A patent challenge makes the domestic gout generic "run" for ten years

Recently, the State Intellectual Property Office issued the decision on the examination of the request for invalidation Jiangsu Zhiyuan Pharmaceutical Co., Ltd (hereinafter referred to as Zhiyuan pharmaceutical) and Nanjing Huawei Pharmaceutical Technology Group Co., Ltd jointly acted as the petitioner for invalidation, making the patent right of "Topaz crystal type patent" held by Fuji Pharmaceutical Co., Ltd (hereinafter referred to as Fuji pharmaceutical) in China officially invalid Fu Jie, vice president of research and development of Zhiyuan pharmaceutical industry, said: "this battle has been won, and the domestic imitation drug tuoyisite tablet is expected to go on the market 10 years in advance!" The patent minefield gout and hyperuricemia are the fourth high disease after hyperglycemia, hyperlipidemia and hypertension According to statistics, the incidence rate of hyperuricemia in China is 10%, and over 80 million patients have been gout This disease has become the second largest metabolic disease in China But unfortunately, at present, there are not many kinds of anti gout drugs in China, and there are few drugs to choose The main clinical treatments were colchicine, non steroidal anti-inflammatory drugs, hormones, drugs to promote the excretion of uric acid and drugs to inhibit the synthesis of uric acid Among the anti gout drugs, topilast is a unique one In 2013, the drug was approved for production and sale in Japan, and it is a mild, safe and efficient specific drug for reducing uric acid Unfortunately, however, the drug has not yet been launched in China However, Fuji pharmaceutical, the manufacturer of the drug, has long applied for a patent for topiramate in China According to experts, Fuji pharmaceutical has set up two patent minefields around Topaz tablets, one is compound patent, which expires in 2022, while the most critical crystal patent will not expire until 2033 This is the "patent network" strategy often used by international pharmaceutical companies, which aims to extend the patent protection period of drugs as much as possible to obtain high profits This also means that if Chinese pharmaceutical companies want to copy tropist tablets, they must wait until 2033 Bao Fengqi, head of Zhiyuan pharmaceutical R & D department, told SciTech daily that before 2033, gout patients in China could only eat imported drugs with high prices As early as 2014, Zhiyuan pharmaceutical industry began to launch the development of domestic generic topilast tablets In the face of the daunting patent minefield, their original idea was to take a detour "But it soon became clear that there was no way around it." Bao said "The generic drugs should be consistent with the original research drugs to achieve equivalence If different crystal forms are used on the basis of the same compound composition, the solubility of the drugs will not meet the requirements, which will affect the absorption of patients, and will not be consistent with the efficacy of the original research drugs." Bao Fengqi said that in order to make the domestic good drugs listed earlier, there is only one choice left for Zhiyuan pharmaceutical industry at the moment, to launch patent challenges and win development space The so-called "patent challenge" refers to the challenge of patents by private pharmaceutical enterprises to make generic drugs legally listed, break the market monopoly of original drugs, and reduce the price of drugs Zhang Qian, deputy director of respiratory department of Changzhou Second People's Hospital, said The reporter learned that as early as 2001, domestic enterprises launched patent challenges against Pfizer's drug "Viagra" After several years of Marathon sawing, they finally failed Of course, at present, there are also cases of Zhengda Tianqing and other companies' patent successfully challenging international pharmaceutical enterprises, but for Zhiyuan pharmaceutical, a private small and medium-sized pharmaceutical enterprise, it is a rare case to launch a patent challenge to multinational pharmaceutical enterprises In the words of Fu Jie, "an invention patent is examined and authorized by the patent office It is even more difficult to" invalidate "it in turn Either a new reference document is retrieved or the examiner's error in applying the law is found For example, a patent has been authorized in more than a dozen countries and has been recognized by examiners of patent offices of many countries, which shows that everyone thinks that it has no substantive defects Now it's hard to overturn the opinions of so many technical and legal experts " In order to fight this war, Fu Jie and his colleagues have worked hard for more than four years Through thousands of experiments and sleepless nights in the laboratory, they finally found that there was a fatal defect in the patent protection of Japanese pharmaceutical companies Although it was a "small gap", it made the crystal type patent for the whole patent "survival" lose its originality in the strict sense Later, it turned out that this was the most critical evidence point in the whole process of patent challenge However, unlike the frequent court battles in movies, the essence of patent challenges is to use detailed data and rigorous argumentation to unlock the patent chain of the other party and perfectly transform technical language into legal language For this reason, Zhiyuan pharmaceutical specially employs patent lawyers with rich experience to cooperate with the technical team However, Fuji pharmaceutical also has an extremely rich experience in patent protection Fuji pharmaceutical hired a lawyer, who was the agent of the patent at that time, who is far more familiar with the patent of TOPEX The pharmaceutical companies of both sides started a game of equal strength On February 11, 2018, Zhiyuan pharmaceutical filed a request for invalidation to the Patent Reexamination Board On August 27, 2018, the first oral hearing of the case was held, and on February 18, 2019, the second oral hearing was held It seems like a placid event, but behind it is Zhiyuan pharmaceutical team's polishing of the legal text again and again "Despite the difficulty, we are more and more confident and waiting for the victory time." Bao said Opening a new window in drug research and development "victory always belongs to those who persist to the end." "In fact, around 2014, there were more than 20 domestic pharmaceutical companies that imitated topiramate tablets, but most of them gave up at last," Fu Jie said "This success also opened a window for our company's drug R & D application The mystery of patent challenge has been revealed If patent issues are involved in the process of product development, I believe we can face them bravely We are not afraid of the original R & D company, but dare to continue to challenge." Fu Jie said Tang Xiaofeng, general manager of Beijing Jichi Intellectual Property Agency Co., Ltd., who has been engaged in patent litigation for a long time, said that many countries in the United States, Japan and Europe have patent challenge systems, which are allowed by national laws, supported by policies and relied on the deep understanding and application of patent technology and laws by invalid claimants Experts pointed out that enterprises should also pay attention to that before the patent challenge, they should ask professional patent agents to do a good job in patent legal research and analysis, otherwise, there is a great possibility of losing the lawsuit Although the battle was won, Fu Jie raised another question in the interview: in the pharmaceutical markets such as Europe, the United States and Japan, once the patent of innovative drugs expires, there are bound to be successful patent challengers who urge them to reduce their prices But at present, many multinational pharmaceutical companies in China, although their products have passed the patent period, are still able to be popular at a high price, resulting in a different picture from other foreign markets in drug use and patient satisfaction Experts said that in the United States, there has always been a concept of "first imitation", which means the first generic drug to be submitted and killed in the patent challenge, and finally approved as the first one to be listed The biggest advantage of first generic drugs is that they can get a 180 day "first generic exclusive period", during which the U.S Food and Drug Administration (FDA) will not approve applications for other generic drugs, and these 180 days often benefit the first generic companies "But in China, the system is still" missing, "Tang said "As a large number of patents of foreign pharmaceutical enterprises are about to expire, there may be new opportunities for Chinese enterprises with R & D strength We should check our own R & D pipeline to determine which patent challenged products to accelerate R & D And if there are some institutional incentives, I believe that the incentive effect on Chinese pharmaceutical enterprises, especially small and medium-sized enterprises should be great " Fu said.