Stem Cells, Their Patentability, and Implications

Stem Cells, Their Patentability, and Implications

Stem cells have been one of the world’s most controversial topics for decades. There has been a constant debate on the use of human stem cells for the purposes of research. Supporters claim that doing so would do much to advance knowledge of human health and the medical field. Opponents, however, claim that this practice violates ethical standards.

Another dimension of the stem cell debate lies in the field of intellectual property. Many human embryonic stem cells have been patented. However, in many other cases, those who applied for such a patent saw their application rejected according to legal stipulations. From these facts, the evidence is clear that even intellectual property authorities are divided on the question of the patentability of stem cells.

Patentability of Stem Cells Around the World

Not every country’s intellectual property laws regard stem cells as material which can be patented. Some allow any patent on human embryonic stem cells to be approved if it adheres to all other existing patent regulations. Such patents not only claim the stem cells themselves; they also claim the processes involved in making the cells to prepare them for use in research.

In other countries, intellectual property authorities permit the granting of patents for multipotent and pluripotent human embryonic stem cells. However, these same authorities do not allow totipotent stem cells to be patented because they have the potential to develop into a living human. Other jurisdictions have completely banned the granting of patents related to human stem cells or even inventions involving those cells.

Patentability of Stem Cells and Ethics

In most countries, any item which is to be patented is required to be one which contains elements of inventiveness, novelty, and industrial applicability. If an invention related to stem cells or stem cell technology fulfills these requirements, some might assume that a patent would automatically be granted. However, such is not the case because many intellectual property bodies only grant patents to ethically sound inventions. Many authorities do not regard stem cell research as being ethically sound.

For this reason, the only stem cell-related inventions for which some intellectual property authorities grant patents are those which are derived from asexually produced human embryos or in-vitro fertilization. In almost all cases, such inventions violate neither public order or morality in any way. Although there may be some dissenting voices, these are typically few and far between.

Stem Cell Patents and Medical Therapy

The increasing number of stem cell patents around the world may lead to breakthroughs in medical therapy processes. Therapeutic applications for stem cells can be patented if the intellectual property authorities in question regard the application as being part of an inventive process. As these therapeutic applications have a utilitarian purpose, there is an increased possibility for them to be patented.

However, there is also a possibility for any item related to stem cell therapy to be denied a patent. This may be the case when an intellectual property court rules that the item does not necessarily have industrial utility because it is a therapeutic method. Others deny patents for therapeutic processes involving stem cells because they believe that the commercial exploitation of such items represents a violation of morality and human rights.

Stem Cell Patentability and Its Effects on Research

Scientists who work in areas where stem cells and related technologies face patent bans or restrictions have had to make use of alternative methods to create human stem cells for research. These patent restrictions have therefore forced scientists and institutions in such areas to spend much more time and money on research and development. Patent restrictions on stem cells may thus serve to have a chilling effect on stem cell research.
Some researchers have attempted to circumvent this problem by using somatic cells in their work. Somatic cells differ from embryonic stem cells because they are not reproductive. Somatic cells can usually be patented. It is possible, though difficult, for somatic cells to be reprogrammed to a fully pluripotent state in which it resembles an embryonic stem cell. However, given the cost and labour inefficiency of doing so, most researchers and scientists are in favour of allowing stem cells and related inventions to receive patents.

This article is brought to you by Exy Intellectual Property Malaysia and Singapore.