epi Comments on paper CA/PL 4/17

Comments by epi on the document CA/PL 4/17 by the President of the EPO presenting options to the Committee on Patent Law (CPL) on "Patentability under the EPC of plants and animals produced by essentially biological processes following the EU Commission Notice of 3 November 2016 on certain articles of Directive 98/44/EC of the European Parliament and of the Council of 6 July 1998 on the legal protection of biotechnological inventions"

A. Introduction / Preliminary Remarks

Document CA/PL 4/17 was prepared at the request of the Committee on Patent Law (CPL). The task was "to analyse the effect of the EU Commission Notice on the EPO's legal framework and practice, and to present options for the way forward, including a proposal for amending the Implementing Regulations to the EPC".

The following observation is taken as the starting point:

"To consider product claims to conventional plants (and animals) allowable under Article 53(b) EPC on the basis of decisions G 2/12 - G 2/13 [...], which could not take into account the EU Commission Notice in the interpretation of Article 53(b) EPC, would bring the Office's practice into conflict with the interpretation of the EU Biotechnology Directive set out in the EU Commission Notice and endorsed by the Council of the EU and the European Parliament." (CA/PL 4/17, item 60)

Four options have been presented in CA/PL 4/17. epi favours option 1.

B. Comments on Option 1

In the eyes of epi, a continuation of the examination practice based on the interpretation of Article 53(b) EPC established by decisions G 2/12 - G 2/13 is the way forward for the EPO until, if at all, the relevant law will eventually be amended.

epi would like to emphasize that

i. A conflict with Plant Breeders' Rights was alleged, which however does not exist (cf. EU Commission Notice, Introduction, 4th paragraph).

ii. The preparatory history leading to the EU Commission Notice does not support the view that plants should be excluded from protection.

iii. The Expert Group on the Development and Implications of Patent Law in the field of Biotechnology and Genetic Enginieering in its final report also came to the conclusion that no change is necessary.

C. Comments on Option 3

In case it is concluded that an amendment to the Implementing Rules and the EPO examination and granting practice is necessary, the following arguments and proposals are provided for further consideration:

According to Option 3, the Implementing Regulations to the EPC are amended so as to overcome the conflict between the Enlarged Board's interpretation of Article 53(b) EPC and the EU Commission Notice. A concrete proposal to amend Rule 28 EPC is provided, i.e. by adding a section (2) reading "Under Article 53(b), European patents shall not be granted in respect of plants or animals exclusively obtained by means of an essentially biological process" (Document, item 98).

The concrete wording of suggested new Rule 28(2) EPC creates the additional potential problem that it defines the plants to be excluded from patentability as being "exclusively obtained by means of an essentially biological process". In G 2/07 - G 1/08, the Enlarged Board has interpreted the term "essentially biological process for the production of plants" very broadly. It was held that the presence of additional technical steps (e.g. genetic engineering) either upstream or downstream of the steps of sexual crossing and selection does not bring a plant production process out of the Article 53(b) process exclusion (G 2/07 - G 1/08, point, penultimate paragraph). As a consequence, it cannot be excluded that an exemption of plants obtained by an essentially biological process could also affect technically produced plants (e.g. genetically engineered plants). In view of this, the considerations set out under items 71 to 77 of the Document, according to which "plants obtained by crossing and selection only" would be excluded by the new Rule 28(2) EPC, are difficult to follow.

In view of epi the above-mentioned problems can be overcome by an amendment of Rule 27 and optionally Rule 28 as outlined below. The discussion on the patentability of plants is triggered by fears of classical breeders that patents will be granted with generic claims on plants that could cover plant lines the breeder needs to work with. Of particular concern in this regard are claims wherein the plants are not defined clearly enough so that the breeder may have difficulties in determining whether he works in the claim or not. The epi proposal addresses the concern of unclear scope of plant patents.

It should also be noted that plant breeding is a technical field that is actively changing since a few years by integrating more technological advances, and epi believes that the EPO should rather support the technological advancements in this field. Importantly, there is a need for patent protection for new traits the development of which requires considerable efforts and time. A protection gap in this regard should clearly be avoided.

In this regard, it should be noted that recent EPO case law has already contributed to better defining the patentability requirements for inventions relating to plant traits resulting from traditional breeding. For instance, in T 967/10 and T1988/12, the Technical Board of Appeal denied clarity of claims directed to conventionally produced plants because of lacking genetic information allowing identification of the plants. In view of this, the concerns of breeders could be alleviated by requiring that conventionally bred plants can only be patentable if the claim covers what was reasonably contributed by the inventors and if a third party can clearly and easily determine whether it is operating within the claimed scope. Hence, one measure could be to revise the Examination Guidelines of the EPO to reflect the above-mentioned case law. Optionally, Rule 27(b) EPC could accordingly be amended in the following way:

Rule 27 - Patentable Biotechnological Inventions

Biotechnological inventions shall also be patentable if they concern: ...

(b) plants or animals if the technical feasibility of the invention is not confined to a particular plant or animal variety, and if the plants or animals are characterized by genetic information as an identifiable technical feature.

To further clarify the subject matter optionally Rule 28 could be amended as follows:

Rule 28 - Exceptions to patentability

(2) Under Article 53(b), European patents shall not be granted with respect to plants or animals at the various stages of its formation and development, and any part thereof, exclusively obtained by means of a[n essentially biological] process, which does not contain any essential technical step.

Focusing on better defining the clarity requirement for plant-related inventions would also address a point raised in the EU Commission Notice where indirectly a line for defining which products obtained by such processes shall be patentable and which not has been drawn. The above proposal uses this technical requirement for a definition of products. This would result in a legal situation which conforms with the intention of the legislator by Directive 98/44/EC as it has been construed in the Commission Notice, namely ensuring that only novel and inventive plants characterized by clear, unambiguous and verifiable technical features remain patentable.

The amendment of Rule 27 optionally could be accompanied by an amendment of Rule 28, to more clearly define what is meant by an essentially biological process - one that does not contain any essential technical step. This contributes to clarification.

With these amendments a third party would not only be able to readily determine whether it operates within the scope of the claims, but it would also be able to check much more easily whether prior art exists affecting novelty or inventive step of the claimed invention.

D. Comments on Option 4

epi is not in favour of option 4 because of its lacking binding effect on the Boards of Appeal which creates legal uncertainty. However, in case a Rule change is made, epi is in favour of adapting the Guidelines and to clearly explain that subject-matter for which protection is sought must be defined by identifiable and unambiguous technical features which are imparted to the product by the process.

E. Conclusion

epi sees two possible options for resolving the issue at stake without creating legal uncertainty for the users of the EPO and third parties:

  • (Preferred) Leaving the EPC and its Implementing Regulations as is, so that the legal certainty that the Enlarged Board established by G 2/12 - G 2/13 prevails. The EU Commission Notice would have to be dismissed as insufficiently supported. The national patent law diverging from the Directive with respect to the patentability of conventionally produced plants would have to be reverted so as to be in line with the wording of the Directive.
  • Address the concerns in the area by clarifying the criteria with which plants obtained by essentially biological processes should comply by amending the Examination Guidelines and optionally amending Rule 27 EPC as proposed under item 18, above.