1. Patent is to encourage, protect, use invention and creation, so as to stimulate the development of industries. This is the legislative purpose stipulated upon the first article of the Patent Act amended and promulgated on February 6, 2003, and as a result, the purpose of patent examination is to confirm whether the claimed invention has the value to be protected by a patent. Further, the important points of the examination are whether the claimed invention is industrially applicable, and is satisfied with the requirements for patentability including novelty and inventive step (see Article 22 of the Patent Act amended and promulgated on February 6, 2003), while examining whether the description has disclosed the invention in a manner that is clear and sufficient for the same to be understood and carried out by a person ordinarily skilled in the art, and whether claim(s) have defined the claimed invention, and whether each claim is disclosed in a clear and concise manner and is supported by the description (see Article 26, Paragraphs 2 and 3 of the aforesaid Act).

2. Regarding the patent application of the medicine-and-pharmacy-related invention, the specification must be provided with relevant experimental data and information, in order to evidence the effect of the claimed invention. However, neither the Patent Act nor the Patent Examination Guideline has stipulated any specific format or type of the experimental data. That is, there is no requirement for the applicant to submit any human clinical trial data, while other types of data, i.e. laboratorial in vitro test or animal test data, can also be adopted to evidence the effect of the invention, and which is determined under a case-by-case basis. In a usual prosecution for a patent application of the medicine-and-pharmacy-related invention, the applicant has to evidence merely that the claimed invention (such as a medicinal composition) has the claimed treating effect without further proof regarding the safety or side-effect of the medicinal composition. Only when the applicant asserts that the features of its invention are to enhance the safety or to decrease the side-effect, the examination will be covered for the very first time upon whether there is sufficient data to support its claimed effect.

3. The missions and responsibilities of the Taiwan Food and Drug Administration are “ the proposition and implementation of the administrating laws, regulations and policies of food, drugs, controlled drugs, medicinal equipment, cosmetics (hereafter referred as “products”), verification, examination, inspection and registration of the products, checking and consulting of the manufacturers’ producing process, scientific and technical development and inspective research of the products, risk evaluation and risk administration of the products, product security watch, investigation and resolution of hazardous incidents, and promotion of consumer protective measures.” Further, the objective for examination, inspection and registration of the drugs is to identify and confirm the quality, safety and curative effect of the drugs based upon scientific evidence, in order to protect and secure the health of our fellow countrymen; furthermore, the examining items for a new drug include toxicological and pharmacological tests, pharmacokinetics, clinical trial, chemical manufacture control, labelled container and instruction leaflet…etc., while a generic drug is allowed to conduct a bioequivalence test instead of clinical and non-clinical trials, whereas patent-related issues are neither the purposes nor the importance for examination, inspection and registration of the drugs. Accordingly, the examining items for a new drug include toxicological and pharmacological tests, pharmacokinetics, clinical trial, chemical manufacture control, labelled container and instruction leaflet…etc., whereas whether the requirements for patentability are satisfied is neither the purpose nor the emphasis for examination, inspection and registration of the drugs; on the contrary, the quality and safety of the drugs are not the objectives for patent examination, and the examining items for a new drug, such as toxicological and pharmacological tests, pharmacokinetics, clinical trial, chemical manufacture control, labelled container and instruction leaflet…etc. are neither necessary subjects for patent examination. Therefore, the purpose and the emphasis for patent examination and for examination, inspection and registration of the drugs are totally different, and an invention that is filed as a patent application will be allowed with a patent as long as the requirements of the Patent Act are satisfied and the invention is worth to be protected by a patent, whereas whether the invention is proved to be held with quality, safety and curative effect so as to be able to protect and secure our fellow countrymen is neither the subjective of the patent examination, nor involved with any process for distribution permit of a drug. In other words, a patented drug is not thereby necessarily able to be approved through drug inspection and registration for a distribution permit to sell the drug in the market accordingly, and allowance for a patent is neither a prerequisite for a drug to be granted with a distribution or manufacture permit. As a result, there is no necessary relevancy between patent allowance and drug distribution permit.