Intellectual Property IP Issues

The access to plant biodiversity from natural habitats is fraught with legal complication, especially for broad-scale corporate campaigns involving the collection of hundreds, or even thousands, of species. Furthermore, many plants have been employed for ritual or medicinal uses and their commodification has sociological implications not addressed by IP considerations. The resolution of these issues, discussed in detail in the Chapter 4, is complicated by the asymmetry between biodiversity-rich developing nations and technology-rich Western countries. 

As a result of this ambiguity, many countries have placed barriers on the exporting of biological materials, even for non-commercial research. In retrospect, rather than fuelling biodiversity conservation, the CBD has raised unrealistic expectations and has proved inadequate to cope with the complexity of drug discovery. 

The commodification of traditional knowledge poses problems that also transcend intellectual property considerations since, in indigenous communities, medicinal plants can have cultural, symbolic and ritual values that go beyond a simple medicinal or economic use. Thus, the cultivation of a plant outside its natural habitat and the capture of its medicinal properties into a commercial product can generate mistrust, inequality and betrayal because the loss of the cultural value is not addressed by any monetary compensation. These problems have been exemplified by the development of Hoodia gordo-nii,46 a sacred life force of the South African San, which was turned into a commercial slimming aid .47 

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In addition, many other aspects have to be considered when developing a catalytic reaction for indnstrial nse catalyst separation, stability, and poisoning handling problems space time yield process sensitivity toxicity of metals and reagent safety aspects as well as the need for high pressure equipment. Last but not least, intellectual property (IP) issues were and still are of great concern (see below). 

I m wondering whether Dow and other companies in the industry have experienced a comparable over-the-wall experience in which you have the scientist working on R D while the agreements are negotiated over the wall by intellectual property lawyers with boilerplates, who may not necessarily appreciate some of the tradeoffs involved in the collaboration and cooperation issues. How sophisticated have the lawyers needed to become, and is this going to be a topic of greater contention or cooperation with intellectual property (IP) ... 

A number of different characterization techniques mentioned above are used to help distinguish between co-crystals and salts and it should be noted that in some cases differentiation between the two may still be difficult. It should also be pointed out that although salts and co-crystals often posses different properties (e.g., stability or solubility), these issues from a pharmaceutical development standpoint may not be influential as long as the process can be monitored and closely controlled. However, for intellectual property (IP) rights and regulatory issues, differentiating between a co-crystal and a salt is important. 

Components sourced from other companies that use Previously Developed Software (PDS) This issue most often arises due to the purchase of sensors and actuators which have embedded software - the so-called Smart Sensor problem. The difficulty here is that the pedigree of the PDS may be unknown, or the quality control system used by the supplier company may be considered inadequate, or else the supplier company may be reluctant to divulge information about the software because they consider it threatens their Intellectual Property (IP). Acronym alert Software-based devices can also be known as COTS devices - since they use Commercial Off The Shelf software, as opposed to bespoke software. Software whose origins are unknown can be called SOUP - Software Of Unknown Provenance. 

Many of the issues that should be considered in the sourcing of biocatalysts and biocatalyst-derived materials are much the same as for traditional reagents and chemistry-derived materials. Some of these are cost, quality, reliability of the vendor, control and security of intellectual property (IP), freedom to operate (FTO), the vendor s business model, avoidance of being single sourced, etc. Some of the perceived differences and issues are often due to the fact that biocatalysts, and somc-ing aspects associated with them, are still an emerging or developing area. 

The most frequently considered product attributes are technical or qualitative in nature however, there are also issues such as Intellectual Property Rights (IPR - or more often just IP) where its quantity must also be matched or exceeded by its quality. A patent must not only be in existence, it must be written in such... 

The vast majority of compounds are provided with no intellectual property rights retained by the snpplier. As a consequence, the end nser is able to captnre IP for use of the compounds immediately on making a discovery. Composition of matter rights is another issue, however, since in almost aU cases, the compounds are already in the public domain. Thus, in these situations, the end user only creates novel compositions of matter through chemical modifications to the initial hits as part of a lead-optimisation... 

In Europe, some of the universities will charge a fee. This gets to the issue of overhead. They actually make money. A decision in that case was, Okay. We aren t going to argue with you on intellectual property. Who knows whether anything will come out of this research Who knows whether there s going to be an invention You pay us a fee, right up front, versus uncertainty later, and you get to own the IP. We know exactly what that s worth. Very few U.S. universities ever think about that. 

Farnley and colleagues [96] have recently reviewed the complexity of intellectual property around biotechnology and biotechnology products. The authors note that the IP issues for small molecules and macromolecules, with a few exceptions, may be more similar than commonly assumed. The most important difference relevant to this overview is that each step in the discovery process may potentially be subject to different intellectual property considerations, which the authors note as unusual. The major differences between small-molecule and macromolecule patenting are shown in Table 1.3-11. 

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