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Leo Melchers
Masterclass Octrooigilde – Nov 11, 2015
Balancing access & protection in
Agriculture: Shaping a new IP use
Octrooieren van innovaties in planten
2
Helping small and large farms meet the challenges of global
food security
Our ambition
is to bring greater food security in an
environmentally sustainable way
to an increasingly populous world
by creating a worldwide step-change
in farm productivity
450Msmallholder
farms
~2.0 Ha
8Mlarge-scale
farms
>100 Ha
Classification: PUBLIC
3
Demand for food is driven by population growth and rising
calorie consumption
World population
> 80% of growth
in emerging markets
1950
2.5 billion
2011
7 billion
2050
9 billionEmerging
Developed
Source: FAO, Syngenta analysis
0
1
2
3
4
1970 1990 2010 2030 2050
World demand for grains*
bn tonnes
+50%
* Cereals, rice and corn
Food
Feed
Classification: PUBLIC
4
Environmental stresses are increasing
World stress map
Climate change is already reducing water and arable land
Source: UNEP, Cline, Syngenta
Climate change impact
High
Medium
Low
1950 2030
1 hectare
fed 2 people
1 hectare needs
to feed 5 people
requiring better use of existing farmland
Agriculture
uses 70% of the
world’s fresh water
withdrawals
Classification: PUBLIC
Grow more from less
5
1990’s 2000’s 2010’s 2020’s
Marker Discovery
Marker Assisted
Breeding Molecular
BreedingConventional
Breeding
Conventional
Breeding
Parallelism
Discovery
Prediction
Predictive
Breeding
Convergence
Breeding in the 21st century: Technology convergence
Accelerated link between germplasm and traits
Environment & Weather data
Trait associations
Phenotype
Information
Crop Models
Pedigree
Information
Gene networks
Increased scientific understanding & increased opportunity of patentable inventions
Classification: PUBLIC
6
Breeder’s challenge: Bring new genetic diversity into a plant
● Breeding targets
- Yield improvement
- Crop quality
- Insect resistance
- Fungal resistance
- Drought tolerance
- Stress tolerance
- Plant architecture
- Post harvest storage
- Taste
- Resistance to lodging
- Resource use efficiency
- …… and more !!
Classification: PUBLIC
7
Balancing IP protection & access to genetics
● Unprecedented need for innovation
● Increasing technification and investment
● Increasing complexity of regulatory, IP and legal landscapes
Classification: PUBLIC
Incentive for innovation
($ return / exclusivity)
Incentive for
knowledge sharing
Access to
genetic resources
Manageable transaction
/ legal / regulatory costs
8
XIR
IR
A
Variety C
B
Plant Breeder’s Right vs. Patents – we need both systems
● Protects: Plant variety
Variety is defined by all phenotypical characteristics.
● Breeders exemption:
- Competitors can use commercialized variety for breeding
- New developed variety can be freely commercialized
 Efficient protection for a plant variety
 No efficient protection for IR Trait
X
● Protects: IR Trait (Invention)
All plants with the IR Trait are protected.
● Research & breeders exemption (DE, FR, CH, NL, EU):
- Competitor can use variety A for breeding
- Commercial use of variety C requires a license
 Efficient protection of IR Trait
 No efficient protection for variety A & B genetics
Plant Breeder’s Right system Patent system
Classification: PUBLIC
IR = Insect Resistance Trait
Protects the part but not the whole
Plant Breeder‘s Right
Patents
Protects the whole but not the part
IR
IR
A
Variety C
B
9
● No industry alignment on the value of patents for
innovation
● Patents reduce access to biodiversity & stimulate
industry consolidation
● Native traits are present in nature, thus are not
inventions
● License negotiations are complex & time consuming
● Multinationals will decide what food you will eat
The IP controversy
Classification: PUBLIC
10
Confrontation
Stronger IP vs. Broader access
Cooperation
Incentive for innovation and Broad access
Classification: PUBLIC
11
IP as a Tool
A matter of use
Classification: PUBLIC
12
TraitAbility – Syngenta e-Licensing platform
TraitAbility provides quick & easy access to our patented native traits and
enabling technologies  improve plant breeding and increase innovation
in agriculture
 Licensing plant innovations in new ways
E-licensing provides easy access to technology and genetic diversity
 Breeding technologies are just a click away
TraitAbility is quick and easy to use, focus your efforts on breeding,
not negotiations
 Clear access under standard terms
Simple, clear access to the traits and technologies you need,
licensing and financial terms are transparent and standard for all
users (FRAND terms)
Classification: PUBLIC
www.Traitability.com
13
International Licensing Platform (ILP)
● Scope
- Global access & use of plant traits for vegetables breeding.
