case study – legal (un)certainty in plant...

CASE STUDY – LEGAL (UN)CERTAINTY IN PLANT PATENTING

Aylsa WilliamsPartner

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Relates to broccoli plants with high glucosinolates – anti-carcinogenic

Applicant: Plant Bioscience Limited◦ Protects, develops and transfers innovative

technologies from public and private sources worldwide

◦ Based in Norfolk◦ www.pbltechnology.com

Licensed – technology Marketed product - BeneforteTM

“BROCCOLI” Patent EP1069819

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Patent Application Filed with EPO 8 April 1999 Examined by EPO and patent granted in 2002


Brassica villosa growing wild in Sicily vs cultivated broccoli

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Claims as granted:

+ product by process claims


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Claims as granted:

Also broccoli inflorescence obtained from hybrid plant; and Brassica plant cell claims


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Oppositions filed April 2003◦ Opponents: Syngenta & Groupe Limagrain A53(b) EPC – “essentially biological processes” re. claims 1-

3 (the method claims) other objections (e.g. novelty, inventive step, added matter,

insufficiency)

Heard by Opposition Division (OD) 17 June 2004◦ OD decided patentable in amended form


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Claims upheld as patentable by OD:

+ product by process claims


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Claims upheld as patentable by OD:

Also broccoli inflorescence obtained from hybrid plant; and Brassica plant cell claims amended in same way as above claim


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All straightforward so far [?]…. Syngenta & Groupe Limagrain each filed an

Appeal (with Technical Board of Appeal [TBA]) in April 2005

Appeal Interlocutory Decision 22 May 2007 Found to be novel, inventive, enabled & no added matter But important point of law re. A53(b) EPC – claims 1-3 (the method

claims) – TBA refers specific questions relating to “essentially biological processes” (method) claims to Enlarged Board of Appeal (EBA) – G2/07


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Third party Amicus curiae briefs Consolidated G2/07 (“Broccoli”) & G1/08

(“Tomato” EP1211926) Decision of EBA 9 Dec 2010 non-microbiological process (method) for the production of plants

which contains the steps of sexually crossing the whole genomes of plants and of subsequently selecting plants is in principle excluded from patentability as being ‘essentially biological’.

To be patentable – an additional step of a technical nature is necessary, which step ‘by itself introduces a trait into the genome or modifies a trait in the genome of the plant produced’ so that the introduction or modification of that trait is not the result of mixing of the genes of the plant chosen for sexual crossing


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Job done – law clarified! Legal certainty reigns…

Back to TBA for a decision….

Patentee filed claims deleting all process (method claims) – leaving plant “product by process” & granted plant “product” claims

No objections by Opponents/Appellants to “plant” claims in broccoli case ….. Patent going to be maintained by TBA….


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“Tomato” case – 2nd referral to EBA Syngenta request stay of broccoli decision

pending outcome Fresh ground of opposition A53(b) EPC against

product claims Only with permission of proprietor Need for legal certainty….

What would you choose?….


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So here we go again…

2nd Decision TBA - 8 July 2013 TBA refers specific questions relating to “whether exclusion of essentially

biological processes (A53(b) EPC) can have negative effect on allowability of product claims directed to plants” to Enlarged Board of Appeal (EBA) – G2/13


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2nd Decision of EBA 25 March 2015 (G2/13 –“Broccoli II”)

Exclusion of essentially biological processes for the production of plants in Article 53(b) EPC does not have a negative effect on the allowability of a product claim directed to plants or plant material such as fruit.


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Job done – law clarified (again)! Legal certainty reigns (again)…

Back to TBA for a decision….

TBA decision to – maintain patent with product by process and product claims – published 18 Jan 2017 (next week!)


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Intended to provide legal certainty◦ proprietors of such technologies; and◦ third parties

Legal Certainty?

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8 Nov 2016 European Commission – issued comments on Biotech Directive (98/44/EC)

Exclusion under Art. 4 to essentially biological processes (=Art. 53(b) EPC) - intended to include within its scope products resulting from those processes.

Under this interpretation, plants formed from classical breeding and selection would not be patentable in Europe.

Contradictory to “Broccoli II” EBA decision

Legal Uncertainty?

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EPO is intergovernmental organisation Independent of European Union (EU) EPO not under direct jurisdiction of EU courts

However…

12 December 2016, EPO announcement that all Examination and Opposition proceedings in cases which related to a plant or animal obtained by an “essentially biological process” would be stayed.

Legal Uncertainty?

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GM plants and non-GM plants obtained by classical breeding and selection can be patented (if not restricted to specific variety)

Plant Variety Rights (PVRs) available to protect specific varieties

Potential impact on theplant breeding industry…

Patents and PVRs

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PVRs - are limited by “breeders' exemptions” & “farmer’s privilege”

EP patents once granted are a bundle of National Patents – infringement under National law

Patents and PVRs

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DE, FR, CH, NL – have breeders’ exemptions for patents

More recently: DE, FR, NL – amended laws to exclude products obtained by essentially biological processes

UK + others – no breeders’ exemptions for patents

National laws – divided opinions

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UPC Agreement A27(c) = exempts from patent infringement the

use of biological material for the purpose of breeding, or discovery and developing other plant varieties (breeders’ exemption)

A27(i) = farmers exemptions

UK Government intends to ratify UPC Agreement – has to pass through Parliament

Germany yet to ratify

The potential future

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Provide a plant breeders' exemption in all national EU patent laws?

Patent term extensions (e.g. like SPCs)

The future… uncertain

Keep patents & PVRs as way of protecting innovation and of generating financial return for reinvestment in more breeding?

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Legal uncertainty to continue for foreseeable future…

case study – legal (un)certainty in plant...

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