EU Commission Says Plants And Animals From Conventional Processes Not Patentable

The European Commission has issued its opinion on certain articles of the EU directive on biotechnological inventions, in particular the patentability of plants or animals obtained as a result of natural occurrence such as selection and crossing. The Commission found that the intention of the EU when drafting the legislation was to exclude such products from patentability.

The European Commission Notice on certain articles of Directive 98/44/EC of the European Parliament and of the Council of 6 July 1998 on the legal protection of biotechnological inventions was published on 3 November.

The Commission’s notice is not legally binding and the document states: “The Notice is intended to assist in the application of the Directive, and does not prejudge any future position of the Commission on the matter. Only the Court of Justice of the European Union is competent to interpret Union law.”

Directive 98/44/EC deals with the legal protection of biotechnological inventions and harmonises national law on the patentability of inventions relating to biological material. Discussions have been ongoing about the patentability of plants or animals obtained through a conventional breeding methods.

In March 2015, the European Patent Office Enlarged Board of Appeal decided on the so-called “Tomato II” and “Broccoli II” cases, that such plants were indeed patentable (IPW, Biodiversity/Genetic Resources/Biotech, 1 April 2015). This decision created an uproar among civil society saying that the EPO is favouring giant agrochemical companies to the detriment of small breeders and consumers.

The issue is expected to be considered by the European Patent Office Administrative Council in its meeting on 21 November, an EPO source said. The EPO is not an EU body but includes the EU member states.

The European Parliament, on 17 December 2015, took a non-legislative resolution saying that “a ban on the patenting of products obtained by conventional breeding techniques, such as crossing, is essential to sustain innovation, food security and small businesses,” (IPW, Biodiversity/Genetic Resources/Biotech, 8 February 2016).

The parliament also asked the European Commission to look into the patentability of products derived from essentially biological processes, the issue of cross-licensing between patents and plant variety rights, and access to deposited biological material, according to the EU Notice issued yesterday.

In February, an EPO spokesperson told Intellectual Property Watch that the EPO is merely implementing the law that was handed down to them by its member states, particularly the European Patent Convention.

The notice explains that Article 4 of the biotech directive addresses the patentability of plants and animals, and specifically excludes plant and animal varieties from the scope of patentable subject matter. Article 2 defines an essentially biological process as consisting entirely of natural phenomena such as crossing and selection. However the directive “does not state whether plants or plant material (fruits, seeds, etc.), or animals/animal material obtained through essentially biological processes, can be patented.”

According to the commission notice, “the main rationale for the March 2015 decisions of the Enlarged Board is that exclusions from the general principle of patentability have to be narrowly interpreted in law. From its analysis of the official background documents for the negotiation leading to the EPC [European Patent Convention] in 1973, the Enlarged Board determined that nothing could be interpreted in the sense that plants or plant materials obtained through essentially biological processes were to be excluded from patentability.”

“While these decisions of March 2015 are in line with the intentions of the drafters of the EPC, it is questionable whether the same result would have been reached in the EU context,” the notice said.

Looking at the preparatory work spanning several years before the adoption of the biotech directive, and at the interpretation of the directive in the EU context, the commission took the view that the “EU legislator’s intention when adopting Directive 98/44/EC was to exclude from patentability products (plants/animals and plant/animal parts) that are obtained by means of essentially biological processes.”

According to European Union source, through this notice, the EU Commission provides information that will assist in enhancing legal security in the biotech, plant and animal breeding sectors.

EPO to Consider EU Commission Notice

An EPO spokesperson told Intellectual Property Watch that “In 1999, the EPO Member States decided to integrate the EU Directive on Biotech into the EPO’s legislation. If they decide that the recent interpretation given by the EU Commission in its communication needs to be followed as well, the Office will implement it, as we also implemented ECJ interpretations of the Directive in the past.”

“The responsible subcommittee of the EPO’s Administrative Council is expected to address this issue in its meeting on 21 November,” he said.