1. Institut der beim Europäischen Patentamt zugelassenen Vertreter Institute of Professional Representatives before the European Patent Office Institut des mandataires agréés près l'Office européen des brevets 1 Patentable Subject-Matter in the area of Biotechnological Inventions Nicole van der Laan AIPLA-epi Meeting 13 March 2014

2. Agenda 2 Patentability of Plants: – –Legal Basis – –Case Law Further Biotech Subject-Matter epi Involvement Nicole van der Laan AIPLA-epi Meeting 13 March 2014

3. Patentability of Plants 3 Nicole van der Laan AIPLA-epi Meeting 13 March 2014

4. Legal Basis 4 Art 53 EPC: Exceptions to patentability European patents shall not be granted in respect of: (a) inventions the commercial exploitation of which would be contrary to "ordre public" or morality; such exploitation shall not be deemed to be so contrary merely because it is prohibited by law or regulation in some or all of the Contracting States; (b) plant or animal varieties or essentially biological processes for the production of plants or animals; this provision shall not apply to microbiological processes or the products thereof; (c) methods for treatment of the human or animal body by surgery or therapy and diagnostic methods practised on the human or animal body; this provision shall not apply to products, in particular substances or compositions, for use in any of these methods. Nicole van der Laan AIPLA-epi Meeting 13 March 2014

5. Case Law on Plants 5 Decision EBoA, Transgenic Plant/ Novartis II (G 1/98) “A claim wherein specific plant varieties are not individually claimed is not excluded from patentability under Article 53(b) EPC, even though it may embrace plant varieties.” – –Confirmed in Sunflower case (T 1854/07) – –See also Art 4(2) Biotech Directive (98/44/EC) – –and R. 27(b) EPC Nicole van der Laan AIPLA-epi Meeting 13 March 2014

6. Case Law on Plants II 6 EBoA, Tomato I (G 1/08), Broccoli I (G 2/07) – –Essentially biological processes EBoA, Tomato II (G 2/12), Broccoli II (G 2/13) – –Products (i.e. plants) obtained by such processes Nicole van der Laan AIPLA-epi Meeting 13 March 2014

7. Case Law on Plants III 7 Decision EBoA, Tomato I (G 1/08), Broccoli I (G 2/07) 1. A non-microbiological process for the production of plants which contains or consists of the steps of sexually crossing the whole genomes of plants and of subsequently selecting plants is in principle excluded from patentability as being "essentially biological" within the meaning of Article 53(b) EPC. 2. Such a process does not escape the exclusion of Article 53(b) EPC merely because it contains, as a further step or as part of any of the steps of crossing and selection, a step of a technical nature which serves to enable or assist the performance of the steps of sexually crossing the whole genomes of plants or of subsequently selecting plants. Nicole van der Laan AIPLA-epi Meeting 13 March 2014

8. Case Law on Plants IV 8 Decision EBoA, Tomato I (G 1/08), Broccoli I (G 2/07) 3. If, however, such a process contains within the steps of sexually crossing and selecting an additional step of a technical nature, which step by itself introduces a trait into the genome or modifies a trait in the genome of the plant produced, so that the introduction or modification of that trait is not the result of the mixing of the genes of the plants chosen for sexual crossing, then the process is not excluded from patentability under Article 53(b) EPC. 4. In the context of examining whether such a process is excluded from patentability as being "essentially biological" within the meaning of Article 53(b) EPC, it is not relevant whether a step of a technical nature is a new or known measure, whether it is trivial or a fundamental alteration of a known process, whether it does or could occur in nature or whether the essence of the invention lies in it. Nicole van der Laan AIPLA-epi Meeting 13 March 2014

9. Case Law on Plants V 9 Referral EBoA, Tomato II (G 2/12), Broccoli II (G 2/13) “Can the exclusion of essentially biological processes for the production of plants in Article 53(b) EPC have a negative effect on the allowability of a product claim directed to plants or plant material […]?” Nicole van der Laan AIPLA-epi Meeting 13 March 2014

10. Case Law on Plants VI 10 CFI The Hague, Taste of Nature v. Cresco (8 May 2013) Process exclusion of Art 53(b) EPC does not affect product claims Nicole van der Laan AIPLA-epi Meeting 13 March 2014

11. Further Biotech Subject-Matter 11 Human embryonic stemm cells: − −Art 6(2)(c) Biotech Directive (98/44/EC) − −Art 53(a), R. 28(c) EPC − −EBoA, Use of embryos/WARF (G 2/06) (25 November 2008) − −CJEU, Brüstle (C-34/10) (18 October 2011) − −BGH, Brüstle (27 November 2012) Nicole van der Laan AIPLA-epi Meeting 13 March 2014

12. epi Involvement 12 epi Biotech Committee: − −Amicus curiae briefs − −Meetings with EPO directors − −EC Expert Group − −Overview national laws Nicole van der Laan AIPLA-epi Meeting 13 March 2014

13. Institut der beim Europäischen Patentamt zugelassenen Vertreter Institute of Professional Representatives before the European Patent Office Institut des mandataires agréés près l'Office européen des brevets Thank you for your attention! 13 Nicole van der Laan, Legal Advisor at epi nicole.vanderlaan@patentepi.com Nicole van der Laan AIPLA-epi Meeting 13 March 2014