The legal debate

[This is a summary of the legal debate as described in our report 2018.]

The legal frame work of the European patent law, the so-called European Patent Convention (EPC), excludes plants and animals from patentability. Article 53(b) reads that

no plant or animal varities or essentially biological processes for the production of plants

shall be granted. However the European Patent Office (EPO) has granted thousands of patents on the basis of these legal provisions in recent years, it has very often disregarded and undermined the prohibitions.

Though the EPO is NOT part of the EU,  the European Patent Convention (EPC) is based on the Patent Directive of the EU (“Legal Protection of Biotechnological Inventions” 98/44/EC). It also includes the definition (originally Article 2 (2) of EU Directive 98/44/EC and adopted as part of the Implementing Regulations of the EPC (Rule 26 (5)):

A process for the production of plants or animals is essentially biological if it consists entirely of natural phenomena such as crossing or selection.

This causes several legal problems. First, the debatable meaning of “essentially biological process”, secondly, the lack of clarity whether the plants and animals derived from such processes should be patentable. In 2010, The Enlarged Board of Appeal (EBA), which is the highest legal instance, argued that processes containing or consisting of the steps of crossing and selecting should be excluded from patentability as being “essentially biological”. This decision raised several questions, as it is not in line with provision of Article 2 (2) of EU Directive 98/44/EC and Rule 26 (5), EPC.

In 2015, the EBA decided again upon the patentability of conventional breeding:

While processes for conventional breeding cannot be patented, plants and animals stemming from these processes are patentable.

This interpretation is not only contradictory in itself, but it also undermines the prohibitions in European patent law. In response, the EU Commission issued an explanatory notice, which concluded that products (plants/animals and plant/animal parts) that are obtained by means of essentially biological processes are excluded from patentability.

Consequently, there was some urgency that the EPO should adapt its legal practice in accordance with the interpretation presented by EU institutions. However, in the decision taken by the Administrative Council in June 2017, the EPO failed to fully adopt the EU Commission notice. The EPO still considers only plants and animals derived from crossing and selection as not-patentable, while treating processes that concern the selection without crossing or random mutations as patentable inventions

In November 2017, the EPO published new Examination Guidelines, taking into account the June 2017 changes to the Implementing Regulations to the EPC with regard to patentability of “essentially biological” breeding. These guidelines clearly show that the EPO still considers conventional breeding to be being patentable.

More information in our report