Chapter on
Patent Examination Guidelines for
Pharmaceutical-Related Invention Revised
The Taiwan Intellectual Property Office has promulgated a new revision to Chapter 13 of the Patent Examination Guidelines for Pharmaceutical-Related Inventions, which took effect on January 1, 2020. The revision aims to improve the patent examination mechanism of Taiwan through the consultation of related cases from the United Kingdom, Japan and Europe. A summary of the some changes in the revision is as follows.
Reaching a diagnostic conclusion as the immediate purpose
A non-patentable diagnostic method is required to incorporate “all” steps from obtaining data to make a diagnostic conclusion, including measurements from the biological system, identification of the difference between the measured data and the standard value, and determination of diagnostic result from the difference. Hence, a claimed invention is not patentable when the method (1) directs to a living human or animal system; (2) relates to disease diagnosis; and (3) aims immediately to obtaining a diagnostic result.
In determining whether a method directs to a living system, one must consider whether the claimed method involves interactions between method’s steps and the living system. However, the type or intensity of interaction is not determinative. As long as the operation of method requires a living system, it refers to one directing to a living system and therefore not patentable. To the opposite, when a method does not immediately direct to disease diagnosis but for obtaining data from a system (such as blood pressure measurement, CT imaging, and glycemia measurement), it is eligible for patent because the acquired data are only intermediate information which alone cannot serve to bring about diagnostic result.
Claim(s) covering both therapeutic and non-therapeutic effects
Methods which possess both therapeutic and non-therapeutic effects that are “not separable” are considered non-patentable methods for treatment. However, when the two kinds of effects are separable and the claim is limited to be non-treatment in nature, the claimed method is patentable.
For example, an invention for oral health titled “a method using a composition X for removing dental plaque” describes in the specification that the claimed method generates beauty effects of removing dental plaque and improving tooth appearance. As a matter of course, the invention also cures gum disease and prevents tooth decay. The method invention is therefore not patentable.
In the contrary, a mere cosmetic enhancement such as applying a composition to prevent hair loss and a process to resurface the aged skin is patentable.
The revision further emphasizes that a method which involves both ex vivo processes and in vivo steps is a non-patentable therapeutic method. Examples of this are as dialysis and closed-loop blood circulation (where the blood leaves the system for e.g. adding with anticoagulant agents or being cleansed of immunoglobulins before returning to the bloodstream).
Written description, novelty, and inventiveness
The revision introduces several tips to illustrate the rules governing description, novelty, and inventiveness.
For derivative forms of compounds, such as pharmaceutically acceptable salts or esters, stereoisomers, hydrates, and others, they can be included in the compound claim if the specification clearly describes that the compound has derivatives and a person having ordinary skill in the art can understand the use well enough to generate the derivative without undue experimentation based on the specification’s disclosure.
For an invention of a different pharmaceutical dosage form, such as "a transdermal patch" or "an orally-administered sustained-release lozenge", the claim must define both the specific active ingredient and the necessary technical features related to the dosage form, such as excipients and compounding dosage. Merely stating the property parameters (solubility for example), pharmacokinetic or pharmacodynamic parameters as the necessary technical feature does not meet the written description requirement.
If the technical features of an invented pharmaceutical composition are a compound or a group of compounds which produce specific pharmacological effects, the novelty of the composition mainly depends on the compound or group of compounds. That is to say, if the claimed pharmaceutical composition distinguishes a prior art composition from one or a group of compounds of particular pharmacological effect, the claimed composition will be considered novel.
For a drug or agent containing hydrated compound, different amounts of water would yield different effects on a drug’s solubility, dissolution rate, and bioavailability, as well as an agent’s chemical and physical stability. If a specific compound is expected to have hydrates, and a person having ordinary skill in the art is motivated to search for the optimal water content and to this end successfully finds the optimal water content, an invention for that hydrated compound will be deemed to not have inventiveness. More evidence for unexpected results or others is necessary in order to overcome a rejection.
Lastly, the revision introduces several examples demonstrating that an invention may or may not have novelty when it involves any new (1) pharmaceutical use, (2) application for a particular type of patients, (3) dosage, (4) administration routes, and (5) time intervals between administrations. An invention may or may not have inventiveness when it involves any (1) different dosages, (2) application for a particular type of patients, (3) relatedness of pharmacological effect, and (4) treatment for different diseases but having a common causative factor, as the revision suggests.
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