Influence of draft Patent Act amendment on protection of biotech patents

According to Article 24 of the Patent Act, animal and plant varieties are not patentable subject matter. As an incentive to encourage the development of the Taiwanese biotech industry, in the draft amendment to the Patent Act the Taiwan Intellectual Property Office (TIPO) has proposed to allow animal and plant varieties as patentable subject matter in the near future.

This article discusses the patentability of animal and plant varieties under the draft amendment and the possible impact of such patentability.

Scope of patentable animal and plant varieties
As the current Article 24 will be deleted, in the future inventions involving animal and plant varieties and essentially biological processes may be patented as long as they meet certain criteria relating to novelty, inventive step (also referred to as non-obviousness), industrial applicability (also referred to as utility) and other features such as enablement and written description.

Product inventions: animal or plant varieties
The typical product inventions involving animal and plant varieties include cells, organs, products of tissue culture, transgenic animals or plants, and new species of animals or plants as long as they are product of human intellect and effort.

On the other hand, inventions relating to germ cell, fertilised egg, morula, blastula, embryo, fetus or human cloning are, and will continue to be, not patentable as they are considered contrary to public order, morality or public health, as expressly provided in Article 24(3) of Patent Act and Article 24(2) of the draft amendment.

In addition, if the animal or plant varieties in question (referred to as “biological materials”) may not easily be acquired by a person ordinarily skilled in the art, the biological materials must be deposited with a local depository institution. Under Article 3 of the Regulations of Biological Material Deposits Relating to Patent Application, the depository institution will accept the deposit of bacteria, actinobacteria, yeasts, fungi, mushrooms, plastids, bacteria phages, viruses, animal cell lines, plant cell lines, hybridoma and other biological materials. However, as animal and plant varieties are not currently patentable, at present depository institutions do not accept the deposit of animals or plants varieties. Further, the regulations are currently designed for microorganisms and may not be appropriate for animal or plant varieties. As such, the regulations will have to be amended after the draft amendment is promulgated.

Process inventions
There are two types of biological process under the Patent Act: essentially biological process and non-essentially biological process.

Inventions involving essentially biological processes
According to The Benchmark of Patent Examination, the guide for patent prosecution, the term “essentially biological process” refers to a process wholly depending on the rule of nature, such as interbreeding, cross-breeding and syngenesis.

There are several barriers to the patentability of essentially biological processes. First, the production of animal or plant varieties is usually based on randomisation and is rarely achieved solely through manmade efforts. In this case, it is typically difficult to meet the criteria of enablement and industrial applicability. Moreover, it is not always easy to show the inventive step. For instance, the interbreeding of beans with trait A and beans with trait B to produce beans with both traits A and B can easily be accomplished by a person ordinarily skilled in the art based on prior art.

Therefore, although essentially biological processes are in principle patentable under the draft amendment, the TIPO will grant a patent for an essentially biological process only when the criteria of inventive step, industrial applicability and enablement are met. 

Inventions involving non-essentially biological processes
The term “non-essentially biological process” refers to a process involving manmade techniques, such as genetic engineering and transgenic techniques, even if the process involves certain essentially biological processes.

Despite the patentability of non-essentially biological processes, the TIPO will not grant patents for processes relating to human cloning, human embryo cleavage, human germ line modification, formation and development of the human body, industrial or commercial application of human embryo, and mosaic from human germ cells or pluripotent stem cells, on the ground of morality concerns.

Taiwan was founded on agriculture and is famous for its agricultural techniques. While a number of issues remain and will have to be addressed by the courts and the TIPO once the new rules are put into practice, the proposal in the draft amendment to recognise the patentability of animal and plant varieties is expected to improve and encourage development in the Taiwanese biotech industry.

This is an Insight article, written by a selected partner as part of IAM's co-published content. Read more on Insight

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