Scintilla – a flash, a spark, an iota. Shorthand for creativity and an indicator of inventiveness under Australian law.






Friday, August 26, 2016

To be human, or not to be human: that is the [patentability] question

By Claire Gregg, Patent Attorney, and Dr Trevor Davies, Partner 


Advances in biological manipulation of cells and stem cell technology continue to test the law on what can be patented.

A recent decision of the Australian Patent Office makes clear that an invention that includes a step on the pathway to the production of a potential human being, even if the end result is not a human being, is not patentable. Claims to the use of cellular structures that may mimic the embryonic process but cannot result in a human being are patentable.

Background


'Human beings, and the biological processes for their generation' is one of the few legislated exclusions from patentability under Australian law. In one of only a handful of decisions of its kind, the Patent Office recently considered the scope of this exclusion in International Stem Cell Corporation [2016] APO 52

The case concerns patent applications AU 2012216371 and AU 2013205483, each having claims directed to producing non-embryonic human stem cells and their uses. The claims involve a step of generating an early developmental structure, parthenogenic blastocyst, which is formed following activation of a human oocyte. This structure is analogous to a blastocyst formed following fertilisation of an oocyte by a sperm during the very early stage of embryonic development. 

Although the parthenogenic blastocyst has the same general morphology as a blastocyst produced following normal fertilisation, and also progresses through early development in a manner that mirrors cell division following fertilisation, it is not the same.

The relevant claims were repeatedly rejected during examination on the basis that they represent a biological process for the generation of a human being. Unable to overcome these rejections, the Applicant, International Stem Cell Corporation, requested a hearing before the Patent Office.

The relevant law


According to section 18(2) of the Patents Act 1990 (Cth), 'human beings, and the biological processes for their generation, are not patentable inventions'. Section 18(2) has not been the subject of any judicial decisions to date in Australia, however, its scope was considered at length by the Patent Office in Fertilitescentrum AB and Luminis Pty Ltd [2004] APO 19.

The Deputy Commissioner in Fertilitescentrum considered that it was the intention of Parliament to exclude from patentability all steps along the path from fertilisation to birth. Thus, it was held that section 18(2) applies to 'a fertilised ovum and all its subsequent manifestations" as well as biological processes that include "the processes of generating the entity that can first claim a status of human being'.

In Woo-Suk Hwang [2004] APO 24, it was held that section 18(2) extends to an artificially activated ovum, which the Delegate did not consider to be sufficiently different from a fertilised ovum to render it outside the ambit of the section. The Delegate in Hwang also found that, provided the nuclear DNA of the ovum was human, the presence of non-human mitochondrial DNA did to detract from its 'essentially human characteristic'.

One small 'human' step


The relevant claims include the use of an activated human oocyte that contains human nuclear DNA. However, the Applicant argued that the claims are outside the ambit of section 18(2) because one unpatentable step in a claim should not render an entire claim unpatentable. 

To support this argument, the Applicant relied on an analogy with the other grounds of patentability under the Act in which claims are considered in their entirety, stating that '[a] claim is not deemed to lack novelty for example when one integer of the claim lacks novelty'.

The Delegate was not persuaded by this argument, and instead looked to the intention of Parliament in drafting the exclusion to patentability in section 18(2). Having regard to Fertilitescentrum, the Delegate stated at [22] (emphasis added):

I consider that the exclusion of biological processes where a (potentially human) entity is created, and is subsequently used (or even destroyed to allow the use of the cells produced) for another purpose, provides a clear representation of the type of mischief that Parliament was addressing. Put another way, it would be inconsistent with the intended purpose of s18(2) if the inclusion of additional steps following the production of a human being or human embryo resulted in the claim circumventing the s18(2) exclusion.

Potential to be human


The Applicant also argued that the relevant claims were outside the scope of the exclusion from patentability because blastocysts formed via parthenogenic activation of unfertilised human oocytes do not have potential to become a human being. The Delegate agreed, stating at [30] (emphasis added):

[T]he entity produced following parthenogenic oocyte activation does not have the potential to lead to birth so does not lie on the pathway from fertilisation to birth, and thus cannot claim the status of a human being. At each point from oocyte activation to the formation of the blastocyst, as well as developmental stages further down the developmental path, the entity is not a human being.

In reaching this decision, the Delegate considered the differences between a parthenogenic blastocyst and a blastocyst produced by fertilisation and concluded that this developmental structure cannot be considered a human being because:
  • it contains only maternal DNA, not a complete genome;
  • it lacks all the imprinted genes that would be provided by the paternal genome;
  • it is incapable of developing the extraembryonic tissues that support embryogenesis; and
  • the oocytes activated in the claimed methods cannot divide and produce all of the differentiated cells of an organism.
The claimed processes were therefore held to be patentable because they were not capable of generating a human being.

This decision is consistent with the findings of the Court of Justice of the European Union in International Stem Cell Corporation v Comptroller General of Patents, Designs and Trade Marks, Case C-364/13 (18 December 2014), in which it was held that 'in order to be classified as a ‘human embryo’, a non-fertilised human ovum must necessarily have the inherent capacity of developing into a human being'.

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