Discussion on the compulsory license of drug patent from Gilead's response to the patent dispute of Ridgeway

China's novel coronavirus global CEO Daniel O Day responded to the patent dispute in the vortex in February 4th when a public declaration of the Wuhan virus declared the invention patent of China (the use of 2019 new coronavirus) was anti - Day A female participant asked Daniel O'Day how Geely would respond to the patent application of Wuhan virus Institute after it was reported that China's Wuhan virus Institute had applied for Ridgeway's patent to China's patent agency If China's patent agency approved the application, how would Geely protect its rights and interests? Daniel O'Day replied: I just heard about this last night (Wuhan Virus Research Institute rush injection in China) Now we are pushing forward the clinical trial of this medicine at the fastest speed Here I want to say very clearly to you that this matter does not affect our efforts for World Health and health at all Our responsibility is to be responsible for the patients First, we need to determine the medical steps , based on science and clinical to prove whether the drug is effective for patients, but also to speed up the production of the drug, in case it is proved effective, it can be provided to patients all over the world as much as possible As for novel coronavirus pneumonia, we will not consider it now I just said that, like any other medicine, patents are not only chemical, but also all the methods of use, including new crown pneumonia virus This medicine is also applicable to all parts of the world, but we will not go to the patent right now, we will always find ways to help patients Of course, we will take independent steps to protect our intellectual property, but now we put patients first Judging from this passage, Gilead expresses humanitarianism and takes patients as the priority But novel coronavirus pneumonia is worth noting: two, 1, gilid said they had a very perfect patent protection "All the methods used include new crown pneumonia virus, which is also applicable to all parts of the world", not worried about patent disputes 2 "As for patents, we don't think about it now," gillid said, "of course protecting our intellectual property as an independent step." Geely will not consider it now, but it does not mean it will not consider it in the future, and will take independent steps to protect Geely's intellectual property Analyzing Geely's patents, we can see that Geely has a complete global patent protection for compounds Gilead company has applied for PCT patent for similar drugs and treatment methods for virus of ridcivir for global patent layout The PCT patent PCT / us2011 / 045102 was applied on July 22, 2011, with 57 patent applications of the same family, The patent cn2011800357761 "methods and compounds for the treatment of Paramyxoviridae virus infection", which entered the national stage in China, was authorized on November 25, 2015 At present, the patent is in an effective state The compound structure of the patent is written by Markush, which has a wide range of protection, and has a relatively high-level summary on the therapeutic use Claim 21 is the molecular structure of the protected radcivir The patent protects compounds and therapeutic uses, and belongs to basic patent and core patent In addition, Gilead has applied for a patent for the use of ridcivir in the treatment of coronavirus The patent application number is cn2016800667968, and the invention name is: a method for the treatment of virus infection in the family sandiviridae and coronaviridae The current legal status of the patent application is waiting for the actual examination proposal The case entered the stage of substantive examination on August 8, 2018, and has not received the notice of examination opinion or been authorized Novel coronavirus was reported in January 21st by the Wuhan Institute of viruses in China, according to the information released by the Wuhan Institute of virus in February 4th For the analysis of the possibility of Wuhan virus applying for the patent license, please refer to another article published by the author, "can Wuhan virus apply for the patent for anti new coronavirus use successfully?"? " The author believes that if there is no effective comparative experimental data to prove the unexpected technical effect, it is likely that radcivir's anti coronavirus patent applied for by Wuhan virus will not be granted due to its lack of creativity Wuhan virus institute can also use the priority to supplement the relevant comparative test data within one year from the application date to prove the unexpected technical effect So the question is, if the patent applied for by Wuhan virus is finally authorized, does it mean that Wuhan virus institute can independently use the indication patent of new coronavirus without the consent of geelide company? The answer is no, because Gilead already has patents for compounds and therapeutic uses, which are basic patents and core patents Wuhan's anti new coronavirus patents are peripheral patents at most if they can be authorized To implement this patent, we must obtain the license from Geely, because this patent is not independent, and we need to rely on the license of the basic patent to implement it In the future, if the compound is to be used commercially for the new crown virus indication, it may involve cross licensing between the two parties, that is, Wuhan needs to use the compound patent under the license of Geely De, while Geely De needs to use the new crown virus indication patent under the license of Wuhan, and pay the patent license fee to each other This raises a related question, that is, under the current epidemic situation, whether it is necessary to consider compulsory licensing of Geely's related patents? Next, let's talk about compulsory patent licensing from the new crown candidate Ridgeway 1、 Introduction of compulsory license system of drug patent Compulsory license of drug patent is a component of the system of compulsory license of patent, which takes drugs as the object of license In our country, compulsory license of drug patent is defined as: for the purpose of public