摘要
Abstract
As patent protection periods approach their end,a large number of generic veterinary and agricultural drugs in China face patent infringement risks when implementing patents for administrative approval purposes.Resolving the infringement dilemma for non-human drug market entry has become a practical need and key adjustment direction in the current drug patent system.Looking at the establishment and evolution of the Bolar exemption system in the United States,it has undergone multiple expansions over the past 40 years in response to industry changes to achieve a balance of interests among generic drug companies,original drug companies,and the public.However,there are theoretical and institutional gaps regarding whether China's Bolar exemption system can be expanded to non-human drug fields,the methods of expansion,expansion limits,and the principles and restrictive standards that should be followed,all of which require systematic research.Through in-depth analysis,it's clear that expanding the Bolar exemption system to non-human drug fields has both theoretical legitimacy and practical feasibility.Regarding legitimacy,first,this expansion aligns with industrial policy orientation.The Bolar exemption,which developed from experimental use patent exemptions,has followed industry changes in its creation and development.By including patent implementation activities related to veterinary and agricultural drug administrative approval within the safe harbor scope,it can promote the timely market entry of generic veterinary and agricultural drugs in China and optimize the current industrial structure.Second,it helps improve the accessibility of healthy food.Under the food safety strategy background,the Bolar exemption,as a patent policy regulation tool with public policy attributes,can effectively regulate excessive monopolies of veterinary and agricultural drug patents and coordinate the tension between patent holders and public interests regarding healthy food accessibility.Furthermore,from an international rules perspective,this expansion complies with international law.The veterinary and agricultural drug Bolar exemption meets the three-step test criteria specified in Article 30 of the TRIPS Agreement,making it a compliant adjustment under the international treaty framework.Regarding expansion limits,first,from an institutional perspective,the Bolar exemption has independent institutional value and should not be conflated with patent-term compensation systems.Original drug companies often equate the two citing interest balance,but this deceptively apparent balance usually masks appeals for their interests.Second,from an object perspective,based on the comparative advantages of industrial policy theory,expansion in the veterinary and agricultural drug field should be limited to chemical drugs with current industrial market entry demands and should not prematurely extend to veterinary and agricultural biologics to avoid misallocation of basic resources and failures in medical patent policy due to institutional adjustment biases.Regarding specific implementation paths,considering China's current Bolar exemption system status,comparative analysis results from other jurisdictions,and the timing cycles of previous Patent Law amendments in China,a two-step approach is recommended for expanding its application to non-human drug fields.The first phase would draw from the U.S.judicial exemption model to achieve transitional judicial expansion before Patent Law amendments.The second phase would formally incorporate non-human drugs into the Bolar exemption's legal framework during the fifth amendment of the Patent Law,promoting the formation of a competitive advantage in China's generic veterinary and agricultural drug industry through a stable institutional system.关键词
Bolar例外/非人用药/产业政策/制度扩张/竞争格局Key words
Bolar exemption/non-human drug/industrial policy/institutional expansion/competitive landscape分类
社会科学
