Published on March 4, 2014
EVALUATION OF SOME LEGAL CASES IN THE FIELD OF PLANT RELATED PATENTS Symposium Veredelen en beschermen Symposium Breeding and Protecting On plant related patents Rijswijk, 11 June 2013 TJEERD F.W. OVERDIJK Advocaat Vondst Advocaten
Outline Why do plants need patents? Patents and PVRs – collision issues; Case law; Conclusions.
Inventions are good – so patents are good Inventions are good and should be promoted; Lord Justice Jacob: “Without a reliable patent monopoly there is simply no incentive to invest.” Contract model: Invention is awarded with monopoly; In return the invention must be published;
Why patents next to PVRs? Rationale for PVRs largely same as for patents; PVRs protect plant varieties. But what if the innovation is something else than a plant variety? The Biotech Directive 98/44 brought important expansion of the realm of patents into the plant related industry;
Collision issues: Extended possibilities for protecting biotech inventions lead to substantial increase of material overlap of patent rights and the world of plant breeding.
Patents v PVRs - biggest difference: Breeders’ Exemption PVR laws provide for open innovation, the perfect balance of interests, including the general interest of continuous improvement of plant varieties: Breeders’ Exemption; Under Breeders’ Exemption plant varieties are immediately available for further improvements by other breeders; Most patent laws lack Breeders’ Exemption; In case of patent breeders have to wait 20 years!
Exclusions to patent monopoly: Scope of PVRs is not so wide, therefore we do not need that many exclusions. Patents can relate to any kind of object or process -> very wide scope. Therefore: Make clear what is deemed devoid of technical nature; Certain objects or processes should remain available for all; Separate the realm of patents from other protection regimes, such as PVRs.
Exclusions to patent monopoly (2): Excluded subject matter; discoveries, scientific theories and mathematical methods; inventions contrary to "public order" or morality; plant or animal varieties; essentially biological processes; medical treatment; diagnostic methods; Research exemption; Compulsory licensing.
Themes of decided cases: Where are we now with patentability of plant related inventions? (excluded subject matter; what is essentially biological?); Regular aspects of validity (novelty, inventiveness, enablement); Scope of protection / infringement issues.
The most well known plant patent cases:
Case 1: Broccoli & Tomato G 2/07; G 1/08 What is ‘essentially biological process’; Decision of 09-12-2010: 1) Processes for the production of plants based on steps of sexually crossing the whole genomes of plants and of subsequently selecting plants are in principle excluded from patentability.
Case 1: Broccoli & tomato (2) 2) Processes cannot escape the exclusion by adding a technical step that enables or assists the crossing of genomes; 3) Process of crossing and selection may be patentable if it includes a technical step that introduces a trait into the genome or modifies a trait in the genome that is not the result of the mixing of the genes of the plants used for the crossing;
Case 1: Broccoli & tomato (3) 4) For the purpose of examining whether a process is excluded from patentability it is not relevant whether technical step: - is new or known measure; - trivial or fundamental alteration of a known process; - does or could occur in nature; - constitutes the essence of the invention or not.
Case 1: Tomato - follow up T 1242/06 Patentee requested claim amendment whereby claims were restricted to two independent product claims: "1. A tomato fruit of the species Lycopersicon esculentum which is naturally dehydrated, wherein natural dehydration is defined as wrinkling of skin of the tomato fruit when the fruit is allowed to remain on the plant after a normal ripe harvest stage, said natural dehydration being generally unaccompanied by microbial spoilage."
Case 1: Tomato - further questions to EBA 1) Can the exclusion of essentially biological processes in Article 53(b) EPC have a negative effect on the allowability of a product claim directed to plants or plant material such as a fruit? 2) In particular, is a claim directed to plants (or plant material) other than a plant variety allowable even if the only method available for generating the plant is an essentially biological process? 3) Is it relevant in this context that the protection conferred by the product claim encompasses the generation of the claimed product by means of an essentially biological process (…)?
Confrontations on the battle field
Case 2: Chicory - Enza v. Vilmorin Patent EP 771 523 for “A cytoplasmic male sterile vegetable plant cell of the compositae family and also a method for obtaining such plant”; Vilmorin sells chicory varieties Goldwin F1 and Crenoline F1 – do they infringe the Enza patent?
