Filter and Barrier in Biotechnology Patent Applications in China

Abstract

China has a history of more than 30 years in biotechnology R&D and industry development. In 2012, China's biotechnology industry gained approximately RMB2000 billion in production value.1 China's Patent Law (hereinafter referred to as “CPL”) has been revised three times since its enactment in 1985: in 1992, 2001, and 2008. Patent protection in biotechnology has come to occupy center stage in terms of a gradually improving range and level of protection.2 Generally, biotechnology patents, like those in other fields, are granted as long as they meet the requirements for novelty, creativity, and utility under the CPL.3 “Novelty,” in this context, refers to the patent neither deriving from existing technology nor having been the subject of a previous patent application. “Creativity” means that, in comparison with existing technology, the invention has noticeable material features and represents a remarkable advance. “Utility” refers to the invention or utility model being able to produce a useful or positive effect. However, patent applications in the biotechnology field are particular in terms of technology application, laws/rules, social ethics, etc.4; therefore, the concepts “filter” and “barrier” are especially established in CPL for biotechnology patent applications.

“Filter” for Biotechnology Patent Applications—Biotechnology Subjects That are not Granted Patents

Biotechnology patents mainly involve the invention of animal and plant species; microbes and germ plasm; biological products; innovative methods of genetic engineering, microbiology, or genetic therapy.5 However, not all of these subjects are granted patents. According to the provisions of CPL, any invention or creation violating national law, or social morality, or which is against the public interest, is not granted a patent.6 In addition, the following items are not granted patents: (1) scientific discoveries; (2) rules and methods of intellectual activity; (3) methods for diagnosis and treatment of disease; (4) animal and plant species; or (5) substances produced from nuclear transformation. However, methods for the development of animal and plant species may be granted patents.7 These provisions constitute a “filter” for patent applications in the biotechnology field.

Animals and plants are living objects, not human inventions: patents for them are not granted. There is a paradox in that transgenic animals or plants are produced by such methods as DNA recombination or genetic engineering and yet, according to CPL, transgenic animals and plants are not granted patents. As for such things as stem cells, embryos, or other developmental stages or precursors of animals and plants (such as germ cells or zygotes), if the same are able to develop and grow into adults (whether under natural or artificial conditions), they are also regarded as animals and plants and therefore are patent ineligible.

The CPL also addresses another strand of biotechnological development: cultivation of animal somatic cells, as well as animal tissue and organs (excluding embryos). These parts are unable to develop into adults under natural conditions, and state-of-the-art technology imbues them with economic value; thus, the granting of a patent is allowed.8

Microbes, including bacilli, actinomyces, epiphytes, viruses, plasmids, protozoa, algae, etc., have their own filtering treatment in Chinese patent law. In classical biology, microbes belong neither to animals nor plants, and accordingly, are generally subjects granted patents. However, CPL does not unconditionally grant patents to microbe-specific inventions, and those microbes existing in nature without the need for any technical treatment by humans are excluded from patents, for these are scientific discovery (not inventions), and discoveries are not granted patents. Only a microbe that becomes a pure culture by isolation and which has a special industry use, and where the technical solution for application is repeatedly obtainable or operable, is granted a patent by itself.

As for the patentability of flesh in various formative and developmental stages, including human germ cells, zygotes, and embryos, although ethical debate exists in the Western world, patenting them is unequivocally considered against social morality in China. The social morality referred to in CPL reminds us of the importance of public order and good morals—which means hewing to righteous and acceptable ethical and moral conduct. Any inventions or creations violating social morality will not be granted patents. Influenced by this concept, human embryo stem cells and their preparation methods, methods for changing human genetic traits (including of the reproductive system), human cloning methods and cloned humans, applications of human embryos to industrial or commercial purposes etc., are not granted patents because they violate the principles of public order and good morals (ordre proper in European law).

Essentially, a gene or DNA segment is a chemical substance that can be obtained from microbes, plants, or animals by isolation or prepared by other means. The filtering mode is basically the same as with plants and microbes, described above: if any gene or DNA segment is found in nature, it is only a (scientific) discovery and not granted a patent. However, when any gene or DNA segment is isolated for the first time, and its base sequence is not found in any existing technical record and can be expressed accurately, and when the gene or DNA sequence is valuable for industrial use, the gene or DNA segment and its method for production are objects for the granting of patents.

