1.1 Please give details of the major acts and directives governing patents (with reference to specific paragraphs where necessary)
Patent Law of the People's Republic of China came into force on 1 April 1985. It was amended three times in 1993, 2001 and 2009. The third amendment became effective as of 1 October 2009.
Implementing Regulation of the patent law came into force on 1 April 1985. It was amended three times in 1993, 2001 and 2010. The third amendment became effective as of 1 February 2010.
The Guidelines for Examination came into force on 1 April 1993. Since then, there have been four major amendments in 2001, 2006 and 2010. The third amendment became effective as of 1 February 2010.
1.2 Is your jurisdiction party to any international conventions on patent protection? When did it join these conventions?
China joined the Paris Convention for the Protection of Industrial Property on 19 December 1984. The Paris convention came into force in China on 19 March 1985. China joined the Patent Cooperation Treaty (PCT) on 1 October 1993 which came into force on 1 January 1994. Further to this, China joined the Agreement of World Trade Organization on Trade-related Aspects of Intellectual Property Rights (TRIPS) on 11 December 2001.
1.3 Which are the major bodies responsible for assessing patent applications and granting patents?
The Chinese Patent Office of the State Intellectual Property Office (SIPO) is responsible for assessing patent applications and granting patents.
1.4 What is the procedure for obtaining patent protection? What are the key stages of the process? What fee is payable?
There are three types of patents in China: invention patent, utility model patent and design patent.
Invention applications have to go through both preliminary examination and substantive examination before patent rights can be granted. A preliminary examination can usually be completed in a matter of four to five months if the applicants fulfil all the formality requirements. Only after this can an invention application be published, which usually occurs around 18 months from filing date. Upon request for substantive examination by the application, which can be made any time within three years from the earliest priority date, an application will enter into substantive examination procedure which can only occur after publication of an invention application. Following this, a number of office actions may be issued and responded. Once these actions have been addressed, an application is then granted or rejected. In case of rejection, applicants can appeal to the Patent Reexamination Board (PRB) and further to two more instances in courts.
The filing fee is RMB950 (US$146), the examination fee is RMB2500 (US$385) and the issue fee is RMB255 (US$39). In addition, the excess claims fee is RMB150 (US$23) per claim in excess of 10, and the excess page fee is RMB50 (US$7.7) per page in excess of 30 and RMB100 per page in excess of 300 (US$15.4). Annuities range from RMB900-8000 (US$139- 1231) depending on the year.
Utility model and design applications only need to go through a preliminary examination. However, this not a simple registration process. During a preliminary examination, claim language of utility model applications or drawings of design applications are examined closely amongst other things, including formality. Notice of amendment or office actions may be issued and responded. Similarly, a decision to grant or reject will be made. In case of rejection, applicants can appeal to PRB and also to two more instances in courts.
For utility models and designs, the filing fee is RMB500 (US$77) and the issue fee is RMB205 (US$32). There is no examination fee. In addition, the same excess claims fee as for inventions applies to utility models. Annuities range from RMB600-2000 (US$92-308) depending on the year, for either utility models or designs.
It is to be noted that there is no procedure to revise a granted patent of any type, except that a patentee could try to partially invalidate its own patent to revise its claims. However, this practice is considered dangerous.
1.5 What are the criteria for patentability?
Article 22, the third amendment of the Chinese patent law, provides that any invention or utility model must possess novelty, inventiveness and practical applicability.
Article 23 of the third amendment of the Chinese patent law provides that any design must not belong to prior design and that no application for the same design has been filed with the SIPO before, and published after, the application date of that design. In addition, Article 23 also provides that any design must be distinctly different from existing designs or a combination of features in existing designs, and that any design should not be in conflict with the lawful rights acquired by others prior to the date of application.
Article 25 further prescribes that patent rights shall not be granted for scientific discoveries, rules and methods for intellectual activities, methods for the diagnosis or treatment of diseases, animal or plant varieties and substances obtained by means of nuclear transformation.
In practice, methods of treatment and diagnosis, including dosing regimens, methods of determining risk of illness, assays/ tests directly leading to diagnosis, gene screening diagnosis, and methods for the prevention of diseases (including immunization) are not patentable. Animal and plant varieties are not patentable. Animals and plants as such living materials capable of developing into animals and plants, essentially biological processes, and surgical methods, are not patentable. For ethical reasons, cloning of human being, commercial use of human embryos and human embryo stem cells and their preparation are not patentable.
Moreover, software-related inventions are often rejected on the ground that they do not fall in the definition of invention as prescribed in Article 2 of the patent law, ie, they are not technical solutions.
1.6 Is it possible to patent a gene or a drug target?
A gene is patentable if it is isolated for the first time, contains a sequence that has not previously been disclosed, and has an established utility in industry. Similarly, a drug target is patentable if the target itself is isolated for the first time and has an established utility in industry.
1.7 How long is patent protection for healthcare products?
Depending on the type of patent that protects the healthcare products, patent protection can be 20 years for invention patents, 10 years for utility model patents and 10 years for design patents. None of these terms are extendable.
1.8 Is it possible to gain patent extensions, eg to cover delays in registration, or for additional or paediatric indications?
There are no provisions in this regard. Hence, it is not possible to obtain any patent term extension or adjustment for any type of patents in any technical area.
1.9 Under what circumstances can a patent be revoked or invalidated?
According to Article 45 of the patent law, anyone could request the PRB to declare a patent is invalid after a patent is granted. It must be noted that the only authority that is supposed to determine validity is PRB, rather than a court. Article 65 of the Implementing Regulations prescribes the grounds that can be used to invalidate a patent. Specifically, these grounds are outlined as follows:
1.10 Please give details of the major acts and directives governing the entry of generic versions of a drug (with reference to specific paragraphs where necessary)
An application for generic entry may be filed with the Chinese Food and Drug Administration (FDA) within two years to patent expiry. However, the licence by the FDA can be granted only upon termination of the patent (Article 19, the Chinese FDA's measures on administration of drug registration).
