There are enough similarities between the regulatory dynamics of the agricultural sector and those of the pharmaceutical industry to warrant the extension of supplementary protection certificates (SPCs) to plant-related products, according to some in-house lawyers.
Like with any new drug, regulatory hurdles for modified plants can delay a product’s release to the market until the business only has a few years left on its related patents.
Faced with high R&D costs and a long experimental timeline to breed new plant varieties, sources at seed companies argue that the extended protection given by SPCs would help bolster innovation in the sector by generating higher returns on investment.
“There are several similarities between pharma and the seed and agriculture industry,” says the research manager for a European seed company. “A lot of R&D goes into a pill. The same is true of a seed; and a lot of time and investment goes into creating the right genetics.
“We spend 30% of our turnover in R&D, which is the highest of all industries,” he adds.
He says one of the reasons an SPC would be beneficial to the agricultural sector is because it would provide enough incentive for seeds companies to patent a product rather than protect it with a trade secret.
“SPCs would make it more attractive to file patents on plant traits. They would stimulate research in biological traits because, at the moment, we are not sure whether we should file for patents on these inventions or whether to keep the information secret.”
Under current regulations, competitors are not allowed to commercialise patented plant varieties, but they can use them for research purposes. If more companies opt to keep their seeds as a trade secret, that trend could inhibit innovation in the industry by denying others the opportunity to build on existing research.
“We are facing long product pipelines. It takes five to 10 years on average to develop a new plant variety, so it is not a fast process,” says the research manager for the seeds company. “It is also not great for licensing purposes if we only have a few years left on a patent by the time a product comes to the market.” He argues that the benefit of having a patent, and thereby the extension of the SPC, is blocking other parties on technology trait development, and the need for others taking a licence until the patent lapses.
SPC no need
But other sources argue that agricultural SPCs are not strictly necessary.
Instead of relying on patent protection for new plant varieties, many sources in the industry rely on community plant variety rights (CPVR) to protect their innovations. According to the Community Plant Variety Office, a European Union agency, a CPVR renders national protections and patents ineffective.
The head of IP at a French seed company tells Patents Strategy: “Among the 300 plants that we produce every year, we use plant breeders right at the last stage of development instead of a patent. This way we don’t have a time gap running out on a patent.”
One reason companies prefer CPVRs is because of the growing uncertainty over what plant-related products are excluded from patentability.
Last year, the EPO did an about face when its Technical Board of Appeal ruled that plants produced by essentially biological processes are patentable, contrary to the EPO’s guidelines from 2017 that excluded them from protection.
“The variations on what is patentable in Europe are making life hard,” says the seed company head of IP. “In the US, the matter was settled 20 years ago. For us the uncertainty is a big deal, and a bit more clarity would be great.”
With many companies preferring CPVRs as well as the uncertainty around the patentability of plants in Europe, SPC extension becomes a moot point.
“We have not been addressing this topic of SPCs,” says Angela Martinez, head of IP and legal affairs for Brussels-based advocacy group Euroseeds. “On the face of it, these SPCs could be useful for our companies so they can extend the terms of their patents. But for society as a whole, it is good the patents expire earlier without the SPC.”
Martinez tells Patent Strategy that new plants produced exclusively through biological processes have historically been excluded from patenting, and the remainder are usually those that qualify as genetically modified organisms (GMOs) under the EU GMO Directive.
With most member states opting out of GMO cultivation, it does not make sense for many seed companies to seek a patent until the EPO clarifies its stance on what qualifies as a natural biological process for patentability.
“We don't have GMOs on our market so the variety registration process is not an issue. Where you have the issue is the GMO approval process because that takes years, but for conventional varieties of plants obtained by biological processes it isn't really an issue.”
She adds that relatively few patents are granted in the industry to plants that manage to get through the regulatory hurdles, but that these few are high revenue earners for their developers. For these few and far between plants that get patent approval, an SPC extension would be a welcome advantage to their lifeline.
