We've got a new niche!

The SCN Blog has a new name and a new home: http://www.signalsblog.ca

After nearly four years and 207 blog posts, we finally outgrew our dish, so to speak. Late last year, we began planning with the newly-formed Centre for Commercialization of Regenerative Medicine, who indicated an interest to begin blogging in the sphere. (Perhaps you'll recall our name contest?) Why have two blogs competing when one can do the job? The result is Signals Blog (the new name came from an SCN staff member who sadly was not eligible for a prize), which will continue to bring the same level of insight, commentary and research news you've found on the SCN Blog, but will add new perspectives and news on biomaterials, regenerative medicine and commercialization.

We think it's a great partnership that will provide a more comprehensive view of the world of stem cells and regenerative medicine. 

To ease the transition for readers, all archived posts from the SCN Blog have been moved to their new home and RSS feeds will be updated to the new address. Comments will be closed on this site, but we'll keep a copy of the archives here for the short term. 

This is our final post on this site: please update your links and check out our new niche at www.signalsblog.ca!

View from the floor 3: Till & McCulloch Meetings

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A crack in the origin of eggs: policy and fertility implications of oogonial stem cells

by Lisa Willemse, with Ubaka Ogbogu and Timothy Caulfield

The announcement last week that a team of researchers had identified stem cells responsible for generating human eggs caused a ripple of excitement for several reasons. Not only does the news end a controversy regarding an assertion by the same research team that such oogonial stem cells even existed in humans (based on research done in mice), it would appear that this finding will rewrite medical textbooks and change a long-held belief that women are born with all the eggs they will ever have.

Indeed, if oogonial stem cells can give rise to full developed oocytes, it represents a significant crack in the entire notion of fertility and the possibility that adult women of any age could reproduce, as many have noted. If this is the case, IVF clinics could one day find their doors wide open, with fewer limitations on what and who could be a potential client for treatment. 

A seemingly obvious question, then, would be whether such procedures to create eggs for fertilization from oogonial stem cells, either for research or reproductive purposes, would be legal. As we have seen many times before, policy is rarely able to anticipate the directions of science, and thus there is no provision that explicitly deals with the use of stem cells to create oocytes.

In Canada, such activities fall under the Assisted Human Reproduction Act (AHRA). Ubaka Ogbogu, Assistant Professor in the Faculty of Law at the Universtiy of Alberta (and regular contributor to this blog) notes:

Under the AHRA the process of creating oocytes from oogonial stem cells is not banned, but likely regulated (Assisted Human Reproduction Canada license required), however, if the recent Supreme Court of Canada decision is implemented by the federal government, the activity might not even be regulated at all or fall to the provinces to regulate. This would apply for oocytes created for reproductive purposes, but not necessarily for research purposes -- using the oocytes for stem cell research would be likely banned depending on the method, which would follow the same rules as for using normal oocytes for stem cell research. 

A further question that complicates matters, is whether the eggs, when created using this method, can be considered reproductive material. Answers to that question may have to wait until science has taken the time to both replicate the initial study and assess the quality and exact nature of the resulting eggs. As with many new findings, it will be some time before any of it translates into clinical options.

 

Breakfast in the shire: How is the UK reacting to Brüstle v Greenpeace?

by David Kent

Last week I attended a breakfast at Eversheds, a law firm in Cambridge entitled Stem cell patenting, Brüstle v Greenpeace: business breaker or business as usual? which focused on the practical implications of the recent decision from the Court of Justice of the European Union on human embryonic stem (ES) cells. The event organizer, Adrian Toutoungi began the session with a summary of where things stand for hopeful patent applicants which included much of the information that Ubaka Ogbogu reported in his recent article on this site with two interesting supplements:

1. If the implementation of the invention requires the destruction of human embryos, it will not be patentable and it is irrelevant that such destruction may occur at a stage long before implantation
2. Inventions are also not patentable even if the claims of the patent do not cover the actual use of human embryos.

Following this groundwork, two speakers gave their viewpoints on where this leaves the field, both with respect to pursuing patents in the current climate and with the future of ES cell research in the UK. 

First up, Neil Thornton provided historical context for the ruling.  Prior to this new ruling, the status quo was the Wisconsin Alumni Research Foundation (WARF) patent that prohibited human ES cells and cells derived from human embryos from being patented. This new ruling extends the prohibition to cells derived from human ES cell lines or cells derived from human ES cells. Whereas the WARF ruling allowed for patents on inventions that utilized previously created ES cell lines, the Brüstle v. Greenpeace ruling very clearly does not. Dr. Thornton pointed out that the European Patent Office (EPO) is not bound by the Court of Justice of the European Union and has not yet made an official statement regarding the Brüstle v. Greenpeace ruling (though one is expected soon). However, he did quote EPO president Benoit Battistelli from his blog where he said, “If the judges rule in favour of a restrictive interpretation of biotech patentability provisions, the EPO will immediately implement it.” 

