On 20 January public oral proceedings in opposition will take place at the European Patent Office in Munich for European patent EP1962578, which covers virus-resistant melon plants.
The patent relates to melon plants resistant to a virus - cucurbit yellow stunting disorder virus (CYSDV) - that attacks melons, turning them yellow and reducing fruit yield. The plants are made resistant by the introduction of a gene from another melon plant by way of a conventional breeding method involving the use of a genetic marker ("marker-assisted breeding"). The gene which is responsible for the resistance was first found in a melon plant in India catalogued in 1961. The plant has been publicly available since 1966.
The patent covers the modified plant, parts of the plant and its fruits and seeds, but not the breeding process for obtaining the plant.
The patent application was filed with the EPO on 21 December 2006 and the grant of the patent became effective on 4 May 2011. The patent is owned by Monsanto Invest B.V., and has been opposed by Nunhems B.V. as well as by a number civil society groups.
The grant of European patents by the EPO is covered by the European Patent Convention (EPC), an international treaty ratified by 38 European states. The EPC defines the rules and procedures for granting patents for the territory of these states. Incorporating the relevant provisions of EU Directive 98/44 EC on the legal protection of biotechnological inventions, the EPC is applied by patent examiners dealing with patent applications in all technical fields, including biotechnology. The procedure is rigorous: Less than 50% of all patent applications are actually granted, in most cases with the scope of protection of the claims reduced over the original filing. In biotechnology, this figure is even lower, with fewer than one in three patent applications being granted.
Any third party wishing to contest the grant of a European patent can file a notice of opposition to the patent within a period of nine months from the publication of the mention of grant. The notice must contain detailed reasons for the opposition, i.e. it must state how the patent contravenes the provisions of the EPC. The opponent then becomes party to an independent inter partes procedure before an Opposition Division of the EPO, in which he has to argue his case and oppose the views of the patent holder. The Opposition Division is made up of three technical experts and, in some cases, a patent law expert, who have to decide whether the patent can be maintained or whether it should be revoked, either in part or in full.
About five percent of the patents granted by the EPO are opposed, mostly by competitors of the patent holder, but in some cases also by individuals, NGOs or special interest groups. The decision of the Opposition Division can be appealed before the second-instance in-house judiciary of the EPO, the Boards of Appeal. Their ruling establishes a final decision on whether or not an invention can be patented under the EPC. The case law emerging from such procedures is essential for the development of patent practice at the EPO.
The EPO received two notices of opposition to the "melon patent" in February 2012. One of them was from Nunhems, the vegetable seed-producing subsidiary of Bayer CropScience, who objected to the patent on technical grounds, including lack of novelty and inventiveness of the patented plants. The other was from a coalition of NGOs and private persons, who, in addition to technical arguments, voiced their concerns over the use of conventional breeding methods.
This case was stayed ex officio, however, until the EPO’s highest judicial instance, the Enlarged Board of Appeal had ruled on a landmark case, known as "broccoli and tomato II", as the decision on the melon patent opposition depended entirely on the outcome. In March 2015 the Enlarged Board issued its decisions (G2/12 and G2/13) on “broccoli and tomato II” (ruling that the products of essentially biological processes (i.e. plants or fruits) are not excluded from patentability even if they are obtained from such a non-patentable method. Consequently, the EPO has resumed work on the cases that had been stayed.
According to the EPC, the task of the EPO is to grant European patents "for any inventions, in all fields of technology", provided that they are new, involve an inventive step and are industrially applicable. Biotechnology is an important sector of activity of the EPO, involving areas as diverse as microbiology, diagnostics, enzymes for detergents, genetic engineering and plants. Since its creation in 1978 the EPO has granted well over 1.5 million patents in all fields of technology. However, less than 3% of the total of all granted patents deal with biotechnology.
Both the EPC and the EU directive on biotechnological inventions stipulate that plants are patentable if the technical feasibility of the invention is not confined to a particular plant variety. In other words, a patent may only be granted if the invention can be carried out in a number of plants.
In the area of plants, most patent applications relate to genetically engineered (GM) plants and typically concern characteristics such as improvements in yield, higher nutritional value or resistance to drought and pests. However, there is no requirement under patent law for a plant to be modified by genetic engineering techniques for it to be patentable. In recent years, therefore, the EPO has also received a number of patent applications relating to plants obtained by new breeding techniques, such as marker-assisted breeding. Legal clarification as to whether such inventions are patentable under the EPC is still ongoing. A number of important decisions have already been rendered which provide legal clarification as to whether such inventions are patentable under the EPC
The EPO's Enlarged Board of Appeal (EBoA) ruled in G 1/98 that plants are in principle patentable if the technical teaching of the invention is not limited to a specific plant variety or varieties. In 2010 the EBoA decided, in what is known as the "broccoli and tomato I case" (G 2/07 and G 1/08), that a process for the production of plants comprising the steps of crossing and selection is excluded from patentability even if it contains an additional step of a technical nature, such as the use of molecular genetic markers. The EBoA was then asked in another referral to clarify whether the products of such processes (i.e. plants or fruits) are likewise excluded from patentability. In its decisions (G2/12 and G2/13, known as “broccoli and tomato II”) of March 2015, the Enlarged Board ruled that the products of essentially biological processes could still be patented – if the conditions of patentability are fulfilled – even if they are obtained from such a non-patentable method.
The number of patent applications the EPO receives for conventionally bred plants is low (around 70 applications per year), and 7 patents have been granted since 1995.