In their monthly column, Carlos María Romeo Casabona and Iñigo de Miguel Beriain, take a look at the legal issues in synthetic biology.

 

New opinion on IP!

The Opinion of the General Advocate of the European Court of Justice, in relation with the case  delivered on 10 March 2011, has been published.

Its final conclusion is this:

 

V –    Conclusion

119. In view of all the foregoing considerations, I propose that the Court give the following answers to the questions asked by the Bundesgerichtshof:

Article 6(2)(c) of Directive 98/44/EC of the European Parliament and of the Council of 6 July 1998 on the legal protection of biotechnological inventions must be interpreted as follows:

–        The concept of a human embryo applies from the fertilisation stage to the initial totipotent cells and to the entire ensuing process of the development and formation of the human body. That includes the blastocyst.

–        Unfertilised ova into which a cell nucleus from a mature human cell has been transplanted or whose division and further development have been stimulated by parthenogenesis are also included in the concept of a human embryo in so far as the use of such techniques would result in totipotent cells being obtained.

–        Taken individually, pluripotent embryonic stem cells are not included in that concept because they do not in themselves have the capacity to develop into a human being.

–        An invention must be excluded from patentability where the application of the technical process for which the patent is filed necessitates the prior destruction of human embryos or their use as base material, even if the description of that process does not contain any reference to the use of human embryos.

–        The exception to the non-patentability of uses of human embryos for industrial or commercial purposes concerns only inventions for therapeutic or diagnostic purposes which are applied to the human embryo and are useful to it.

 

This Opinion raises a huge debate, which is directly connected with synbio. What should be the limits of patenting life? Should we consider it impossible to patent whatever may come from the research involving hESC? Shouldn’t this include IPS cells, as far as the knowledge necessary to develop them comes from that source? We foresee a complicate future!

Carlos María Romeo Casabona

Iñigo de Miguel Beriain

 

 

 

 

 

Sythetic biology: a monopolistic market? Legal measures to prevent this framework

The rising of monopolies in the synthetic biology market is not really a remote eventuality, if we consider that the nature of the additive system results in the most used parts being produced at an increasingly lower cost, a fact which suits the companies to create large part libraries, which contain everything required to construct devices and systems. Should this dynamic continue (something quite probable), it is feasible that in a few years the libraries will become concentrated in the hands of a few, with the less competitive disappearing in favour of those that bring a greater number of parts together, in a “the winner takes it all” type dynamic. And, once one or several companies are in the position that they can dominate this vast library, it will be simple for a situation of monopoly or of come about or of monopolistic competition over the entire market, dominated by private companies, with all that this entails.

The certainty of this risk should lead us to promote competition in this sector. However, to this end we do not believe that the patent is particularly effective. Rather to the contrary, it may serve as a facilitating instrument for the result trying to be avoided, especially if the “raising the bar” policies which are being promoted by the European Patents Office, for instance, are not adopted by all the offices all over the world. In light of this evidence, the stimulus of the systems of joint-ownership between small inventors, in the “open source” style which allowed for the development of Linux, may be a good solution for avoiding monopolization of the sector. So too would the intervention of public entities, obviously, be this directly, through the development of legislation on this sector that provides for the licenses to patents in specific cases, or indirectly, through subsidising the development of essential parts without which these large compilations shall remain limbless, parts that will remain behind in the public sphere and to which companies will only have access to in exchange for permitting, in turn, free access to their libraries (it will be a form of “patent sharking” carried out by public institutions to destroy private monopolies). And finally, it would also be justifiable to use anti-monopoly laws which have already been used in other sectors of human activity (some of which are, incidentally, closely related to software) to prevent the abuse of a dominant position, with greater or less success.

Iñigo de Miguel Beriain

Applying the Precautionary Principle to Synthetic Biology

Of the various principles that are applicable to the use of synthetic biology, the precautionary principle has acquired a noteworthy function. The precautionary principle arose from the search for the protection of human health and the environment against certain activities characterised by a lack of sufficient knowledge of possible consequences, in other words, as a tool for those cases where current scientific knowledge cannot reliably establish if these activities are harmless or, to the contrary, possibly harmful. Therefore, the precautionary principle exists in a yet uncredited environment of scientific uncertainty and suspicion that the activity subjected to evaluation may be seriously harmful.

