When it was founded in 1988, the Vidon Group was first established on Breton lands, in the maritime region of Saint-Malo, before expanding in France and internationally. As a result of this historic location on the Channel coast, the Vidon Group has always been committed to protecting marine biological resources and marine by-products, which include micro-algae, a category of micro-organisms.
Micro-organisms are living beings, invisible to the naked eye, generally unicellular. They include, in particular, microalgae, bacteria, viruses, plasmids, unicellular fungi such as yeasts and certain protozoa.
The protection of micro-organisms as living organisms is governed by a number of specific rules. This article focuses in particular on the patentability of micro-organisms, and therefore micro-algae, before the European Patent Office (EPO) and the United States Patent and Trademark Office (USPTO). As the French National Institute of Industrial Property (of French acronym INPI)’s approach in this area is very similar to that of the EPO, it will not be specifically addressed[1] .
The EPO’s approach
A naturally occurring micro-organism that is merely discovered cannot be protected by a patent if it is a discovery as such, which is excluded from patentability[2] .
However, if it is demonstrated that a micro-organism, although existing in its natural state, has a particular technical effect, not yet known, for example producing an active principle of particular interest, the micro-organism itself may be patentable as one of the aspects of the invention[3] . In fact, a micro-organism that occurs naturally and is isolated can be validly protected if it meets the patentability criteria (novelty and technical effect justifying an inventive step and an industrial application). The European Patent Convention (EPC) lists a number of patentable biotechnological inventions, including biological materials isolated from their natural environment or produced by means of a technical process, even when they pre-exist in their natural state[4] .
However, animal and plant varieties, such as seaweed varieties, obtained by essentially biological processes, that do not involve any direct technical intervention, are directly excluded from patentability (unlike genetically modified plants, for example, which are patentable)[5] . Microorganisms obtained by microbiological processes are not concerned by this exclusion[6] .
Furthermore, when patent protection is sought for a micro-organism, it is often necessary to deposit a sample of this biological material with an International Depositary Authority (IDA) recognized by the Budapest Treaty[7]. In some cases, such a deposit is necessary to meet the requirement of sufficiency of disclosure, another criterion for obtaining a European patent[8] . This approach is particularly essential when the public does not have access to the micro-organism and that it is not possible to provide a written description enabling a person skilled in the art of the invention in question to reproduce it technically and identically[9] .
There are fifty IDAs in the world, spread over some thirty countries. Each of them accepts only certain types of micro-organisms. In the case of micro-algae, their deposit is not accepted by all the IDAs, and in particular not by the National Collection of Microorganism Cultures (of French acronym CNCM) of the Pasteur Institute, which is the competent IDA in France. However, the CCAP (Culture Collection of Algae and Protozoa) in the United Kingdom and the BEA (Banco Español de Algas) in Spain are qualified European authorities for the deposit and conservation of micro-algae, and also the ATCC (American Type Culture Collection) and the NCMA (Provasoli-Guillard National Center for Marine Algae and Microbiota) are competent authorities on American territory. Under the Budapest Treaty, all States party to the Treaty, including the member States of the EPC and the United States, recognize deposits made with one of the IDAs in patent proceedings, regardless of the territory in which the IDA is located.
The deposit of a micro-organism with an IDA made no later than the filing date of a European patent application can then be used to define the micro-organism of an invention to be protected and meet the criterion of sufficiency of description. It should be noted that when the depositor of the micro-organism and the applicant of the patent application are not one and the same person, it is necessary to justify to the EPO that the depositor of the micro-organism has given authorization for reference to be made to the deposit with the IDA in the patent application, and has unreservedly and irrevocably agreed to make it available to the public in accordance with the applicable Rules[10]. However, restricted access to the micro-organism is provided throughout the term of the corresponding patent: the supply of a sample to a claimant[11] who requests it is conditional on his undertaking not to communicate the micro-organism or one of its derivatives to third parties and to use it only for experimental purposes, unless the applicant or patent owner expressly waives this[12] . The applicant for a patent may also restrict access to the micro-organism to an independent expert, until the European patent is granted, or for 20 years if the patent application is not granted[13] .
Thus, a micro-organism in the claims of a European patent application may be validly defined in various ways, which may include: its IDA deposit number, its isolated character, its characteristic genetic sequence(s), a functionality, or structural and/or functional characteristics resulting from genetic modifications made to the micro-organism. In addition, other products or processes of interest resulting from the use of a patentable or unpatentable micro-organism as such may also be protected, if they meet the patentability criteria. These may include a compound produced by or derived from the micro-organism (e.g. a biopolymer or a particular active ingredient), a process using the micro-organism, or its use, for example in therapy, cosmetics, agriculture, etc.