With reference to the hot topics of genetic diagnostic or treatment methods, such as (for example) a “method for treating tumors using gene therapy” or “diagnosing coronary disease by use of grouped nucleotide sequences,” these are considered by CPL to be “method[s] for diagnosis and treatment of disease,” which cannot be granted patents; patent applications will be rejected. However, CPL allows the granting of patents for instruments or equipment used in the diagnosis or treatment of disease, as well as for a substance or material used in the diagnosis and treatment of disease. And if the above examples are instead described as the “application of a preparation of a new gene to curing tumors,” or the “preparation of a coronary heart disease diagnostic kit using grouped nucleotide sequences,” or the like, the same could become patent eligible9—that is, the way a claim is conceptualized and presented is critical in determining patentability.

“Barrier” In Biotechnology Patent Application: How is Sufficient Patent Information Publicized?

Publication is a requirement generally stated in the patent laws of various countries. The patent specification should include a clear and complete statement for the realization, by technical personnel in the relevant field, of the patented material or process, i.e., the patent specification should include a clear topic and accurate wording, so that technical personnel are able to reproduce the patented object without recourse to creative labor.10 However, the difficulty for publication of biotechnology is that sufficient technical publicity, as required by the patent, is not satisfied only through such literature as the patent specification11; therefore, CPL includes special provisions relating to the publication of biotechnology patent applications. But the principle of these provisions is likely to arouse disagreement between the patent applicant and the patent examination office, leading to formation of a “barrier” in front of patent applications.

Collection of Biomaterial

The significance of collecting biomaterial is three-fold:

1. Meeting the requirement for publicity;

2. Providing evidence of the novelty of the biotechnology patent application (also necessary for any proceedings thereafter involving infringement of the patent rights); and

3. Benefitting others on expiration of the patent, so that the patent becomes social wealth (if the patent application involved new biomaterial, in the absence of collection, the public would have no access to or samples of the biomaterial, and written specification of the biomaterial will likely be insufficient to enable implementation of the patent technology by technical personnel).

The applicant should also submit a sample of the biomaterial to a collection organization recognized by the State Intellectual Property Office of the People's Republic of China, before or on the date of application (or if there is any claim of priority, by or on the priority date), together with a collection certificate and a survival certificate presented by the collection organization at the time of application (or within 4 months at most from the date of the application). If the applicant fails to submit said certificates in time, the sample is considered not submitted for collection. The classification name, collection organization, and collection number should be indicated clearly in the specification.12 The collection organizations appointed within China are the China General Microbiological Culture Collection Center (CGMCC) and the China Center for Type Culture Collection (CCTCC).

Generally, biomaterials that should be submitted for collection are:

1. New material, lately filtered and isolated from nature;

2. New material obtained from known biomaterial by unrepeatable methods (e.g., mutation);

3. Tangible material with specific characteristics.

However, biomaterial generally recognized as being “publicly accessible” does not need to be collected, including:

1. Marketable commercial biomaterial from home and abroad, accessible by the public before the date of application, if the commodity name, producer, and product ingredients are indicated clearly in the use manual;

2. Biomaterial recognized by the intellectual property office(s) of various countries or international intellectual property organizations, and which has been published in patent gazettes (or had a patent granted) on or before the priority date of the patent application submitted to China's patent office; and where patent literature relating to publication of collection information is indicated in the specification, together with a record of the name of the collection organization and the collection number;

3. Biomaterial published in non-patent literature before the date of application, with comment on the source of the reference literature in the specification, statement of public availability of the biomaterial, and a certificate submitted by the biomaterial holder to guarantee distribution of the biomaterial to the public within 20 years from the date of application;

4. Or where technical personnel in the relevant field are able to (re)produce the biomaterial simply by following the description of the patent specification, without recourse to creative labor.

Requirement for Experimental Method and Experimental Data

In general, the utility of an invention patent is a technical judgment. Several cases where insufficient utility exists are given in the Guidelines for Patent Examination in China, such as there is no reproduction of technical solution, violation of the order of nature, etc.13—of which the former refers to a technical solution which technical personnel in the relevant field are unable to reproduce. Reproduction of the technical solution should not rely on any random element and must be capable of being repeated. In patent examination, the examiner is generally required to clearly and fully introduce the technical solution without failure in composing the biotechnology patent, such as the biomaterials used, other materials and sources, operations, procedures, process parameters, isolation and purification methods, special equipment needed, etc. However, use of such words as “random,” “filtering,” etc. does not necessarily limit reproducibility.

