Dr. Victoria Longshaw, Dr. Jim Onishi and Dr. Nigel Parker

The challenges of patenting inventions in various biotechnological fields have drastically increased around the world over the past year. However, the recent changes to patentable subject matter have not been uniformly applied in all patenting jurisdictions. For example, while the permissive approach to patenting isolated DNA is similar in both Europe and Australia, the approach to patenting inventions using stem cells, or inventions that are derived from stem cell material or the use of stem cells, is very different.

In Europe, the approach to patenting of inventions involving stem cells is governed by the exclusion under Directive 98/44/EC Article 6 of inventions where their commercial exploitation would be contrary to ordre public or morality. This includes any uses of human embryos for industrial or commercial purposes where implementation requires the prior destruction of human embryos or their prior use as starting material.

In contrast, the Australian approach to patentability of inventions involving stem cells is governed by the exclusion in terms of Section 18(2) of the Patents Act 1990, which states that human beings, and the biological processes for their generation, are not patentable inventions in Australia.

Thus, subject matter involving the generation of a human embryo cannot be patented in Europe or Australia. However, while actions resulting in the destruction of a human embryo will preclude patentability in Europe, such actions will not necessarily preclude patentability of inventions involving stem cells in Australia.

The European position

Following the Decision in Oliver Brüstle v Greenpeace eV [2012], the Court of Justice of the European Union (CJEU) ruled that, in terms of Article 6(2)(c) of Directive 98/44/EC, an invention is not patentable in Europe if its implementation requires the prior destruction of human embryos or their prior use as starting material.

In International Stem Cell Corporation v Comptroller General of Patents [2013], the United Kingdom Patents Court was asked to consider whether this exclusion to patentability encompassed parthenogentically-activated oocytes which are incapable of developing into a human being (“parthenotes”). Following a request for a preliminary ruling from the High Court of Justice of England and Wales, Chancery Division, the Court of Justice delivered its opinion of Advocate General Cruz Villalón on 17 July 2014.

The patentability of inventions using parthenotes has been clarified in the opinion of Advocate General as not being included in the term “human embryos” as defined in Article 6(2)(c) of Directive 98/44/EC on the legal protection of biotechnological inventions. Therefore, unfertilised human ova whose division and further development have been stimulated by parthenogenesis, that are not capable of developing into a human being and that have not been genetically manipulated to acquire such a capacity are not considered by the Advocate General to be included in the term “human embryos.

The High Court of Justice of England and Wales has yet to hand down its Decision in the matter. If this Court follows the opinion of Advocate General, an invention may be considered patentable in Europe even if its implementation involves the use of parthenogentically-derived stem cells or their prior use as starting material.

The Australian position

In terms of Section 18(2) of the Patents Act 1990, human beings, and the biological processes for their generation, are not patentable inventions in Australia. Furthermore, in terms of Section 18(3), an innovation patent cannot be obtained which claims plants or animals, or the biological processes for the generation of plants and animals.

In Fertilitescentrum AB and Luminis Pty Ltd [2004], a Decision by the Deputy Commissioner of Patents considered that the prohibition of “human beings” is a prohibition of patenting of any entity that might reasonably claim the status of a human being, and that a fertilised ovum and all its subsequent manifestations are covered by this exclusion. The prohibition of “biological processes for (the generation of human beings)” was considered to cover all biological processes applied from fertilisation to birth only insofar as the process is one that directly relates to the generation of the human being.

The Australian Patent Office, IP Australia, accepts the meaning of “human being” as set forth in Fertilitescentrum AB and Luminis Pty Ltd [2004], and considers that human stem cells and human stem cell lines per se are patentable because these cells are not considered to be human beings or potential human beings within the meaning of Section 18(2).

Human embryos, however, are considered to be human beings within the meaning of Section 18(2). Accordingly, human embryos and processes for generating or culturing human embryos for any purpose, including the harvesting of stem cells, are not patentable in Australia. This exclusion therefore extends to all means of generating human embryos such as the generation of embryos by nuclear transfer, altered nuclear transfer, activation of gametes and parthenogenesis.

As yet, there has been no challenge made to this exclusion with regards to the generation of human embryos by parthenogenesis. However, while not binding in Australia, the opinion of Advocate General of the High Court of Justice of England and Wales may persuade an Australian Court in the event that this aspect of the patentability exclusion of Section 18(2) is challenged in Australia.

Take Home Message

The approach to patenting inventions using stem cells, or derived from stem cells, is very different in Europe and Australia.

In Europe, inventions involving the use of parthenogentically-derived stem cells or their prior use as starting material, may yet be considered patentable. However, any invention which requires the prior destruction of human embryos or their prior use as starting material remains unpatentable.

In Australia, while human stem cells and human stem cell lines per se are patentable, claims that are directed to human embryos and processes for generating or culturing human embryos for any purpose, including the harvesting of stem cells, remain unpatentable.

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