Can You Patent Embryonic Stem Cells? - The ECJ Ends the Fight, For Now

As was discussed quite extensively on this very blog some months ago, the genesis of human life and its formidable times are a topic riddled with controversy and a myriad of viewpoints, yet the topic has not come to contention much in the judiciary. Since the opinion of Attorney General Villalon, discussed by this very writer in the link above, the actual decision of the European Court of Justice has been anticipated by many, especially in light of the potential future of stem cell research in the EU. The ECJ's decision is hugely important in a world-wide context, potentially seeing a precedent which will either hinder or enable other similar jurisdictions to allow or disallow similar patents, even in light of the Myriad Genetics saga in the US.

The case in question, International Stem Cell Corporation v Comptroller General of Patents, Designs and Trade Marks, for the uninitiated, deals with two patent applications, filed by the International Stem Cell Corporation, relating to stem cells; more specifically "...methods of producing pluripotent human stem cell lines from parthenogenetically-activated oocytes and stem cell lines produced according to the claimed methods, and... the isolation of pluripotent stem cells from parthenogenetically-activated oocytes, and product-by-process claims to synthetic cornea or corneal tissue produced by these methods". To put things into more simplistic terms, the applications (GB0621068.6 and GB0621069.4) relate to the usability of stem cells or their production from oocytes (female egg cells). A more detailed expression of the facts and the prior judgments can be found in this writer's article discussing the Attorney General's opinion.

A parent's dream, endless potential (Source: Bizarro Comics)

The Court was therefore faced with the same question posed to the Attorney General: "...whether Article 6(2)(c) of Directive 98/44 must be interpreted as meaning that an unfertilised human ovum whose division and development to a certain stage have been stimulated by parthenogenesis constitutes a ‘human embryo’ within the meaning of that provision" and be unpatentable under the Directive. The interpretation of the Article in question hinges heavily, as discussed by the Attorney General, on the ECJ's earlier decision in Oliver Brüstle v Greenpeace, where the Court saw that "...any human ovum must, as soon as fertilised, be regarded as a ‘human embryo’ within the meaning and for the purposes of the application of Article... since that fertilisation is such as to commence the process of development of a human being". This is a key distinction, as the cells in ISCC's applications would not be capable of development into a human being. Even with this in mind the Court saw that "...a non-fertilised human ovum must be classified as a ‘human embryo’" as the cells, when harvested, are still capable of being fertilized and possess the potential to develop into a human foeatus, thus falling within the meaning of a 'human embryo'.

The Attorney General saw things differently in his interpretation of the law, and the Court in the case in hand agreed with him: "...a non-fertilised human ovum must necessarily have the inherent capacity of developing into a human being" to fall under the definition of a 'human embryo', contrary to Brüstle. ISCC's patents cover the use of cells in a state where they cannot possibly be fertilized and multiply, thus not, under the Court's current considerations, be classified as a 'human ebryo', and be exempt from patenting. The Court then summarized its position very well: "...where a non-fertilised human ovum does not fulfil that condition, the mere fact that that organism commences a process of development is not sufficient for it to be regarded as a ‘human embryo’... [and] [b]y contrast, where such an ovum does have the inherent capacity of developing into a human being, it should... be treated in the same way as a fertilised human ovum, at all stages of its development".

In the end the ECJ rejected the notion that ISCC's patents would encompass a 'human embryo', and accepted the patenting of stem cells, so long as they are truly incapable of development, either inherently or through genetic manipulation (which ISCC indicated it would be doing to the cells in their applications). What this decision demonstrates is a much more open approach to patenting stem cells, and in this writer's opinion, represtents a healthy and morally correct approach to stem cells and patents, especially in light of potential future developments in the field and a correct application of the law. 

Whether the courts will face any new cases dealing with different, potentially more nuanced and 'grey' approaches to stem cells or genetics in general in the future remains to be seen, but the potential dvelopment in the area is exciting, both from a human perspective and a legal one as well. 

Source: IPKat

Can You Patent Embryonic Stem Cells? - Preliminary Thoughts

Sometimes people seeking patents just seem to want to be the focus of hatred or controversy, especially when it comes to newer areas of medicine or scientific progression. Although this blog has discussed more unsavory topics, such as patenting clones or the method of selecting desirable traits for your child, the field constantly brings forward more interesting questions posed to the judiciaries of various countries. It so happens yet another such a question has been posed, this time pertaining to the potential patenting of embryonic stem cells; a topic which has been discussed at length by our neighbors across the pond in the US.

