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The medical device industry is under special care

scanning: author: from: time:2020-11-03 classify:Industry news

The medical device industry is "cared for"

Core reminder: China will make heavy efforts to rectify the “patent hooliganism” of technology-intensive enterprises. "Economic Information Daily" reporter learned on the 3rd that the National Development and Reform Commission's Price Supervision, Inspection and Antimonopoly Bureau organized a preparatory meeting to formally initiate the research and drafting of the "Guidelines for the Abuse of Intellectual Property Anti-monopoly Regulations" (hereinafter referred to as "Guidelines"). Experts said that the drafting and promulgation of the "Guide" will have a substantial impact on the exercise of intellectual property rights in the fields of information and communications, medicine, and medical devices, as well as the sales of products and services.

 


The medical device industry is "cared for"

 
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  It is reported that the "Guide" will refine the relevant provisions of the "Anti-Monopoly Law" with regard to monopoly agreements, abuse of market dominance, and operator concentration related to intellectual property rights, and in particular, give specific guidelines on the circumstances under which exemptions can be claimed.

The reporter learned that technology-intensive industries such as information and communications, medicine, medical equipment, automobiles, agricultural machinery, and seed industries are areas of high incidence of monopoly in the field of intellectual property rights. The "IDC case" and "Qualcomm [weibo] case" sponsored by the National Development and Reform Commission As well as the SAIC’s anti-monopoly investigations of Microsoft are concerned about the abuse of intellectual property rights, it has become a trend to implement stronger anti-monopoly enforcement against these industries.

"Although patent rights have a tremendous role in promoting the prosperity and development of technology, if they are allowed to become a tool for right holders to grab monopoly benefits, then the so-called'patent cockroaches' or'patent hooligans' will become rampant in the world. A stumbling block to technological progress and industrial development.

   At the same time, improper or excessive anti-monopoly enforcement may also crack down on innovation and lead to insufficient research and development. "An official from the Price Supervision Bureau of the Development and Reform Commission pointed out that for anti-monopoly law enforcement in the field of intellectual property rights, maintaining a balance between intellectual property rights and anti-monopoly is the key point.

   In April this year, the State Administration for Industry and Commerce promulgated the "Regulations on the Prohibition of Abuse of Intellectual Property Rights to Exclude and Restrict Competition", which stipulates non-price monopoly agreements and abuse of dominant market positions constituted by the exercise of intellectual property rights.

Professor Shi Jianzhong of China University of Political Science and Law pointed out that the "Guide" drafted by the National Development and Reform Commission is expected to detail the three major monopolistic behaviors related to intellectual property rights, including price and non-price monopoly agreements, abuse of market dominance, and concentration of operators. In particular, the circumstances under which exemptions can be claimed in accordance with Article 15 of the Anti-Monopoly Law, and which circumstances may be deemed to have “justified reasons” required by Article 17 are given specific guidelines, so as to reduce the number of law enforcement agencies. Discretionary space, reducing corporate compliance costs and other purposes.

   Based on the local and borrowing from other countries

   It is understood that in terms of working procedures, the National Development and Reform Commission will entrust relevant parties to carry out targeted research on the subject and form a preliminary draft on this basis. After that, the Development and Reform Commission will extensively solicit opinions from relevant parties, form a mature draft based on full research and demonstration, and solicit public opinions in accordance with legal procedures. After discussion and approval, it will be issued by the Anti-Monopoly Committee of the State Council.

Regarding how the "Guide" should be drafted, Lu Yanchun, deputy director of the Price Supervision, Inspection and Anti-Monopoly Bureau of the National Development and Reform Commission, said that four relationships must be handled properly: the relationship between being based on the local area and learning from the world's advanced experience, the relationship between the certainty of rules and the flexibility of the system, The relationship between problem orientation and moderate forward-looking, the relationship between comprehensive improvement of rules and choice, etc.

Regarding how to deal with the relationship between being local and learning from the world's advanced experience, Su Hua, an associate researcher at the Institute of American Studies of the Chinese Academy of Social Sciences, said that the United States and Europe have implemented antitrust laws for many years. When regulating abuses of intellectual property rights to restrict competition, the United States applies the principle of reasonableness. The prohibition and exemption model applied by the European Union has been continuously revised and developed in practice, which is worthy of China's reference.

   For example, in my country, Qualcomm's anti-monopoly investigation ended with a fine of 6.088 billion yuan from the National Development and Reform Commission and Qualcomm's implementation of a package of rectification measures. But Qualcomm is currently facing antitrust investigations from the European Union, the United States, South Korea and other countries and regions. In recent years, the EU has gradually increased its antitrust review of high-tech companies such as Qualcomm, Apple and Google.

   Qualcomm said in a document submitted to regulatory authorities in April that the European Commission notified it in October last year that it was investigating how Qualcomm sells and promotes chip products, as well as discounts and other financial incentives offered to customers. In May, the European Commission issued a questionnaire to Qualcomm's competitors, asking how Qualcomm's business methods and patent licensing methods have affected these companies.

   On April 28, the Korean Fair Trade Commission disclosed that it was investigating Oracle [Weibo] in the United States to find out whether the company’s practice of bundling new software in maintenance service contracts is anti-competitive. South Korean regulators pointed out that Oracle also requires customers to pay maintenance service fees for all Oracle software in use, instead of letting customers choose which software maintenance service they want.

   At the same time, antitrust private litigation is also worthy of attention. On May 7, the California High Court overturned the lower court’s decision to dismiss the prosecution and restarted the class action proceedings regarding the reverse payment agreement reached by the German pharmaceutical giant Bayer for its Cipro antibiotic drug. The agreement stipulates that Bayer will pay Barr Laboratories US$398 million, and Barr Laboratories agreed to postpone the introduction of its Cipro generic drug.

  According to a judgment of the U.S. Supreme Court in 2013, the reverse payment agreement between the original research drug and the generic drug company to settle patent litigation may violate antitrust laws. The court stated that the plaintiff US Consumer Group must prove that the reverse payment agreement is not only to avoid the cost of patent litigation between Bayer and Barr, but to delay the entry of generic drugs into the market.

   The reporter learned that the “patent hooliganism” of the above-mentioned multinational companies is also partly similar in China. For example, in terms of the abuse of patent rights, there have recently been reports of suspected monopolistic behavior of patented drug pricing and patent claiming entities in the telecommunications industry. In this regard, relevant departments are conducting research.