China's TRIPS-plus provisions in response to the strategy of expansion

Abstract: In recent years, the United States and the European Union and other developed countries the flexibility provided by TRIPS agreement, signed with other countries in the free trade agreement by adding a large number of TRIPS-plus provisions. These provisions on TRIPS and limit the expansion of intellectual property protection standards to improve In the field of pharmaceutical patent protection is pArticularly prominent. Practice has proved that, TRIPS-plus provisions seriously affected the availability of drugs in developing countries. China is a large number of developing countries rely on generic drugs in the domestic legislation and free trade agreements signed international treaty, the TRIPS-plus provisions shall remain on high alert, careful introduction of the patent link system for the protection of data exclusivity restrictions set to retain compulsory licensing, parallel importation provisions of TRIPS allows flexibility as far as some of the options for domestic policy space reserved .

Keywords: TRIPS; TRIPS-plus; patent protection; Medicines

Introduction

In recent years, the United States and the European Union and other developed countries to use TRIPS flexibility in terms of the agreement, market access and cross-border Investment is the temptation to sign a free trade agreement with them in developing countries (Free Trade Agreements, hereinafter referred to as FTAs), in these FTAs add some provisions to improve intellectual property protection standards. As these terms than the protection provided by TRIPS standards, known as TRIPS-plus provisions. With the popularity of FTAs, more and more with developing and developed countries signed TRIPS-plus provisions in FTAs, in pArticular in the field of pharmaceutical patent protection, TRIPS-plus expansion is pArticularly prominent. TRIPS-plus provisions of the strong expansion of the international protection of intellectual property rights in order of impact, erosion, while the multilateral system of intellectual property protection, medicines in developing countries can and sexual (ie acquired) inevitably have a negative impact. Therefore, China as the world's largest developing country, in-depth study TRIPS-plus provisions and the early development of a strategy to tackle important practical significance.


A, TRIPS-plus provisions of the origin and development

Early in the 19th century, the international community began to pay attention to intellectual property protection. The international protection of intellectual property rights are international treaties and domestic Law are two ways in which international treaties plays a very important position. Before the birth of the TRIPS Agreement, the international community has a series of international conventions protecting intellectual property rights, such as the protection of industrial property rights <<Paris Convention>>, copyright protection <<Berne Convention>> and protect neighboring rights <<Rome Convention>> and <"On the intellectual property integrated circuits Treaties>> and so on. However, the United States and other developed countries, a higher degree of protection of intellectual property rights, these conventions can not meet the high standards of developed countries on intellectual property protection needs. For example, "<Paris Convention>> does not provide patent minimum term of protection for trade secrets nor the Convention specifically to protect, in addition, without an effective solution to the dispute settlement system of intellectual property disputes.

The beginning of the Uruguay Round negotiations, the United States threatened to withdraw from the negotiations, requiring intellectual property into multilateral negotiations. Taking into account the Uruguay Round agreements as a package deal, including the developing countries hope that some of the things, such as return of textile agreement, trade in services agreement, but to strengthen the dispute settlement mechanism, developing countries made compromises and concessions to the final In 1991, the GATT Director-General presented the final draft of the framework of the Uruguay Round, where <<and trade (including trade in counterfeit goods within) the intellectual property rights "Agreement" (referred to as the TRIPS Agreement) was adopted basic .1994 5 April, 125 members of the negotiating pArties signed in Marrakesh, Morocco, including TRIPS, including the Uruguay Round of multilateral trade negotiations the final legal documents. can be said, TRIPS is the victory of the developed countries to developing countries, provided for the international harmonization of intellectual property protection and coordination of the "minimum standards", that is, members of the protection provided for intellectual property can be higher than it not be less than the protection established by TRIPS standards and requirements. and other than international treaties protecting intellectual property, TRIPS protection of intellectual property to expand the scope to extend the term of protection in general. In addition, TRIPS Agreement also provides detailed and comprehensive intellectual property enforcement measures, including administrative and judicial procedures, and disputes relating to intellectual property included in the GATT / WTO dispute settlement mechanism, strengthen the international trade activities among the members of the protection of intellectual property obligations.

