【Volume 68】In recent years, with the booming development of genetic engineering and medical diagnostic technologies, the number of biotech and pharma patent applications has also increased around the world. Due to the special nature of biomedical inventions which involves the essence of life and ethical concerns, special provisions have been set forth on the eligibility of such patents, and the criteria for determination of eligibility vary from country to country. Thus, the same patent application may be filed with very different filing strategies in countries such as Taiwan, the United States, Japan and China.

This article is divided into two parts:

• Part I will introduce and compare the regulations on the eligibility of biotech and pharma patents and related practices in Taiwan and the United States.
• Part II will 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 reference for applicants seeking patent protection in these countries.

Taiwan

(1) Patent Subject Matter Eligibility

• According to Article 24 Taiwan Patent Act, animals, plants, and essential biological processes for the production of animals or plants (i.e. breeding based on general sexual hybridizations, etc.) are subject matters not to be granted, except for processes for producing microorganisms.
• The said animals and plants also include genetically modified animals and plants. The said essential biological processes refer to breeding based on the sexual hybridizations of entire genomes and subsequent selection of animals or plants. Thus, for example, if a method includes the introduction of a gene or trait into a plant by genetic engineering, rather than based on the entire genome recombination and the natural mixing of plant genes, the method is not an essential biological process and is patent eligible.
• Chapter 2, Part 2 of the Patent Examination Guidelines stipulates that^[1] : Matters in natural forms, such as wild plants or natural crystals, are subject matters of invention patents which shall not be granted. However, for a matter obtained by separation from nature for the first time which has different structure, form or other physical chemistry properties from those known and can be clearly defined, both the matter and separation method thereof satisfy the definition of an invention. For example, if a gene or microorganism is found to exist in nature and is obtained by a special isolation procedure, then the gene or microorganism itself meets the definition of an invention.

(2) Diagnostic and Therapeutic Method

• According to Article 24 Taiwan Patent Act, diagnostic, therapeutic and surgical methods for the treatment of humans or animals are the subject matters of the invention patents of statutory exclusion^[2] . Criteria for determining eligibility of diagnostic and therapeutic methods in Chapter 13, Part 2 of the Patent Examination Guidelines are as follows:

1. A subject matter is a “diagnostic method” if it fulfills the following three conditions^[3] :

(i) applied to a living human body or animal body;

(ii) regarding disease diagnosis;

(iii) for the purpose of obtaining disease diagnosis.

2. A “therapeutic method” refers to a method of a disease treatment or a disease elimination for the purpose of restoring or obtaining a living human body or animal body health. Provided that the technical features of any step in the method are used to treat the disease and are applied to a living human body or animal body, the subject matter still should not be granted even if the method contains other non-therapeutic steps^[4].

3. According to Chapter 13 2.2.2, Part 2 of the Patent Examination Guidelines, a “surgical method” refers to an invasive or interventional therapy or treatment applied to a living human body or animal body using an instrument. If the method of a claimed invention consists of more than one step, the method is unpatentable when one of the steps is a surgical step performed on a living human or animal body, even if the method also contains other non-surgical steps^[5].

The United States

    (1) Biology-Related Subject Matters

As far as biology-related inventions are concerned, an organism or biological molecule already existing in nature is not patent eligible. For instance, in Association for Molecular Pathology v. Myriad Genetics^[6] , the US Supreme Court determined that isolated DNA is ineligible as it is only a product isolated from nature; on the contrary, cDNA is patent eligible because it is not a natural product and lacks the introns, which is different from naturally occurring isolated DNA fragments.

A non-natural/genetically modified organism or biomolecule is eligible for patent protection when it has “significantly different characteristics” compared to its naturally occurring form. Thus, in principle, animals and plants are patentable subject matters in the United States if it can be proved that the animal or plant in an invention is an artificial and non-natural product. However, the exception is human beings, which are not patent eligible even if they have been non-natural/genetically modified. In Diamond v. Chakrabarty ^[7], for example, a living microorganism was recognized as an eligible subject matter because it was a genetically engineered bacterium with the new ability to break down crude oil, and the bacterium was produced by human technology rather than available in nature, and was therefore patent eligible.

It is worth noting that certain non-patent eligible plants may still be protectable by plant patent rights or non-patent rights.

    (2) Diagnostic and Therapeutic Methods

Diagnostic and therapeutic methods are patentable subject matters.

1. Detection or Diagnostic Method

• If a method of detection or diagnosis relies on “routine or conventional” techniques (e.g. PCR amplification, standard immunoassay), it is drawn to the statutory exceptions of natural laws and/or mental steps and is patent ineligible. Same is true for prognostic methods and methods of predicting treatment efficacy.
•  Thus, diagnostic features are often paired with an active treatment step in US claims, for example, a method comprising: diagnosing a patient and then treating the patient on the basis of the said diagnosis. In addition, the kit used for the diagnostic test is also an eligible subject matter.

2. Therapeutic Method

• A therapeutic method must comprise the specific therapeutic (drug administration) steps, e.g. “treating a specific patient with a specific dosage of a specific compound to achieve a specific outcome”. In practice, though, it is also usually acceptable for a claim to recite treating a patient with a “therapeutically effective amount” of a specific drug. In this case, relevant embodiments must be provided to support the claimed effect.
• Furthermore, it is not permissible to explicitly instruct withholding treatment from the patient, e.g. if the claim is written as “A method of treating a patient according to whether the patient has genotype A or B: wherein, if the patient has genotype A, treat the patient with a kinase inhibitor; wherein, if the patient has genotype B, do not treat the patient”, then it is patent ineligible and the step “wherein, if the patient has genotype B, do not treat the patient” should be deleted.