Analysis of the Patent Law of the New Analysis of the Patent Law brought the opportunity to my country's pharmaceutical companies
Release time: 2010-09-25 & nbsp & nbsp & nbsp Source:
my country has implemented a new Patent Law from October 1, 2009，The "Implementation Rules for Patent Law" that is supported by it will also be implemented from February 1, 2010。The author analysis of this article believes，In the field of medicine，The modification of the Patent Law adapted to the current demand for intellectual property protection at home and abroad，At the same time, it provides opportunities for Chinese pharmaceutical companies to imitate certain market monopoly products，It also laid a legal basis for the rapid entering of the imitation products of Chinese pharmaceutical companies，Some product technologies such as confidential formulas may become the application object for confidential patents。The author's suggestion，Domestic pharmaceutical companies should seize the market opportunities brought by the new Patent Law，Make full use of the relevant provisions in the Patent Law to formulate the company's market development ideas and intellectual property strategies。As an industry legal expert，Its analysis and suggestions should attract the attention of domestic pharmaceutical companies。
Modification of Patent Law in my country，It is based on the changes in the legal environment at home and abroad and the specific national conditions of our country。Overall，New "Patent Law" is conducive to the technological innovation and market competitiveness of Chinese enterprises。For pharmaceutical companies，The New "Patent Law" provides at least four opportunities。
Prevent foreign economic forces from disorderly penetration
Article 5 of the New Patent Law stipulates: "Violation of the law、Regulations on administrative regulations obtain or use genetic resources，Invention creation of the completion of the genetic resource，No Patent Rights "。Article 26, paragraph 5 stipulates: "Invention creation of relying on genetic resources，The applicant shall explain the direct source and original source of the stake online sports bettingStake Sports Bettinggenetic resource in the patent application document; the applicant cannot explain the original source，Reason should be stated "。
my country participated in the United Nations Environment and Development Conference held in Rio de Janeiro, Brazil in June 1992，and sign on the Convention on Biological Diversity，November 7 of the same year，The Standing Committee of the National People's Congress approved the Convention。December 29, 1993，The Convention is officially effective in my country。One of the basic principles in the Convention on Biological Diversity is the consent of informedness，my country makes full use of the rights given by the International Convention，The source disclosure of the genetic resource acquisition or utilization of genetic resources in the new "Patent Law" is effectively connected，In order。
Article 26 of the Patent Law Implementation Rules stipulates that "genetic resources refer to the body、Animals、Materials that contain genetic function units with genetic function and have potential or potential value "。Among them, my country is internationally reserved internationally in the world。Due to the development and utilization of genetic resources, rely on certain technical and funds as prerequisite，Therefore，This provision is introduced，Playing the region of my country's traditional resources in the region of China's own region。At least in recent years，Some foreign companies that are developing new drugs from traditional pharmaceutical resources in my country，Application for hiding its behavior or delaying its new drug patent，So that Chinese pharmaceutical companies get a chance to get gasp in the fierce market competition。
Provide opportunities for local companies
Article 48 of the New Patent Law，In two situations，Any unit or individual with implementation conditions can mention compulsory licenses to implement invention patents or practical new patents。These two situations are "the patent person has been granted three years from the date of being awarded by patent rights，Four years from the date of the patent application，Those who have not been implemented without proper reasons or have not been fully implemented;，In order to eliminate or reduce the adverse effects of the behavior on the competition "。Article 50 of the New Patent Law stipulates: "For the purpose of public health，Drugs that obtain patent rights，The patent administrative department of the State Council can be manufactured and exported to the compulsory licenses of countries or regions that meet the international treaties that meet the participation of the People's Republic of China. "。
The contradiction between the exclusive public health and the drug market has always been a hot issue discussed by relevant international organizations，November 14, 2001，The World Trade Organization (WTO) Dorha Minister's Meeting approved the "My stake betting appDoha stake sports betting appDeclaration on the TRIPS Agreement and Public Health"，Clarified the sovereign rights of the WTO member government take measures to protect public health。December 6, 2005，WTO member states unanimously adopted "Modification & LT; Trade -related Intellectual Property Agreement & GT; Decision"，Put forward "the necessary range of export members for production and selling medicines to qualified members" can be implemented for mandatory licenses。November 29, 2005，The State Intellectual Property Office awarded my country's "Patent Implementation Measures for Patent Implementation of Patent Health issues involving public health issues"，Specific implementation of the above international resolution。New "Patent Law" provides the support of domestic legislation for the "Patent Law" issued by the "Patent Implementation of Patent Implementation of Public Health"。
Due to the new "Patent Law" and "Patent Law Implementation Rules", the application of compulsory license has been implemented with relatively loose regulations，such as "For Public Health"、"Can't meet the needs of domestic patented products or patent methods", etc.，Therefore, my country's pharmaceutical enterprises, especially the pharmaceutical enterprise association, can be based on the layout and market demand of my country's pharmaceutical market，Selective application for compulsory license applications for some foreign patented products in China，This can not only break the foreign pharmaceutical group's market exclusive in my country and the exclusion of domestic drugs，and can get the production or use of the patented product or method，The purpose of achieving effective participation in market competition。
Lay the legal foundation for the enters of generic drugs
Article 69 of the Patent Law of the New Patent Law stipulates that "the information required for providing administrative approval，Manufacturing、Use、Imported patented drugs or patent medical equipment，and specifically made for it、Imported patented drugs or patent medical devices "does not be regarded as infringing patent rights。This regulation is also called "Bolar" (BOLAR Exemption).
