Challenges of Overseas Entities in Filing for Plant Variety Right in China
18 Dec 2020
In 2019, China accepted a total of 7032 applications for new varieties of agricultural plants and 802 applications for new varieties of forestry plants, of which overseas applicants accounted for 5.65% and 18.2% respectively. Compared to 2018, the total number of applications increased by 36% and the total number of grants increased by 13.86%, with an overall year-by-year increase in the volume of applications and grants of overseas entities. With the increase in the volume of applications for new plant variety rights by overseas entities, the difficulties and challenges encountered in its application process are worthy of understanding in advance.
The agricultural and forestry industries are both highly regulated in China. The provision of germplasm resources by Chinese entities to other countries and the cooperation with overseas institutions on the use of germplasm resources must be approved by the agricultural or forestry authorities. The introduction of germplasm resources from abroad shall go through procedures for approval, plant quarantine, and registration in accordance with the different agriculture and forestry requirements.
1. Plant New Variety Protection Catalogue and Registry
Amongst the many plant varieties, only the new plant variety rights of genera or species of plants included in the National Plant Variety Protection Catalogues can be applied for. As of August 2020, China has issued 11 batches of Protection Catalogues of agricultural plant varieties which contain 191 genera and species, and six batches of Protection Catalogues of forestry plant varieties, which contain 206 genera or species.
China has been a member of the International Union for the Protection of New Varieties of Plants (UPOV) and a party to the 1978 Act since April 1999. In early 2017, UPOV launched an international e-filing system for plant variety rights called UPOV PRISMA, in which China joined in July 2017. Among the filing for new plant variety rights in China, only lettuce (Lactuca sativa L.) can be applied for through this system. The remaining varieties must be applied to the China State Forestry Administration Office for the Protection of New Varieties of Plants and the Plant Variety Protection Office of the Ministry of Agriculture of China (collectively, the “PVR Offices”).
Foreign individuals, overseas companies and other overseas organizations cannot apply for plant variety rights in China by themselves and must entrust an agency to handle the application.
2. Denomination of Candidate Variety
There are certain criteria for naming a candidate variety that will be filed in China. The variety’s denomination shall be distinguishable from the names of already-known botanical genera or species.
The denomination of the candidate variety shall not only be comprised of numbers and shall not mislead a person on the characteristics and features or the identity of the breeder(s) of the new plant variety. The denomination must also not include country names or overseas geographic names known to the public, nor be similar to the denominations of renowned international organizations.
Although the denomination will become a generic name of the new plant variety once the plant variety right (“PVR”) is granted in China, such denomination is allowed protection upon granting of the PVR. Sales of granted varieties without their registered denomination will be subject to administrative punishment by China State Forestry Administration or the Ministry of Agriculture and Rural Affairs of China.
3. DUS Test
The Distinctness, Uniformity and Stability (DUS) test must be carried out pursuant to the ‘DUS Testing Guidelines Concerning the Relevant Breeds of Plants’ issued by the China State Forestry Administration and the Ministry of Agriculture and Rural Affairs of China.
There are two stages in a PVR filing in China: preliminary examination and substantial examination. During the substantial examination, the applicant may choose to conduct the DUS at a test center designated by the PVR Offices or engage a local organization to conduct a third-party DUS test that will be verified onsite by the PVR Offices. For forestry PVR filings, there is an additional choice of purchasing a test report from overseas authorities if a DUS test has been conducted overseas. Such alternative is not applicable to agricultural PVR filings. A major benefit in carrying out a DUS test in a designated test center is that the test is taken free of charge, while the main benefit in engaging an organization to conduct the test is that it would be more flexible in time and venue. It should also be noted that the PVR Offices have ceased charging filing fees and annuities for PVR since April 2017.
If an applicant opts to conduct the test in a test center designated by the PVR Offices, the PVR Offices will specify a period during which the propagating materials of the candidate variety and the comparative variety shall be submitted to the test center. Therefore, overseas applicants have to carefully calculate timelines for shipping the propagating materials to the Chinese importer and test center, and also take into account quarantine trial growth periods required for certain specified genera or species.
For tests conducted by a local organization engaged by the applicant, the time and venue for onsite verification must be reported to the PVR Offices after completion of the preliminary examination and publication of the application. Before engaging the local organization, it is best to set out an appropriate written agreement. The agreement shall specify terms in relation to the transfer, disposal, testing and return or destruction of the propagating materials, limit the purpose for the use of intellectual property relating to the materials and information disclosed by the applicant and the test data. In particular, the agreement must prevent the testing organization from leaking the propagating materials to protect the novelty and commercial value of the candidate variety.
4. Importation of Propagating Materials
The PVR Offices will set a deadline for the submission of propagating materials to designated test center where the applicant selects the DUS test to be conducted at.
It would be advisable for an overseas applicant to have imported the propagating materials of both the candidate variety and the comparative variety before filing the PVR application, provided it will engage a local organization to conduct the DUS test or to temporarily help to cultivate the materials for later submission to the designated test center.
It is recommended for the applicant to engage an importer to get an import permit from Chinese Plant Quarantine Administration. The permit is an important prerequisite for importing propagating materials into China and the valid term and port will be specified on the permit.
The materials must be reach a designated port in the valid term with other supporting documents, such as a plant quarantine certificate of the export country. The material is likely to be conducted phytosanitary tests and quarantine trial growth upon its arrival at the designated port.
5. Novelty Requirement
Under relevant Chinese laws, the novelty requirement is met if: i) the propagating materials of the candidate variety have never been sold prior to the filing date; ii) with the approval of the breeder, have been sold within the PRC for not more than 1 year; iii) in the case of lianas, forest trees, fruit trees and ornamental trees, the propagating materials have been sold outside the PRC for not more than 6 years; or iv) in the case of other varieties of plants, the propagating materials have been sold outside the PRC for not more than 4 years.
Notwithstanding the novelty requirement, the PVR Offices are very likely to refuse an application for a variety that is close to the expiration of its novelty period. Therefore, an earlier application is recommended to prevent the potential risk of refusal.