China’s new seed law: Molecular varieties and macro developments

By Mark Cohen

China’s new and much anticipated Seed Law went into effect on March 1, 2022, after being announced this past December.  There are two unofficial US Government translations available: one text provided by USPTO, and another with commentary by USDA.  Both translations offer red-lined comparisons with the prior 2015 text.  The NPC Observer has linked to resources on the passage of the Seed Law.  In addition,  a summary of the new Law from the Chinese Department of Laws and Regulations at the Ministry of Agriculture and Rural Affairs (MoA) is available here.       

Plant Breeders’ Rights (PBRs) are significantly expanded now in China

The new Seed Law reflects a significant expansion in the scope of plant breeders’ rights (PBR) protection in China.  PBRs are a sui generis form of intellectual property protection available in many countries for plant varieties, similar to but distinct from patents or other forms of IP.  This change in the Chinese PBR system has been in the works since at least 2016. In 2019, a draft proposed amendment to China’s “Regulations on the Protection of New Varieties of Plants” (“Regulations”) (2014) (中华人民共和国植物新品种保护条例) (“Draft PVP Regulations”) was floated, apparently by the MoA for public comment. It contained many changes like those in the new Seed Law. Commentary from MoA on that 2019 draft is available in Chinese here.  It appears likely, in retrospect, that the MoA draft may have been an agency “trial balloon” intended to accelerate drafting of the Seed Law and new PVP regulations, much as both CNIPA and NCA attempted unsuccessfully to launch draft revisions of  the patent law and copyright law in recent years.  Nonetheless, there are reports from MoA that the “government” is working on a draft of updated regulations in line with the new amendments to the Seed Law, though it is unclear if that is a draft from the State Council or a line agency.  MoA noted on March 16, 2022 on its website that its plans for 2022-2023 include “Implement the newly revised Seed Law, advance the revision of the new plant variety protection regulations, and speed up the implementation of the essentially derivative variety (“EDV”) system. Study and revise the implementation rules of the regulations on the protection of new varieties of plants (Ministry of Agriculture Part).”  The Reference to the “MOA Part” may refer to the need to coordinate with other agencies on drafting of State Council regulations.

Essentially Derived Varieties (EDVs) are now protected in China

The first major change in the Seed Law is the introduction of EDVs, which are required to be protected by China if/when it accedes to UPOV ’91, the latest UPOV Convention.  As China is currently a member of UPOV ’78, the inclusion of EDVs is a major step in the direction of accession.  Hinting strongly at exactly that, the definition of EDVs in the new Seed Law closely mirrors UPOV’s definitions. This is a positive departure from the Draft PVP Regulations, which were the first to formally float the idea of EDVs into the Chinese PVP system, but did not precisely use UPOV’s definition.  A comparison of the definitions of EDVs in the texts of the new Seed Law, the Draft PVP Regulations, UPOV ’91, and the parallel United States statute, the Plant Variety Protection Act of 1970 (PVPA) appears at the end of this blog.

It is noteworthy that, although the Seed Law ultimately did not adopt quite the same definition of EDVs proposed in the 2019 draft regulations, the Seed Law nonetheless “elevated” the concept of EDVs from  a proposed regulatory draft to actual law. This may reflect behind-the-scenes collaboration between the National People’s Congress Agriculture and Rural Affairs Committee, which was responsible for the Seed Law amendments, MoA and other interested parties.

Nonetheless, the concept of EDVs is somewhat slippery, and an easily workable definition has been notoriously elusive. At a high level, they are somewhat like the concept of derivative works in copyright. As was explained in an earlier blog post “Per UPOV ’91, a new variety is considered “essentially derived” from an initial variety when it is both “clearly distinguishable from” and “predominantly derived from the initial variety, . . . while retaining the expression of the essential characteristics . . . of the initial variety.” A breeder may obtain a PBR for an EDV “in the same way as for any variety,” but if they wish to commercialize the EDV, they must obtain authorization from the initial variety’s titleholder. In contrast, under the ’78 scheme, rights to the initial variety are more limited, and no authorization from the initial variety’s titleholder is required to commercialize a variety that the ’91 Act would consider an EDV.” A short video illustrating the general concept of EDVs is available here.

