Following a Notice of the European Commission related to certain parts of the EU Biotech Directive, the EPO has amended its Implementing Regulations to exclude from patentability plants and animals exclusively obtained by means of an essentially biological process. Examination of pending applications and oppositions relating to such plants and animals will now be resumed.

The Administrative Council of the EPO have enacted the rule change in order to address uncertainties and possible divergence in patent practice in this technical field across Europe, as discussed in our earlier News article.

Previous decisions of the EPO's Enlarged Board of Appeal in the "Tomato II" and "Broccoli II" cases ( G 2/12 and G 2/13) held that the exclusion of essentially biological processes for the production of plants by Article 53(b) EPC does not have a negative effect on the allowability of a product claim directed to plants or plant material. Therefore, such product claims were potentially allowable under the EPC.

However, the Commission Notice set out the Commission's view of the intention of the legislator when adopting the EU Biotech Directive, which was implemented in the EPO's legal framework in 1999. Their conclusion was that such plants and animals are not patentable under the Directive.

The amendment to Rules 27 and 28 takes account of the Commission Notice. According to an EPO press release the change "almost unanimously safeguards uniformity in harmonised European patent law. It contains an important precision to patenting practice at the EPO, providing more clarity and legal certainty for users of the European patent system."

However, we note that "clarity" and "legal certainty" are not necessarily guaranteed, as noted by CIPA in their Observations on the proposed rule changes.  Only the Court of Justice of the European Union (CJEU) can provide a definitive ruling on the interpretation of provisions of EU law such as the Biotech Directive. Therefore, it may be possible for a reference to be made to the CJEU, seeking a ruling on the interpretation of the relevant provisions of the Biotech Directive.

In spite of this, the EPO's new Rules are effective immediately and shall apply to European applications filed on or after 1st July 2017 as well as pending applications and granted patents.

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