Brief Study on Arrangement of PCT Claims in Biology
Jin Tianyun patent agent of Beijing Kangxin Patent Agency Co., Ltd.,[Comprehensive Reports]
Currently the biological technology develops rapidly and more and more biology- related enterprises choose patents to protect their R&D results. With the global development of knowledge economy, the number of patent applications from Chinese institutions and enterprises in foreign countries or regions increases fast. PCT application, as a way for Chinese patents to enter other countries or regions, is no doubt important for applicants.
It is well known that there are international and national stages of PCT patent application. The application is submitted, searched and preliminarily examined (optional) at the international stage and then it is up to the national bureaus to decide whether to grant the patent. At the national stage, a translation of the application is required pursuant to regulations of each country and some fees may be charged. To comply with these regulations and reduce the fees, the applicant may modify the application, especially the claims. But note that the modification should not be out of the scope disclosed in the international application. This requires a quality patent application with good arrangement of claims at the international stage.
Although there is similarity among the Patent Laws of countries, the difference of detailed provisions may be great, especially in biology.
Different countries grant different patents. This article will discuss the arrangement of PCT claims in biology according to regulations in China, US., Europe, India, Australia, Brazil and Russia on unpatentable subject matters and claims.
I. China’s relevant regulations
1. About unpatentable subject matters in biology
As in other technical fields, an patentable subject matter in biology also involves products, methods and applications, but there are still some that are excluded from the patentable scope.
In China, main provisions in biology that involve unpatentable subject matters are Article V and XV of the Patent Law. As provided for in Article V, the patent right shall not be granted to inventions that break laws or social ethics or impair public welfare; or to inventions depending on genetic resources which are obtained or used by breach of laws and administrative regulations and depend on them. It is provided for in Section 1 to 4, Article XXV that a patent right shall not be granted to scientific discoveries, rules and methods of intelligent activities, disease diagnosis and treatments and species of animals or plants.
Wherein, the inventions that are against social ethics include manmade sex organs or alternatives that are not used for medical purpose, methods for human to intercourse with animals, methods that change the genetic integrity of human reproductive system or people whose genetic integrity of reproductive system is changed, cloned human or methods to clone human, industrial or commercial application of human embryos, as well as the methods to change the genetic integrity of animals that may cause pain to animals but no material benefits to the treatment of human or animals. Guidelines for Patent Examination explicitly provides that stem cells of human embryo, human body at the stage of shaping and growth shall not be granted patent right. But material medicines can be protected by Swiss- type claims.
2. About claims
In China, additional fees will be charged for those patent applications containing more than 10 claims, 150 yuan for each additional claim.
There is no limitation on the number of independent claims.
When there are more than 2 claims cited in multiple dependent claims, only the preceding one can be selected and shall not be the basis of the other dependent claim.
II. U.S.’s relevant regulations
1. About unpatentable subject matters in biology
Patent Law of U.S. has little limitation on patentable subject matters. It considers that “any technology created by human in the world” is patentable. The diagnosis and treatment methods of diseases are patentable, different from China and most other countries or regions. Furthermore, there are plant patents in U.S., which protect new and distinctive plants cultivated by asexual propagation. The subject matter of a plant patent usually includes transmutative sprout and mutant, and hybridized and newly- found seeds. But it is noticeable that the Supreme Court of the United States announced a final sentence to Myriad case in June 2013, considering that a separated DNA is not a subject matter stated in Article 101 of Patent Law of U.S. This predicted that U.S. tightened the patents of gene technology.
Moreover, there is no provision of ethic examination in U.S., where a loose examination standard is adopted. Therefore, there were many people that received patent right for inventions related to stem cells of embryo.
2. About claims
As provided for by Patent Law of U.S., additional fees shall be charged if a patent application contains more than 20 claims. 80 dollar shall be charged for each additional claim (40 dollar for small entities). When there are more than 3 independent claims, 420 dollar shall be charged for each additional independent claim (210 dollar for small entities). If there is one or more multiple dependent claim(s), the examination board of U.S. will split the multiple dependent claim and charge 780 dollar (390 dollar for small entities). It is noticeable that the number of U.S. claims is based on the number of technical plans.