Other changes—and not-changes—in the Seed Law

Another major change is the expansion of protection to propagating materials and harvested materials.  The language in these sections reads similarly to UPOV ’91.

Interestingly, there was one change introduced in the Draft PVP Regulations that did not make it into the amended Seed Law. The Draft PVP Regulations discussed the use of molecular markers in DUS (Distinctness, Uniformity and Stability) variety testing.  Use of molecular markers in DUS testing is not required by UPOV’ 91, but molecular markers have been gaining popularity in infringement proceedings in China, and were incorporated into the Several Provisions on the Specific Application of Law in the Trial of Dispute Cases of Infringement on the Right to New Plant Varieties No. 2)  (最高人民法院关于审理侵害植物新品种权纠纷案件具体应用法律问题的若干规定（二) , which I previously blogged about. However, their use during initial variety testing for DUS examinations may not be as widely accepted, and additional guidance from examination authorities in new regulations or examination guidelines, may be necessary to clarify how molecular markers be used in examination.   Both Liz Freeman Rosenzweig and Mei Gechlik (behind a paywall) have written on Chinese guiding cases on molecular markers.  Ms. Gechlik’s comments are focused on the continuing significance of the guidance cases in light of the incorporation of relevant principles in the recently revised judicial interpretation on plant varieties.  Dr. Freeman Rosenzweig’s earlier comments focused on the use of guiding cases as precedent to judicially “legislate” principles for adjudication of EDVs.

Implementing regulations are not yet available

Further guidance might be available at such time, if any, as there are implementing regulations to the Seed Law. Note, however, that such implementing regulations may not be a high priority for the State Council as we are still awaiting draft or final implementing regs to the Patent Law and Copyright Law (which came into effect June 1, 2021), and the recent MoA announcement on its legislative priorities for 2022-2023 merely talks about “advancing the revision” of PVP regulations, most likely in conjunction with other agencies, and without a date certain for completion.

The changes in the Seed Law have been met with praise in the industry (see, e.g., Dr. Edgar Krieger on LinkedIn: Good news from China: Improved rules for plant variety protection).  Whether these changes will spur a higher volume of PBR applications in China from around the world remains to be seen.

Comparison of EDV definitions:

2019 Draft PVP Regulations:

 “A variety that is distinct from the original variety, but retains the basic characteristics or characteristics of the original variety, except for the differences caused by the derivation”

Newly amended Seed Law:

 “An essentially derived variety (EDV) refers to a variety that is essentially derived from the original variety or derived from an EDV of the original variety. It is obviously different from the original variety. Except for the difference in traits caused by derivation, it is the same as the original variety in terms of expressing the basic characters produced by the genotype or combination of genotypes of the original variety.”

UPOV ’91:

“A variety shall be deemed to be essentially derived from another variety (“the initial variety”) when (i) it is predominantly derived from the initial variety, or from a variety that is itself predominantly derived from the initial variety, while retaining the expression of the essential characteristics that result from the genotype or combination of genotypes of the initial variety, (ii) it is clearly distinguishable from the initial variety and (iii) except for the differences which result from the act of derivation, it conforms to the initial variety in the expression of the essential characteristics that result from the genotype or combination of genotypes of the initial variety.”

US PVPA:

 “The term “essentially derived variety” means a variety that—(i) is predominantly derived from another variety (referred to in this paragraph as the “initial variety”) or from a variety that is predominantly derived from the initial variety, while retaining the expression of the essential characteristics that result from the genotype or combination of genotypes of the initial variety; (ii) is clearly distinguishable from the initial variety; and (iii) except for differences that result from the act of derivation, conforms to the initial variety in the expression of the essential characteristics that result from the genotype or combination of genotypes of the initial variety.” 7 U.S.C. § 2401(4)(A).

“2022 Seed Treatment Special” magazine will come out this June. For Feature sponsoring or advertising, please contact Christina at christina@agropages.com.

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