THE FUTURE OF BIOTECH PATENTING IN EUROPE

1. THE FUTURE OF BIOTECH PATENTINGIN EUROPE What every biotech practitioner can do after Monsanto v Cefetra René John Raggers, Ph.D. European Patent Attorney RRA@EPC.NL www.epc.nl

2. ECJ Monsanto (short) Article 9 Biotech Directive The protection conferred by a patent on a product containing or consisting of genetic information shall extend to all material, …, in which the product in incorporated and in which the genetic information is contained and performs its function. Function for which it was patented is protection by the genetic information of the biological material (soy plant) against herbicide.

3. Practical implications These are suggestions… Questions on interpretation of judgment remain Case law is needed to confirm or reject.. EPO national courts

4. 1 Functions “Performs its function” Biological function or Any function? Patented function? Expressed as protein? Function in living materials? Is “kit comprising primers” “Material in which product is incorporated” ? Oligonucleotide for ex vivo use? Fragments? Describe functions in detail Provide soy products vs. provides resistance Provides better diagnostic vs. detects presence of SNP Consider to add to dependent claims Broader/downstream functions may ▲ enforcement

5. 2 Method claims for downstream ECJ: Soy meal ≠ directly obtained product Method for making soy meal ..growing herbicide resistant plant....harvesting..processing…  soy meal = directly obtained product (“Proven” by presence of DNA) Method for producing protein Method for producing pharmaceutical composition Include methods claims for downstream products Describe/enable downstream products

6. 3 Product claims comprising DNA Soy meal comprising the sequence Soy meal from which the sequence can be isolated Distinguishable over soy meal Inventive step may come from method claims Analogy.. Method for making skin substitute inventive Skin substitute allowed since starting materialgave “scabs” on edgesNo inventive effect in substitute However, EPO might object

7. 4 Claim unique product features Claim products with unique property due to DNA if possible without reference to gene X… Plant fruit with high shelf life … Plant fruit with high shelf life, obtained by method Better results with the product Identify & describe unique product features

8. 5 Isolated sequences Continue claiming Some suggest these are not protected anymore (not “perform their function” in a tube) However “perform function” in Directive in relation to material..incorporated (Possibly not “when isolated”) Function is foreseeable (ECJ point 36) Like in soy plant (not treated with herbicide) Directive Art 3 and 5 clearly intended protection (and IA only in description) Continue claiming (isolated) sequences

9. 6 Use claims and Plant Variety Add use claims (label claims) Use of sequence for detecting SNP Use of sequence for making resistant plant Use of sequence for making soy meal ?? In case of plants: protect varieties via Plant Variety Protection

10. S In summary… EPO and national case law required No “golden bullet” solutions For now..Better safe than sorry… Have basis in your application! Emphasize downstream use/commercial use more Method claims Characterize unique product features Co-ordinate with European attorneys Divisional rules One independent claim per category Double-patenting Enablement & disclosure Medical claims

11. THANK YOU René John Raggers www.epc.nl RRA@EPC.NL 0031 6 109 82 801