- Limited “non-regulated” traits (excl. sweetcorn) & Free for research and breeding
- FRAND remuneration for commercial use (independent expert committee)
- Pull-in mechanism for licensee’s patents
● Open Clearing House
- Global - Everyone can join - Patent owners and parties without patents
- Pro-competitive effects:
Low transactional costs, Incentives for innovations, Faster innovation cycles.
“Free access” but not “access for free”
Association
11 Members
Classification: PUBLIC
14
Benefits – ILP Vegetable
Benefits
Fair competition • Breeders with/without patents can become an ILP member
• ILP members have certainty to access patented traits of other
members
• ILP provides “free access but not access for free”.
ILP members can apply a “breeders exemption” in the USA.
Fair Reward • The breeder / innovator gets a fair reward for their investments &
risks.
ILP facilitates FRAND license terms.
Reduce transactional
costs and time
• Standard license agreements are available & MFN terms are applied
Create transparency • Information on which commercial varieties comprise patented traits
Industry alignment • The solution re-aligns the seed industry, which is critical in view of the
CBD challenges
Classification: PUBLIC
15
What is the “breeders rights” debate about ?
● Three EU members (NL, FR, DE)  limited BE
● Limited BE allows plant breeders to use biological materials, covered by patents,
for breeding new varieties without the consent of the patent holder.
Upon commercialization  a license agreement needs to be in place.
● A number of plant breeders would like to go further, install a Full BE, and
commercialize the resulting new varieties without paying royalties
● The Dutch Ministry of Economic Affairs aims to include a Full BE in Directive
98/44/EC, or eliminate the patent protection of plant-related inventions
- SEO survey: Analysis of effects of the introduction of a Full BE on the other biotech sectors
- Analysis of plant patents
- New legal analysis of TRIPS vs Breeders exemption in 98/44
- ……….. All 3 reports ready by Dec. 2015 ?
BE = Breeders ExemptionClassification: PUBLIC
16
Risks of opening Directive 98/44/EC
● Directive 98/44/EC;
- defines a stable and predictable framework for all biotechnological inventions,
- is essential to foster innovation and guarantee technology transfer & sharing
of scientific findings in the EU
● Risks of revising Directive 98/44/EC:
- Reduction of investments, competitive disadvantage for EU scientists
- Reduced scope to patent plant-related inventions will incentive to keep
innovations as trade secrets  undermines the social contract inherent to the
patent system
- Trade secrets block access to new scientific develops  harmful to EU SMEs
- Ending patent protection of plant-related inventions violates EU international
obligations (i.e. TRIPS)
Classification: PUBLIC
17
The “Problem”
Classification: Public
EU plant varieties covered by patents
Impact: Limited - primarily legal uncertainty
 Transparency
 Access to genetic diversity
 Access to patented plant innovations
Incentive for innovation
 A problem only arise if patented plant
material is on the market.
 Less than 1000 EU varieties are covered
by only 24 patents (<5% of all EU varieties)
 >70% of the varieties are covered by 3
patents owned by SMEs or universities
 >90% of license income goes to SMEs
and universities.
 Only one patent litigation (patent found invalid)
EU plant varieties covered by patents
[525]
[160]
[57]
18
Existing solutions and proposals
1. The Limited BE: effective for all EU patents (Unitary Patent) - ratified in 2016
2. Patent Quality: EPO initiative - Raising the bar on patent quality
3. Transparency: Seed Industry developed PINTO data base (patent info on plant varieties)
4. Access: Seeds Industry provide “free access but not access for free”;
o Bilateral licensing
o Company E-licensing platforms – quick & easy access to patented Native Traits
o Patent clearing-house: f.e. International Licensing Platform Vegetable (ILP)
These solutions immediately addresses the needs of plant breeders
without the need for changing Directive 98/44/EC and
risk jeopardizing investments and innovations/growth in Europe
Existing tools offer the desired outcomes and balances rights of patent owners
and plant breeders, as well stimulates innovations in plant breeding
Classification: PUBLIC
19
Scenario B
Access & benefit sharing
Scenario A
Legal ban of plant patents
Scenarios
Scenario B
Access & benefit sharing
Cooperative solutions supported by legal measures
 Increase transparency
PINTO database as role model
 Legal duty to disclose patents covering varieties
 Limited breeders exemption
 Unitary Patent / UPC
 Facilitate licensing
“International Licensing Platform” as role model
(“free access but not access for free)
 Legal ”clarification” of compulsory license
Pro: Fast, global, adaptable
Con: Requires mindset change
 Less black & white debate - more dialog
Scenario A
Legal ban of plant patents
 Clear & simple?
Simplistic: Difficult to limit to “native traits”
 Removes blocker for innovations?
Reduced incentive for trait innovation
Trade secrets as alternative
Damage to other life-science industries
 Legal certainty?
Lengthy: >10yrs to change Dir.98/44 & EPC
No global solution
 Pro-SME breeder?
