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Summary for the biotech and safety open book exam
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Biotechnology and safety, GMP andintellectual property
Exam
MIR604 is a genetically modified maize developed to confer field protection against corn root
worms. The inserted gene is a modified cry3A-gene from Bacillus thuringiensis (Bt) ssp.
Kumamotoensis. This gene codes for a Bt-toxin, which confers resistance to western
corn rootworm (Diabrotica virgifera virgifera), northern corn rootworm (Diabrotica
longicornis barberi) and other related coleopteran species. Agrobacterium tumefaciens-
mediated gene transfer is used for transforming the maize, using a modified pmi-gene from
Escherichia coli, that allows the transformed plants to utilise mannose as a sole
carbon source, as selection marker. The maize will be used for animal feed production.
1) Are the products considered “genetically modified organisms” in the EU?
2) Can you identify 2 environmental concerns that you feel should be considered important
when bringing the product to the market? How can you collect information in order to
determine that the risk is acceptable?
3) Do you see any issue related to access of genetic resources (within the context of the
Convention of Biological Diversity)?
4) Assuming that the concept of the case is new
- How could you safeguard the intellectual property rights of the different aspects
of the above outlined case? Think broadly and work out in detail.
- If you would have chosen to use patent protection, how would you defend the
inventive step (non-obviousness) of the invention under patent law. Work out in
detail
- A competitor has a granted European patent, with filing date of 04-01-2005 on the
concept of using the a modified pmi-gene as a selection marker. The maize feed
production facility is in Europe. Can this maize feed be exported to Brazil? Can it be
produced or sold in Europe?
5) Are there any timing aspects to consider regarding when to submit a biosafety
authorization (assuming it is applicable in this case) and filing a patent application?
1
,How to tackle this
1) Identify the information needed
What would be worthwhile to protect (product, process, service,...)?
Is there something new?
Is there an invention
Is it patentable or not (patent eligible)
Other (i.e. non-patent) ways to protect it
2) If there is something patentable: apply the problem solution approach to argue
inventiveness (non-obviousness)
What is the closest prior art?
What is the difference of what you try to claim?
Is there a technical effect resulting from this difference?
Define the problem to be solved
Is the solution to this problem (i.e. the difference of point 2) obvious for a
person skilled in the art of the invention?
3) Is there a plant variety right that could be protected?
What is the commercially interesting product (plant, fruits, seeds, processed
material)?
Is the variety new (i.e. sold previously)?
Distinct, uniform and stable (i.e. is there a phenotypical difference)?
Or is It merely a genetic difference not resulting in a phenotypical difference?
4) Other IP rights possible?
TM (name, logo, …)?
Design for packaging?
Utility model?
Database protection?
Copyright
Trade-secrets/know how (and how to safeguard secrecy and deposit)?
5) What about the freedom to operate (FTO) question?
What is the commercially interesting product (plant, fruits, seeds, processed
material)?
Is it covered by the 3th party patent for PVR?
If yes, is the IP right still valid/ in force?
If yes, in which territory and does that affect your business?
Are there potential import/export issues?
If there is a potential freedom to operate issue, how can you solve it?
Do you have something to offer to the 3th party?
6) What about the potential timing issues?
Virtually all IP rights are ‘about being first’
Secrecy vs publication and creating own prior art (this sometimes includes
also applying for authorization, clinical trials, grants in big consortia, …)
2
, Take into account what you can do prior to filing e.g. a patent application
while needing to collaborate with 3rd parties
Introduction
What is a GMO?
- "any technological application that uses biological systems, living organisms, or
derivatives thereof, to make or modify products or processes for specific use”
UN Convention on Biological Diversity, Art. 2
- The application of:
a) In vitro nucleic acid techniques, including recombinant deoxyribonucleotide acid
(DNA) and direct injection of nucleic acid into cells or organelles or
b) Fusion of cells beyond the taxonomic family,
That overcomes natural physiological reproductive or recombination barriers and that
are not techniques used in traditional breeding and selection.
Cartagena protocol on biosafety, Art.3
3
, - Uncontrolled transfer of many genes at random
- Limited to compatible species
- Only possible for species with sexual reproduction
- Limited to traits available in compatible species
- Limited understanding of underlying mechanisms
- uncontrolled effect on many genes at random
- challenge to screen desired function
- limited understanding of underlying mechanisms
- Transfer of single well defined genes with known properties
- It is also known which traits the gene is associated with
Gene editing
Establishing a mouse model with multiple mutations
- Conventional tools:
Single mutations, sequential steps
Each single mutation up to a year and cost US $20 000
- CRISPR system
Single step, multiple mutations
Few weeks and CRISPR tools costing US $30
Synthetic biology
4
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