Tomatoes, broccoli and peppers
Suzanne Renes
Dutch and European Patent Attorney | Business Development Manager Life Sciences
Ever heard of the famous "Tomato / Broccoli" patent case law or the follow-up "Tomato /Broccoli II" (yes that is really what they are referred to as)? If you haven't and you're in the biotech space, you might want to keep reading...
These two cases were considered landmark cases when it came to patenting biological materials, specifically plant and animal varieties, in Europe, but in 2020 they were overturned by the (in)famous "Pepper" case law (again this is really how they refer to this case).
So what are these cases actually about? Well, there is a specific article in the European Patent Convention (art. 53 EPC to be precise) that governs exceptions to patentability (i.e. things that cannot be patented). Point (b) of this article states that plants or animal varieties or "essentially biological processes" for the production of such plants or animals are not patentable. Of course, major discussions were held as to what would fall under this article and what wouldn't, which is also where "Tomato / Broccoli" and its sequel came into play.
Initially, the practice (as decided through the case law Tomatoes/Broccoli II) was that you could not patent the process if it was "essentially biological", but the product of such a process was patentable. Illogical? Perhaps. Many people would agree that this seems counterintuitive, but that is what the case law decided, so that is how it should be done... or not?
In 2017 a new paragraph for "Rule 28" was added in the EPC, which further elaborated on Art. 53, and in this new point (2) of said Rule, it was now specified that products (i.e. animals or plants) obtained exclusively through the essentially biological process were not patentable. This contradicts the established Tomatoes/Broccoli case law and so it was no surprise that a new decision was published in 2020 ("Pepper") that overturned the standard set by this older case law. Strangely enough, a time limit was put on the applicability of this case law, in that any patent granted or filed before Rule 28(2) EPC came into force should be judged according to the previously applied case law standard set by Tomato/Broccoli II... just to make things less confusing. The EPO referred to this as a "dynamic interpretation", which is a strange way of saying that it considers both case laws to be correct interpretations of the EPC, but one was no longer valid when Rule 28(2) was introduced.
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The result is that plants and animals that were bred using classical breeding methods, which only involves mixing of the genes of the parental lines (e.g. no genetic modification), are patentable if you filed your patent application before 1 July 2017, and are not patentable if they were filed after. How and/or if those patents from before July 2017 will be enforceable is another question entirely.
Since the publication of the decision some case law has tried to apply the (in)famous "Pepper" case law standard, but it's not been easy. The case law has been frowned upon by many and a lot of different opinions have been expressed on the fairness of this case law. Especially since the Rule concerned was entered into the EPC because there was pressure from the European Parliament and European Commission to limit the patent protection on plant and animal varieties obtained through natural breeding methods. This was controversial in and of itself due to a lack of a referral to the European Court of Justice.
Because of all this, I don't believe that this is the end of the 'vegetable case law' saga, but what will be next remains to be seen...
To conclude, as it currently stands it is no longer possible (in Europe) to obtain patent protection for animal or plant varieties if there is no gene modification involved in at least one of the steps of the process to produces said animals or plants. If you're unsure whether your technology would fall under the exclusions of Art. 53 and Rule 28, reach out to a patent attorney like myself to obtain the advice you need to decide how to proceed.