Patentability Of Some Biotech Uncertain In Europe As Examination, Opposition Suspended

The patentability of plants or animals that have been obtained by natural occurrence such as selection and crossing has been a recurrent issue discussed at the European Patent Office (EPO). A recent notice from the European Commission challenged a ruling by the EPO Enlarged Board of Appeal on such patents, prompting yet more discussions in the organisation. In the meantime, all examination and opposition on such patents have been halted at the EPO. Industry is concerned that the EPO ruling might be questioned, and warns of effects on innovation, harm to applicants. Civil society is concerned about a non-transparent process.

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 was contrary to a 2015 ruling of the EPO Enlarged Board of Appeal (IPW, Biodiversity/Genetic Resources/Biotech, 1 April 2015) and (IPW, Biodiversity/Genetic Resources/Biotech, 4 November 2016).

In December, the EPO decided to stay all proceedings in examination and opposition cases in which the invention is a plant or animal obtained by an essentially biological process.

According to a European Patent Office (EPO) December press release, the decision followed discussions by EPO member states in the organisation’s Patent Law Committee of the Administrative Council about the EU Commission notice.

The EPO in the release, said, “In its practice the EPO applies the Biopatent Directive, which was introduced into the European Patent Convention by decision of the EPO member states in 1999 and which has no explicit provision in relation with plants or animals obtained from such processes.”

“Should the EPO member states follow the interpretation offered by the European Commission Notice, the EPO will implement their decision,” it said.

According to an EPO notice dated 24 November, “The President of the EPO has decided that, in view of the potential impact of the Commission Notice, all proceedings before EPO examining and opposition divisions in which the decision depends entirely on the patentability of a plant or animal obtained by an essentially biological process will be stayed ex officio.”

The EPO notice also states that “If proceedings are stayed, the examining or opposition division concerned will inform the parties accordingly. At the same time, it will withdraw any communications setting them time limits to react, and will despatch no further such communications until the resumption of proceedings.”

Notorious cases at the EPO in recent years about the patenting of conventional plants were the so-called “Tomato II” case on a “method for breeding tomatoes having reduced water content and product of the method”; and the so-called Broccoli II case involving a “method for selective increase of the anticarcinogenic glucosinolates in brassica species,” on which the EPO Enlarged Board of Appeal decided that those inventions were patentable.

EPO Defends its Practice

The decision taken by the EPO President, a source from the EPO Directorate Patent Law, told Intellectual Property Watch, follows the principle of good administration practice, which requires that “while a legal provision is reconsidered, the practice based on it is stayed, as it is the case when a question of law is referred to the Enlarged Board of Appeal.”

According to the EPO source, “once proceedings have been stayed no further communications are despatched by the examining/opposition division and any communications setting time limits are withdrawn.”

“Proceedings are stayed until the impact of the Notice on the EPO practice will be clarified by the Administrative Council, as the EPO governing body composed by the representatives of the member states,” the source said, adding that “the EPO and its member states are making an effort to reach a clarification very soon.”

Another source at the Directorate Patent Law told Intellectual Property Watch that the EPO Administrative Council (the governing body of the EPO), and one of its subcommittees,  the Committee on Patent Law, “intend to have the topic on the agenda of their respective meetings during the first half of this year.”

The EPO will release a final decision as soon as it has been reached by the Administrative Council, the source said.

The EPO calendar of meetings is here. The Board of the Administrative Council meets several times a year. The next meeting dates for the Board are 16 February, 26 April, and 23 May. The next meeting of the full Administrative Council is scheduled for 28-29 June, and the Committee on Patent Law will meet from 27-28 April.

Industry Disagrees with Commission Notice

According to EuropaBio, the European association for bioindustries, products obtained by essentially biological processes for the production of plants should remain eligible for patent protection.

“Patents for such innovations should be granted when the claimed inventions meet the stringent criteria for patentability applied to any other field of technology,” EuropaBio Secretary General Nathalie Moll told Intellectual Property Watch.

“We respectfully disagree with the retrospective view of the Commission that the EU legislators’ intention when adopting Directive 98/44/EC may have been to exclude such products from patentability,” she said in an email.

“[W]e are disappointed with the EPO’s recent decision … to stay examination of patent applications in which the decision depends entirely on the patentability of a plant or animal obtained by an essentially biological process,” she said. “However, we do notice that the Commission limits the definition of essentially biological processes to a narrower definition than the one provided by the Enlarged Board of Appeal of the EPO. Therefore, whilst we await further legal clarity, we do hope that the EPO also thoroughly acknowledges this narrower definition.”

CropLife International told Intellectual Property Watch that it was surprised by the EPO’s announcement of December. “There seems to be no legal basis for the EPO to decide to stay all proceedings,” the source said.

“Such stay can only be legitimate if there is an open question of law, i.e., a pending referral to the Enlarged Board of Appeal. However, the Enlarged Board of Appeal has issued a decision on this subject matter, which continues to be binding on the EPO.”

“It is therefore essential,” said the source, “that the examination process of the EPO takes its normal course, since otherwise legitimate patent applications will incur an illegitimate delay, with damaging consequences for the applicants.”

According to Moll, the Commission’s interpretation raises three main issues: The first is that it creates “a legal vacuum and conflicts with the opinion of the Enlarged Board of Appeal of the EPO – the competent European patent granting authority – which recently reached the opposite conclusion in the Broccoli and Tomato II cases.”

“In the absence of patent protection for an invention obtained by essentially biological processes, plant breeders will be discouraged from research, development and investment to foster innovation and, therefore, there will be fewer innovative features for plant breeders to access and farmers to use,” she said.

Finally, she said, “the exclusion of products from essentially biological processes from patentability does not address or resolve any concerns with respect to access to such products and predictable commercial availability. ”

“As EuropaBio, we encourage further discussion in the area and would welcome the opportunity to work with all stakeholders towards securing a balanced and flexible patent protection approach for plant-related inventions,” she said.

Civil Society Sees Process Lacking Transparency

Public Eye (former Bern Declaration), which is a party in several opposition cases at the EPO, told Intellectual Property Watch that it “certainly welcomes the halt to grant new patents on products derived from essentially biological processes as long as no political decision has been taken.”

However, the Public Eye source said the way the proceedings have been halted was done in a “very non-transparent” way and “casts a bad light” on the EPO.

As a party to several opposition cases, Public Eye said it has never been informed about a formal halt on the cases and “about the reasoning behind it.”

The Public Eye source remarked that the EPO notice stated that in the event of a staying of proceedings, the examining or opposition division concerned will inform the parties accordingly. “This never happened,” he said.

 

Image Credits: Flickr – Jonas Ingold, Flickr – International Atomic Energy Agency