"Bolar exception" system is first produced in the United States，originated from the 1984 U.S. Roche Company to the BOLAR company's drug patent infringement case，Its basic spirit is，Actions to implement related patents in order to perform clinical experiments and registration for drugs and medical devices，Not regarded as infringing patent rights，Give infringement exemption。After that，The United States will extend Bolar exception to all medical products，Including human or animal medicine、Biological Products、Medical equipment and health products。Following the United States，Japan、Canada and other countries have clarified the rules of Bolar exceptions in its national patent Stake Sports Bettinglaw。stake betting appThe "Bolar Exception" system was introduced in the new "Administrative Measures for the Registration of Drug Registration", which my country implemented on October 1, 2007，Article 19 of this Measures make the applicant's regulations that the applicant can submit new drug registration applications 2 years before the expiration of patent rights。
Determination of "Bolar exception" in the new "Patent Law"，Not only is it conducive to my country's pharmaceutical companies to actively use the patented technology that is about to expire abroad，And provides clear legal provisions for legal issues such as "production and operation purposes" in the past。Chinese pharmaceutical companies should follow the development status of domestic and foreign diseases and the main direction of domestic pharmaceutical and health reforms，Make full use of the "Administrative Measures for Drug Registration" and various patented databases，Select the type of medicine or medical equipment suitable for its own development，Preparation for production of related products as soon as possible，Strive to push medicines or equipment with market prospects as soon as possible to the domestic market。
Confidential formula, etc. may become a confidential patent
Confidential patents originated from the middle of the eighteenth century。At that time，A number of patents such as rifle guns and rear guns applied by British weapon manufacturer Amsterrand are publicly disclosed，Paris、Police in Berlin and other places quickly used them on the weapon system，greatly improved method、The combat capability of both Germany。To maintain national security，The British Parliament passed the "Army Fire Invention Patent Act" in 1859，Proposed to keep some patented applications confidential，Don’t be disclosed in normal procedures，So as the first to introduce the administrative measure of confidentiality in the patent system。Subsequent，Most countries that implement the patented system resolve。The confidential patents mentioned in the original Patent Law in my country are also targeted at national defense patents，In the revision of the "Implementation Rules of Patent Law"，In Article 7, paragraph 2 specially increased the "State Council's patent administrative department believes that the invention or utility model patent application that it accepts involves national security or major interests other than national defense interests requires confidentiality，Decision to make a timely decision to process in accordance with a confidential patent application，and notify the applicant。Review of the application for confidential patent、Review and the special procedures for the invalidation of confidential patent rights，It is stipulated by the Patent Administration Department of the State Council "。
Chinese pharmaceutical companies should pay special Stake Sports Bettingattention My stake betting appto the statement of "involving major national interests"，If the original confidential patent is only staying on the paper，Now there are clear classifications，Involved in national defense interests、Visible national security、Three categories involved in major interests。The explanation involving major interests is flexible，That is to say，Like Yunnan Baiyao、Six Shen Wan and other previous confidential products belong to "involving major interests of the country"，You can apply for a national confidential patent，Some new discovery or innovative pharmaceutical products (including confidential formula and effective compound)，As long as the effect is precise、With special effects，All application objects for confidential patents。
In short，Chinese pharmaceutical companies should actively use the market opportunities brought by the new Patent Law，Make full use of relevant provisions in the patent law to formulate the company's market development ideas and intellectual property strategies。but，The law always has a double -edged sword，The new "Patent Law" is brought to the market opportunities of my country's pharmaceutical companies，It may also exacerbate the domestic drug market competition and bring more intellectual property disputes，At the same time, it will also stimulate foreign economic forces to formulate new restraint measures for my country's pharmaceutical industry，This may cause a new round of trade disputes。For these problems，The industry must also give full understanding and attention。
Modification of Patent Law in my country，It is based on the changes in the legal environment at home and abroad and the specific national conditions of our country。Overall，New "Patent Law" is conducive to the technological innovation and market competitiveness of Chinese enterprises。For pharmaceutical companies，The New "Patent Law" provides at least four opportunities。
