湖北省医疗器械专利转化中的制约因素分析

Analysis of constraint factors in the patent transformation of medical devices in Hubei Province

目的了解医疗器械专利转化过程中存在的困扰因素。方法2019年3~7月对5个学术团体及4家企业的专利持有人、专利转化企业(包括孵化企业)技术骨干及投资基金从业人员发放调查问卷。调查影响医疗器械专利转化中涉及的转化平台及技术、单位转化环境、专利产品注册证的获取难度、资金情况、销售渠道等因素,整理数据得到提问大纲。根据判断抽样法选取以上3类人群中31名进行访谈,通过专利转化流程顺序和力场分析法进行分析。结果发放调查问卷共计170份,收到有效答卷158份。问题较集中在专利年费高、获取专利产品注册证难、资金匮乏、缺转化条件、销售不畅等。认为专利维护费用高15名,缺少转化平台与技术15名,打击仿冒产品不力8名,产品未纳入医保5名,优质专利署名变更5名,产品生产资质获取耗时长、费用高4名,早期参与的基金抽离4名。结论医疗器械专利的成功转化,需要在提高专利质量的同时借助发达国家的经验,推出利于转化的各项政策。

Objective To analysis the constraint factors in the process of patent transformation of medical devices.Methods From March to July 2019,questionnaires were issued to patent holders,technical backbone of patent transformation enterprises(including incubation enterprises)and investment fund practitioners in 5 academic groups and 4 enterprises.The factors affecting the transformation platform and technology involved in the patent transformation of medical devices,the unit transformation environment,the difficulty of obtaining the patent product registration certificate,the capital situation,and the sales channels were investigated,and the data were sorted out to get the question outline.According to the judgment sampling method,31 people from the above three categories were selected for interview,and the sequence of patent transformation process and force field analysis were used for analysis.Results A total of 170 questionnaires were issued and 158 valid answers were received.The problem focuses on high annual patent fee,difficulty in obtaining patent product registration certificate,lack of funds;lack of conversion conditions,poor sales,etc.Fifteen persons think the patent maintenance cost is higher,15 persons lack of conversion platform and technology,8 persons failing to crack down on counterfeit products,5 persons whose products are not covered by the insurance,5 persons with signature change of high quality patent,4 persons with long time and high cost to obtain product production qualification,4 people early participation in the fund withdrew.Conclusion For the successful transformation of medical device patents,it is necessary to improve the quality of patents and introduce various policies conducive to the transformation based on the experience of developed countries.