The case in question is International Stem Cell Corporation v Comptroller General of Patents, initially having been dealt with in the High Courts of the UK, having since been referred to the European Court of Justice for clarification. Although the opinion delivered is of the Advocate General Cruz Villalon's, it still remains an important indication of the potential direction of the ECJ's ultimate decision on the question, but is no way binding.

What the matter dealt with were two patent applications filed by the International Stem Cell Corporation, namely GB2431411 and GB2440333 (application numbers GB0621068.6 and  GB0621069.4 respectively), which effectively sought to patent certain applications for the use of human stem cells taken from embryos. Upon first inspection the patents were rejected by the UK Intellectual Property Office, based on the ECJ's previous decision in Oliver Brüstle v Greenpeace almost three years ago, which sought to decide what the definition of a 'human embryo' was under Directive 98/44/EC. This decision was important for the case in hand as it effectively limits the patentability of embryos, through which embryonic stem cells, for commercial or industrial purposes. The decision in Brüstle was why the patents were rejected at first instance, and serves as a platform from which the Advocate General formulated his view on the case.

To give more exposition on the patents at hand, as said above, they both deal with specific applications involving human stem cells extracted from embryos. Application GB0621068.6, titled "Parthenogenic activation of human oocytes for the production of human embryonic stem cells", to put in incredibly simplistic terms, deals with the production and cultivation of stems cells from unfertilized oocytes (female egg cells) through the manipulation of oxygen tension. These cells are often referred to as "parthenotes", which can turn into practically any cell type in the human body. Application GB0621069.4 deals with the use of said parthenotes to produce synthetic corneas. What is worth noting is that the ECJ saw, in Brüstle, that "...any human ovum after fertilisation, any non-fertilised human ovum into which the cell nucleus from a mature human cell has been transplanted, and any non-fertilised human ovum whose division and further development have been stimulated by parthenogenesis constitute a ‘human embryo’". This would, through superficial assessment, include Stem Cell Corporation's inventions and therefore prevent them from being patented.

The distinguishing factor for the Stem Cell Corporation, in their argument, is that the cells harvested have been modified so that they cannot continue human development; a reason under which the UK IPO rejected the application: "...Brüstle was intended to exclude from patentability only organisms capable of commencing the process of development which leads to a human being". This would run contrary to Schedule A2 of the Patents Act 1977 and the Directive it implements. According to the Stem Cell Corporation "...the inventions in question concern parthenogenetically-activated oocytes [ which are] not 'capable of commencing the process of development of a human being...' due to the phenomenon of genomic imprinting" and are therefore beyond the interpretation of Brüstle and the legislation.

The Advocate General's opinion is an interesting one, as he argues that "[t]he wording of Article 6(2) [of the Directive] itself makes clear that the list of prohibitions is non-exhaustive", which leads to an issue of whether the Directive would therefore include a non-developmentally capable parthenote. Mr. Villalon proposed that "[t]he non-exhaustive character of the list in Article 6(2) of the Directive implies that the exclusion of a parthenote from the concept of human embryo contained in Article 6(2)(c) of the Directive, does not prevent a Member State from excluding parthenotes from patentability based on Article 6(1) of the Directive".

Mr. Villalon furthered this point by arguing that the Directive is not one which is meant to be the 'law of bioethics'. Interpreting the Directive can lead to a discussion of morality and public impression; a discussion the judiciary will have to address to a degree. He leaves the matter more for Member States to decide, to see whether they deem the prohibition of embryonic patents a necessity in light of morality of public order.

Discussing submissions from the UK, France, Sweden and the Stem Cell Corporation, in addition to his understanding of the Brüstle case, Mr. Villalon did come up to a conclusion where he saw that the term 'human embryo' should not include developmentally incapable parthenotes: "Unfertilised human ova whose division and further development have been stimulated by parthenogenesis are not included in the term ‘human embryos’ in Article 6(2)... of [the] Directive... as long as they are not capable of developing into a human being and have not been genetically manipulated to acquire such a capacity".