Prevent foreign economic forces from disorderly penetration
Article 5 of the New Patent Law stipulates: "Violation of the law、Regulations on administrative regulations obtain or use genetic resources，Invention creation of the completion of the genetic resource，No Patent Rights "。Article 26, paragraph 5 stipulates: "Invention creation of relying on genetic resources，The applicant shall explain the direct source and original source of the stake online sports bettingStake Sports Bettinggenetic resource in the patent application document; the applicant cannot explain the original source，Reason should be stated "。
my country participated in the United Nations Environment and Development Conference held in Rio de Janeiro, Brazil in June 1992，and sign on the Convention on Biological Diversity，November 7 of the same year，The Standing Committee of the National People's Congress approved the Convention。December 29, 1993，The Convention is officially effective in my country。One of the basic principles in the Convention on Biological Diversity is the consent of informedness，my country makes full use of the rights given by the International Convention，The source disclosure of the genetic resource acquisition or utilization of genetic resources in the new "Patent Law" is effectively connected，In order。
Article 26 of the Patent Law Implementation Rules stipulates that "genetic resources refer to the body、Animals、Materials that contain genetic function units with genetic function and have potential or potential value "。Among them, my country is internationally reserved internationally in the world。Due to the development and utilization of genetic resources, rely on certain technical and funds as prerequisite，Therefore，This provision is introduced，Playing the region of my country's traditional resources in the region of China's own region。At least in recent years，Some foreign companies that are developing new drugs from traditional pharmaceutical resources in my country，Application for hiding its behavior or delaying its new drug patent，So that Chinese pharmaceutical companies get a chance to get gasp in the fierce market competition。
Provide opportunities for local companies
Article 48 of the New Patent Law，In two situations，Any unit or individual with implementation conditions can mention compulsory licenses to implement invention patents or practical new patents。These two situations are "the patent person has been granted three years from the date of being awarded by patent rights，Four years from the date of the patent application，Those who have not been implemented without proper reasons or have not been fully implemented;，In order to eliminate or reduce the adverse effects of the behavior on the competition "。Article 50 of the New Patent Law stipulates: "For the purpose of public health，Drugs that obtain patent rights，The patent administrative department of the State Council can be manufactured and exported to the compulsory licenses of countries or regions that meet the international treaties that meet the participation of the People's Republic of China. "。
The contradiction between the exclusive public health and the drug market has always been a hot issue discussed by relevant international organizations，November 14, 2001，The World Trade Organization (WTO) Dorha Minister's Meeting approved the "My stake betting appDoha stake sports betting appDeclaration on the TRIPS Agreement and Public Health"，Clarified the sovereign rights of the WTO member government take measures to protect public health。December 6, 2005，WTO member states unanimously adopted "Modification & LT; Trade -related Intellectual Property Agreement & GT; Decision"，Put forward "the necessary range of export members for production and selling medicines to qualified members" can be implemented for mandatory licenses。November 29, 2005，The State Intellectual Property Office awarded my country's "Patent Implementation Measures for Patent Implementation of Patent Health issues involving public health issues"，Specific implementation of the above international resolution。New "Patent Law" provides the support of domestic legislation for the "Patent Law" issued by the "Patent Implementation of Patent Implementation of Public Health"。
Due to the new "Patent Law" and "Patent Law Implementation Rules", the application of compulsory license has been implemented with relatively loose regulations，such as "For Public Health"、"Can't meet the needs of domestic patented products or patent methods", etc.，Therefore, my country's pharmaceutical enterprises, especially the pharmaceutical enterprise association, can be based on the layout and market demand of my country's pharmaceutical market，Selective application for compulsory license applications for some foreign patented products in China，This can not only break the foreign pharmaceutical group's market exclusive in my country and the exclusion of domestic drugs，and can get the production or use of the patented product or method，The purpose of achieving effective participation in market competition。
Lay the legal foundation for the enters of generic drugs
Article 69 of the Patent Law of the New Patent Law stipulates that "the information required for providing administrative approval，Manufacturing、Use、Imported patented drugs or patent medical equipment，and specifically made for it、Imported patented drugs or patent medical devices "does not be regarded as infringing patent rights。This regulation is also called "Bolar" (BOLAR Exemption).