For most developing countries, TRIPS standards of IP protection under the whole, been far higher than their domestic intellectual property protection. However, due to economic, political, technological, and cultural development is uneven, destined to develop countries and developed countries in protection of intellectual property conflicts and contradictions. developed countries in science and technology development, technological Innovation ability, strong protection of intellectual property pursuit is endless. Despite the signing of TRIPS indicates that the international intellectual property the formation of a new and higher protection of international standards, but developed countries that the negotiations did not meet their intellectual property for all purposes, such as the existence of some flexibility in terms of TRIPS, or allow the obligation of the pArties to explain to their advantage, thus the members to develop and implement intellectual property regimes provide some flexibility. in the TRIPS agreement, the United States and other developed countries to start negotiations immediately, trying to broaden the scope of protection, and enhance the implementation of mechanisms to reduce the flexibility of TRIPS provisions, reduce the developing countries and the least developed countries special and differential treatment. However, developed countries did not achieve the intended purpose over the years, especially in 1999 after the failure of WTO Ministerial Conference in Seattle, developed countries realized that to achieve at the multilateral level to further improve intellectual property protection standards purpose is very difficult, and began turning from a multilateral forum to seek to conclude bilateral and regional FTAs, adding some new terms, setting new standards for intellectual property protection. Compared with the TRIPS, these terms
Setting a higher standard of intellectual property protection, a wider range, an increase of the obligations of signatory states of intellectual property protection, which is called TRIPS-plus provisions. Due to the developed countries led by the U.S. has absolute advantage in technological Innovation, most In fact all developed countries have a patent, which TRIPS-plus provisions in the patent field, particularly in the field of drug patents is particularly prominent.


Second, TRIPS-plus expansion of the terms of the TRIPS Agreement

TRIPS-plus provisions of the standard ways to improve intellectual property protection are diverse, the most important way is by adding new provisions, the introduction of the new system in order to expand on the TRIPS Agreement. FTAs highlighted in this way, the rules of interpretation, the patent system link the introduction of data exclusivity protection, extend the term of patent protection and so on.

(A) the interpretation of the rules on the emphasis on "Innovation"
Recent bilateral FTAs in the interpretation of the rules clear emphasis on "Innovation" and the importance of the return to Innovation, which in the TRIPS Agreement is not. If the United States and Australia FTA Annex 2C (Annex 2c) of the agreement outlined in the rules of interpretation , clearly states that "The Parties undertake to promote a national Health care quality improvement and public Health conditions, for which the two sides abide by the following principles ... ... The parties acknowledge that new medicines to improve quality medical services in the importance of recognition of Research and development in the system the importance of medicine and government policy through intellectual property protection and other support to the importance of their ... .... "principles of interpretation that emphasizes the recognition of innovation, the return and protection, in fact, played a role in improving standards of patent protection.

(B) market access to drugs is linked to its patent position
In the traditional standard, the Patent Office decision whether drugs originality, novelty, is to meet the requirements of the patent, and pharmaceutical drug regulatory authorities assess only whether the market must be the quality, safety and efficacy. Application whether the generic drugs maker listed the rights of patent infringement, the decision of the drug control authorities no fundamental impact. TRIPS does not explicitly mention the manufacturer of generic drugs before the patent expired in order to obtain approval to market generic drugs are entitled to use of patented drugs rights. However, TRIPS Agreement Article 30 provides for a limited number of exceptions, such as Research exception, first with the exception [1]. Dispute drugs in Canada, the Panel also ruled that TRIPS Article 30 allows some exceptions to this exist [2]. However, the recent FTAs signed by many patent position in the shift the pharmaceutical market and whether to approve the link. These provisions of FTAs within the country's drug regulatory authority without the patent holder's consent shall not be registered to generic drugs (Note : Arts 19 (5) (3) of CAFTA-DR; 17 (9) (4) of US-Chile; 15 (9) (6) of US-Morocco; 16 (7) (5) of US-Singapore; and 14 (8) (5) of US-Bahrain.), this is the link to the so-called patent system. These provisions not only delayed the market entry of generic drugs may also hinder the use of TRIPS compulsory licensing recognition. because the Government under a compulsory license to allow the production commercial production, but also to the drug Administration authorities still need to register. If the drug patent expires, drug regulatory agencies are prohibited to give generic product registration, then the compulsory license will not be realized.