SME’s have large patent estate and income
Industries w/o patents are not more diverse
(e.g., software)
Classification: PUBLIC
20 Classification: PUBLIC
21 Classification: PUBLIC

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Masterclass 2015 Octrooigilde Syngenta-Leo Melchers

  • 1. Leo Melchers Masterclass Octrooigilde – Nov 11, 2015 Balancing access & protection in Agriculture: Shaping a new IP use Octrooieren van innovaties in planten
  • 2. 2 Helping small and large farms meet the challenges of global food security Our ambition is to bring greater food security in an environmentally sustainable way to an increasingly populous world by creating a worldwide step-change in farm productivity 450Msmallholder farms ~2.0 Ha 8Mlarge-scale farms >100 Ha Classification: PUBLIC
  • 3. 3 Demand for food is driven by population growth and rising calorie consumption World population > 80% of growth in emerging markets 1950 2.5 billion 2011 7 billion 2050 9 billionEmerging Developed Source: FAO, Syngenta analysis 0 1 2 3 4 1970 1990 2010 2030 2050 World demand for grains* bn tonnes +50% * Cereals, rice and corn Food Feed Classification: PUBLIC
  • 4. 4 Environmental stresses are increasing World stress map Climate change is already reducing water and arable land Source: UNEP, Cline, Syngenta Climate change impact High Medium Low 1950 2030 1 hectare fed 2 people 1 hectare needs to feed 5 people requiring better use of existing farmland Agriculture uses 70% of the world’s fresh water withdrawals Classification: PUBLIC Grow more from less
  • 5. 5 1990’s 2000’s 2010’s 2020’s Marker Discovery Marker Assisted Breeding Molecular BreedingConventional Breeding Conventional Breeding Parallelism Discovery Prediction Predictive Breeding Convergence Breeding in the 21st century: Technology convergence Accelerated link between germplasm and traits Environment & Weather data Trait associations Phenotype Information Crop Models Pedigree Information Gene networks Increased scientific understanding & increased opportunity of patentable inventions Classification: PUBLIC
  • 6. 6 Breeder’s challenge: Bring new genetic diversity into a plant ● Breeding targets - Yield improvement - Crop quality - Insect resistance - Fungal resistance - Drought tolerance - Stress tolerance - Plant architecture - Post harvest storage - Taste - Resistance to lodging - Resource use efficiency - …… and more !! Classification: PUBLIC
  • 7. 7 Balancing IP protection & access to genetics ● Unprecedented need for innovation ● Increasing technification and investment ● Increasing complexity of regulatory, IP and legal landscapes Classification: PUBLIC Incentive for innovation ($ return / exclusivity) Incentive for knowledge sharing Access to genetic resources Manageable transaction / legal / regulatory costs
  • 8. 8 XIR IR A Variety C B Plant Breeder’s Right vs. Patents – we need both systems ● Protects: Plant variety Variety is defined by all phenotypical characteristics. ● Breeders exemption: - Competitors can use commercialized variety for breeding - New developed variety can be freely commercialized  Efficient protection for a plant variety  No efficient protection for IR Trait X ● Protects: IR Trait (Invention) All plants with the IR Trait are protected. ● Research & breeders exemption (DE, FR, CH, NL, EU): - Competitor can use variety A for breeding - Commercial use of variety C requires a license  Efficient protection of IR Trait  No efficient protection for variety A & B genetics Plant Breeder’s Right system Patent system Classification: PUBLIC IR = Insect Resistance Trait Protects the part but not the whole Plant Breeder‘s Right Patents Protects the whole but not the part IR IR A Variety C B
  • 9. 9 ● No industry alignment on the value of patents for innovation ● Patents reduce access to biodiversity & stimulate industry consolidation ● Native traits are present in nature, thus are not inventions ● License negotiations are complex & time consuming ● Multinationals will decide what food you will eat The IP controversy Classification: PUBLIC
  • 10. 10 Confrontation Stronger IP vs. Broader access Cooperation Incentive for innovation and Broad access Classification: PUBLIC
  • 11. 11 IP as a Tool A matter of use Classification: PUBLIC
  • 12. 12 TraitAbility – Syngenta e-Licensing platform TraitAbility provides quick & easy access to our patented native traits and enabling technologies  improve plant breeding and increase innovation in agriculture  Licensing plant innovations in new ways E-licensing provides easy access to technology and genetic diversity  Breeding technologies are just a click away TraitAbility is quick and easy to use, focus your efforts on breeding, not negotiations  Clear access under standard terms Simple, clear access to the traits and technologies you need, licensing and financial terms are transparent and standard for all users (FRAND terms) Classification: PUBLIC www.Traitability.com
  • 13. 13 International Licensing Platform (ILP) ● Scope - Global access & use of plant traits for vegetables breeding. - Limited “non-regulated” traits (excl. sweetcorn) & Free for research and breeding - FRAND remuneration for commercial use (independent expert committee) - Pull-in mechanism for licensee’s patents ● Open Clearing House - Global - Everyone can join - Patent owners and parties without patents - Pro-competitive effects: Low transactional costs, Incentives for innovations, Faster innovation cycles. “Free access” but not “access for free” Association 11 Members Classification: PUBLIC
