Development Ethical and Societal Issues Satyen Baindur PhD

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Stewardship in Nanotechnology Development: Ethical and Societal Issues SATYEN BAINDUR, PHD Ottawa Policy Research Associates, Inc. OPRA Report 2006-4-1 Issued April 2006 ------------------------------------------------------------------------------------------------ broad patent claims can be granted for “pioneering” inventions, which involve a breakthrough that opens a whole new field. For example, it may be claimed that the process for making carbon nanotubes, discovered in the early 1990’s, was one such. On the other hand, “improvement” inventions are usually not granted such broad claims. An example of an “improvement” invention is a batch of purified nanotubes having a certain ratio of semiconducting to conducting (i.e., metallic) nanotubes. The nanotechnology field is also distinctive as far as IP rights are concerned, in that, given the many different possible applications for a specific nanotechnology innovation; the claims of patent applications have often tended to be quite broad. There is therefore a perception in the nanotech community that “patent thickets” may have developed in some nanotech sectors. A case in point that is particularly relevant to cancer nanotechnology may derive from the fact that quantum dot patents are largely held by photonics and electronics companies, while dendrimer patents are held largely by pharmaceutical and cosmetics companies. Thus innovators developing a product involving both might very well have to negotiate a patent thicket with multiple patent holders. Therefore an important set of issues in the field of nanotech IP arise from the need to prevent the development of patent thickets, and to factor in the interdisciplinary and convergent nature of nanotechnology to weed out overly broad individual patent claims as well. Other issues that arise in related areas include those dealing with the definitional characteristics of nano- and nanobiotechnology, both for patent granting purposes and for regulatory purposes. Here the physics-based definition of 1-100nm size range will not suffice 13 , and may even tend to inhibit legitimate patent filings on the one hand, as well as encourage trivial filings on the other. For example, merely bringing a previously existing product into the nanosize range is considered patentable by some and not by others - this is a relevant issue to settle. The characterization of nanomaterials, both in general and in the context of specific health-related applications is an important step 13 Note that the Greek word ‘nano’ means ‘dwarf’ or ‘very small’, and this is the sense in which the term is likely to be used as a prefix outside the strict physics context. 16 16
Stewardship in Nanotechnology Development: Ethical and Societal Issues SATYEN BAINDUR, PHD Ottawa Policy Research Associates, Inc. OPRA Report 2006-4-1 Issued April 2006 ------------------------------------------------------------------------------------------------ prior to clinical trials and subsequent submission for regulatory approval. In the US, the National Cancer Institute has specifically established a Nanotechnology Characterization Laboratory tasked with carrying out pre-clinical testing and characterization of nanotechnology-related cancer treatments. Such a characterization facility would interface with both intellectual property offices and with regulatory approval mechanisms. It would also have to coordinate with standards setting and metrology institutions 14 . The academic background of patent examiners, and whether it includes sufficient inter-disciplinary focus, both to recognize and discourage overly broad patent claims on the one hand, and encourage truly novel applications on the other, is another relevant issue. A related issue deals with standards setting, measurement, and verification of nanoparticle and nanomaterial related claims. This capacity is critical to patent granting, regulatory approval, and to health and safety evaluation. In the health and safety context, moreover, the related issue of dose metrics is relevant in estimating the exposure to nanomaterials, and can be acted on only when there are widely accepted measurement standards. The importance of standards and verification is greater in the nanomaterial context because many of their properties appear strongly dependent on the physicochemical environment in which they find themselves. This fact has actually impeded reproducibility and verification of research results even in a purely academic context, and the issue is likely to be even more critical in the commercialization context. 17 14 Specifically, the Nanotechnology Characterization Laboratory (NCL) at the US National Cancer Institute is tasked with developing and performing ‘an analytical cascade’ that tests the pre-clinical toxicology, pharmacology and efficacy of nanoparticles and devices (US NCL Business Plan, 2006), and interfaces with all potential application streams in health, safety and manufacturing. 17
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Development Ethical and Societal Issues Satyen Baindur PhD

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