(Continued) Detailed Guide to Eligibility Requirements for Biotech and Pharmaceutical Patents in the United States, Taiwan, Japan and China

Previously, we introduced biotech and pharmaceutical patent eligibility in Taiwan and the United States. Due to the special nature of biomedical inventions, special provisions have been established on the eligibility of biotechnology and pharmaceutical patents, and the criteria for determining eligibility vary from country to country.

In this second part, we continue to present and compare the regulations and practices on the eligibility of biotechnology and pharmaceutical patents in Japan and China, and analyze in more detail the similarities and differences between Taiwan, the United States , Japan and China to provide guidance to applicants. apply for patent protection in these countries.

Japan

(1) Subjects related to biology

Natural substances which are mere discoveries and not creations are subjects which should not be granted. According to Chapter 1, Part 3 of the Japanese Patent Examination Guidelines, artificially isolated microorganisms, genetically modified animals and plants, etc. involve creativity and are therefore patent eligible[1]. However, Article 32 of the Japanese Patent Law provides that inventions applied to human beings are considered contrary to public order or morality and are not patentable.[2]. In addition, according to Chapter 2, Part 7 of the Japanese Patent Examination Guidelines, in order to comply with clearance and support requirements, genetic engineering-related inventions such as gene sequences, proteins and cells , etc must be fully disclosed in the specification. due to the unique complexity of these technical fields[3].

(2) Diagnostic or therapeutic methods

In Japan, it is explicitly stated in Chapter 1, Part 3 of the Patent Examination Guidelines of Japan [4] which corresponds to the industrial applicability [5]in Article 29 of the Japanese Patent Law, that diagnostic, therapeutic and surgical methods for the medical treatment of human beings are legally excluded which do not meet the requirements of industrial applicability and are not therefore not patentable. The critical steps in the Japanese patent examination guidelines and exemplified chart are described below.

Step 1

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

(i) a method of surgery on humans;

(ii) a method of therapy of humans; Where

(iii) a method for the diagnosis of man.

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

2nd step

Step 2 asks if a claim is:

(i) a product (for example, drugs, pharmaceutical compositions or medical devices); Where

(ii) a non-medical method of treatment (eg, Swiss-type claim).

If a claim relates to a non-medical product or method of treatment, it is industrially applicable; otherwise, go to step 3.

Step 3

Step 3 asks if an object matches an exception, i.e.:

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

(ii) a method of collecting information from the human body by measuring the structures and functions of body organs; Where

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

If an object belongs to one of the above exceptions, it is industrially applicable; otherwise, it will not be granted.

China

(1) Subjects related to biologyChina

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

(2) Diagnostic or therapeutic methods.

Diagnostic or therapeutic methods are also subject to legal exclusion under Article 25 of the Chinese Patent Law. [9], and the determination criteria are as follows:

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

2. immediate objective: to obtain diagnostic results or to treat a disease.

Thus, the diagnostic and therapeutic use of a substance (drugs, cosmetics, etc.) is not eligible.

For example, when the “indissociable” 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 purposes, comprising the topical application of the composition …”, she is still ineligible.

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

Similarly, methods and uses of medical devices and ancillary systems related to treatment are eligible for patents. For example, “A detection method for an intravenous transfusion medical alarm,…” is also considered patentable because the information gathered by the detection is only used to reflect the transfusion status rather than the patient’s condition.

Strategies Suggested by Wisdom

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

With regard to the invention of specific gene sequences and microorganisms, applications filed in China, Japan or Taiwan are rarely considered ineligible for patent, whereas in the United States, genes and microorganisms organisms are often considered natural products and risk rejection due to subject matter eligibility requirements under 35 USC §101 unless the applicant can prove that the claimed invention was artificially engineered to contain characteristics significantly different from those of the laws of nature.

On the other hand, although there are certain requirements regarding how diagnostic and therapeutic methods can be claimed, they are patentable subject matter in the United States, while they are not patentable subject matter in Japan, China and in Taiwan. It is recommended that applicants overcome this problem by writing the claimed subject matter as a pharmaceutical composition, or rewording the claimed subject matter as a Swiss-type claim, and then limiting it to the method of treatment.

Moreover, if a medicine is known to have a secondary medical use and the applicant drafts the claim as a product with a new use, Japan recognizes the novelty of the medicine; however, under the practices of Taiwan and China, any claim stating a known medicine as object is considered not new because the medicine is already known, i.e. the new use has no contribution to the novelty of the allegation. In addition, biotech case precedents are also useful references that applicants should pay attention to before applying for biotech and pharmaceutical patents.

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