(C) the special protection of undisclosed data
Traditionally, pharmaceutical manufacturers will market and sell in the market before, to be the country's drug regulatory authority for the grant listing. In order to ensure drug quality and safety, drug developers must conduct clinical trials and results and other data submitted to the drug Administration authorities. Drug Administration authority does not conduct clinical trials, nor to test the drug, but rather rely on the results of clinical trials provided by the applicant and other data. When applicants apply for the same after the drugs register, do not need to re-do the same clinical trials, but only need to prove their drugs and medicines has been registered with the same quality and efficacy, which greatly facilitated the market entry of generic drugs. TRIPS Agreement Article 39.3 stipulates that members of the new chemical raw material for the Application of drugs or pesticides The marketing authorization, and considerable efforts are required to provide a complete testing and have not been published or other information, should be to prevent the information being used unfairly in the business world. This provision does not require members of the pharmaceutical data exclusivity should be by way of for protection, members should have the right to enforce the terms of obligation in any way. In the present about 150 WTO members, only 60 members of the exclusive rights of a similar data protection Laws, and national legal experts on data exclusivity WTO still controversial whether an agreement obligations.

Recently, however, the United States and Singapore, Chile, Australia, Morocco and Bahrain signed a bilateral FTAs, but did not disclose the data to provide a wider range and higher level of protection. In these FTAs, the protection of undisclosed data is no longer limited to "after considerable efforts" to obtain data only, but extended to any and drug safety and effectiveness of related information. Moreover, these FTAs have not disclosed the data given the exclusive right to the exclusive five-year (Note: Arts 17 (10) (1) of US-Chile; 15 (10) (1) of US-Morocco; 14 (9) (1) (a) of US-Bahrain; 16 (8) (1) of US-Singapore; and 17 (10) (1) of US-Australia FTA.). Under these provisions, the original inquest five years after registration period, in the process of Application for registration of generic drugs, the applicant and a country's intellectual property management institutions are not allowed dependent on the original drug Research clinical Research data provided by the applicant and other data. Thus, the effective period of data exclusivity, generic drug manufacturer generic drugs if you want to put on the market, it must also be submitted and the results of clinical trials to the drug Administration authorities. However, to do clinical trials is expensive, generic business is difficult to do this. Even if imitation providers to do this, get the required data, but the cost of doing experiments naturally raise the generic drugs prices. In addition, another experiment also delayed time to market generic drugs. Also note that, FTAs in the data exclusivity period is provided independent of the patent, regardless of whether the drugs patented in the country. Therefore, even if a drug in A country does not have access to patents, data exclusivity to some extent played the same role with the patent protection to ensure that the pharmaceutical companies a certain period of monopoly, to build a man-made drugs into the country barrier.

(D) ensure the effective duration of patent protection
TRIPS requires its members to grant patent protection period of at least 20 years, starting from the patent Application. However, the experimental pharmaceutical products require a longer time and up the processing time, therefore, intend to apply for patent protection to pharmaceutical companies conducting basic Research the early stage of patent Applications filed for regulatory approval than might be back for many years. In general, the patent application and registration approval time is usually 8 to 12 years, which means that successful applicants to receive a monopoly of the patented drugs greatly reducing the number of years. According to the provisions of TRIPS, in order to avoid undue shortening duration of patent protection, Member States should ensure that patents granted within a reasonable time. But TRIPS does not define what is "reasonable period", there is no clear result of the delay "patent term" and shorten the time the patent should be how to compensate the patentee. However, the U.S. recently signed FTAs provide that if a country's drug regulatory agencies in reviewing applications for registration, or the Patent Office granted a patent in assessing whether there is "unreasonable" delay, then the Government should extend the patent term to compensate for the pharmaceutical company to US-Chile (Art. 17 (10) (2) (a)); US-Singapore (Art. 18 (8) (4) (a)); US-Australia (Art. 17 (10) (4)); US-Morocco (Art. 15 (10) (3)).). extension of patent term may have little impact on the developed countries, but the development of poverty public Health problem in the country but there may be a significant impact.


Third, TRIPS-plus provisions of the restrictions on the TRIPS Agreement

In addition to the validity and scope of the TRIPS Agreement and vigorously expand the outside, TRIPS-plus provisions of the TRIPS Agreement through the rights of members to limit to achieve higher than the TRIPS Agreement, broader and stronger intellectual property protection purposes [3].

