Agrifood-related legal developments

– selected topics

Philippe de Jong

Altius Agrifood Law seminar, 18 September 2020

for personal use – not to be published or reproduced

/DISCLAIMER

• This presentation reflects the personal opinion of its

author and not that of any past or present clients.

• This presentation is for information purposes only

and does not constitute legal advice.

• Your copy of this presentation is for your personal

use only and shall not be published, distributed or

reproduced without the author’s prior written

consent.

2for personal use – not to be published or reproduced

/NOT ON THE MENU TODAY

• IP reformRoadmap (07/2020)

• The Nagoya Protocol MILIEU report (05/2020)

• Farm saved seedCJEU decision in C-239/18

• The “other” Nadorcott caseC-186/18 – where has it gone?

• (Whole) insectsAG Opinion in C-526/19 (novel food)

• Organics reformDelay + public consultation (increase in organic surface)

• …

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/OUTLINE

I. Blocky peppers

II. Nadorcott mandarins

III. COOL

IV. Deforestation

V. Mutagenesis

VI. Neonics4

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/ I. BLOCKY PEPPERS

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/THE EPC• “The following shall not be patentable: essentially

biological processes for the production of plants …” (A.53(b) EPC)

G 2/07 (“Broccoli”)

G 1/08 (“Wrinkled tomato”)

G 2/12 (“Wrinkled tomato II”)

G 2/13 (“Broccoli II”)

Courts The Hague 2013

• As of 2017: Rule 28 (2) “Under Article 53(b), European patents shall not be granted in respect of plants or animals exclusively obtained by means of an essentially biological process” (+ disclaimer)

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/

• T 1063/18 (Blocky pepper)

• Contradiction between EPC (as explained by Enlarged

Board of Appeal) and Rules

Article 164(2) EPC: EPC prevails

• No need for new referral to EBA, because issue already

decided in G 2/12

THE TBA

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/THE PRESIDENT

• “single BA decision not binding for the examination

division”, who continued to apply Rule 28(2)

• Examination division continued to apply R28(2) EPC

• 4/4/2019: President decides to refer case to EBA: case

G 3/19

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/THE INITIAL QUESTIONS• Question 1: can the Rules overrule you?

Enlarged Board: “seeks carte blanche for AC”

• Question 2: can you please change your mind?

Enlarged Board: “already contains answer in thinly disguised form”

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/THE RE-PHRASED QUESTION

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/THE ANSWER

• Admissibility

Article 112 EPC (“point of law of fundamental importance”

and “two Boards of Appeal have given different decisions on

that question”)

• On the substance

Grammatically, systematically, teleologically and historically

Tomato/Broccoli II must stand

But under dynamic interpretation (Rule 26 EPC, Commission

Notice, national legislative developments), its outcome

should be changedPrevious interpretation “can never be taken as carved in stone”

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/THE ANSWER (2)

BUT:

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/THE FINAL WORD• Value of EBA decisions?

• Lack of uniformity/certainty is not result of A. 53(b)

EPC

• No more EPC patents for conventionally bred crops

or their propagating material

• But if granted or applied for prior to 1/7/2017, still

enforceable

• CJEU could still be wet blanket, but would it really?

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/ II. NADORCOTT MANDARINS

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/THE EU REGULATION

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• Article 13(2)-(3):

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/ABSOLUTE VS. CONDITIONAL

• PM

Absolute protection

• HM

Conditional protection

HM must have been obtained through unauthorized use of

PM, AND

Right holder must not have had reasonable opportunity to

exercise its rights further upstream (i.e. against the

unauthorized use of PM)

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/BACKGROUND OF THE CASE• CJEU Nadorcott decision 19 December 2019

Very specific context, but seeming endorsement of

“infringing use” interpretation of “unauthorized”

• Facts:

unauthorized propagation by nursery and subsequent planting

by grower of Nadorcott treesPartly during period of provisional protection

Partly after grant

Mandarins harvested and sold after grant

• HM obtained through “unauthorized use” of PM?

Use without consent or infringing use?

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/THE CJEU DECISION• Mandarins harvested from trees propagated and planted

after grant: yes

• Mandarins harvested from trees propagated and planted

between application and grant: no

• Justification is given not on the basis of A. 14(2) UPOV

1991 (A. 13(3) EU Regulation), but on the basis of

availability of different remedies

A. 94(1) EU Regulation (injunction + “reasonable

compensation” vs. A. 95 EU Regulation (only “reasonable

compensation”)

for personal use – not to be published or reproduced18

/THE CJEU JUSTIFICATION (1)

• “It follows that, as regards the period of protection

referred to in Article 95 of Regulation No 2100/94, the

holder of the Community plant variety right may not

prohibit performance of any of the acts referred to in

Article 13(2) of that regulation on the ground that he or

she did not provide authorisation. Therefore,

performance of such acts does not constitute

‘unauthorised use’ within the meaning of Article 13(3)

of that regulation” (§44 of the Nadorcott decision)

• = (hybrid form of) infringing use!