"Bolar exception" system is first produced in the United States，originated from the 1984 U.S. Roche Company to the BOLAR company's drug patent infringement case，Its basic spirit is，Actions to implement related patents in order to perform clinical experiments and registration for drugs and medical devices，Not regarded as infringing patent rights，Give infringement exemption。After that，The United States will extend Bolar exception to all medical products，Including human or animal medicine、Biological Products、Medical equipment and health products。Following the United States，Japan、Canada and other countries have clarified the rules of Bolar exceptions in its national patent Stake Sports Bettinglaw。stake betting appThe "Bolar Exception" system was introduced in the new "Administrative Measures for the Registration of Drug Registration", which my country implemented on October 1, 2007，Article 19 of this Measures make the applicant's regulations that the applicant can submit new drug registration applications 2 years before the expiration of patent rights。
Determination of "Bolar exception" in the new "Patent Law"，Not only is it conducive to my country's pharmaceutical companies to actively use the patented technology that is about to expire abroad，And provides clear legal provisions for legal issues such as "production and operation purposes" in the past。Chinese pharmaceutical companies should follow the development status of domestic and foreign diseases and the main direction of domestic pharmaceutical and health reforms，Make full use of the "Administrative Measures for Drug Registration" and various patented databases，Select the type of medicine or medical equipment suitable for its own development，Preparation for production of related products as soon as possible，Strive to push medicines or equipment with market prospects as soon as possible to the domestic market。
Confidential formula, etc. may become a confidential patent
Confidential patents originated from the middle of the eighteenth century。At that time，A number of patents such as rifle guns and rear guns applied by British weapon manufacturer Amsterrand are publicly disclosed，Paris、Police in Berlin and other places quickly used them on the weapon system，greatly improved method、The combat capability of both Germany。To maintain national security，The British Parliament passed the "Army Fire Invention Patent Act" in 1859，Proposed to keep some patented applications confidential，Don’t be disclosed in normal procedures，So as the first to introduce the administrative measure of confidentiality in the patent system。Subsequent，Most countries that implement the patented system resolve。The confidential patents mentioned in the original Patent Law in my country are also targeted at national defense patents，In the revision of the "Implementation Rules of Patent Law"，In Article 7, paragraph 2 specially increased the "State Council's patent administrative department believes that the invention or utility model patent application that it accepts involves national security or major interests other than national defense interests requires confidentiality，Decision to make a timely decision to process in accordance with a confidential patent application，and notify the applicant。Review of the application for confidential patent、Review and the special procedures for the invalidation of confidential patent rights，It is stipulated by the Patent Administration Department of the State Council "。
Chinese pharmaceutical companies should pay special Stake Sports Bettingattention My stake betting appto the statement of "involving major national interests"，If the original confidential patent is only staying on the paper，Now there are clear classifications，Involved in national defense interests、Visible national security、Three categories involved in major interests。The explanation involving major interests is flexible，That is to say，Like Yunnan Baiyao、Six Shen Wan and other previous confidential products belong to "involving major interests of the country"，You can apply for a national confidential patent，Some new discovery or innovative pharmaceutical products (including confidential formula and effective compound)，As long as the effect is precise、With special effects，All application objects for confidential patents。
In short，Chinese pharmaceutical companies should actively use the market opportunities brought by the new Patent Law，Make full use of relevant provisions in the patent law to formulate the company's market development ideas and intellectual property strategies。but，The law always has a double -edged sword，The new "Patent Law" is brought to the market opportunities of my country's pharmaceutical companies，It may also exacerbate the domestic drug market competition and bring more intellectual property disputes，At the same time, it will also stimulate foreign economic forces to formulate new restraint measures for my country's pharmaceutical industry，This may cause a new round of trade disputes。For these problems，The industry must also give full understanding and attention。
