In-house counsel reveal that uncertainty has grown in the agricultural industry after a controversial decision on plant patents from the European Patent Office (EPO) last week.
The office’s Technical Board of Appeal (TBA) decided that plants produced by essentially biological processes must be patentable, contrary to the EPO’s guidelines from 2017 that excluded them from patent protection.
The decision was the latest in a series of attempts over 10 years to clarify whether patent protection can be attained for plants in Europe. But sources say it could reopen the discussion and usher in another decade of doubt in the sector.
“The board’s choice is a big deal for plant patentability in Europe, but it is unlikely that we have heard the last on this matter,” says the IP manager at a European seeds firm. He adds that the result was a legal interpretation, however, and was expected.
“This discussion is being opened up again and again, and now we could face a situation where the Biotech Directive is reopened and we are plunged into legal uncertainty for a long time”
The head of IP at a global seeds company adds that the amended Rule 28 of the European Patent Convention (EPC) – which extended patent exclusion to plants produced by essentially biological processes – has now been declared null and void. But the decision will likely be scrutinised by legislators and agricultural organisations, and could be overturned.
“This discussion is being opened up again and again, and now we could face a situation where the Biotech Directive is reopened and we are plunged into legal uncertainty for a long time,” she says.
The EPO has since said it will consider possible actions together with EU member states. Lawyers have pointed out that if the legislator wants to ensure patents cannot be granted on plants produced by essentially biological processes it will have to change Article 53(b) with an intergovernmental conference.
The head of IP adds that she is not a fan of this outcome and had hoped that the rules surrounding plant patent protection would stay the same.
One source says that his company and the sector broadly will now look at how it can guarantee access to patented plants to ensure that breeding innovation is not stifled.
Going against the grain
The TBA gave its new decision in in oral proceedings for case T 1063/18 on December 5. It concluded that Rule 28(2) of the European Patent Convention, amended in 2017, was in conflict with Article 53(b) of the same legislation as interpreted by the Enlarged Board of Appeal in Broccoli/Tomato II (G 2/12).
Article 53(b) excludes essentially biological processes for the production of plants from patent protection.
The case concerned Syngenta’s European patent application for EP 2753168, entitled “New pepper plants and fruits with improved nutritional value”. The EPO Examining Division rejected the application in view of amended Rules 27 and 28 EPC. The company filed an appeal against this rejection that culminated in last week’s result.
The EPO recently revoked one of Bayer’s patents covering long-stemmed, easily-harvested broccoli because of the 2017 amendments to Rules 27 and 28 EPC.
“Even if I do not know if our patents will be granted in Europe I may still file them [in the US] because those same products will be sold and need to be protected in the US”
The exclusion of plants and animals from patentability was introduced by the EPO’s Administrative Council following a notice from the European Commission that said the directive on biotechnological inventions (98/44/EC) intended to exclude products exclusively obtained by means of an essentially biological process.
Before that, the EPO’s Enlarged Board of Appeal had held that certain tomatoes and broccoli were patentable. The constant changes to these rules has driven enormous uncertainty in the sector.
“After the board made its decision in 2015, we admitted that it went against our position that if something is developed by conventional breeding it should not be patentable – but at least we had legal certainty and could adapt,” says the seeds company head of IP.
She adds that the company then had to adapt to the changes to Rule 28, which it welcomed because they fell in line with the business’s position. The business will now need to adapt again.
The seeds company IP manager says: “The constant change has been a big challenge because we are filing patents and playing the game, and as we do the rules keep changing.”
The head of industrial property at a seeds company adds that his company has had to be very selective about what it would or would not try to patent in case the rules were altered again.
He adds that this has been a particularly difficult process for his company because it has a global reach and regularly files patents for, and discloses inventions in, less restrictive jurisdictions.
“We file and disclose inventions in the US, for example, where there is not the same restrictions on plant patenting as there is in Europe. Even if I do not know if our patents will be granted in Europe I may still file them there because those same products will be sold and need to be protected in the US.”
Concerns cropping up
A concern among some seeds companies and organisations is that patenting plants obtained through essentially biological processes will hamper innovation in the industry.
The sector relies on a sharing culture to innovate and survive because its subject matter exists in nature – this was accounted for by Plant Breeders’ Rights because they allow competitors to buy protected products for the purposes of further breeding and development.
“The constant change has been a big challenge because we are filing patents and playing the game, and as we do the rules keep changing”
Seeds companies have attempted to ensure access to patented inventions by creating an International Licensing Platform, which licenses under fair, reasonable and non-discriminatory terms.
But patents beget patents. One source points out that his company has been compelled to patent some of its inventions to put itself in a better position when it comes to licensing negotiations.
The seeds company head of IP adds: “Seeds companies are filing patents because the situation is as it is. You need patents to get access to competitor patents, which is why small vegetable seeds companies that are traditionally against plant patents are filing for them.”
The Technical Board of Appeal’s conclusion last week that plants obtained by essentially biological processes are patentable has thrown uncertainty back into the mix. The legislator may choose to change this outcome with an intergovernmental conference and change the rules yet again, costing seed businesses time and money. This would mean they would have to change their patent strategies yet again.