(A) the restrictions on compulsory licensing
TRIPS compulsory licensing is a recognition of the Government to allow the temporary use of patents, imitation of patented products manufactured under license as a public Health protection measures .2001 Doha Declaration reaffirmed the country to use compulsory licensing and to determine what conditions the right to grant compulsory licenses, a clear stipulates that the State should be able to take full advantage of the flexibility of TRIPS to promote public Health. However, since the implementation of TRIPS from the beginning through the FTAs the United States to limit the flexibility of TRIPS. through FTAs limit the flexibility of compulsory licensing, in the following two aspects: on the one hand, FTAs through data exclusivity provision limits the use of compulsory licensing; the other hand, restrictions can be applied to the case of compulsory licensing. Some FTAs also set other restrictions on compulsory licensing conditions, such as the United States signed the FTA with Singapore by raising the compensation standards for further enhanced the threshold for compulsory licensing, and to restrict the transfer of proprietary technology. Generally speaking, often accompanied by licensing proprietary technology licenses, if not proprietary technology, the licensee, the patent's value often greatly reduced.

(B) the restrictions on parallel importation
Parallel importation refers to one country, the importer or licensee of intellectual property without the consent of their legitimate in the international market with the flow of imports of goods, intellectual property and sold to the country's behavior. TRIPS Article 6 clearly show that The agreement does not involve exhaustion of intellectual property rights issues. This shows that countries in this issue is difficult to reach consensus, so the agreement evasive on the issue is neither supported nor opposed the right to solve the problem, leaving the Member States. The Doha Declaration also recognized the right of WTO members enjoy in this, so parallel importation does not violate TRIPS Agreement itself. However, in recent years, FTAs on the United States through strict restrictions on parallel imports or even prohibited. For example, the United States and Morocco FTA section 15 ( 9) (4) and the United States and Australia FTA section 17 (9) (4) to prohibit parallel importation. Although these two agreements provide that only when the patent owner or by contract or other restrictions on parallel imports, the Law only the ban on parallel imports, but this rule is still effective in limiting parallel imports, making the patent holder to segment the market by the contract and maintain price discrimination. While in Australia, Singapore, already in the country such action had been taken, however, FTAs that Government will be difficult to change the Law to abolish the restrictions on parallel importation. In addition, developing countries that practice makes it difficult to support public health for the origin of parallel imports.

(C) use of old drugs new restrictions on the patentability
TRIPS Article 27.1 provides that any technological inventions, whether products or processes can be patented. According to the regulations, products and methods can be patented, but a new use for old drugs can get patent protection, TRIPS does not clear. Under U.S. Law, the new use of old drugs is a way to grant patents on methods to achieve the purpose of protection. will this provision be interpreted as allowing Member States to decide whether the "old drug new use" patent protection, it seems can not not be. However, TRIPS Article 27.3 also provides that member states can be human and animal disease diagnosis, treatment and surgical methods excluded from the scope of patent protection. So, WTO members will be "old drug new use" exclusion outside the scope of patent protection, or violation of TRIPS provisions. However, the United States with Australia, Morocco and Bahrain FTAs signed are not allowed such flexibility exists. For example, the US-Australia FTA in respect of the provisions of Article 17.9.1 should have been the use of known products or use new products, new methods are known to provide patent protection. US-Pakistan FTA US-Morocco FTA is further provided a new use of known products, including for the treatment of humans and animals are available to patent protection.

(D) limits the grounds of patent revocation
In the TRIPS negotiations, under what circumstances can undo the patent, is a lot of controversial issues. TRIPS Article 32 of the last to avoid controversy, there is no direct reference to the withdrawal of the reasons this issue, but merely provides that "the decision of revocation of a patent should the opportunity for judicial review. "Most scholars agree that, TRIPS will be grounds for revocation of a patent decision by the members of their own [4]. Therefore, Member States have the power to demand revocation of a patent the public interest, including the case of patent abuse. However, the recent signing of FTAs in the United States to limit the patent case that could undo. in the United States and Singapore, Chile, Australia, Morocco, Bahrain and Central American countries have bilateral FTAs in the following provisions, "the parties shall be provided only in accordance with reject the patent application be withdrawn under the conditions of the patent situation. the parties may be stipulated in the presence of fraud, misrepresentation, unjust act or determination of the case of revocation of a patent the patent unenforceable. "can be seen that the case of revocation of a patent can be greatly reduced, these FTAs do not allow for other public interest requirements of revocation of a patent.

