EPO-EU Conference Examines Hot Topic Of Patentability Of Plants In Europe

The last couple of years have brought heated discussions in Europe on the patentability of plant innovations, leading to a recent amendment of patent application rules at the European Patent Office. Two major actors share this innovation landscape: the biotechnologists and the plant breeders, with similar but not identical needs for protecting their invention. A joint conference on innovation in the plant sector was held recently by the EPO and the Community Plant Variety Office.

The European Patent Office (EPO) and the (European) Community Plant Variety Office (CPVO) held a joint conference on 29 November on innovation in the plant sector. The programme of the conference is here [pdf]. In February 2016, the EPO and the CPVO signed a cooperation agreement on these issues. The EPO delivers patents on plant inventions, according to the European Patent Convention, and corresponding rules. the CPVO delivers plant variety rights.

On November 2016, the European Commission issued a Notice on certain articles of Directive 98/44/EC, concluding that products (plants or animals) produced by essentially biological processes are not patentable (IPW, Biodiversity/Genetic Resources/Biotechnology, 04 November 2016), leading to industry concerns (IPW, Biodiversity/Genetic Resources/Biotechnology, 9 February 2017). That notice contradicted a decision of the EPO Enlarged Board of Appeals on so-called tomato and broccoli cases.

Following the EU Commission notice, on 29 June the EPO Administrative Council took a decision to amend regulations 27 (patentable biotechnology inventions) and 28 (exceptions to patentability) of the European Patent Convention to exclude from patentability plants and animals exclusively obtained by an essentially biological breeding process. The EPO published its 2017 examination guidelines [pdf] in November.

A process for the production of plants or animals is essentially biological if it consists entirely of natural phenomena such as crossing or selection, according to the European Patent Convention.

All applications and examinations had been halted after the Commission note. According to an EPO spokesperson, the EPO examiners apply those guidelines on a case-by-case basis. “Consequently, treatment of the stayed cases, too, has been resumed, but it is still too early to provide any results yet as the processes are ongoing. Moreover, it should be borne in mind that applicants and patentees in general also have the possibility to withdraw their pending cases out of their own motion. This may be expected as plants or animals exclusively obtained by an essentially biological process are not any longer patentable,” he told Intellectual Property Watch.

EPO – CPVO Collaboration

Traditionally in Europe, the biotechnology industry relies on patents to protect its inventions, while breeders mostly operate under a sui generis system, which provides a breeders’ exemption allowing breeders to access breeding material.

Margot Fröhlinger, principal director, Unitary Patent, European & International Legal Affairs at the EPO, said at the conference that the EPO and the CPVO are jointly committed to ensure that industry and breeders maintain their confidence in the validity and quality of patents and of plant breeders’ rights. Plant breeders’ rights and patents are complementary rights, which co-exist she said. The EPO and the CPVO cooperation is threefold: the exchange of technical knowledge, working tools and best practices; cooperation in responding to technological developments; and increasing efficiency and accountability.

Francesco Mattina, vice-president of the CPVO said that the CPVO is an agency of the European Union, established in 1995, and based on the International Union for the Protection of New Varieties of Plants (UPOV) Convention of 1991.

Clarity Needed on Terms

Jean-Luc Gal, policy officer at the European Commission DG Growth, said at the time of the discussions leading to the 1998 EU Directive 98/44/EC on the legal protection of biotechnological inventions (biotech directive), the clear dividing line was the topic of genetically modified organisms.

Gal remarked that the EU notice is non-binding and related issues are still being discussed. The commission has no intention of modifying the biotech directive, he said.

Bettina Wanner, head of IP advocacy for Bayer Intellectual Property GmbH, speaking on behalf of the European Crop Protection Association (ECPA), praised the benefits of patents, in particular as a vector for innovation, and voiced some concerns about the EPO Administrative Council decision. She said the decision does not provide clarity on important terms such as essentially biological processes. Clarity should remain about the patentability of technical processes, she said.

The ECPA suggests to clarify that only plants with a technical feature, which are characterised by clear, unambiguous, and verifiable genetic information, deserve patent protection.

The same request of a clear definition of “essentially biological process” was made by Claudia Hallebach, head of research and development, legal affairs and intellectual property for KWS SAAT SE, a global crop breeding company headquartered in Germany. She also called for open access to breeding material, and underlined the fact that patents are creating monopolies. She said patents could spur innovation but access to breeding material should be preserved through open platforms or patent pools.