Dr. Thornton also speculated on the way forward for those pursuing patents, saying that inventions excluded because they use human ES cells could be viewed as applying to only those technologies where there is no plausible alternative. Therefore, depending on what exactly ends up in the EPO statement, there may be room to patent an invention that could plausibly have used cells from these alternate sources at the time of patent filing (i.e.: using a non-embryo destructive cell source or technique like induced pluripotent stem cells (iPS) or single blastomeres.

Dr. Thornton elaborated with a clever analogy of a obtaining a patent on a method to open a locked safe, which would have a morally acceptable use (by a locksmith) and a morally unacceptable use (by a burglar). Under the EPO's current guidelines, he continued, a morally unacceptable use for an invention is not sufficient to deny patent protection if the invention can also be used in a morally acceptable way. He then speculated that if inventions relating to human ES cells were treated in the same way, the EPO could possibly grant claims that would cover the use of cells produced by embryo destructive or non-destructive techniques. There was some discussion following this point around how similar iPS cells are to ES cells and whether or not they could be viewed as a plausible alternative. 

The second speaker was Cathy Prescott of Biolatris (I featured Dr. Prescott in a previous entry on the Royal Society meeting in 2010), who presented on the impact of this ruling for venture capitalists, industry, and academics. Dr. Prescott started with some numbers that made very clear the low level of investment from members of the BVCA (British Venture Capital Association) into the biotechnology field (1% of all technology investments in the UK) citing reasons of uncertain risk management especially in the area of intellectual property which is viewed as the major currency in the biotech sector. According to Dr. Prescott, “No IP = a non starter.” 

From an industry perspective, she noted that the products and services focused on human ES cells were largely either “tools and reagents” or “therapeutics” and quoted a major company delivering tools and reagents into the research market as saying “if this ban were to prevent patenting of downstream methods… [it would] negatively affect business.” The final area that Dr. Prescott commented on was academic research. The most obvious impact, which has precedence in the United States, is that scientists themselves may relocate to those more permissive environments – in this case, to those where they can protect their of applied research. Secondly, it is entirely possible that various EU states may query whether or not it is worth funding non-commercializable research. For now though, Dr. Prescott stressed that both the EC and the UK are committed to continuing to fund ES cell research as a priority area despite patent concerns, including the major government investment made last autumn.

Overall, as an academic researcher, I found the event particularly useful as a high quality synthesis of the ruling’s implications. It certainly left the impression that things were far from decided. For now, it seems that we will have to wait and see what the EPO decides with respect to ES related patents and how stem cell scientists and universities will move forward with respect to patenting in this sector. 

 

Trading on hope: A look at what motivates stem cell tourists and what happens when it goes wrong

In recent years, the research community has been quite outspoken in its condemnation of rogue stem cell clinics operating in many countries across the globe. Indeed, through announcements made by health and related ministries in China, India and the US, it appears the message is beginning to be heard.  

On the heels of a recent 60 Minutes newscast in the US, a similar exposé aired on January 14 here in Canada. In it, Stem Cell Network Scientific Director Michael Rudnicki spoke with Global TV’s Carolyn Jarvis, condemning stem cell tourism and the agencies that offer them as “despicable” (view the entire Global TV 16x9 segment here). His interview was just a small part of the broadcast, in which the news team looked at the unproven and unapproved therapies offered by a clinic operating in Mexico and a Canadian-based travel operator that offers packages to help people access the services.

Along with Rudnicki, the program profiles several patients, one of whom was successfully treated in an FDA-approved clinical trial for MS, another who was unsuccessfully treated in a Mexican clinic, and a set of parents raising funds to seek treatment in China for their five-year-old son. Each of the struggle to balance the pain of dealing with their ailments, the hope that stem cells could help them, and the risks involved in these experimental therapies.

Exercising caution over unproven therapies: India holds public consultation meetings to update stem cell guidelines

by David Kent

Last fall, I wrote on the Eurostemcell documentary film entitled Stem Cell Revolutions: A Vision of the Future, which featured some experimental stem cell treatments in India, and since that time, I have tried to keep my finger on the pulse of what has been happening in India with respect to stem cell therapy.