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/THE CJEU JUSTIFICATION (2)

• Procedural remedy as limitation of scope of substantive

right?

A. 95 itself (implicitly) refers to authorization

“reasonable compensation” implies authorization is required

• UPOV HM Explanatory Notes main source of inspiration

AG Opinion: “the UPOV Council states that the performance of

unauthorized acts implies that the breeder’s right ‘has been

granted and is in force”

• AG: patent law comparison + reasonable expectation

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/AND NOW?

• Creates legal uncertainty

Irreconcilability “infringing use” approach with earlier case law

Effectively annihilates value of provisional protection

Article 95 interpretation up for debate

• But beware of overestimation

Very specific situation and scope Provisional protection

Outside of licensing context (Kanzi)

Intra-EU context

• Future challenge possible/necessary

• Call to amend UPOV (Note) and/or EU Regulation

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/FURTHER READING

• P. de JONG, “The protection of vines, grapes and wine

under plant variety rights law, with a particular focus on

the EU”, in J. Chaisse, D. Friedmann, F. Dias Simoes

(editors), Wine Law and Policy: From National Terroirs

to a Global Market (London/Boston: Brill, 2020)

Forthcoming

for personal use – not to be published or reproduced22

/ III. COOL

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/THE FIC REGULATION

• Food information shall not be misleading as to its

country of origin or place of provenance (A. 7)

• Indication of CoO or PoP is mandatory if its omission

might mislead the consumer as to the true CoO or PoP of

the food, in particular if the information accompanying

the food or the label as a whole would otherwise imply

that the food has a different CoO or PoP(A. 9 + 26(2))

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/CJEU C-686/17 (“ORIGIN”)

• Decision 4/9/2019 re “origin” of fresh fruit andvegetables and interplay between FIC vs. CMO/UCC

• Mushrooms labeled “Origin: Germany”, but onlyharvest took place there; all preceding steps tookplace in BE/NL

• Ag-CMO Regulation: CoO label is mandatory, but nodefinition of CoO – reference to UCC

• UCC delegated rules: CoO is country of harvest

• No additional application of general rule (A. 7 - 26) FIC Regulation that food information should not be misleading as to CoO

• No need for further specifications

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/CJEU C-363/18 (“COUNTRY”)• Decision 12/11/2019

• FR law requiring food products from Israeli occupiedterritory to (i) mention specific origin (e.g. “GolanHeights”), + (ii) disclaimer (“e.g. Golan Heights, Israelisettlement”)

• (i): Obligation under FIC is not limited to reference to acountry (UCC also refers to territory)• Israel ≠ sovereign entity under international law, but occupying power

• misleading if “Israel” as CoO

• (ii): Obligation under FIC also applies to PoP• specific geographical area within country or territory of origin

• disclaimer may be regarded as indication of PoP

• without it, EU consumers might be misled to be believe that, in case ofWest Bank, it comes from Palestinian producer or, in case of GolanHeights, from a Syrian producer

• since EU consumers’ purchasing decisions might be influenced byviolations of international law, information is mandatory

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/CJEU C-485/18 (“MANDATORY”)

• AG Opinion 16/7/2020

• FR law requiring producers to state origin (place ofcollection, packaging and processing) of milk (or milk asingredient) on label

• Level of mandatory food info (A. 9, 10 and 26(2) FIC) =maximum harmonization (from which milk is notexcluded)• No general freedom for MS to impose additional (i.e. to A. 9-10)

mandatory CoO rules

• Only under specific conditions of FIC safeguard clause (A. 39), incl.objective requirement of (scientifically) “proven link between certainqualities of the food and its origin or provenance” (e.g. tainted tastedue to transport of milk), and if proportionate

• Even if FR rule applies without distinction to local andimported products, mere possibility (through CoO label)to distinguish between the two, will cause prejudiceagainst foreign product (§47 of Opinion)

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/PRIMARY INGREDIENTS

• A. 26(3) FIC Regulation: If CoO/PoP is given, but not the

same as that of primary ingredient, CoO/PoP of primary

ingredient must be given or stated to be different

• As of 1/4/2020: Implementing Regulation 2018/775

Reference to geographical area (e.g. “non-EU” or name of

third country)

Or statement “(name of the primary ingredient) do/does not

originate from (the country of origin or the place of

provenance of the food)” or any similar wording likely to have

the same meaning for the consumer

Specific presentation requirements (e.g. font, manner of

depicting)

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/TAKE HOME MESSAGE

• Not just CoO, but also ToO and PoP matter

• Interplay with UCC and sectoral legislation (CoO rule in specific rules not generally misleading under FIC)

• COOL ≠ nationalistic tool (preferred treatment nationalproducts = partitioning EU market)

• For fresh fruit and vegetables CoO is place of harvestMilk = country/territory where animal was raised?