Fourth, TRIPS-plus provisions of the reality of the case study

Jordan as a typical developing country, in 2001, and the United States signed a FTA, the agreement is full of TRIPS-plus provisions. Australia as a developed country, also signed in 2004 with the U.S. FTA, the TRIPS-plus agreements with the United States about the terms FTA is very similar. Today, entry into force of the two FTAs have been a few years, from a practical effect, the two agreements are the availability of drugs had a negative impact.

(A) Jordan
With many developing countries, Jordan joined the WTO TRIPS Agreement, one of a package agreement before the heavy reliance on generic drugs. Still, Jordan was signed with the U.S. FTA, received higher than the TRIPS standards of IP protection. From the United States About FTA has been signed, TRIPS-plus provisions for a multinational pharmaceutical companies to prevent generic drugs to compete with a powerful tool. In fact, many pharmaceutical companies in the Jordanian market for the sale of a new drug is not patented, but by the TRIPS-plus provisions, in particular, data exclusivity protection to prevent generic drug competition. Since 2001, the Jordanian drug prices rose by 20% [5]. drug prices rose a number of factors, including a very important reason is that the data exclusivity protection, and other strict standards of IP protection, resulting in a lack of corresponding competitive generic drugs and patent medicines [6].

Respect to the introduction of foreign capital in the FTA negotiations, the United States advocated the signing of the United States about FTA will encourage inflow of foreign capital the local pharmaceutical industry. The fact is that neither the multinational pharmaceutical companies have not signed licensing agreements to transfer technology to local pharmaceutical companies, Most drugs are imported rather than local production. According to the Federation of Jordanian pharmaceutical industry statistics, and now most of the effect of technology licensing agreements are signed before 1999. Although Egypt has not signed with the U.S. FTA, its intellectual property rights level of protection is not as Jordan [7], but it attracted a lot of Investment. from 1995 to 2007, the Egyptian pharmaceutical industry has attracted Investment of over 200 million U.S. dollars, of which 39% came from multinational companies. These Investments, including technology licensing agreements and foreign pharmaceutical companies to set up a foreign-funded enterprises. and Jordan compared to more foreign Investment into Egypt, the main reason is obviously the huge Egyptian market to pharmaceutical companies to provide a more attractive business opportunities. In addition, Jordan has imported drugs 70% of the amount of drugs, while only 10% in Egypt [8].

Not only that, the United States about the high standards of FTA on intellectual property protection does not improve the development of Jordan's level of local pharmaceutical companies. In fact, Jordan local enterprises only 0.1% of sales on research and development of new drugs, which is part of the Investment is mainly used in the minor improvements to existing medicines, the introduction of medicines management technology, rather than the development of new drugs. Since 2000, the Jordanian pharmaceutical companies have not made a new drug patent applications. Of course, these pharmaceutical companies for drug development are not There are many reasons such as lack of funds. But the beauty about FTA in TRIPS-plus provisions, such as strict data protection restrictions, also intensified the situation, but Jordan can not afford to pharmaceutical companies for clinical trials. In addition, infrastructure and lack of professionals, but also makes difficult to carry out drug development. TRIPS to introduce a new intellectual property protection, increasing the price of new drugs and give the country the availability of essential drugs to bring obstacles.

(B) Australia
Australia is the developed countries, the US-Australia FTA also contains a similar FTA with the United States about TRIPS-plus provisions. US-Australia FTA link into the patent system did not disclose the data given the exclusive right to the exclusive five-year, but did not disclose the data for provides greater range and higher level of protection, the protected data is no longer limited to undisclosed "by a considerable effort" to obtain data only, but extended to any and drug safety and effectiveness of related information. For old drugs new use if the problem can be patented ����, the United States and Macao FTA also eliminated the flexibility of TRIPS to require the new known products should use Huo ʹ�� known product of the new method to provide patent protection. In addition, the United States and Macao FTA Jinzhi parallel importation, but also limits the scope of compulsory licensing, limiting the revocation of a patent case.

