Since the medical industry changes fast and many types of medical invention were filed in Taiwan, TIPO amended the patent examination guideline to clarify some ambiguity of evaluating eligibility and patentability by listing more examples and adding detailed description. The amendment on the medical-related inventions in the patent examination guideline came into force on January 1, 2020.

It is known that methods for treating diseases and diagnosing diseases are not an eligible subject matter for patent in Taiwan according to Taiwan Patent Act. However, many disputes for the eligibility between the applicants and the examiners happen in recent years, especially in the technical fields of oral caring, cosmetic methods, pain-relieving, weight-losing, contraception, abortion, treatment of infertility, and ex vivo treatment of body samples.

The recent amendment of the patent examination guideline describes the principles for determining whether the medical related subject matter of is eligible. Basically, if the methods described in the claims of the patent applications are (1) applied to live human bodies or animal bodies, (2) related to the diagnosis of disease, and (3) focusing on obtaining direct results of diagnosis simultaneously, the methods would be deemed as methods of diagnosis, which are not eligible claims for patents. However, if the objects of the methods do not focus on obtaining direct “results” of diagnosis, these methods could be eligible claims. Some examples of eligible claims such as measuring blood pressure (without getting direct diagnosis results), image forming methods of CT scanning (without getting direct diagnosis results), image forming methods of live bodies by magnetic field inducing signals (without getting direct diagnosis results), and methods for measuring the contents of glucose in blood (without getting direct diagnosis results) are listed in the amended guideline. Readers of patent examination guidelines can understand the rules and apply the principles for determining the eligibility of claims easily.

Moreover, the amended patent examination guideline also adds some description for determining whether the methods of claims are methods of treatment or not. If the methods of the claims can generate treatment effects and non-treatment effects at the same time, and the generated treatment effects and non-treatment effects cannot be differentiated clearly, the methods of the claims would be deemed as ineligible claims because treating methods are involved. In contrary, if the generated treatment effects and non-treatment effects can be differentiated clearly, the methods would be deemed as eligible claims.

For example, if the methods for plaque removal (in oral caring fields) through using chemical compound A can also have an effect for preventing tooth decays or treating gum disease, the methods for plaque removal would be determined as ineligible claims because treatment methods are included.

Furthermore, simple cosmetic methods are also described in the amended guideline for helping evaluating the eligibility of claims. If simple cosmetic methods do not involve treatment effect, these methods could be deemed as eligible claims. For example, simple cosmetic methods for avoiding hair losing, or strengthening nails could be eligible claims because that these effects of these methods illustrated above are not treatment effects.

In addition, according to the amended patent examination guideline, methods for relieving pains or quitting addiction (e.g. for smoke, drugs, or alcohols) are also deemed as ineligible claims because of their treatment effects. The methods for reducing or relieving the syndromes (e.g. night sweats or nausea) accompanied quitting addiction are also determined as ineligible claims for the same reasons.

As to the methods for reducing weight, if the methods are only applied to improving the physical appearance without treating obesity, the methods for reducing weight could be deemed as eligible claims.

Ex vivo treatment methods of body samples are basically deemed as eligible claims. However, if steps of replanting, returning, or re-infusing the ex-vivo-treated samples into live bodies are included in the ex vivo treatment methods, the ex vivo treatment methods would be deemed as ineligible claims. For example, methods for treating blood including steps of application of closed loop to re-infuse the ex vivo treated blood back into live bodies will be determined as ineligible claims.

The recently amended patent examination guideline describes basic ways for determining the eligibility of claims of medical related inventions. Examples and principles of several special technical fields for determining the eligibility of claims are also listed and described in the amendments. It shows the efforts of TIPO for clarifying the ambiguity and it’s also helpful to reduce the disputes about claim eligibility.