Why the interest in promoters?
The interest in promoters stems from the myriad opportunities for controlling gene expression. The study and understanding of the function of their multiple components and the factors associated with their performance have opened up the possibility of modulation of the expression of genes in homologous organisms as well as in heterologous organisms, where foreign promoters together with genes of interest are inserted. Promoters are regarded as molecular biological tools crucial for the regulation of the expression of genes of interest. As such, promoter-related patents have a huge influence in follow-on research and development in biotechnology.
What sort of information do we provide on promoters?
There is virtually an endless number of promoters, potentially as many as there are genes. For example, a diploid flowering plant has an estimated 25 000 genes. As full genome sequences of different organisms (e.g., such as Arabidopsis) are becoming available, a great number of promoters are being identified, isolated and evaluated, and many more are likely to pop up in the near future. If we attempted to present them all, it would be a daunting and almost never-ending task. Our aim instead is to present scientific and patent information on some of the most widely used promoters.
The information included in this document comprises:
- Primary information about promoters. Over the last two decades, the concept of what a promoter is has changed. Previously considered to be a string of a few functional sequence elements, promoter sequences are now known to include many structural elements which can have complex functional interactions. We present a view of a consensus promoter, its common elements and functions and describe the basic differences between eukaryotic promoters and prokaryotic promoters. This information has been compiled from a variety of scientific books and journal articles.
- Types of promoters. This section describes different categories of promoters: constitutive promoters, tissue-specific promoters, inducible promoters, and synthetic promoters and their modes of operation, properties, applications and drawbacks. A selection of widely used promoters within these categories is presented in detail. The scientific information has been compiled from scientific books and printed and on-line journals, and information provided by researchers.
- Intellectual property aspects of promoters. As in many burgeoning areas of science with potential far-reaching commercial applications, promoters and their uses are being patented. The analysis of every promoter subject to patent protection would be overly time consuming and probably ultimately not very useful, because almost every gene is likely to be a source of a promoter. Instead, our analyses focus on patents with claims relating to the broad categories of promoters described above, and on details of selected patents with claims relating to specific types of promoters, in some cases. The information deals with:
- Patents on selected widely-used promoters and general promoter types. We assess the possibilities for, and limitations on, further development of technologies that are based on understanding controls that regulate gene expression. The patent analyses provided include general patent information such as patent numbers, total number of patents identified relating to a particular promoter, applicant names, dates of filing, priority claims, grant dates and expected expiry dates. Additionally, we analyse claims of selected relevant patents, including aspects of the prosecution history of certain patents.
- Overlapping patent protection. Although the inventions protected by individual patents cannot be exactly the same, in certain cases, there are patents that due to the breadth of their claim scope may encompass other protected inventions. Additionally, there may be patents sharing common features. Where this is the case, this report attempts to point out the relationships between claims of different patents and the possible room left to maneuver around these claims. Take into account that there may be patents that have not been identified in our searches and further, that there may be patents, that while not entirely about promoters, may have an effect on limiting freedom to operate in technologies relating to regulation of gene expression. For example, this is the case for the restrictive reproductive technologies, dubbed “Terminator” and ” Verminator” technologies, which may have a great impact on the use and development of methods to regulate the expression of genes related to plant reproduction and seed generation.
- IP rights and their impact on the commercialization of technology based on promoters. Although many people regard studies of promoters as being confined to academic research circles, press releases and information provided by agrobiotech companies illustrate how patent rights are used as commercial assets in the agrobiotechnology industry. Patents with claims relating to plant regulatory regions may circumscribe subsequent development and innovation in research on promoters and other research areas that rely heavily on understanding mechanisms for controlling gene expression.