Last month a pair of interesting statements were made in the India Times:

“As of today there is no approved indication for stem cell therapy as part of routine medical practice, other than bone marrow transplantation.”

This was followed by:

Whose life is it anyway? Building patient needs and goals into stem cell clinical trials

by Lisa Willemse

In a traditional view of medical research, advances tend to be measured against the overarching goal of cure. Noble as this might be, research is rarely such a black and white affair -- if we have learned anything, it’s that there are innumerable shades of grey.

Even the goal itself can be questioned, especially when achieving it could be 50 years into the future.

Tick, tock, clock – the clock is ticking for you

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New York loves stem cells

by Lisa Willemse

Art shows are not exactly routine activities for those who work in research, let alone in the field of stem cells. So when an art exhibit that examines our perceptions of biotechnology and stem cell research opens in New York, it's something of an occasion. Even more so if New York embraces the show right back, which certainly appeared to be the case of the crowd in attendance, as well as some of the other activities planned around the exhibit.

We've blogged about the Perceptions of Promise exhibit before - the inaugurual exhibit in Calgary early in 2011 garnered a fair bit of attention from critics and the popular press, but the show's presence at the Chelsea Art Museum (running until November 19) somehow underscores the importance of this endeavour. 

Maybe it's because having a show in a trendy New York gallery is a proud achievment for any artist. Maybe it's that all-too-Canadian need to be recognized outside our own country. I'd like to think it has more to do with the importance of the topic itself, which we have so often seen can be polarized and clouded with hype as well as legal, political, economic and religious overtones.

Personally -- and I'm not alone in this sentiment -- I think there needs to be more thoughtful and informed discsussion about biotechnology in atypical locations -- not in labs, but in coffee joints, at dinner parties, on the street, in schools. And if shows such as this one help achieve this, by asking people to think about what it means to them and to stimulate interest and greater understanding, so much the better.

Read full news release. 

Images all from Perceptions of Promise at the Chelsea Art Museum, NY. Top artwork by Sean Caulfield, centre by Royden Mills, bottom by Liz Ingram and Bernd Hildebrandt

EU stem cell patent ruling: too early to predict impact

by Ubaka Ogbogu

The Court of Justice of the European Union (ECJ) ruled this week that scientific research patents cannot be granted for human embryonic stem cell products under European Union (EU) law. The patent in issue, held by Dr. Oliver Brüstle, Director of the Institute of Reconstructive Neurobiology at the University of Bonn, concerns isolated and purified neural precursor cells derived from human embryonic stem cells, their derivation process, and use for treatment of neural defects. Soon after the patents were granted in 1997, Greenpeace Germany filed a successful challenge annulling the patents in the German Federal Patent Court. Dr. Brüstle appealed to the German Federal Court of Justice, which then referred the case to the ECJ for a preliminary ruling on the legal questions raised by the case. 

EU law prohibits the patenting of uses of human embryos for industrial or commercial applications. The main question before the ECJ was whether this prohibition extends to patents on uses of human embryos for scientific research purposes. The Court answered yes, noting that while the aims of scientific research differs from industrial or commercial pursuits, the “grant of a patent implies, in principle, its industrial or commercial application.” In answering the other questions posed in the case, the ECJ also ruled that the meaning of human embryo includes a fertilized human ovum, a non-fertilized human ovum into which the nucleus of a human somatic cell has been transplanted, a non-fertilized human ovum whose further development is stimulated by parthenogenesis, and stem cells derived from human blastocysts. According to the court, the crucial consideration in classifying an entity as a human embryo is whether the technique used to create it (fertilization, parthenogenesis, nuclear transfer, derivation, etc.) commences the process of development of a human being.

The ruling effectively excludes any human embryonic stem cell inventions or products from being patented for any purpose. Without the incentives and protections of the patent system, some are speculating that the ruling will cast a chill on stem cell research in the EU, and may cause researchers to either turn to iPS research or migrate to jurisdictions with more permissive patent regimes. While I agree that the ruling will have some impact on research conduct and progress, I think it is too early to assess what that impact might be. The role that intellectual property (IP), especially patents, play in the context of biotechnology is nuanced, and there is currently no strong evidence to suggest that IP actually promotes the benefits associated with it in the biotech context. So claims that this would affect collaboration, cause brain drain, impact funding, research translation, etc., depend on the assumption that patents play a significant role in all these areas, a view that is much contested.

The ruling, though preliminary, it is binding on all national courts and tribunals in EU member states.