A few days before the conference, on 21 November, the International Community of Breeders of Asexually Reproduced Ornamental and Fruit Varieties (CIOPORA) had released its position on patents for plant-related inventions (IPW, Biodiversity, Genetic Resources, Biotechnology, 23 November 2017). Philippe de Jong, vice-chair of the CIOPORA Working Group on Patents, presented the position paper and said as a matter of principle, plant-related inventions should not be treated so differently as they are essentially deprived of patent protection. If an invention meets the patentability requirements of novelty, inventive step and industrial applicability, then it should be patentable, he said.

CIOPORA does not support the view that products from essentially biological processes should be automatically excluded from patentability, he added.

Niels Louwaars, director of Plantum, the Dutch association for the plant reproduction material sector, said breeders need protection to invest, in particular intellectual property rights, to prevent the product of their research from being too easily copied by free riders.

Breeders spend between 15 to 30 percent of their turnover on research and development (R&D), and most R&D investment is made on the basis of plant breeders’ rights protection, he said.

IP rights are an important element in innovation policy, and the breeders’ exception is crucial, said Louwaars. Breeders are not worried about the number of patents, but worried that the material they have been working on for many years may fall under the scope of a patent.

Breeders are looking at some of the granted patents with disbelief, Louwaars said, adding that the use of mutation technique should not be used as a pure escape from the exclusion of essentially biological processes and product. Not every application of CRISPR-CAS will be considered as equally inventive by breeders.

Judiciary has to Step Up Said Academic

Axel Metzger, professor of civil law and intellectual property law at Humboldt University in Berlin, giving an academic view about the EU Commission note, said the EPO Enlarged Board of Appeals, which is a judiciary body shifted its responsibility to take a policy decision back to the legislator, the EU, which in turn said it does not want to amend the directive, so as not to “open the Pandora’s box.” He qualified this as “a tragedy.” The EU Commission, the executive body, had to try to solve the issue, he said, and the opinion of the EU Commission changed the landscape, he added.

Metzger criticised the decision of the EPO President Benoît Battistelli to freeze all pending proceedings after the publication of the EU Commission note. The EPO Administrative Council then took over, he said, and took a decision, but such decision comes at a price and if it had retroactive effects, could pose patent validity issues.

The European Patent Convention is a very static instrument, he said, and the more dynamic European Union has difficulties because of the political controversy around the issue. He called for the judiciary body (EPO Enlarged Board of Appeals) to step up.

EPO Explanation on Patentability

Heli Pihlajamaa, director patent law at the EPO, explained that since 1 July 2017, conventional plants have been excluded from patentability, which applies both to pending patent applications and new applications.

The EPO added information on this exclusion in its guidelines for examination, she said. In particular, the guidelines state that “the exclusion extends to plants and animals exclusively obtained by means of an essentially biological process where no direct technical intervention in the genome of the plants or animals takes place, as the relevant parental plants or animals are merely crossed and the desired offspring is selected for.”

The guidelines also explains that the term exclusively, as used in rule 28 (“excludes products (plants/animals and plant/animal parts) exclusively obtained by non-technical, i.e. essentially biological processes.”) is used to mean that “a plant or animal originating from a technical process or characterised by a technical intervention in the genome is not covered by the exclusion from patentability even if in addition a non-technical method (crossing and selection) is applied in its production.”

Pihlajamaa explained the technicalities of patentability criteria, taking a random example of a red cucumber.

It the cucumber in question is obtained through conventional breeding, crossing and selecting, the plant is not patentable. Parts of the plant, which are propagating material such as seeds, are also excluded from patentability. Parts of the plant which are not propagating material, for example oil, are patentable if they meet general patentability criteria.

Mutagenesis, which is a process by which the genetic information of an organism is changed, either occurring naturally or through a technical intervention, is much discussed at the moment, she said. Technical interventions include several methods, including CRISPR-CAS, a gene editing method. If the red cucumber was obtained through such methods, providing it meets general patentability criteria, it would be patentable in principle, she said. The same applies to plant parts, products, and traits. Natural mutations are excluded from patentability.

If the red cucumber was to be a genetically modified organism, the process and plants would in principle be patentable, Pihlajamaa said, and the same goes for plant-derived products, traits, and genes.

 

Image Credits: Flickr – International Atomic Energy Agency (IAEA)