health, the patent administration department under the State Council can manufacture and export the drugs with patent right to eligible countries or regions To understand the compulsory licensing system of drug patents, we need to make clear several definitions First of all, what are the drugs? The definition of drugs used in drug patents: "drugs refer to substances used to prevent, treat and diagnose human diseases, purposely regulate human physiological functions and specify indications or functions, usage and dosage, including Chinese herbal medicines, Chinese herbal pieces, Chinese patent medicines, chemical APIs and their preparations, antibiotics, biochemical drugs, radioactive drugs, serum, vaccines, blood Liquid products and diagnostic drugs, etc It is worth noting that on February 1, 2019, the decision of the State Council on Amending the detailed rules for the implementation of the patent law of the people's Republic of China (hereinafter referred to as the "decision") came into effect, in which the "patented drugs" were defined as "medicines needed to solve public health problems" Any patented product in the field or the product obtained directly according to the patented method ", including the active ingredients required for the manufacture of the product and the diagnostic articles required for the use of the product which have obtained the patent right This modification means that non-traditional concepts such as drug intermediates and test kits are included in the licensing object of the compulsory licensing system of drug patents Secondly, we should understand the boundary of the exercise of rights, that is, under what circumstances the compulsory license of drug patents can be implemented Article 49 of the patent law stipulates that in case of a state of emergency or emergency, or for the purpose of public interest, the patent administration department under the State Council may grant a compulsory license for the exploitation of a patent for invention or utility model Article 50 for the purpose of public health, the patent administration department under the State Council may grant a compulsory license to manufacture and export the patented drugs to countries or regions that conform to the provisions of the relevant international treaties to which the people's Republic of China is a party It is also worth noting that in order to meet the needs of responding to the public health crisis, the compulsory licensing system has been revised since February 1, 2019 with the implementation of the decision: The condition of "underexploitation of patent" for compulsory license is defined as the situation that the mode or scale of patent exploitation by the patentee and its licensee can not meet the domestic demand for patented products or methods Finally, the relevant law and how to implement and the consequences Articles 55, 56 and 57 of the patent law and articles 74 and 75 of the detailed rules for the implementation of the patent law have relevant provisions In summary, before applying for compulsory license, the applicant should consult with the patentee to obtain voluntary license as much as possible After the decision to grant a compulsory license for exploitation of a patent is made, it shall be registered and announced to limit the scope and time of the license, and a decision to terminate the compulsory license for exploitation shall be made after the reasons are eliminated The units and individuals who have obtained the compulsory license for implementation shall not have the exclusive right to implement, and shall not have the right to allow others to implement, and shall be paid to use Article 31 of TRIPS agreement stipulates that all countries can grant compulsory license for "no implementation", "public health", "national security", "dependent patent" anti competition "and other reasons In addition, it should be noted that both TRIPS Agreement and patent law of other countries emphasize that before applying for compulsory license, the applicant should negotiate reasonably with the patentee to obtain voluntary license, which is not only a procedural issue 2、 The classic case of patent compulsory license (India granted the first compulsory license of drug patent) China has never implemented the compulsory license of drug patent so far But China's neighbor, India, the same populous country, once granted the first compulsory license for drug patents in 2012 The author introduces the case in detail 1 Background: Bayer company has the patent right of sorafenib Sorafenib is used to treat renal cancer and liver cancer Although it can not cure the patients completely, its use can prolong the life of patients with advanced liver cancer and kidney cancer Bayer launched its products around the world in 2006 under the trade name of Nexavar, received a license to import and sell the drug in India in 2007, and launched the product in India in 2008 In the same year, Bayer's solafeni was patented in India (No 215758) Dojme's sales in India remain at about 200 doses per month The cost of taking dojme for a month in India is about $5600, which is equivalent to the wage of the lowest wage worker in India for three and a half years NATCO is an Indian generic manufacturer According to NATCO, there are at least 100000 patients with different types of renal cancer and liver cancer in India In addition, 30000 new patients are diagnosed with these two diseases every year, and nearly 24000 patients die Bayer supplies only 2% of India's patients with kidney and liver cancer For this reason, NATCO has developed the process needed to manufacture solafeni, required and obtained the license of the pharmaceutical regulatory department for the production of generic drugs, and requested Bayer to grant the voluntary license, which Bayer refused to grant So NATCO applied for a compulsory license 2 Article 84 (1) of the Indian patent law stipulates that: anyone can apply for compulsory patent license after 3 years from the date of patent authorization: ① the public's reasonable requirements for the patented invention have not been met; ② the public cannot obtain the patented invention at a reasonable and affordable price; ③ the granted patent