Medicine-related inventions are of great importance in Taiwan. In every year between 2005 and 2007, the Intellectual Property Office (TIPO) received more than 2000 patent applications related to medicine inventions classified as A61 under the International Patent Classification (IPC). According to TIPO’s Annual Report 2008 (published in July 2009), medicine-related applications under A61K ranked as one of the top classes of total invention applications arranged by IPC subclass in both 2007 and 2008.
The Patent Examination Guidelines for medicine-related inventions first became effective in 1991. To reflect the revision of patent provisions in 2004, the Patent Examination Guidelines for medicine-related inventions were newly published by TIPO on June 3, 2009 and became effective on the same date.
Under the Guidelines, examination of medicine-related inventions will be conducted in a consistent manner. The main points of the “Patent Examination Guidelines for Medicine-Related Inventions” are summarized below.
I. The Scope of Medicine-Related Inventions
Medicine-related inventions include compounds, pharmaceutical compositions, diagnostic or test agents, cosmetics and other related inventions in the field of medicine.
II. Categories of Subject Matter of the Patent Application
The subject matter of medicine-related inventions is generally classified into product inventions, process inventions, and use inventions.
A. Product Inventions
Product inventions include the following.
(a) Compounds, for example, “a compound of general formula I”.
(b) Compositions, for example, “a pharmaceutical composition” and “a pharmaceutical composition for treating hepatitis C”.
(c) Dosage forms, for example, “an oral sustained-release tablet”.
(d) Kits, for example, “a kit for detecting hepatitis C virus”.
(e) Inspection devices, for example, “a portable medical inspection device”.
B. Process Inventions
Process inventions include the following.
(a) Preparation methods of compounds, for example, “a method for the preparation of a compound of general formula I”.
(b) Preparation methods of compositions, for example, “a method for the preparation of a pharmaceutical composition”.
(c) Preparation methods of dosage forms, for example, “a method for the preparation of an oral sustained-release dosage form”.
Detection methods, for example, “a method for screening liver diseases”.
C. Use Inventions
Use inventions include the following.
(a) Uses of compounds or compositions for the manufacture of medicaments, for example, “use of a compound according to claim 1 for the manufacture of a medicament for the treatment of sleep disorders”.
(b) Uses of compounds or compositions as medicinal material, for example, “use of perfluoroalkyl-containing metal complexes as contrast media in MR-imaging for visualization of plaque, tumors and necroses”.
III. Statutorily Unpatentable Subject Matter
A. Diagnostic, Therapeutic or Surgical Operation Methods for the Treatment of Humans or Animals are Unpatentable
In accordance with Article 24, Subparagraph 2 of the Patent Act, diagnostic, therapeutic or surgical operation methods for the treatment of humans or animals shall not be granted an invention patent. A diagnostic, therapeutic or surgical operation method must be conducted on a living human or animal body and have a direct purpose for diagnosis, treatment or prevention of diseases to fall within the scope of the ineligible subject matter.
B. Determining Diagnostic, Therapeutic or Surgical Operation Methods for the Treatment of Humans or Animals
Whether a medicine-related invention is considered as a diagnostic, therapeutic or surgical operation method is determined based on the subject matter of the medicine-related invention. If the subject matter of a medicine-related invention is directed to a product rather than a method, said medicine-related invention belongs to a product invention, which is not a statutorily unpatentable subject matter, even if the use of said product is for diagnostic, therapeutic or surgical methods.
IV. The Format of a Pharmaceutical Composition Claim Concerning First Medical Use
Regarding a pharmaceutical composition claim claiming a composition not previously disclosed for medical use (first medical use), the pharmaceutical composition claim does not need to specify the first medical use. For example, the format “a pharmaceutical composition, comprising compound X …” is considered definite and supported by the description of the invention if the claimed pharmaceutical composition meets all three of the following conditions:
1. the pharmaceutical composition was not previously disclosed for medical use,
2. the specification discloses at least one mode or example for carrying out said medical use, and
3. the disclosure of the specification is sufficient to enable a person skilled in the art to prepare and use said pharmaceutical composition.
However, a new use of a known pharmaceutical composition (second medical use) should clearly specify the new disease(s) or pharmacological effect(s) to be distinguishable from the prior medical use.
V. Unity of the Invention
A. Compound Claims
(a) Unity of Markush Claim
A “Markush” claim is where a single claim is defined by a number of alternative elements. If the alternative elements in a Markush claim possess similar nature, they shall be regarded as technically related and having the same or corresponding special technical features and the claim may be considered as meeting the requirements of unity.
Whether the alternative elements (i.e., alternative compounds) in a Markush claim possess similar nature is determined by compliance with the following conditions:
(i) all alternative compounds possess a common property or activity; and
(ii) j all alternative compounds possess a common structure, that is, all alternative compounds possess an essential chemical structural element, or k under the circumstances that they do not have a common structure, all of the alternative compounds belong to the same class of compounds recognizable by a person skilled in the art.
(b). Intermediates and End Products
A medicine-related invention directed to an intermediate(s) and an end product(s) would be considered to meet the requirements of unity if said medicine-related invention meets both of the following conditions:
(i) the intermediate(s) and the end product(s) possess the same basic structural element, that is, j the intermediate(s) and the end product(s) possess the same basic chemical structure, or k the chemical structures of the intermediate(s) and the end product(s) are technical-related and one of the basic structural elements of the intermediate(s) is incorporated into the end products, and
(ii) the intermediate(s) and the end product(s) are technical-related, that is, the end product(s) is directly produced from the intermediate(s) or directly separated from the intermediate(s).
B. Pharmaceutical Composition Claims and Medical Use Claims
If a pharmaceutical composition claim and a medical use claim are directed to two different diseases, it is necessary to determine whether the pharmaceutical composition claim and the medical use claim belong to a single general inventive concept, that is, possess the same or corresponding special technical features. For example, the pharmaceutical composition claim and the medical use claim would be deemed to meet the requirement of unity if the treatment or diagnosis of two different diseases involves a common mechanism.