Whether the ECJ sees things like the Advocate General will remain to be seen, but the opinion at least leaves the option of embryonic patents relating to cells which are not able to develop into a human being. This is a promising sign in light of future developments in the field of using stems cells to treat humans, yet still limiting it to ones where there is a lesser issue of morality, i.e.  the development of a human being. This writer for one is quite keen on reading the Court's opinion upon its publications, along with a healthy amount of others I am sure.

Source: PatentlyO

Can You Patent Clones?

As this humble writer is an identical twin, the existence of two things which are at least genetically almost exactly the same, was never in doubt and almost seemed mundane at times. Yet for others this may not be this easy to comprehend, and can almost act as a novelty of sorts. A subject matter of pure science fiction, cloning has always been a topic of great discussion, even outside of genetic oddities such as identical twins. Although personally this writer has never indulged in the idea of patenting his own sibling, the question has risen with regards to clones in the United States in a recent case a mere few days ago.

The decision in question is In Re Roslin Institute, which was dealt with in the US Court of Appeals early this month. The case concerned the creation of a woolly mammal, Dolly the Sheep, by Keith Henry Stockman Campbell and Ian Wilmut in Edinburgh Scotland in the mid-1990s. Dolly was cloned through a method called somatic cell nuclear transfer, where the nucleus of a cell is removed and planted into an enucleated oocyte; the female's egg cell prior to it maturing. By fusing the two Mr. Campbell and Mr. Wilmut could create an embryo, which could subsequently be implanted into a surrogate mammal, creating a cloned copy of the animal from which the original nucleus is taken from as a baby animal. The creator's of this new cloned mammal were awarded a patent for the process in 2009; however the patent was not at issue in this case. What was at issue was their US Patent Application No. 09/225,233, which was initially rejected by the Patent Trial and Appeal Board and then appealed.

Lauren was disappointed not being able to patent her sister

Under contention in their '233 application were a few claims, more specifically claims 155 and 164: "155. live-born clone of a pre-existing, nonembryonic, donor mammal, wherein the mammal is selected from cattle, sheep, pigs, and goats... [and] 166. The clone of any of claims 155-159, wherein the donor mammal is non-foetal". The case is one of the first to apply the new Myriad Genetics Supreme Court decision (more on which can be found here and here), where the Court saw that isolated genes cannot be patented as they were naturally occurring and not "...markedly different" from their natural forms. Roslin did argue that clones "...[are] the product of human ingenuity... [and] not nature’s handiwork, but [their] own". Clearly on the outset one can argue that a genetic clone, although clones by humans, is still the handiwork of nature as the clone is still a near identical copy to the original cell donor. Further proving this very point, the court pointed out that Dolly does not have "...markedly different characteristics from any [farm animals] found in nature", even though the process of cloning was one done by man. To put things bluntly: "Roslin did not create or alter any of the genetic information... of its claimed clones... [n]or did [Roslin] create or alter the genetic structure of [the] DNA used to make its clones". Clearly therefore the clone cannot be patented, as it is not markedly different from the original cell donor.

The Roslin Institute did argue that the resulting animal would be different from the donor animal in terms of phenotypic differences, such as size, color and shape. The claims contain nothing pertaining to differences in phenotype, and what is claimed still maintains the genetic copy, which would be natural and have no marked differences. This was discussed in the Funk Bros. Seed v Kalo Inoculation: "[t]heir qualities [i.e. phenotypes] are the work of nature. Those qualities are of course not patentable. For patents cannot issue for the discovery of the phenomena of nature".

Justices Dyk, Moore and Wallace dismissed the appeal, and therefore closed the door on patenting clones, at least to some extent: "To be clear, having the same nuclear DNA as the donor mammal may not necessarily result in patent ineligibility in every case. Here, however, the claims do not describe clones that have markedly different characteristics from the donor animals of which they are copies[, therefore making them ineligible]". Some opinions have been given against this decision, such as Pilar Ossorio who saw that "[t]his ruling is taking away an incentive for research organizations to pursue more research into cloning, at least on the margins".

The impact of this decision can be said to potentially negatively affect the future of cloning, and more so cloning either in agriculture or medicine. The court did still leave the patentability of clones open for future consideration, however on the face of the decision it seems highly unlikely unless the new clones are markedly different from the original organism from which they are cloned.

Source: JDSupra