The availability of the Arabidopsis genome and gene sequences represent an opportunity to investigate the influence of such data on patenting, patenting opportunities, and patenting strategies of stakeholders. Such an investigation is useful, not only to those patenting related “inventions”, but also to those who use the data, the model system, or who intend to use similar systems. Whilst other genomes, including those of bacteria (e.g. E. coli), invertebrates (e.g. C. elegans and Drosophila), and the human genome (Jensen and Murray, ref###) are also useful in this regard, the availability of an analysis for a popular plant genome offers many advantages for those in the plant sciences and/or agribusiness. Understanding what has happened in Arabidopsis with respect to patenting allows us to better understand:
- The evolution of patenting strategies of the stakeholders
- Freedom to operate issues relating to the data
- The extent to which the organisms genome is protected by patents
- The ability of the patenting system to deal with such “inventions”
- The influence of related patenting activities on public and not for profit research
Although most of the members of the AGI were not for profits or government institutions, funded through public money, companies such as Monsanto (throught Cereon Genomics Inc) and (###) Perkin Elmer Applied Biosystems (### CHECK THIS) did support their efforts. Monsanto also sequenced the related Landsberg genome, and has supplied this data to the not-for-profit research community. Hence the sequencing and sequence data that exists today for Arabidopsis was affectively acheived through collaboration between private and public organisations. The end result of this collaboration, the genomic sequence, the ESTs, and the genetic markers are available to scientists throughout the world (either directly via public databases such as GenBank and dbEST, or under agreement with Monsanto for the Landsberg data).
However, a number of problematic issues exist with respect to Arabidopsis sequence data, particularly the data that was (and still might be) the focus of bulk sequence claims made by Paradigm Genetics Inc, and to a lesser extent those made by Mendel Biotechnology Inc. and Ceres Inc. Such companies have sought to protect their investment in Arabidopsissequencing and research through patenting of large groups of genes. The initial step in such a strategy has been to apply for patent protection over large groups of genes. This “maximalist” strategy is not uncommon in patenting strategies focused towards other similar technologies, and arguably makes good business sense. Unfortuneately, once applications for large groups of sequences are made, this generates uncertainty for others in the field.
Almost paradoxically, patent applications may have a similar or greater influence on downstream deliverability of products and services than patents themselves. Compared to granted patents, applications may have the following properties:
- Very large numbers of sequences in claims sections (sometimes many thousands)
- Extremely broad claims (possibly overlapping into the genomes of distantly related organisms)
- Applications can be re-written (and continuations made) to include additional details of utility and enablement
One drawback of the ability of applicants to make applications for many hundreds or thousands of genes and/or nucleic acid sequences is the uncertainty this generates in the minds of potential users of the technology.
Uncertainty can take many forms, and this can result in researcher/strategists asking questions such as:
- How many, if any, of these claims will be granted?
- What influence will a granted claim on an Arabidopsis homolog have on the deliverability of products arising from my research?
- Who do I talk to about licensing gene “X” ?
- Are applications with “abandoned” status REALLY abandoned? Or are there continuations, CIPs, or divisionals just around the corner?
This uncertainty may form a barrier to use of the technology by others. Additionally, as we have seen in previous chapters, the strategies used by some applicants seem to rely heavily on establishing an early priority date for bulk sequence applications and then supplying “inventiveness” and “enablement” at some much later date. It is also possible for owners of the IPR to license technologies that are not-as-yet patented.
These properties of patent applications and the uncertainty generated by them produces a de facto protection for the technology under application. Hence, although most of the claimed sequences present in bulk sequence applications will never produce a granted patent, they are in effect “protected” by the applicant and some aspects of the monopoly possible under a granted patent (de jure protection) is acquired by them.
As we have seen in the case of bulk sequence applications, few sequences from applications have made their way into granted patents. Possibly because applications themselves offer a form of protection that allows income to be derived from licensing without the need for a granted patent. At this point granted patents appear to hold far less Arabidopsis sequences than patent applications. This is almost certainly due to the economies involved in making and maintaining applications rather than generating, maintaining and defending granted patents.
|Imagine the cost of producing granted patents for 1,800 transcription factors at ~US$20,000 each!
Then compare with the economy of filing 2 or 3 new continuations each year.
It is unlikley that the originators of the US patent office envisaged that continuation and divisional applications would be used in this way, since the original system was established essentially to allow monopoly protection of mechanical inventions and not genomic information. Arguably, granted patents offer a far higher degree of certainty for both applicant, licencees, and business than does a patent application. However, the creation and maintenance of uncertainty (either wittingly or unwittingly) provides in some cases a more economical business tool to monetise a technology.
Future for this Landscape
Charting an IP landscape surrounding any genome is a large undertaking. To ensure that this landscape is useful to as many as possible and is functional as soon as possible, we have chosen to analyse briefly only a small part of the IP surrounding the Arabidopsis genome. The choice to focus our analysis on only patent documents involving bulk sequence claims was made to ensure we could meet these initial goals. As with any landscape, constant revision and additions are required to keep the cartography accurate and relevant. With this in mind, we do not intend that this present version of the landscape is finished. It is instead a first step towards a more detailed landscape. The intention has always been that this document should by dynamic and flexible, and that user comments would help shape future landscape efforts.
Towards this end, the landscape is marked throughout with user commentable regions. We would be very interested to hear your comments about any of the regions of the landscape which you feel could be improved. We are particularly interested to hear from people who have first hand experience in these matters (Arabidopsis research, patenting, licensing, and legal aspects). User feedback will help us in directing future efforts to expand and update the landscape (and, if necessary, make corrections to the existing landscape).
Providing your input and help at an early stage of this project may very well create a landscape that provides yourself and users like you with a useful and valuable resource.
29th June 2006