Taiwan Intellectual Property Office (TIPO) promulgated on June 3, 2009 “Examination Guidelines for Medicinal Inventions” under “Section 2 of Substantive Examination on Invention Patent” and the same guidelines took effect from the same date. Thus the medicinal invention applications will be examined by TIPO per the new guidelines as from this date.
The highlights of the said examination guidelines are summarized as follows:
This chapter mainly regulates the special judgment and handling in examining patent application relating to medicinal inventions. As to the general requirements (such as novelty, inventive step and industrial applicability) in common with other fields, they should be referred to the General Principles as provided under Chapters 1 to 8 of the same Guidelines.
“Statutorily unpatentable subject matters” as referred to in the medicinal inventions, the unpatentable “diagnostic, therapeutic or surgical operation methods for the treatment of humans or animals” are explained, respectively, under the Guidelines as follows:
- “Diagnostic methods for the treatment of diseases in humans or animals” must simultaneously include the following three conditions:
- 1) using a living human or animal as a target;
- 2) diagnosis of disease; and
- 3) acquiring the diagnostic results of disease as a direct purpose;
- “Therapeutic method for the treatment of diseases in humans or animals” shall include prevention methods for disease and immunization methods. If both therapeutic effect and non-therapeutic effect were produced and they were difficult to be distinguished from each other, the method as claimed will be deemed as the therapeutic method for the treatment of diseases in humans or animals and is thus unpatentable, and even the claims are written in a way to exclude the therapeutic effect thereof, it is still unpatentable; and
- “Surgical operation methods for the treatment of diseases in humans or animals” are the methods intentionally invading or damaging the living organisms of humans or animals for diagnostic and therapeutic purpose of disease, and are unpatentable as well.
As to the description for medicinal inventions, the specification must be sufficiently disclosed so as to enable a person skilled in the art to practice the invention. Upon examination, if the application is found violating this requirement, the applicant may submit a response, the relevant references or relevant supplemental explanation or experimental results, etc., so as to prove that a person with the ordinary knowledge in the related art is able to understand the contents thereof and to produce or practice the invention based on the prior art existed without undue experiment. However, it shall not be allowed to add new matters into the original specification, such as the mode for carrying out the invention, example or experimental data, etc.
With regard to the forms of expression in a claim, it should preferably be written in the form of a Swiss-type claim, if it is involved with diagnostic, therapeutic or surgical operation methods for the treatment of humans or animals. For example, “Use of compound X for the treatment of disease Y” should be re-written in the form of “Use of compound X in the preparation of a medicament for the treatment of disease Y” in order to be patentable. As to the subject matter of claim not being a diagnostic, therapeutic or surgical operation method, the description relating to the administration regimens, such as a given dose, route of administration, dosing interval, and dosing sequence of different ingredients, etc., in a Swiss-type claim will not be deemed violating Article 24, Paragraph 2 of the Patent Act.
As far as the examination on the patent requirements is concerned, in addition to the general provisions as provided in the General Principles of the Guidelines, this chapter renders a special judgment for medicinal inventions. For example, plastic surgeries and cosmetic methods not for a diagnostic or therapeutic purpose belong to traumatic or invasive methods for the treatment of living humans or animals using medical appliances, and thus are deemed of no industrial applicability. Further, except for the adaptation diseases or pharmacological functions, a new therapeutic use for a known pharmaceutical composition defined by the technical features, such as specific group of patients, specific body part, given dose or administration route etc., is deemed as of novelty, provided that the invention can be clearly distinguished from the prior art. As to the judgement on inventive step, it shall be determined by whether the invention is of an unexpected attribute and effect thereof.