US-Australia FTA has greatly enhanced the price of generic drugs, the drug reduced the welfare system in Australia (Pharmaceutical Benefits Scheme, PBS). Australia has a strong welfare health care system, PBS system is the core of the system. PBS was established in 1948 years, the annual publication of a PBS medicine directory. Drug Evaluation Committee (Australian Drug Evaluation Committee, ADEC) on the drug to assess the safety and efficacy, drug Welfare Advisory Committee (Pharmaceutical Benefits Advisory Committee, PBAC) to assess its cost-effectiveness . If the two institutions have made positive assessment of the directory can be included in the PBS medicines. If Welfare Advisory Committee that a similar pharmaceutical drugs, compared with the market, cost efficiency is not high, it may not be included in PBS catalog, unless it can be proved with similar compared to alternative drugs, its effectiveness and safety of significant improvement. PBS is Australia's most effective public health policy tool. in PBS, the Australian drug prices is only one-fourth of U.S. prices of similar drugs [9] And drug prices than almost all OECD countries, drug prices low [10]. Australia's PBS program to ensure that Australian citizens can afford basic medicines, is an important guarantee of social justice measures. In the US-Australian FTA talks , the United States will target the Australian PBS system. According to the provisions of the US-Australia FTA and the agreement emphasizes the principles and spirit of innovation, Australia in 2007 on the <<1953 National Health Act>> were modified. According to the amendment, PBS has been under the drug list into two categories, namely F1, F2, F1 contains no other drugs have the same biological effectiveness of the alternative prescription drugs, mainly patent medicine. F2 category are mainly generic drugs, for the F2 class of drugs, mandatory price cut. F2 class because of low prices, coupled with the US-Australia Agreement, the other TRIPS-plus provisions, such as patent link system, exclusive protection of databases, making generic drugs more profitable production in Australia difficult, pharmaceutical companies are increasingly reluctant to set up R & D facilities in Australia. In addition, since the US-Australia FTA link system, the introduction of the patent, the exclusive protection of the database to extend the patent protection period, parallel import restrictions and other reasons, in Australia generic drugs significantly longer time to market. generic drug companies willing to establish R & D facilities in Australia and the delay of counterfeit drugs entering the market, not only affects the prices of medicines on the PBS list, but also affected the price of drugs outside the list, including public hospitals, counter sale of private hospitals and government subsidies as well as the safety net is not within the scope of drug prices, leading consumers in the government and the ultimate consumer spending have greatly increased [11]. For this reason, scholars of the US-Australia FTA, Australia has strongly criticized as US-Australia FTA erosion of the sovereignty of Australia to limit its own legislative and policy choice [12], weakened health care system as the core of PBS system has greatly affected the residents the right to equal access to key drugs [13].

Links to Research Papers Download http://www.hi138.com FTA by the United States and the United States and Australia about FTA's impact can be seen, even in developed countries, TRIPS-plus provisions may also have a negative impact on drug prices, R & D weak capacity of developing countries, its negative impact is more significant. Generally speaking, the high standards of IPR protection level of a country's pharmaceutical industry depends on several factors: First, the pharmaceutical industry in a country , domestic producers and foreign manufacturers of power; Second, a country's own R & D capability; Third, a country's ability to produce generic drugs; Fourth, the ability of a country's exports drugs. a country more in these areas strong, then the use of the development of a high standard of intellectual property protection to the stronger ability of national industries. If a country are weak in these areas, it will be difficult to benefit from high standards of intellectual property protection. signing FTAs with which the developed countries may take advantage of a high standard of intellectual property protection to increase pharmaceutical exports, will also facilitate the export and the substantial profits rather than transfer of technology to developing countries. The end result is likely to be given to developing countries can not use the TRIPS flexibility to reduce drug prices, while the pharmaceutical industry itself has not been a corresponding development.


