According to the forecast of China Medical Industry Information Center, the market capacity of medical medical equipment in China will exceed 600 billion yuan in 2019. Under the huge market space, many emerging enterprises have implemented patent infringement under the pretext of “deep research and study out of the road of self-innovationâ€, and intellectual property disputes have become more and more intensive.
As early as 2011, there was a dispute between Mindray and Visa, which launched an intellectual property war. In 2016, eight domestic medical device companies were accused of intellectual property infringement in the United States; Siemens (Shenzhen) VS Shanhai Lian Ying patent application rights Disputes; Shanghai Minimally Invasive Medical Devices and Shanghai New Pulse Medical Technology Co., Ltd. have patent disputes.
Patent holders are frequently infringed
Recently, the holding subsidiary of Inner Mongolia Furui Medical Technology Co., Ltd. (hereinafter referred to as Furui Co., Ltd.) sued Wuxi Hais Kaile Medical Device Medical Technology Co., Ltd. (hereinafter referred to as Haisker) for more patents. .
According to public information, France's Echosens, a subsidiary of Furui Co., Ltd., has the world's first quantitative diagnostic technology for liver stiffness and elastic deformation of liver. 2001 launched the world's first liver fiber non-invasive detection instrument FibroScan. In 2003, FibroScan obtained EU certification and quality certificate. After being listed in Europe in 2005, it obtained the recommendation of various academic circles in the world and the FDA certification. It enjoys a high reputation in the industry and was rated as “Twenty Medical Change Medicinesâ€. One of the breakthroughs in biotechnology.
The product, after entering China, faced an unprecedented intellectual property challenge. The "FibroTouch" liver fibrosis test product launched by a company called Wuxi Haiskel is similar to the "FibroScan" trademark first applied in China, and the core patent technology of FibroScan is applied. For four or five years, the two sides have mutually prosecuted each other's patents, trademark infringement or invalidation, and there have been more than 20 disputes involving the lawsuit.
Since the medical device industry is multidisciplinary and involves a wide range of professional and technical rules, the case has attracted a lot of attention in various subject areas. What are the reasons for such frequent litigation disputes and lengthy trials?
The infringed enterprise faces the problem of proof
Speaking of the difficulty of the case, Professor Xiao Peng of China University of Political Science and Law believes that the combination of software and hardware of medical devices and numerous patent rules have certain problems.
He believes that many cases of intellectual property disputes are difficult to prove because a large amount of infringement evidence is generally only available to the infringed person. When the patent holder is required to prove the infringement of the other party, he often encounters a large difficulty in proof. In the process of judicial practice from legislation to trial, we need to consider how to identify evidence, preserve evidence, reasonably distribute the burden of proof, and implement the system of burden of proof transfer and evidence discovery.
In fact, the state has policies to encourage the protection of pharmaceutical and medical device innovators, and there is also a comprehensive system of solicitation of opinions. However, the work of intellectual property protection in the field of medical and medical equipment needs to be strengthened and improved. In this regard, Wang Jian, a researcher and medical device evaluation expert at the China Food and Drug Administration Institute, also said that the staff involved in the review of drug medical device registration applications and the staff involved in the verification, inspection and supervision, submitted technical secrets and experiments to the applicants. The data is confidential and the person responsible for breach of confidentiality is handled by the medical device, the competent department, relevant laws and regulations, and disclosed to the public.
Wang Jian also believes that Wuxi Haisker's FibroTouch equipment belongs to the second category of medical equipment but involves high-level infringement disputes. The supervision of Class II medical devices also needs to be increased.
Medical equipment private 4G card is suspected of breaking the law
An important message disclosed in the judgment of this case is that Wuxi Haisker's FibroTouch equipment not only infringes patent rights, but also has the behavior of privately installing 4G network cards.
It is recognized in the industry that if the user information and doctor's habits can be obtained through the product, the equipment manufacturer can be easily improved, and the product and the new industry can be redeveloped according to the patient's characteristics and detection conditions. Industry, patients, and doctors are good things and win-win situations. But if companies use private installations and secrets, they will turn good things into bad things.
When the company conceals the 4G card from the hospital and the doctor of the device user, if the patient's sensitive information leaks, the person responsible for the violation is likely to be the hospital and the doctor. The information is collected without the knowledge of the patient, which is more serious than the infringement of intellectual property rights. It is considered as stealing, and stealing the patient's medical information is a great violation of the patient's rights.
The "Network Security Law of the People's Republic of China" enacted by the Standing Committee of the National People's Congress was officially implemented on June 1, 2017. Article 44 clearly states: "No individual or organization may steal or otherwise obtain an individual. Information may not be illegally sold or illegally provided to others with personal information." This is the fundamental guarantee for the security rights of personal information from the legal point of view.
In order to strengthen the platform of medical and health institutions' Internet medical services, smart medical equipment, and security protection of key information infrastructure and data applications, the State Administration of Markets Supervision (formerly the State Food and Drug Administration) began to implement the "January 1, 2018" Guidelines for the Technical Review of Medical Device Network Security Registration. It is clearly pointed out that the problem of medical device network security may not only infringe the privacy of patients, but also may cause the risk of unintended operation of medical devices, resulting in injury or death of patients and users. Therefore, medical device network security is an important part of the safety and effectiveness of medical devices, and is also one of the components of national network security.
In April 2018, the National Health and Health Commission issued the "Guiding Opinions on Promoting the Development of "Internet + Medical Health", which also gave detailed and strict regulations on the security protection of medical health data.
Under the background of the relevant national ministries and commissions, and the introduction of relevant laws, Wuxi Haiskel is still doing its own thing. This is not only a deception and irresponsibility for business partners, but also if there is a personal information collection and transfer behavior of patients. May be suspected of illegal activities.
National respect for intellectual property
Secretary-General of the China Patent Protection Association, He Xuwen, Secretary-General believes that the technical quality of the patented technology held by Furui and its subsidiaries, the patent characteristics of patents for legal rights protection, and the social benefits generated by patents are very high. It is also the root cause of the case that can still win in the case of complicated evidence and various comprehensive and difficult cases. For enterprises, we should do more analysis and early warning work, and use more open thinking to truly achieve the maximum social benefits.
Secretary-General He Xuwen also made it clear that the Chinese government advocates that intellectual property protection is treated equally internally and externally. There is no difference. We should respect the intellectual property rights of all countries. In this case, we saw that the court's decision not only protected the legal rights of a foreign company, but also protected the legal rights of Furui shares and many Chinese investors, reflecting the true value of intellectual property protection.
Talking about respecting intellectual property rights, the president of the Intellectual Property College of Renmin University of China, Liu Chuntian, also quite agrees. He said that the important aspect of enterprise modernization is the change of ideas, which requires respect for labor, respect for talents, respect for knowledge, and respect for creation. At the same time, we must follow the spirit of honesty and trustworthiness and the spirit of the legal system. Every case has the joint efforts of enterprises, courts and lawyers. When the resultant force is formed, it is to contribute fairness and justice to society.
It can be said that the constant disputes over intellectual property rights lie in the fact that many enterprises use labor thinking to look at innovation and believe that labor can cover innovation. When the intellectual property awareness of the whole society in China is improved and the system is sound, such legal gaps will eventually be punished by law.
The so-called innovation that comes from plagiarism will never become a true innovation. Our innovation should not be in the gray area, nor can we regard the violation of the rights of others as the only way to overtake the corner.
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