• If you source from / produce in area of conflict, watchout for misleading statements

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/ IV. DEFORESTATION

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/BIG PLANS AHEAD (1)

• Legislative Initiative draft report (Burkhardt - ENVI) re

“EU legal framework to halt and reverse EU-driven

global deforestation” (cf. Green Deal Resolution)

• Plan: mandatory due diligence rules in “FERC” supply

chains, incl. “proportionate” track & trace, reporting

and disclosure obligations (EC Guidelines ahead)

• Material scope: FERC (at least palm oil, soy, beef,

coffee, maize and cocoa) and FERC-derived

intermediate or final products

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/BIG PLANS AHEAD (2)

• Personal scope: all economic (EU and non-EU) operators

placing FERC (+ derived products) on the EU market,

irrespective of their size and their financial institutions

but no undue burden on SMEs,

• Temporal scope: (status of land on) 1/1/2008

• Timing: EP vote announced for this month (?) / EC IA

ongoing (incl. labeling)In tandem with other initiative “Report on EU’s role in protecting and

restoring the world’s forests” (voted in plenary 16/9/2020)

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/V. MUTAGENESIS

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/BACKGROUND

• CJEU 25/7/2018 (C-528/16)

• All forms of mutagenesis result in GMO under A. 2(2)

GMO Directive

• Organisms obtained by mutagenesis only exempted if

the technique has “conventionally been used in a

number of applications” and has “a long safety

record” (recital 17)

• FR Council of State (7/2/2020):

• not only excludes genome editing, but also random in vitro

mutagenesis

• order to amend listing rules and to identify varieties

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/FR PROPOSAL

• Set of FR decrees notified to EC (6/5/2020)Amended exclusion: “a) Random mutagenesis, with the exception

of in vitro random mutagenesis consisting in subjecting plant

cells cultivated in vitro to chemical or physical mutagenic

agents”

Revocation/deletion from Official Catalogue of certain herbicide

tolerant varieties obtained via in vitro random mutagenesis

• Frustrates EU internal market

• Large amount of objections/opinions filed, incl.

EC and MS detailed opinions

• Standstill extended until 9/11/2020 – FR

obligation to inform EC of action taken35

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/VI. NEONICS

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/CASE C-499/18 P (1)

• Annulment action (2013) against EC Implementing

Regulation 485/2013 (change of approval conditions +

prohibition of use and sale of treated seeds)

• Threshold/standard for starting review of existing

approvals (A. 21 PPP Regulation)“in the light of new scientific and technical knowledge” +

“indications that the substance no longer satisfies the

approval criteria” studies without new scientific knowledge re risk to bees

supplemental application of precautionary principle

level of risk assessment and impact analysis

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/CASE C-499/18 P (2) • Opinion AG 17/9/2020

• Commission may review at any time (in response to “all

conceivable misgivings about an approval”, e.g. new

approval criteria) – not only if new knowledge

• Precautionary principle justifies decision to be taken

based on provisional EFSA risk assessment (rather than

waiting for more comprehensive and accurate scientific

evaluation or final EU guidance)

• No higher (“significant”) degree of scientific certainty re

alleged risk required for existing approvals

• Commission may do own risk assessment (with references

to EFSA experts) (foliar and non-professional use)

• 4 bullet point summary = impact assessment (+ A.53)38

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/ARTICLE 53• PPP Regulation 1107/2009

• Emergency authorizations

“By way of derogation …, in special circumstances a Member

State may authorize, for a period not exceeding 120 days, the

placing on the market of plant protection products, for limited

and controlled use, where such a measure appears necessary

because of a danger which cannot be contained by any other

reasonable means”

• Cases before BE Council of State (derogations for sugar

beet seeds)

“AG” calls for reference for preliminary ruling to CJEUTreated seeds covered by A. 53?

A. 53 applicable to banned or non-renewed substances?

A. 53 limited to situations of urgency?

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/CHECK IT OUT

• Agricultural law in Belgium: overview

• Thomson Reuters Practical Law Guides

• 10/9/2020

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https://uk.practicallaw.thomsonreuters.com/0-607-5386

/CONTACT

Philippe de Jong

philippe.dejong@altius.com

www.altius.com

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