V., TRIPS-plus provisions of the coping strategies of Chinese background

Because the United States and China and the EU have not yet signed bilateral FTAs, the FTAs currently participating in our non-existent problem of TRIPS-plus provisions, but the conclusion of FTAs in the future is likely to face when the pressure of TRIPS-plus. The United States and the European Union through the implementation of TRIPS-plus provisions of FTAs , to some extent, but also the United States stronger and more confident in developing a response strategy adopted. the United States and the European Union found it increasingly difficult to WTO and other multilateral forums to achieve its negotiating objectives, then from the multilateral system into the bilateral system. When the TRIPS-plus provisions to a certain extent, must return to the multilateral system, the TRIPS-plus provisions are certainly reflected in the multilateral forum, therefore, TRIPS can only be seen as the international protection of intellectual property legislation of a multilateral phase rather than the final stage. For us such a populous country, inadequate health care system, more than 97.4% of Western medicine is generic, at least 90% of biopharmaceuticals by foreign enterprises to apply for a patent. Although the research and development of self- intellectual property rights of pharmaceutical drugs is a big country to China from the only way pharmaceutical power, but guarantee the availability of medicines is the reality of the challenges facing our country. spate of recent years, China's SARS, avian flu, H1N1 influenza and other unexpected health and safety incidents, China has been given protection in the event of such events and of the ability of drugs to put a higher demand. In fact, invested heavily in the development of proprietary new medicines for the majority of domestic enterprises is unrealistic for a long time, generic drugs will continue to dominate in our market. It can be said, in response to public health crises made great progress, pharmaceutical research and development capabilities in China to achieve substantial increase before the high standards of intellectual property protection is likely to Our cause greater adverse effects of patent legislation in the future and the conclusion of international treaties, we should maintain a fairly TRIPS-plus provisions of caution. In particular, should pay attention to the following issues:
First, the introduction of the patent system should be carefully linked. In order to maximize the prevention of the occurrence of violations, some of the original research links drug developed to implement the patent system, by setting up part of the review points infringement, allowing the patentee to raise defenses in order to protect the interests of patent holders. In addition to the link in the national patent system, led by the U.S. drug research developed the system through the implementation of the FTAs. But drugs different from general merchandise, drugs in the market before the administrative examination and approval after a long time If you wait until after the expiration of drug patents to allow registration of approval, then in fact extended the term of patent protection and will prevent generic drugs to compete. These provisions not only delayed the market entry of generic drugs, more importantly, market access and patent position will linked, it may hinder the recognition of the TRIPS compulsory licensing of the use is not conducive to the protection of public health and improving the drug's availability. China <<Drug Registration>> Article XIX, on the other has been patented in China drugs, the drug patent applicant may within 2 years before the expiry of the registration application. Article XVIII, the applicant shall apply for registration of their prescription drugs or use, process, use, etc., provide the applicant or another person in China description of the patent and its ownership status; others, there is a patent in China, the applicant shall submit the patent to others, the statement did not constitute infringement. If the foregoing is a link to our patent system, the ambiguity of the unknown of the system is : The application for registration of medicines should be submitted to the requirements of proof of non-infringement is not clear; in the approval process encountered evidence to the contrary, the law does not stipulate how to deal with. It should be noted that the existing <<Drug Registration> > retained the pharmaceutical patent applicants declare the requirements of the application retained for 2 years in advance, but did not keep drugs issue revocation procedures, only the provisions of the registration process occurred in the drug patent dispute, in accordance with the laws and regulations relevant to resolve the patent. If this can be seen as China's pharmaceutical approval process for an amendment to the patent system, I believe that it is a blessing.

Second, set limits for the data protection conditions. Even in the pharmaceutical industry did not get a patent case, the data exclusivity prevents generic drugs can compete. If the pharmaceutical companies patented drugs, the data exclusivity can be to the drug and the duration of the patent after the patent expired some time to enjoy monopoly. When the data exclusivity is a multinational, the compulsory license would be very difficult. Even R & D and manufacture of imitation of the expiry of the patent protection of drugs new forms, the generic pharmaceutical companies are difficult to market because of the exclusive right to make generic enterprise data can not rely on the original patented drug clinical trial data. the United States about the signing of FTA in Jordan market, multinational pharmaceutical companies put a lot of drugs are not patent protection, one of the reasons is that many multinational pharmaceutical companies believe that 5 years of data exclusivity prevents the entry of generic drugs. In fact, as of mid-2006, in Jordan 21 multinational pharmaceutical companies, only three a proposed patent applications, and other pharmaceutical companies have chosen to rely exclusively for at least five years of data protection to the monopoly of the time. In 2005, India <<Patent Law "> amendment, the scope of data protection had intense debate , the conclusion is to reject the data exclusivity, because the prosperity of the country that will have a negative impact of generic medicine, and China agreed to provide six years of data protection, as a condition of joining WTO. China <<Drug Registration>> provisions on access to production or sale of drugs containing new chemical sales permit submitted by the producer or the self-made undisclosed test data and other data, the State Food and Drug Administration approved the license from the 6 years from the date of has been permitted without the applicant agrees to use its outstanding applications for disclosure of information shall not be approved. It can be seen, given the data in our exclusive protection, and without setting any restrictions. In fact, TRIPS provisions on data protection Liuxia considerable room for interpretation, the provisions of protection of members of the data can be limited to "require considerable effort" to get the data. In fact, some Latin American countries in the FTAs with the United States have been forced to accept TRIPS-plus provisions, but Quedui given set of data exclusivity protection restrictions. China can also set conditions on data exclusivity, which is not violation of WTO commitments, do not violate the provisions of TRIPS Agreement.

