THE FUTURE OF BIOTECH PATENTING IN EUROPE. What every biotech practitioner can do after Monsanto v Cefetra. René John Raggers, Ph.D. European Patent Attorney [email protected] www.epc.nl. ECJ Monsanto (short). Article 9 Biotech Directive
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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.
These are suggestions…
Questions on interpretation of judgment remain
Case law is needed to confirm or reject..
“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
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
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
Method for making skin substitute inventive
Skin substitute allowed since starting materialgave “scabs” on edgesNo inventive effect in substitute
However, EPO might object
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
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
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
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
Characterize unique product features
Co-ordinate with European attorneys
One independent claim per category
Enablement & disclosure