The future of biotech patenting in europe
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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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THE FUTURE OF BIOTECH PATENTING IN EUROPE

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The future of biotech patenting in europe

THE FUTURE OF BIOTECH PATENTINGIN 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

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.


The future of biotech patenting in europe

Practical implications

These are suggestions…

Questions on interpretation of judgment remain

Case law is needed to confirm or reject..

EPO

national courts


Functions

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


The future of biotech patenting in europe

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


The future of biotech patenting in europe

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


The future of biotech patenting in europe

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


The future of biotech patenting in europe

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


The future of biotech patenting in europe

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


The future of biotech patenting in europe

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


The future of biotech patenting in europe

THANK

YOU

René John Raggers

www.epc.nl

[email protected]

0031 6 109 82 801


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