Intellectual property rights in the European Union aim to protect companies and businesses from exploitation of their invention and give credit to their investment and effort, giving them an advantage in their fields of activity, especially for small and medium-sized enterprises (SME). More generally, intellectual property focuses on the protection of the product, and the product’s owner (Drahos, 1999).
Intellectual property rights include (European Union, 2019):
- Patents: A patent gives the inventor of the new invention exclusive rights on it for 20 years. This means that any other person is prohibited from use or sale of this invention. However, the patent can be sold to another person or permission can be given for use of the invention in a patent licence agreement. After the limited time period of 20 years the patent expires and cannot be renewed.
- Trademarks: Similar to patent are trademarks. In this case the exclusive rights are not for a specific invention, but on distinctive signs such as designs, logos, sounds, colours, shapes etc. The period of time the trademark protection is active amounts to 10 years, after which time the trademark can be extended.
- Design Protection:Design protection gives a person the exclusive right on the design of parts or the whole product. However, the owner of the design protection can give permission to another person to use this design.
- Copyright: Copyright protects an author of original literary or the creator of scientific or artistic work from the plagiarism of others. This means that no other person is allowed to publish or reproduce the work. The copyright is effective until 70 years after the death of the last author/creator of the work. In non-EU countries which signed the Berne Convention the copyright is valid for at least 50 years after the death of the creator.
- Database Protection: A database which is electronically accessible can be protected in two ways or both in combination. If the structure or design is newly and specifically created for this database and should be protected, then this can be done via copyright. If the focus of protection is on the content and not the structure of the database, the Sui generis right can be applied. Hereby it must be proven that a substantial investment has been made in the form of either financial, material and/or human resources to create the content of the database. The Sui generis protection is valid for 15 years from the date of creation or from the date when the database was published for the first time.
As the biotechnology field has developed over the past decades, intellectual property rights have become more and more necessary for rising biotech companies in order to become integrated into the largely competitive field. Indeed, intellectual property rights have systematically stimulated creativity, innovation and increased competitiveness of commercial activities..
In Europe, the patenting process is free and available to any type of status: institutes, universities, large or small companies and individuals. In an innovation, the patent can cover the design, the goal/aim, the material it is made with, and lastly, the engineered system ("Patent protection in the EU - Internal Market, Industry, Entrepreneurship and SMEs - European Commission", 2019).
If we, team MSP-Maastricht decide to continue post-iGEM and bring the RocKit to the next level by becoming a start-up, our team would need to undertake several measures to protect their creation. First it is important to point out that the RocKit fulfils the patentability requirements, which are following article 52 of the European Patent Convention (EPC) (European Patent Office, 2016) :
- Needs to an invention in any field of technology (GII)
The RocKit is an invention in the field of synthetic biology
- Needs to be susceptible of industrial application (GII)
The RocKit can be used in the chemistry industry, ecology industry, biology research, geology industry, medical research.
- Needs to be new (GIV & GVI)
The RocKit was created by the MSP-Maastricht Team for the iGEM competition.
- Needs to involve an inventive steps (GVII)
It is an innovation that has not been created in the field of synthetic biology
As previously mentioned, Intellectual properties rights would guarantee the RocKit competitiveness and credits, but would additionally bring up opportunities such as:
- A proof of safety and quality of the kit aas the invention will be reviewed and will entitle the kit as harmless and health-secured, an important distinction that can help to build the RocKit’s reputation. Additionally, patents are often the most detailed technical documents made available.
- Allowing indirect exploitation with approval of the RocKit team and licensing contracts, which would allow additional revenue and broader coverage/using of the kit. This would also allow more RocKit users.
However, in the past decades, biotechnology inventions have developed increasingly sophisticated, pushing the European Patent Office to write in 1998 the Directive 98/44/EC, completing the EPC, in the name of ethics and safety. Hence according to the EPC, “biotechnological inventions” are defined as “inventions” which concern a product consisting of or containing biological material, or a process by means of which biological material is produced, processed or used. Additionally, "Biological material” is defined as “any material containing genetic information and capable of reproducing itself or being reproduced in a biological system”. As the directive states in article 4, section 3, while plants, animal varieties and essential biological processes for their production are not patentable, microbiological inventions and other technical processes are eligible to for patents (European Parliament, 1998). Hence any synthetic biology innovation can be patent as long as they are ethical and non-harmful.
The RocKit, as with most synthetic biology designs, is composed of multiple genetic entities, commonly referred to as “parts”, that together form the innovation. Hence, as the system can be subdivided, a common strategy is to patent every one of the individual parts created. However, an important variable must be taken into account, the Contributor agreement with the BioBricks Foundation for iGEM parts. This contributor agreement implies that the RocKit parts would be free of access and protected from any future IPR to whom signed and agree on the BioBrick Part agreement ("Frequently Asked Questions | BioBricks Foundation", 2019). Team MSP-Maastricht is fully aware of this agreement and would respectfully follow it if they ever decide to patent parts of the RocKit. However, their belief is that the sharing of BioBricks plays an integral role in synthetic biology, and it would be regretful if the parts could not be shared with the whole scientific community. The promising alternative to patent “parts” would be to actually patent the method/procedure that was used to create the RocKit. The RocKit is designed as a tool and method which is created for scientists, in order to improve their research. The RocKit method has the potential to be patentable as it is a method of molecular detection, and not a method for treatment, therapy or diagnostics, which are excluded to patentability (European Intellectual Property Helpdesk, 2014). This would make all the parts freely available at the BioBricks Foundation, allowing anyone to engineer something with our parts, while still allow the RocKit method to come under the protection of IPR, according to article 52 of the EPC, (European Patent Office, 2016).
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References
1. Drahos, P. (1999). The universality of intellectual property rights: origins and development. Intellectual property and human rights, 13-41.
2. European Patent Office. (2016). Convention on the Grant of European Patents. München: European Patent Office.
3. European Parliament. (1998). Directive 98/44/EC of the European Parliament and of the Council of 6 July 1999 on the Legal Protection of Biotechnological Inventions. Official Journal of the European Communities, 50, 13-21.
4. European Intellectual Property Helpdesk. (2014). Intellectual Property in Biotechnology. Retrieved from https://www.iprhelpdesk.eu/sites/default/files/newsdocuments/Fact-Sheet-IP-in-Biotechnology.pdf
5. Frequently Asked Questions | BioBricks Foundation. (2019). Retrieved 5 October 2019, from https://biobricks.org/bpa/faq/
6. Patent protection in the EU - Internal Market, Industry, Entrepreneurship and SMEs - European Commission. (2019). Retrieved 5 October 2019, from https://ec.europa.eu/growth/industry/intellectual-property/patents_en