1.11 What are the rules on data protection? Is there a "Bolar" provision allowing access to data before patent expiry?
According to the Chinese FDA's regulations, data exclusivity is given to a company who produces or sells a drug containing a new chemical entity for six years from granting a licence to it.
There is a "Bolar" provision in Chinese patent law in which manufacture, use or import of a patented drug is exempted from patent infringement. However, there is not a provision that allows access to data before patent expiry.
1.12 What is the process for enforcing patent infringement?
China's enforcement system is a two-track system. A patentee can enforce a patent through a judicial route, ie, courts, or an administrative route, ie, local IP offices.
To take advantage of the local IP offices, a patentee should collect evidence and file its complaint with the local IP office. Local IP offices have a big network across China. Those on municipal or provincial levels have the power to hold hearings, carry out investigation and, if infringement is found, order the infringer to stop infringing. The local IP offices can also mediate the amount of compensation between the relevant parties, but they do not have the power to award damages. In passing-off cases only, the local IP offices can do raids, have access to accounting records, confiscate the infringing goods and tools, and impose a fine. The administrative route is usually faster and cheaper with only limited remedies available.
An infringement action can be launched in a court in the defendant's domicile or in the place where infringement occurred. To some extent it is possible for the plaintiff to choose a court; this process is known as forum shopping. Once the court accepts the case, the defendant is served. Subsequently, the defendant will reply in writing. The relevant parties will present evidence and cross examine the evidence. A trial will be held and then judgment made. Injunction and damages are available in court. However, court proceedings are usually time consuming and more expensive.
1.13 What remedies are available to the patent owner, ie the structure of potential damages, and the level of awards commonly given?
In administrative proceedings, injunction is available. Local IP offices can order infringers to stop infringing, but no damages are awarded. Under certain circumstances, the infringer will be fined but the fine goes to the government.
In courts, both injunctions and damages are available. Preliminary injunction and evidence preservation are also available. It is crucial to collect evidence to support claims for damages. Damages can be calculated according to the loss of the patentee, the illegal gain of the infringer, or with reference made to reasonable royalties. In most of the cases, the patentees are not successful in getting high amounts of damages due to lack of evidence. In this case, statutory damages may be awarded at the discretion of the judges with an upper limit of RMB1 million (US$154,000). However, in recent years there have been a number of cases where a court has awarded rather high amount of damages to the patentees, including Chinese and foreign parties.
1.14 Which are the major cases in patent protection cases, ie the ones that are habitually cited in litigation (regardless of product sector)? China is a civil law country and does not follow case law. Hence, decisions in specific cases are not binding and therefore not cited in litigation.
1.15 Name the most important patent protection cases within healthcare over the past 5-10 years?
The most important case is definitely Pfizer's Viagra patent validity case.
The first round of litigation started in 2001, when 13 Chinese generic companies and individuals tried to invalidate the Viagra patent with only one claim directed at a compound called Sildenafil. The grounds submitted in their invalidation requests included inventive step, claim support, sufficiency and clarity. On 5 July 2004, the PRB in its decision No. 6228, decided that the Viagra patent was invalid on the ground of insufficiency. Pfizer appealed PRB's decision and won in both the first instance and second instance courts. In both courts, the judges held that sufficient disclosure was met and overturned the PRB's decision.
According to Chinese practice, the courts are not empowered to directly rule on the validity of patents. Hence, the Viagra patent was remanded to the PRB for further examination of validity based on grounds that were not addressed in decision No. 6228 and the subsequent court proceedings, ie, inventive step and claim support.
On 31 May 2009, the PRB made its decision No. 13420 on the validity of the Viagra patent, in which the PRB decided to maintain the validity of the patent. The PRB found that the patent claim was properly supported by the specification. The patent was also held to be inventive and no appeal had been filed during the period for appealing, which has since expired, which means the Viagra patent was maintained as valid.
1.16 What are the rules on compulsory licences? How often are compulsory licences envoked to provide access to treatment?
According to Article 48 of the patent law, the SIPO may, upon application, grant a compulsory licence for exploitation of an invention patent or utility model patent:
(1) When it has been three years since the date the patent right was granted and four years since the date the patent application was submitted, if the patentee, without legitimate reasons, fails to have the patent exploited or fully exploited; or
(2) The patentee's exercise of the patent right is in accordance with law, confirmed as monopoly and its negative impact on competition needs to be eliminated or reduced.
Article 49 further prescribes that where a national emergency or any extraordinary state of affairs occurs, or public interests so require, the SIPO may grant a compulsory licence for exploitation of an invention patent or utility model patent.
In addition, Article 50 prescribes that for the benefit of public health, the SIPO may grant a compulsory licence for the manufacture of the drug for which a patent right has been obtained, and for its export to the countries or regions that conform to the provisions of the relevant international treaties to which the People's Republic of China has acceded. However, over the past 26 years of Chinese patent history, not a single compulsory licence has ever been granted.
1.17 Please supply details of impending changes to the legislation governing patent protection. How are they likely to affect future litigation?
The third amendment of the patent law was just completed about two years ago. There are no major changes expected any time soon. However, according to China's patent strategy issued by the SIPO, a project analysing the feasibility of having a separate design law is being considered.
1.18 Are there any cases currently going through the courts, which are likely to have a big impact on government policy towards patent litigation, the shape and scale of future claims and industry's ability to defend them? If so, please give details.
We do not think that any ongoing case would have this kind of impact.
【By Stephen Yang and Jiancheng Jiang，Published in Intellectual Property Magazine, September 2011】