III. Relevant regulations of Europe
1. About unpatentable subject matters in biology
In Europe, there is Article 53 that provides for unpatentable subject matters in biology, where the inventions breaking public order and ethics, plants and animals and production methods used mostly for biology, diagnosis and treatment methods for human body or animals, are excluded. For unpatentable subject matters in biology, Europe and China are similar in regulations, such as methods to clone human, methods to change the genetic integrity of human or animals that may cause pain to animals but no material benefits to the treatment of human or animals, and industrial or commercial application of human embryos are explicitly excluded from patentable scope.
The Enlarged Board of Appeal of Europe Patent Office (EPO) decided on 19 February 2010 that the rationality of Swiss-type claims will not be accepted. But in Europe, products with the secondary purpose limited can be patented. There is no absolute but purpose-limited protection for gene order patents in Europe.
2. About claims
According to the regulations of EPO, additional fees will be charged if there are more than 15 claims under a patent application. 210 euro will be charged for each of No.16-50 claims, and from No.51, 525 euro will be charged for each claim. But it is noticeable that EPO allows multiple dependent claims in the patent claims.
Moreover, in Europe, there is only one independent claim in a category (e.g. product, method and purpose) in addition to 3 exceptions as provided for in Rule 43(2) EPC. If there are multiple independent claims in a patent application, the examiner will notice the applicant to identify the claim to be searched. When the applicant does not identify such, the EPO will only search and examine the first independent claim under each category. So it should be avoided to exclude important claims from the scope of the examiner’s search and examination.
It must be explained that those 3 exceptions as provided for in Rule 43(2) EPC include: multiple connected products; different methods to use a product or device; and an alternative plan for a specific problem but not suitable for the same independent claim. In Patent Laws of Europe, which is different from Patent Laws in China, whether a claim is independent or dependent mainly depends on the reference between claims; and if it is the same type with other referential claims, the claim shall be deemed to be a dependent claim.
IV. India's relevant regulations
1. About unpatentable subject matters in biology
There are explicit unpatentable content in the Patent Law of India, of which the following are related to biology: contents including obvious breach of natural laws or meaningless inventions; inventions breaking public order or ethics or causing severe damage to the life or health of human, animals or plants or the environment; simple discoveries of scientific principles or abstract theories or equations or of living or non-living substance in the natural world; or simple discoveries of new forms of known substances, which does not improve the known function of the substances or is only a new property or purpose of the known substances or only the purpose of a known technique, machine or device, unless that known technique produces a new product or uses at least a new reactant (where the salts, esters, ethers, polymorphs, metabolites, pure forms, particle size, isomers, isomer mixtures, complexes, composition and other derivatives of a known substance should be considered as the same substance unless they are significantly different in functions); agricultural or gardening methods; medical, operative, curative, and precautionary diagnosis and therapies or other therapies, or similar treatments that exempt animals of disease diagnosis or make available their economic value or productivity; the whole or any part of a plant or an animal, including seeds, variants and species but excluding micro-organisms and biological methods to produce or reproduce plants or animals in essence.
In other words, there are many unpatentable subject matters in India. Agricultural or gardening methods and new purposes of known substances are also unpatentable, as is different from China and most of other countries and regions.
2. About claims
Currently, the modification of claims can only be made by deletions if a PCT application is accepted at India's national stage.
In India, additional fees will be charged if there are more than 10 claims in a patent application and 1,600 rupee (800 rupee for small entities and 320 for natural persons) for each additional claim.
Multiple dependent claims citing more than two claims are not allowed in India, which should be split.
V. Brazil's relevant regulations
1. About unpatentable subject matters in biology
In Brazil, unpatentable subject matters in biology include: discoveries and scientific theories; methods to diagnose and cure human or animals, and technologies and methods to perform medical or surgical operation on human or animals; the whole or any part of natural organisms and organic materials that are produced naturally or separated from the natural world, including the genome or germ- plasm of any natural organism and any natural biological methods; and inventions that break public order, morality, safety or health. But like China, Brazil accepts Swiss-type claims' protection for the medical appliance of substances.
