The European Court of Justice has today banned patenting of stem cell inventions derived from human embryos which are capable of developing into a human being.
The court held that this exclusion from patentability is not limited to the use of human embryos for industrial or commercial purposes, but also includes the use of human embryos for the purposes of scientific research.
Although the ruling follows an earlier legal opinion, it appears to have caused general dismay among scientists who now fear their research discoveries may not be commercialized into patentable inventions.
The test case was brought by Greenpeace against Oliver Brüstle, director of the Institute for Reconstructive Neurobiology at Bonn University, who holds patents on a technique involving stem cells.
The decision is sure to evoke passionate responses. But despite the criticism likely to follow, it’s useful to remember that the Court expressly left open the patentability of therapeutic or diagnostic uses for human embryos.
Here in Australia, the proposed ban on the patenting of genes and biological materials continues to be a live issue.
Senate Inquiry into Patent Amendment
The recent Australian Senate inquiry into the Patent Amendment (Human Genes and Biological Materials) Bill 2010 (Cth), and its subsequent amendments, handed down its final report in late September, after two days of public hearings and sifting through an overwhelming number of submissions.
Those who had hoped for the Senate Legal and Constitutional Affairs Committee to take an emphatic stance on this very important issue were left bitterly disappointed.
Unable to reach a consensus in its report, the members of the Committee managed to issue two diametrically opposed recommendations in its report – a majority and a dissenting view.
While the majority recommended the Bill not be passed, the dissenting section, sponsored by Senators Heffernan, Siewert, Xenophon and former Senator Coonan, took the opposite view.
Clearly, Senator Heffernan’s private bill hit some raw nerves.
The Patent Amendment Bill
It was met with formidable opposition, mainly from biotechnology and pharmaceutical companies, research institutions and universities, as well as by intellectual property and patent attorneys.
Given these competing interests and the strong views of the senators who supported the Bill, it’s unsurprising to find the divisions entrenched in the final report.
What is surprising are the markedly differing approaches adopted by the majority and dissenting groups.
The dissenting report takes a staunchly partisan approach, focusing on submissions supporting the Bill as well as responding to some of the major criticisms.
Little attention is paid to the vast number of critical submissions received by the Committee.
This dismissive approach is ostensibly justified on the basis that these critical submissions are mainly from “sectorial interests associated with the biotechnology, pharmaceutical and agri-biotech industry”, who “are either holders of patents which contain claims to biological materials that are identical or substantially identical to those that exist in nature” or otherwise have a financial, or other interest in securing the procurement of such patents.
By contrast, the majority part of the report takes a far more evaluative approach. Indeed, the majority of the Committee dedicated the bulk of its report to a detailed review of the submissions.
In particular, it focused on 13 key issues raised in evidence. Chief among these were concerns about the need for the Bill as well as its drafting and efficacy.
The majority seemed most concerned by submissions that characterised the Bill as containing “unclear or ambiguous provisions” that “would result in uncertainty for patent applicants and investors in research, and could result in unnecessary and costly litigation”.
Obviously perturbed by these possible “unintended consequences”, the majority then went on to narrow their concerns to nine “key issues” arising out of the patenting of human genes and biological matter.
Although the ethical, economic and health issues identified are of great importance, it is only the first issue — the distinction between discoveries and inventions — which calls for further attention.
A bedrock principle of patent law is that inventions may be patentable, whereas mere discoveries are not.
Colin Bodkin, a leading commentator on Australian patent law, explains that while there are no clear lines in making this distinction, the difference is said to lie in between:
“observing a scientific fact for the first time” (not patentable) and,
“devising a new and useful result by the application of that fact”(may be patentable).
In truth, the elephant in the room is really what “discovery” and “invention” mean in the context of biological materials.
As complex and as vexed as this is, we must ask whether it’s simply beyond us to define what these terms means in this context.
And – if it isn’t beyond us – are we content to reward people with a “eureka patent” for their efforts? In other words, are we content to reward someone for discoveries, such as identifying and isolating genetic mutations (such as BRCA1 and BRCA2) that exist in nature?
The implied basis for granting a patent for this seems to be the recognition that the process leading to such a discovery is incredibly laborious and cost prohibitive, thus deserving of protection.
That seems to be the current practices of patent offices worldwide, but is it appropriate?
Again, the differing approaches in the dissenting and majority reports are telling.
The dissenting report focused heavily on the discovery/invention distinction in making the case that identifying biological materials, whether new or unknown, is simply an “act of discovery, not an act of invention”.
It turned to the guidance proffered on this point by the 2000 Intellectual Property and Competition Review Committee report (Ergas Committee Report).
That report warns of the dangers of defining the scope of patent rights beyond “reasonable limits”.
It insists that “mere discoveries – that is, the identification and specification of the nature, structure, and properties of existing matter and its interaction – should continue to be excluded from the class of patentable subject matter”.
It suggests this principle “should exclude from the scope of patent protection the mere identification of a gene sequence”.
ACIP would like to maintain the status quo in relation to the test for patentable subject matter as stated in its recent report.
Although one may accept the majority’s view that the proposed amendments “will at best, not assist to clarify the distinction between discovery and invention in the patent system and, at worst, make the distinction more obscure”, it’s difficult to accept the report’s lack of engagement with the implications of the Ergas Committee Report.
To put it another way, in preferring a “technology neutral approach” to the fixing of the line between discovery and invention, the majority report simply doesn’t answer the fundamental question raised by this inquiry – whether, as a matter of principle, human genes and biological materials ought to be patentable subject matter.
Or, to borrow the words of Senator Heffernan, whether “the materials that make us who we are and what we are can be monopolised and commoditised”.
Perhaps the recognition of the Bill as “well-intentioned” by the majority of the Committee provides us with valuable insights into their views on this issue.
If we accept this, then surely we must accept that it’s not beyond the competencies of a skilled parliamentary draftsperson to translate these good intentions into legislation.
Meanwhile, even though s 18(2) of the Patents Act provides that “human beings, and the biological processes for their generation, are not patentable inventions”, the full implications of this prohibition in Australia are yet to be realised.
This latest move by the European Court of Justice may prove important in what is sure be an ongoing tussle over the patentability of human embryos, and, more generally, the patenting of genes and other biological materials.
With all this uncertainty abounding, decisive legislative action is required. Time will tell whether this will happen.