The USPTO’s approach
Only the major differences between EPO practice with regard to the protection of micro-organisms are discussed.
In the United-States, products derived from nature are not eligible for patent protection[14] . Contrary to the European approach, a micro-organism that exists in nature, even if isolated from its environment, is not patentable in the United-States, if it is not shown that the micro-organism for which protection is sought has characteristics (structural, functional or other) that differ from those of the micro-organism present in its natural environment. It does not matter that the presence of this micro-organism in its natural environment or that a new advantageous property of this micro-organism has never been demonstrated. [15] .
On the other hand, a genetically modified micro-organism, or a process using a micro-organism, or a composition combining the micro-organism with another component that provides a technical effect not described in the prior art, may be patentable inventions[16] . Of course, in order to be patentable, these inventions must meet the other patentability requirements applicable in the United States, which are, in particular, novelty, non-obviousness and sufficient written description.
As before the EPO, it is very often necessary to make a deposit with an IDA in order to have a sufficient written description. There are, however, certain differences concerning the date on which this deposit with an IDA must be made and concerning the access to the micro-organism:
- It is possible that the deposit of the micro-organism with an IDA, which would be deemed necessary by the USPTO (United States Patent and Trademark Office) to provide a sufficient written description, would be made after the filing date of the US patent application[17] .
- In the United-States, once the US patent has been granted, the only possibility for the patentee to restrict access to third parties to a micro-organism deposited with an IDA is to require that the request for access be made in writing by an identified third party and communicated to him[18] .
The importance of signing MTAs
Whatever the protection strategy envisaged, it is important that any transfer of a micro-organism of interest to another entity, in the context of research, studies or collaborations, is subject to a specific biological material transfer agreement (better known as an MTA for “Material Transfer Agreement”). Such an agreement, which establishes a framework of confidentiality, is essential to avoid any disclosure that destroys novelty or is likely to challenge the patentability of the invention that could be protected. An MTA is also a mean to formalize the rights over the micro-organisms, the authorizations for use and disclosure, and the obligations regarding the information that must appear in any scientific publications that may be allowed.
Our Attorneys are of course available to provide any additional information you may require and to assist you in the protection of your inventions relating to micro-organisms, particularly micro-algae, to make deposits with the IDAs and to set up MTAs.
[1] in the context of the Directive 98/44/EC of 6 July 1998 on the legal protection of biotechnological inventions.
[2] under Article 52(1) of the European Patent Convention (EPC).
[3] see the Guidelines for Examination at the European Patent Office (DIR EPO) G-II-3.1.
[4] see DIR EPO G-II-5.2 and Rules 27(a) to 27(c) EPC, which incorporate the provisions of the Directive 98/44/EC of 6 July 1998.
[5] under Article 53(b) of the EPC, in conjunction with Rule 28(2) (see also DIR EPO G-II-5.4).
[6] It should be noted that in its decision G 1/98, 5.2, the EPO’s Enlarged Board of Appeal stated that in Article 53 b), the expression “microbiological processes” is synonymous with “processes involving micro-organisms” and that the EPO treats cells and parts of cells as micro-organisms – see also DIR EPO G-II-5.5.1.
[8] the criterion of sufficiency of description is governed by Article 83 of the EPC.
[9] as set out in Rule 31(1) of the EPC.
[11] Rule 33(1) EPC: From the day of publication of the European patent application, the biological material filed in accordance with Rule 31 shall, on request, be accessible to any person and, before that date, to any person entitled to inspect the file under Article 128(2).
[12] Rule 33(1) and (2) EPC.
[13] Rule 32(1) EPC (see also DIR EPO A-IV-4.3).
[14] Article 35 USC 101 of the US Code and Manual of Patent Examining Procedure (MPEP) 2106.
[15] https://www.uspto.gov/sites/default/files/documents/101_examples_1to36.pdf – Assoc. for Molecular Pathology v. Myriad Genetics, Inc. 569 U.S. 576 (2013) “The Court held that the composition was not patent eligible because the patent holder did not alter the bacteria in any way.”
[16] see in particular Diamond v. Chakrabarty, 447 U.S. 303 (1980).
[17] 37 CFR 1.804 of the Code of Federal Regulations.
[18] 37 CFR 1.808 of the Code of Federal Regulations.