Monday, 7 April 2014
10 Points on EPO Biotech Practice and Case Law
This is based on a talk by Enrique Molina Galan, a Director at the EPO, on 15 November 2013 at the CIPA Life Sciences Conference.
1. The patentability of plants is not straightforward in Europe. Plant varieties are excluded protection under the EPC since protection is available under the UPOV treaty. G1/98 allowed claims which embrace plant varieties as long as the relevant technology is not restricted to a plant variety. However it also affirmed that plant varieties were not patentable, even if they were produced by recombinant technology. Thus the assumption was made that the method of producing a plant/variety was not relevant to patentability of the plant/variety.
2. In the EPC the term ‘essentially biological’ was previously interpreted as applying to a process which consists ‘entirely’ of natural phenomena, e.g. sexual crossing. However G2/07 and G1/08 said sexual crossing and subsequent selection is not patentable. This broadened the exclusion as it meant having additional ‘technical’ steps before or after the natural steps did not make the method patentable. It was still ‘essentially biological’. That seems to mean that having any ‘sexual crossing’ step in a claim makes it unpatentable. Growing plants from seeds seems to be OK, though that is not entirely certain.
3. Now the question of whether plants produced by an essentially biological process are patentable is outstanding in G2/12 and G2/13. Allowing such claims would circumvent legislators’ intentions as plants breeders could not be able to commercialise their products. In G2/13 there is the additional question of whether a disclaimer could solve the problem.
4. The EPO is staying examination proceedings on relevant plant applications and in oppositions where the outcome depends entirely on outcome of G2/12 and G2/13. Cases to genetically engineered plants are considered not affected and are not being stayed. The EPO granted around 1,500 plant patents in 1995 to 2012, mostly 2003 onwards. The EPO is staying cases to non-transgenic plants prepared by crossing as well as cases to plant mutants generated by conventional mutagenesis, and about 100 of such cases granted in 1995 to 2012. Thus the number of cases being stayed is going to be small.
5. Turning to disclaimers added to exclude unpatentable subject matter, the EPO decided in G1/03 one could disclaim subject matter for non-technical reasons in the situation where the disclaimer did not have basis in the application as filed (referred to as ‘undisclosed disclaimers’ below). In T329/06 the following undisclosed disclaimer was allowed: ‘provided that the cells are not human embryonic stem cells’.
6. Looking again at undisclosed disclaimers, G2/10 decided that what remains after disclaiming must be present in the application as filed. In this context T2464/10 decided that the undisclosed disclaimers ‘non-human’ (for a claim to an animal) and ‘wherein the cell is not produced using a process which involves modifying the germ line genetic identity of a human being or involves us of human embryo for industrial or commercial purposes’ were allowable.
7. On the question of whether an undisclosed disclaimer could exclude a plant produced by an essentially biological process, Article 53(b) EPC does not exclude such plants from patentability and so at the moment Examiners will not allow this, but the situation may change after G2/12 and G2/13 are decided.
8. The speaker then addressed the question of whether the EPO listens to applicants and IP practitioners in making policy. Added matter has been a controversial area with the EPO being seen as too strict. However the EPO now has the intention to harmonise practice on this at the IP5 level (IP5 is made up of the five largest Patent Offices).
9. The speaker said that Rule 36 regarding the deadline for filing divisional applications was amended in response to pressure from applicants. The recent change to Rule 164 allowing further searches was also cited as an example of this.
10. The EPO is also setting up a working group to look at problems associated with biotech cases, in particular the frequent lack of unity findings and harmonising internal policy on broad claims and inventive step.
You may also wish to see the related articles Top 10 Biotech Claims You Cannot Have in Europe and Top 10 Points about Gene and Protein Sequences.