Patent Protection On Invention Of New Medical Uses

With the long clinical application of medicines, new medical uses may be found in many known medicines. However, in many countries, medical approaches have been left out of the scope of patent protection for years. In order to protect the new uses invention of medicines, a Swiss has claimed the right for medical uses, which is the "Swiss-type-claim". Medical uses claims are divided into the first medical use claim and the second medical use claim (new medical uses claims). But there are a lot of controversies on the scope of patent protection for new medical uses at home and abroad, especially the controversy on the possibility to include the claim of "dosage regimen" into the patent protection. The dosage regimen claim is related to using characteristics like the change on dosing object, dosing method, dosing channel, dosage and dosing interval etc. Therefore, the controversy lies in whether the "dosage regimen" plays a defining role in medication or not.Centering on the issue of granting patent right to the invention of new medical uses, this paper first analyzes domestic and overseas legislation experience as well as the actual conditions in China and then give some suggestions based on the discussion of patent right claim of "dosage regimen"The paper is divided into three parts. Part I analyzes the basic theories for the invention of new medical uses. After illustrating the concept of new medical uses and its history and development, this part makes an analysis on whether the new medical uses patent meet the patent licensing requirement or not from the perspectives of novelty, inventive and activity. Then it discusses the public interests from accessibility of medicines to define the scope of protection for new medical uses patent, combining the characteristics of medicine invention.Part II contains the comparison on relevant laws and regulations between China and oversea advanced countries. Taking the laws and regulations in the USA and European countries as examples, this part illustrates the legislation evolution and current status for new application patent of medicines in above mentioned countries, in the hope of providing some reference to the institutional improvement on new usage patent of medicines in China.Part III puts forward some suggestions on institutional improvements on new medical uses patent. First is to grant the patent right legally and then is to define the scope of protection as well as the affirmation and exemption of infringement in accordance with the scope of protection. Finally, it also gives advices on the reasonable limitations on the patent right of new medical uses.This paper has made the analysis on the patent protection of new medical uses, adopting various research approaches. First, it uses case analyzes method via some typical data and cases to make a thorough and completion investigation and discussion. Second, it concluded the legislation experience home and abroad though method of comparative analysis and get some conclusion from pertinent literature, experience and disciplines to raise the suggestions of improvement on the basis of literature review.