenesis has been clearly disclosed. Such processes do not possess practical applicability and are thus unpatentable unless the applicant can supply evidence to prove the repeatability of the mutation to definitively create the same desired characteristics.
Additionally, an invention utilizing a microorganism does not demonstrate an inventive step if the microorganism used in the invention is of the same genus as another that is known to have the same properties and use. However, if the claimed invention produces unexpected results compared to the known microorganism, the invention involves an inventive step.
An invention using a microorganism includes an inventive step if the taxonomy of the microorganism used in the invention is remarkably different from that of a known microorganism but shares the same use (e.g., a new species that performs the same function).
A typical microorganism claim can read:
Example 1: An isolated strain selected from the group consisting of: enterococcus faecium (Enterococcus faecium) strain 8G-1(NRRLB-50173), a strain having all the identifying characteristics of enterococcus faecium strain 8G-1(NRRLB-50173), enterococcus faecium strain 8G-73(NRRLB-50172), a strain having all the identifying characteristics of enterococcus faecium strain 8G-73(NRRLB-50172), Bacillus pumilus (Bacillus pumilus) strain 8G-134(NRRLB-50174), a strain having all the identifying characteristics of Bacillus pumilus strain 8G-134(NRRLB-50174), and combinations thereof.
Example 2: Culturing of Fusarium (f.), (Fusarium sp.) A method of strain MK7, comprising: (a) culturing a fusarium MK7 strain deposited under ATCC accession No. PTA-10698 in a liquid medium comprising a carbon source and having a pH of 0.5-7.5 to produce a fusarium MK7 strain; and is (b) the Fusarium MK strain was harvested.
The strain patents can also include strain screen methods, primers, strain compositions, etc.
(The author hereby acknowledges the contribution of Ms. Joyce Yao of Santa Clara University High Technology Law Journal (HTLJ) in editing the English language expression.)