  • 14. 14 Benefits – ILP Vegetable Benefits Fair competition • Breeders with/without patents can become an ILP member • ILP members have certainty to access patented traits of other members • ILP provides “free access but not access for free”. ILP members can apply a “breeders exemption” in the USA. Fair Reward • The breeder / innovator gets a fair reward for their investments & risks. ILP facilitates FRAND license terms. Reduce transactional costs and time • Standard license agreements are available & MFN terms are applied Create transparency • Information on which commercial varieties comprise patented traits Industry alignment • The solution re-aligns the seed industry, which is critical in view of the CBD challenges Classification: PUBLIC
  • 15. 15 What is the “breeders rights” debate about ? ● Three EU members (NL, FR, DE)  limited BE ● Limited BE allows plant breeders to use biological materials, covered by patents, for breeding new varieties without the consent of the patent holder. Upon commercialization  a license agreement needs to be in place. ● A number of plant breeders would like to go further, install a Full BE, and commercialize the resulting new varieties without paying royalties ● The Dutch Ministry of Economic Affairs aims to include a Full BE in Directive 98/44/EC, or eliminate the patent protection of plant-related inventions - SEO survey: Analysis of effects of the introduction of a Full BE on the other biotech sectors - Analysis of plant patents - New legal analysis of TRIPS vs Breeders exemption in 98/44 - ……….. All 3 reports ready by Dec. 2015 ? BE = Breeders ExemptionClassification: PUBLIC
  • 16. 16 Risks of opening Directive 98/44/EC ● Directive 98/44/EC; - defines a stable and predictable framework for all biotechnological inventions, - is essential to foster innovation and guarantee technology transfer & sharing of scientific findings in the EU ● Risks of revising Directive 98/44/EC: - Reduction of investments, competitive disadvantage for EU scientists - Reduced scope to patent plant-related inventions will incentive to keep innovations as trade secrets  undermines the social contract inherent to the patent system - Trade secrets block access to new scientific develops  harmful to EU SMEs - Ending patent protection of plant-related inventions violates EU international obligations (i.e. TRIPS) Classification: PUBLIC
  • 17. 17 The “Problem” Classification: Public EU plant varieties covered by patents Impact: Limited - primarily legal uncertainty  Transparency  Access to genetic diversity  Access to patented plant innovations Incentive for innovation  A problem only arise if patented plant material is on the market.  Less than 1000 EU varieties are covered by only 24 patents (<5% of all EU varieties)  >70% of the varieties are covered by 3 patents owned by SMEs or universities  >90% of license income goes to SMEs and universities.  Only one patent litigation (patent found invalid) EU plant varieties covered by patents [525] [160] [57]
  • 18. 18 Existing solutions and proposals 1. The Limited BE: effective for all EU patents (Unitary Patent) - ratified in 2016 2. Patent Quality: EPO initiative - Raising the bar on patent quality 3. Transparency: Seed Industry developed PINTO data base (patent info on plant varieties) 4. Access: Seeds Industry provide “free access but not access for free”; o Bilateral licensing o Company E-licensing platforms – quick & easy access to patented Native Traits o Patent clearing-house: f.e. International Licensing Platform Vegetable (ILP) These solutions immediately addresses the needs of plant breeders without the need for changing Directive 98/44/EC and risk jeopardizing investments and innovations/growth in Europe Existing tools offer the desired outcomes and balances rights of patent owners and plant breeders, as well stimulates innovations in plant breeding Classification: PUBLIC
  • 19. 19 Scenario B Access & benefit sharing Scenario A Legal ban of plant patents Scenarios Scenario B Access & benefit sharing Cooperative solutions supported by legal measures  Increase transparency PINTO database as role model  Legal duty to disclose patents covering varieties  Limited breeders exemption  Unitary Patent / UPC  Facilitate licensing “International Licensing Platform” as role model (“free access but not access for free)  Legal ”clarification” of compulsory license Pro: Fast, global, adaptable Con: Requires mindset change  Less black & white debate - more dialog Scenario A Legal ban of plant patents  Clear & simple? Simplistic: Difficult to limit to “native traits”  Removes blocker for innovations? Reduced incentive for trait innovation Trade secrets as alternative Damage to other life-science industries  Legal certainty? Lengthy: >10yrs to change Dir.98/44 & EPC No global solution  Pro-SME breeder? SME’s have large patent estate and income Industries w/o patents are not more diverse (e.g., software) Classification: PUBLIC