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1 May 2015
Please note that an important update regarding this case law can be found here.
In good news for the biotech industry, the Enlarged Board of Appeal ruled in “Tomato II” and “Broccoli II” cases (G2/12 and G2/13) that the patentability exclusion for essentially biological processes does not extend to the products of those processes.
By way of background, the European Patent Convention sets out that “essentially biological processes” for producing plants or animals are excluded from patentability. Back in 2010 in the combined “Tomato I” and “Broccoli I” cases, (G2/07 and G1/08), the Enlarged Board of Appeal (EBA) was asked to consider if adding technical steps to a claim to a process for making new plants could take the claim out of the scope of the exclusion and into the realms of patentable subject matter. In these cases, the EBA ruled that if the technical step merely enables or assists an essentially biological process, it would not be enough. To avoid the exclusion, the technical step would have to introduce or modify a genomic trait with the result being a genome that goes beyond simple mixing of the chosen parent plant genomes by sexual crossing.
The recent “Tomato II” and “Broccoli II” cases, G2/12 and G2/13, look more closely at how to treat products which are themselves novel (new plant variety parts) but which are defined as having been made by an essentially biological process.
The claims in question were ‘product-by-process’ claims, which define a product by means of the process by which it can be produced. Importantly in this type of claim it is the product that must be novel, inventive and industrially applicable. Patentability of the process is not relevant. The issue at stake was: does it matter if the process is excluded from patentability? Should the exclusion extend to the product in the same way that a process claim’s protection extends to the product? In other words, should a product-by-(essentially biological) process claim be allowable or is it just a clever attempt at circumventing the exclusion?
The EBA analysed the questions from a number of angles, assessing literal interpretations, the purpose of the legislator, earlier drafts of the exclusion, parallel legal sources and changes in technology. No evidence was found that the biological process exclusion should be interpreted as excluding anything other than a process claim. Among other arguments, the EBA seemed to suggest that if the exclusion was intended to cover the products of essentially biological processes, the legislator would have made this explicit. The EBA therefore could not see any erosion of the exclusion’s scope if a product-by-process claim was allowed and therefore came to the conclusion that the exclusion does not extend to products.
This narrow interpretation of excluded subject matter is good news for the biotech industry. Carefully drafted claims should allow companies developing improvements to plant-derived products to protect their work as in these cases which allowed protection over tomatoes with reduced water content and broccoli with increased levels of anticarcinogens, both produced by essentially biological processes.
Life Sciences & Chemistry group
If you require further information on anything covered in this briefing, please contact Andrew Evitt (email@example.com; +44 1179 253 030) or your usual contact at the firm.
This publication is a general summary of the law. It should not replace legal advice tailored to your specific circumstances.
© Withers & Rogers LLP, May 2015