Previously, we introduced the patent eligibility of biotech and pharma patents in Taiwan and the United States. Due to the special nature of the biomedical inventions, special provisions have been set forth on the eligibility of biotech and pharma patents, and the criteria for determination of eligibility vary from country to country.

In this second part, we continue to introduce and compare the regulations and practices on the eligibility of biotech and pharma patents in Japan and China, and further analyse the similarities and differences among Taiwan, the United States, Japan and China to provide guidance for applicants seeking patent protection in these countries.

Japan

(1) Biology-Related Subject Matters

Natural substances that are mere discoveries and not creations are subject matters not to be granted. According to Chapter 1, Part 3 of the Japan Patent Examination Guidelines, artificially isolated microorganisms, genetically modified animals and plants, etc. involve creativity, and thus are patent eligible[1]. However, Article 32 of the Japan Patent Act provides that inventions applied to human beings are considered contrary to public order or morality and are unpatentable[2]. Moreover, according to Chapter 2, Part 7 of the Japan Patent Examination Guidelines, in order to comply with enablement and support requirements, genetic engineering-related inventions such as gene sequences, proteins, and cells, etc. shall be fully disclosed in the specification due to the unique complexity of such technical fields[3].

(2) Diagnostic or Therapeutic Methods

In Japan, it is explicitly stipulated in Chapter 1, Part 3 of the Japan Patent Examination Guidelines [4] which corresponds to the industrial applicability [5]in Article 29 of the Japan Patent Act, that diagnostic, therapeutic and surgical methods for the medical treatment of humans are the subject matters of statutory exclusion that do not meet the industrial applicability requirements and are, therefore, unpatentable. The determining steps in the Japan Patent Examination Guidelines and the exemplified table are depicted below.

Step 1

Step 1 asks whether a subject matter is related to a “medical treatment”, i.e.:

(i) a method of surgery of humans;

(ii) a method of therapy of humans ; or

(iii) a method of diagnosis of humans.

If a subject matter is not medical treatment-related, it is industrially applicable; if a subject matter is medical treatment-related, proceed to Step 2.

Step 2

Step 2 asks whether a claim is:

(i) a product (e.g., drugs, pharmaceutical compositions, or medical devices); or

(ii) a non-medical treatment method (e.g., Swiss-type claim).

If a claim is directed to a product or a non-medical treatment method, it is industrially applicable; if not, proceed to Step 3.

Step 3

Step 3 asks whether a subject matter corresponds to an exception, i.e.:

(i) a method for controlling the operation of a medical device;

(ii) a method for gathering information from the human body by measuring the structures and functions of organs in the body; or

(iii) a method for processing samples isolated from the human body.

If a subject matter belongs to any of the exceptions above, it is industrially applicable; if not, it shall not be granted.

China

(1) Biology-Related Subject MattersChina

According to Article 25 of the China Patent Act, gene sequences, proteins, microorganisms and so on are ineligible if they are in natural forms existing in nature [6]. However, if the isolate is characterized for the first time and industrial applicable, it is an eligible invention. Artificially engineered animal or plant cells are usually patent eligible; however, human germ cells, zygotes, embryos, etc., belong to human bodies and therefore are not granted under Article 5 China Patent Act [7]. Nevertheless, according to Chapter 1, Part 2 of the China Patent Examination Guidelines [8], human embryos that have not undergone in vivo development and within 14 days of fertilization are patent eligible.

(2) Diagnostic or Therapeutic Methods.

Diagnostic or therapeutic methods are also the subject matters of statutory exclusion under Article 25 China Patent Act [9], and the criteria for determination are as follows:

1. object: directed to a living human or animal body; and

2. immediate purpose: to obtain diagnostic results or to treat disease.

Hence, the diagnostic and therapeutic use of a substance (drugs, cosmetics, etc.) is ineligible.

For instance, when “inseparable” therapeutic effect of a composition is described in the specification, even if the claim is defined as “a method of treating the skin for non-therapeutic purpose, comprising topical application of the composition...”, it is still ineligible.

Relatively, an in vitro detection method based on isolated samples is patent eligible. For instance, “A method for detecting cell mitosis in a breast cancer scoring system (to obtain a sample set for training mitosis identification model)” is found eligible because the immediate purpose of the detection is to obtain not diagnostic results but just intermediate results for model training.

Similarly, methods and uses of medical devices and treatment-related auxiliary systems are patent eligible. For instance, “A detection method for a medical intravenous transfusion alarm, ...” is also found patent eligible because the information collected by the detection is only used to reflect transfusion status rather than the patient’s condition.

Wisdom Suggested Strategies

In summary, the eligibility requirements for biotech and pharma patents in Japan and China are similar to those in Taiwan, but significantly different from those in the United States.

Regarding the invention of specific gene sequences and microorganisms, applications filed in China, Japan or Taiwan are rarely considered to be patent ineligible, whereas in the United States, genes and microorganisms are often deemed as natural products and are at risk of being rejected owing to eligibility requirements of the subject matter under 35 U.S.C. §101, unless the applicant can prove that the claimed invention has been artificially engineered to contain features significantly different from those of laws of nature.

On the other hand, although there are certain requirements regarding how diagnostic and therapeutic methods may be claimed, they are patentable subject matters in the United States, whereas they are unpatentable subject matters in Japan, China and Taiwan. It is recommended that applicants overcome this problem by writing the claimed subject matter as a pharmaceutical composition, or by rewording the claimed subject matter as a Swiss-type claim and then limiting it with the treatment method.

Moreover, if a drug is known to have a secondary medical use and the applicant writes the claim as a product with new use, Japan recognizes the novelty of the drug; however, under Taiwan and China practices, any claim phrasing a known drug as the subject matter is considered not novel because the drug is already known, i.e., the new use has no contribution to the novelty of the claim. In addition, biotech case precedents are also useful references which applicants should pay attention to before seeking biotech and pharma patents.