The Impact of Broccoli II and Tomato II on European patents in conventional breeding, GMO’s and Synthetic Biology: A grand finale of a juicy patents tale?

By Timo Minssen

I am pleased to announce our recent paper entitled “The Impact of Broccoli II & Tomato II on European patents in conventional breeding, GMO’s and Synthetic Biology: The grand finale of a juicy patents tale?”, which is available on SSRN, and forthcoming in Biotechnology Law Report, Vol. 34, Number 3 (June 2015), pp. 1-18.

Our analysis deals with a seminal judgment on the controversial and sometimes even emotionally debated European “Broccoli” and “Tomato” patents, which has captivated the European patent and plant science communities for many years: On March 25, 2015, the EBA of the European Patent Office (EBA) finally issued its much awaited decisions on the consolidated referrals G2/12 (“Tomato II”) and G2/13 (“Broccoli II”), clarifying the exclusion from patentability of essentially biological processes, such as conventional crossing and selection, and in particular its impact on the patentability of claims for products resulting from such processes. The so-called “Tomato II” case concerned an invention entitled “method for breeding tomatoes having reduced water content and product of the method,” whereas the so-called “Broccoli II” case involved an invention of a “method for selective increase of the anticarcinogenic glucosinolates in brassica species”.

The first chapter of these complex cases – ‘Broccoli I’ and ‘Tomato I’ – had previously clarified issues pertaining to the patentability of genetically modified organisms. As a result, claims to transgenic plants (or animals) generally do not face objections under Article 53 (b) EPC as long as these are carefully drafted at a higher taxonomic level, i.e. higher than a single plant variety, and even if such claims may embrace plant or animal varieties. On the contrary, claims directed to individual plant or animal varieties or essentially biological processes for the production of plants, including steps of conventional methods for the breeding of plant varieties, had been generally held non-patentable. However, it still remained to be determined, whether Article 53 (b) EPC also excluded the patentability of product claims and so-called product-by-process claims resulting from such excluded processes.

In “Tomato II” and “Broccoli II” the EBA finally confirmed unambiguously that plants or seeds obtained through such excluded processes are – in contrast to individual plant varieties patentable. Moreover, the EBA clarified that this applies even if such claims are formulated in a product-by-process format. Although major industry players had challenged the relevant patent-claims, the outcome is generally favourable to innovative plant breeders and agrochemical companies. As we will point out further below, it might even affect GMOs and Synthetic Biology, due to the increasing combination of conventional and microbiological techniques. So these stakeholders appear at least to have won a battle, but have they won the war?

After all, it should not be forgotten that relentless opposition in Europe against the patentability of plants and plant material produced by conventional methods persists. This is also reflected by the decision of several national legislators to explicitly exlude the patentability of such products. Moreover,vigorous protests against the patentability and commercialization of genetically modified organisms (GMOs) and Synthetic Biology remain a major obstacle to the development of the industry, research and innovation in this increasingly relevant sector.

The significance of these debates, i.e. not only for the ferocious public debate and the evolution of already existing applications, such as food-production and bio-fuels, but also for rapidly emerging fields of science with an enormous potential, such as gene-editing (CRISPR) and biomedical innovations, should therefore not be underestimated. The procedural history of the European Broccoli and Tomato saga is also quite unique, since it was for the first time that the same consolidated cases were considered twice by the Enlarged Board (albeit with amended claims). Moreover, the European legal framework, as well at the institutional and technical context of these cases is rather complex. This leaves many questions open for debate.

Accordingly, section 1 of this paper first provides a brief description of the European legal framework under the European Patent Convention (EPC) and the Biotech Directive and explains the institutional relationship between the relevant actors. This is followed by section 2, which delivers an account of the procedural history and the main arguments of the various parties to the case. Section 3 will then briefly summarize the decisions. This provides the basis for section 4, where we analyse legal effects and practical implications. We will also explain why the affirmed patentability of product and product-by process claims resulting from conventional methods might further effect the areas of GMOs and Synthetic Biology. How these results fit into the wider context of the ongoing European controversies over the patentability and commercialization of the aforementioned technological areas will be discussed in section 5. This will finally allow us to complete the paper with some concluding remarks in section 6.

Timo Minssen

Timo Minssen

Timo Minssen is Professor of Law at the University of Copenhagen (UCPH) and the Founder and Managing Director of UCPH's Center for Advanced Studies in Biomedical Innovation Law (CeBIL). His research concentrates on Intellectual Property-, Competition & Regulatory Law with a special focus on new technologies in the pharma, life science & biotech sectors including biologics and biosimilars. His studies comprise a plethora of legal issues emerging in the lifecycle of biotechnological and medical products and processes - from the regulation of research and incentives for innovation to technology transfer and commercialization.

Leave a Reply

Your email address will not be published. Required fields are marked *

This site uses Akismet to reduce spam. Learn how your comment data is processed.