Third, the TRIPS agreement allows the flexibility to retain the terms. TRIPS-plus provisions limit the use of TRIPS flexibilities in developing countries the right. In the TRIPS Agreement, developing countries enjoy a certain autonomy legislation and policy space for freedom of choice. But in the TRIPS- plus provisions, these provisions were a large number of elastic compression, which greatly limits the TRIPS Agreement in developing countries to enjoy autonomy in accordance with legislative space. even if we were certain aspects of patent law has reached a certain TRIPS-plus provisions of the standard, but participate in such international treaties, and its own legislation and policy space for freedom of choice will be greatly limited. Once a change in the domestic situation to amend the law, freedom of choice will be strictly bound by the treaty, such as the signing of the US-Australia FTA, Australia After the introduction of the patent system and so on TRIPS-plus links to articles attracted wide criticism, so Australia also amended the domestic law TRIPS-plus provisions in order to reduce the negative effects [14], this approach to lead the U.S. strongly criticized and condemned [15].

VI Conclusion

In the WTO was established, the state of intellectual property protection in many developing countries, particularly the level of patent protection is still in the TRIPS-minus state, far short of the standards required by TRIPS. In order to fulfill the obligations under the TRIPS Agreement, including China,�ĺܶ෢չ�й��Ҷ������˺ܴ�Ŭ��.���ǵ���չ�й��һ���Ŭ��ȥ�ﵽTRIPS�涨��֪ʶ��Ȩ������ͱ�׼ʱ,��������Ѿ���ʼͨ��˫���Լ�����ó��Э����һ�����֪ʶ��Ȩ�����ı�׼.�ڹ�ȥ�̶̼���ʱ����,��չ�й��ұ������ϴ�TRIPS-minus��TRIPS,�ٵ�TRIPS-plus�ĵ�·.�ܶ෢չ�й��ҵ�ҩƷ�ɼ��Ի���������,Ӧ�Թ�������Σ��������Ҳ�ܵ�,äĿ���ӷ�����ҵ�֪ʶ��Ȩ��׼,���ܸ������ش���.�ҹ���Ϊ���ķ�չ�й���,��Ϊ����ҩ�������,�ڹ��������Լ��޽�FTAs�ȹ�����Լʱ,��TRIPS-plus����һ��Ҫ���ָ߶Ⱦ���.


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[2] WTO Panel Report. Canada��Pharmaceutical Patents[R].

WT/DS114/R, 7 April 2000.

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[4] Jean-Fr��d��ric Morin. Tripping up TRIPS Debates IP and Health in Bilateral Agreements[J]. Int. J. Intellectual Property Management, Vol. 1, Nos. 1/2, 2006:37.

[5] Malpani, Rohit. All Costs, No Benefits: How the US-Jordan Free Trade Agreement Affects Access to Medicines[J]. Journal of Generic Medicines, Volume 6,Number 3, 2009:206-217
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[15] Zoellick, R. USTR (2009) Letter to Vaile M, Australian Minister for Trade, [EB/OL].[2009-10-05]http://www.dfat.gov.au/trade/negotiations/us_fta/ index.html.


Expansion of TRIPS-plus Provisions and China's Counter-measures:
From the Perspective of Patent Protection for MedicineWU Xue-yan
(Law School of Chongqing University, Chongqing 400044)
Abstract:
In recent years, developed countries like the USA and the EU, taking advantage of elastic provisions of the TRIPS, insert lots of TRIPS-plus provisions into the FTAs while signing Free Trade Agreements with developing countries with market access and FDI as a lure. The added provisions raise the level of protection of intellectual property through the expansion of TRIPS and creation of higher standards. It is proved that in practice the TRIPS-plus provisions have considerably adverse effects on developing countries' access to essential medicines. As a developing country largely depending on generic drugs, China should be cautious about TRIPS-plus provisions while making laws or negotiating free trade treaties with other countries.

Key Words:
TRIPS; TRIPS-plus; patent protection; access to medicineת���� ��������������� http://www.hi138.com