2. About claims
In Brazil, the examination of a PCT application (examined by INPI as ISA/ IPEA) requires 390 real for no more than 10 claims; 100 real for each additional claim from No.11 to No.15; 200 real from No.16 to No.30; and 500 real from No.31.
Multiple dependent claims citing multiple claims are not allowed in India, which should be split.
VI. Australia's relevant regulations
1. About unpatentable subject matters in biology
Australia's patents include normal patents and innovative patents. For normal patents, there are wide- ranging regulations on patentable subject matters. Inventions about products, equipment, methods, techniques or systems other than human or biological methods to reproduce human are patentable subject matters of normal patents, such as diagnosis and therapies of diseases. Innovative patents have less patentable subject matters than normal patents, and they do not protect animals, plants or biological propagating methods for animals and plants.
2. About claims
There is an application fee of AUD 370 at the national stage of a PCT application. The modification fee for a complete manual of normal patents will be charged only when the number of claims after modification is more than 20 and the request of modification is approved. AUD 100 will be charged for each additional claim. For innovative patents, the number of claims should not be more than 5.
VII. Russia's relevant regulations
1. About unpatentable subject matters in biology
In Russia, unpatentable subject matters in biology include: methods to clone human; mutation methods for the genetic integrity of human germ-line cell, industrial and commercial use of human embryos; other solutions and species of plants and animals that cause damage to public welfare and humane and ethical principles and the biological methods to get these species.
What is different from China’s is that diagnoses and therapies of diseases in China pertain to patentable subject matters.
2. About claims
In Russia, additional fees will be charged if the number of claims in a patent application is more than 25, and 250 ruble will be charged for each additional claim. The fee for the examination of a convention’s subject matter is 2,450 ruble, and 1,950 ruble for each additional subject matter.
VIII. Discussion
Based on the above Patent Laws of different countries, the claims of PCT applications in biology can be arranged in the following aspects:
1. Subject matters of the protection of claims
In biology, the patentable subject matters are different among countries and mainly in diagnoses and therapies of diseases, species of animals and plants and methods to reproduce animals and plants, stem cells of embryos, agricultural and gardening methods etc. Although certain additional fees may be charged for additional claims in most countries, there is no requirement for the number and reference to claims at the international stage of PCT applications. Therefore, patentable subject matters of each targeted country can be incorporated into a PCT application. For a particular country, one can choose suitable subject matters and delete unpatentable ones. These subject matters, however, can also be disclosed in only instructions.
And, some subject matters that are unpatentable in some countries and regions can be patentable in other ways. For example, “using some substances to cure a disease” is not patentable in China, but “the application of a substance in the preparation of a medicine that cures a disease” is patentable, that is, Swiss-type claims are acceptable. Therefore, one can try different ways of expression to make some inventions patentable.
2. Reference to claims
In most countries and regions, multiple dependent claims referring to multiple claims are not allowed, and even require to be split in some countries and regions. But they can be written into a PCT application and then they can be accepted directly in those countries or regions that accept them, and they should be deleted or split in those that do not accept them. This can avoid the risk of breaking the limitation on modification when remodifying their reference relation at the national stage due to some undisclosed technical plans cross- referred to in the raw text.
3. Sequence of independent claims
In Europe, for example, in a patent application, there can be only one independent claim in one category in addition to 3 exceptions as provided for in Rule 43 (2) EPC. EPO will search and examine the first set of independent claims under each category if the applicant does not make an explicit identification.
To keep important claims in the scope of the examiners’ search and examination, multiple independent claims in a patent application can be sequenced by their importance. The sequence of claims can be changed when a PCT application is sent to Europe, but you can avoid rearranging them or forgetting to rearrange them if you pay attention to the arrangement of PCT applications when writing it.
Therefore the arrangement of claims during PCT application lays proper foundation for the national stage. The applicant may, as required, balance the protection scope and fees when a PCT application is accepted at the national stage. Proper protection can be gained if you choose proper subject matters and the number of claims.
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