The precautionary principle presumes the progression from the foresight model (knowledge of the risk and of the causal factors) to one of risk uncertainty, characterised by the incalculable nature of the harm and the possible causal link between one and the other, an aspect for which there is only one generally supported presumption in statistical calculations and probabilities. It is in this context of insufficiency or of limitations in the conceptual construction of foreseeability in which the precautionary principle carries out its function. In such situations protective measures should be adopted prior to the manifestation of the harm, in any insufficiently founded case, in order to determine with greater or lesser precision what measures should be adopted and how to go about it.  This should be the case even though verified scientific evidence of the harmfulness of an activity or product does not exist but is suspected, as has been indicated in this point.

However, the precautionary principle is not applicable to every risk situation, but only those which present two main characteristics: firstly, a context of scientific uncertainty; and secondly, the occurrence of significantly serious and possibly uncontrollable and irreversible harm. It is doubtful that this is precisely the case with synthetic biology, given that some of the features of this biotechnology do not sit well with this principle, as described. The precautionary principle resource presumes that the potentially dangerous effects derived from a phenomenon, product or process that has been identified and for which scientific evaluation cannot determine the risk with sufficient certainty. With regard to synthetic biology, it is difficult to conclude that we find ourselves in this scenario.

In terms of what the reaction or response should be, if the precautionary principle is finally applied to this technology, it is appropriate to highlight that in any case it should be used moderately and reasonably, which should lead us to the application of measures exclusively aimed at preventing the risk of especially serious harm. As can be proven, many other illustrative or regulatory principles, which will be mentioned in subsequent posts, are inspired by or derived from this principle.

Carlos María Romeo Casabona

In this comment, Carlos Maria Romeo Casabona focuses on the issues related to risk. SYNBIO. SOME COMMENTS FROM A LAWYER

November 2010

Synthetic Biology (Synbio) is responsible for creating astonishment and confusion more so than significant new moral dilemmas, for the moment at least. However it cannot be denied that the prospect of its development in the coming years raises many issues

As a global issue, as with other life science related research, a balance between potential risks and benefits should be sought. It would also be beneficial to determine whether the development of new legal tools with which to address the associated problems will be necessary, or, alternatively, if it would be sufficient to apply those tools already possessed to this new discipline.

Throughout the following posts, we will focus on the issue of the inherent risks in synthetic biology and the way in which the Law has developed to minimize the consequences of such risks. More specifically, from here onwards, we will assess whether some of the principles which have been generally and specifically applied to biotechnology over the years, with regard to genetically modified organisms (which are most similar to synthetic biology products), may be also applicable to synthetic biology.

In line with this purpose, principles such as the precautionary principle, the licensing and inspection principle, the “step by step” and “piecemeal” principles, the principle of traceability and transparency, as well as possible restrictions to the free movement of goods will be analyzed in future posts.

Carlos Maria Romeo Casabona

Patenting human life, a question of morals?

November 2010

As it is commonly known, some people oppose to the use of the patent system in the case of synthetic biology as they consider it as contrary to morality or public order. Consequently, they have called for the prevention of establishing any form of ownership over genetic material that may be considered human. Therefore the idea that the human genome, however it is expressed, is the heritage of mankind applies to this field. However, this line of opposition clashes with the idea that artificially generated material is patentable, although the result is similar to what exists in nature. The possibility of patenting life is certainly a reality in our time, especially since 1980. It is even perfectly possible to patent genetic material or biological material similar to that of humans, which appears to exclude the vital importance of the idea of “human” from the barriers to what is patentable. For example, if you can patent a bionic arm which can then be implanted in a human, it would be wrong to believe that one could not patent an artificially generated gene merely because it is identical to one that already exists in nature, although this is human nature.

However, it is undeniable that the fact that the organizational system of the patent contains a clause which excludes the possibility of protecting intellectual property when it is contrary to morality or public order raises a degree of uncertainty about what is patentable and what is not. In the first instance, the application of this clause is clear in cases such as altering the genetic identity of humans or others whereby the creation of commercial totipotent cells is sought, at least in the EU. In other cases, however, it is necessary that the rule delineates whether or not they are included among the practices that contravene morality or public order. So, for example, large areas of doubt still remain in terms of pluripotent cells for example. Of course, it is not easy to define to what extent one can mix human and animal material or when the resulting object would be patentable or not. These questions reflect the importance of an issue which is difficult to resolve: How do you determine what is contrary to morality and public order when this is a changing factor in itself? It is obvious that it is the standards and those who have to draft them, that is, the policy makers, which are the most appropriate bodies to identify the boundaries in this sense. So it would be a great idea to arrive into a kind of political consensus on this issue which may lead to a kind of act which erases this polemic.

Iñigo de Miguel Beriain

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