In addition, if the composition must rely on an experimental result to prove a tenable invention patent application involving DNA segments, genes, proteins, and polypeptides, it needs to disclose the experimental method, experimental data, data analysis, and the experiment's conclusion sufficiently to prove the tenability of the technical solution in the patent specification. These experiments may be experiments in either the laboratory or clinical stage. The objects of experimentation may be cells, tissues, or organs of animals and plants. The data obtained may be convincing qualitative or quantitative analysis. Again, the preparation method, dosage, use method, or dosing approach should be disclosed, so that common technical personnel in the relevant field are able to implement the invention without creative labor. For example, in case of preparation of recombinant cells by genetic engineering technology, detailed description is required for the characteristics of the delivered gene, recombinant carrier or host cell, method for delivery of the gene in the host cell, and method for selective collection and certification of transformed cell; the implementation plan should be stated in detail in the patent specification, in terms of full experimental procedures, method for preparation of gene, carrier, and host cell, operation procedures for delivery of gene or carrier, source, dosage, use, particular operation condition of reagent, enzyme, other materials required, etc.

Sequence Table of Nucleotides or Amino Acids

In the case of genetic inventions needing patent protection and involving a nucleotide sequence comprising 10 or more nucleotides or amino acids of proteins or peptides (each composed of four or more l-amino acids), the applicant should submit a corresponding sequence table compiled according to the format of the Standards for Nucleotide and/or Amino Acid Sequence Table and the Sequence Table as Electronic Document, issued by the State Intellectual Property Office of the People's Republic of China. The sequence table should be described as an independent part of the patent specification and arranged in the final part. Furthermore, the applicant should submit the computer-recorded readable copy of the nucleotides or amino acid sequence table. If this copy of the nucleotides or amino acid sequence table is inconsistent with the sequence table contained in the written record in the patent specification, the sequence table of the written submission shall apply.

Disclosure of the Source of Genetic Resource

Genetic resource refers to any genetic material from a plant, animal, micro-organism, or other source containing a genetic functional unit and with actual or potential value in use. The abundant genetic information contained in genetic resources is vitally important to biopharmaceuticals, animal and plant breeding, life science research, etc. With the growth of biotechnology, more and more people utilize biological resources from foreign countries and apply for patent protection in the process of medicinal R&D, or the development of new animal and plant species, without first obtaining approval from the source country of the use of the biological resource.

China is a country with one of the richest genetic resources and is a member country of The Convention on Biological Diversity (CBD). To prevent illegal piracy of China's genetic resources, the CPL as revised in 2008 includes additional content regarding protection of genetic resources, provisions on illegal acquisition or utilization of genetic resources, and a ruling that invention and creation dependent on said genetic resources is not patent eligible.14 This because if this type of invention/creation is granted a patent, it not only justifies the immoral or illegal use of China's genetic resources, but also creates an impediment for China's further development and use of its own genetic resources, in view of the exclusiveness of the patent owner.15

When applying for a patent for an invention or creation dependent on genetic resources, the direct source and original source of the genetic resource(s) should be stated in detail in the application documents,16 so as to provide additional information for judging the legality of acquisition and use of the genetic resource(s). “Direct source” of a genetic resource means the direct channel through which the applicant obtained the genetic resource; while “original source” means the natural growing place or collecting place of the genetic resource(s)(rather than the historic headstream of the species). This subject is discussed in more detail elsewhere in this issue.

Conclusion

China is increasingly focusing on biotechnology and is making remarkable progress in this field. Patent protection of biotechnology in China meets the WTO's requirements of the Agreement on Trade-Related Aspects of Intellectual Property Rights. However, China has not established a special law on biotechnology patents, in contrast to the established biotechnology patent systems in the United States and Europe. This is mainly because of the historic low level of biotechnology R&D in China. According to statistics, patent applications by American applicants accounted for 45% of the global total during 2006–2011, followed by Europe (22%), Japan (15%), and China (11%).17 We believe that with continued development of the biotechnology industry in China, China's level of biotechnology patent protection will increasingly improve. It is hoped that in the near future, China will further revise its laws in regard to patenting animal and plant species, genetic therapies, and other biotechnology topics not currently eligible for patents.

Acknowledgment

This paper is sponsored by Key Projects in the National Science & Technology Pillar Program (No. 2012BAF12B11).