Case 2: Enza v. Vilmorin 1st defence: Term “stably expressible cytoplasmic male sterility” requires merely that the genes which are responsible for the CMS property are stably inherited; Phenotypical expression not necessary.
Case 2: Enza v. Vilmorin 2nd defence: Feature “stably expressible cytoplasmic male sterility” is not present; Enza claims CMS feature must be there because of presence of Cox II gene from Sunflower; Court: unclear which gene is responsible for CMS property. Presence of another gene is insufficient proof that claim is satisfied; Result: claims Enza refused. Costs € 110k.
Case 3: Monsanto v. Cefetra: RR soy meal RR-soybean has genes which enable it to make the so-called enzyme CP4EPSPS, which provides glyphosate tolerance. Patent EP 0 546 090 relating to "Glyphosate tolerant 5-enolpyruvylshikimate-3 phosphate synthesis";
Case 3: Monsanto v. Cefetra – principal questions to and answers from ECJ: 1) Art. 9 Dir. 98/44 does not confer protection when the patented product does not perform the function for which it is patented, even it did in past stages or would be able to do it again; 2) Art. 9 of Dir. effects an exhaustive harmonization and precludes national legislation from offering absolute protection to the patented product as such, regard-less of whether it performs its function in the material containing it; 3) 2) also applies to ‘older’ patents; 4) Articles 27 and 30 TRIPS do not affect the interpretation given of Art. 9 of Dir. 98/44.
Case 4: Radish sprouts Taste of Nature: Raphanus with increased anthocyanin levels; Koppert: Sakura Cress & Sango Sprouts; Cresco: Red Radish Cress & (Red) Purple Radish Cress; Is ToN’s patent invalid because excluded under Art. 53 (b) EPC?
Case 4: Radish sprouts (2) Claim1: A Raphanus sativa plant, obtainable by screening Raphanus sativa plan far their ability to produce sprouts with at least some purple coloring, selfing and/or crossing said plants for several generations and selecting progeny having sprouts with purple coloring, characterized in that the sprout of said plant comprises anthocyanins at a level of at least 800 nmol per gram fresh weight of sprout.
Case 4: Radish sprouts: PI ruling Jan ’12: Breeding methods applied to obtain patented product do not involve any additional technical step and is therefore not protectable; ToN: our patent protects the product; not the process; PI Judge: exclusion of art. 53 (b) also applies to product directly obtained by a process that is not patentable.
Case 4: Radish sprouts: DC ruling 08-05-13: Cresco: patent is null & void: Not novel; not inventive; patent does not enable invention to be carried out; Excluded subject matter under Art. 53 (b).
Case 4: Radish sprouts: on 53(b): DC: exclusion of art. 53 (b) does not apply to product directly obtained by a process that is not patentable: EPC consistently distinguishes processes from products; Requirements for product claims differ greatly from requirements for processes - therefore no indirect protection of process and no undermining of system; Art. 53(b) does not extend to biological processes that would not be reproducible; Art. 64 par. 2 EPC refers to scope of protection.
Case 4: Radish sprouts: on novelty: Novelty: Publications have not disclosed directly and unequivocally the characteristics of the claimed invention; Presentation to jury for AGF Innovation award was not prejudicial for novelty; Deliveries of Sakura Cress and Sakura Mix before priority date: unclear whether these concerned sprouts conforming to the invention -> to be proven by plaintiff.
Case 4: Radish sprouts: inventive step: Inventive step: Whether the person skilled in the art would have: identified the problem solved by the patented plant; consulted the publications referred to by the plaintiff; arrived at the patented plant as obvious from the state of the art at priority date. DC: Skilled person was unaware that the radish sprouts contained anthocyanin.
Case 4: Radish sprouts: Court of Appeal PI ruling 28-05-13: Follows DC on validity including 53(b); Within the framework of PI proceedings the allegations and information of Cresco concerning public availability of patented products is deemed insufficient to assume that it will succeed with its novelty attack; On the basis of information presented on appeal (and lack of specific comments by Cresco) CoA finds infringement sufficiently plausible; PI ruling set aside and injunction given. Costs € 87k (2 instances).
Evaluation/conclusions: Patents are necessary and useful tool to protect plant-related inventions which do not constitute a plant variety; Legal disputes on plant-related patents are like any other patent disputes: Discussions on exclusions, validity, proof of infringement; Can be costly; Some concepts (e.g. the concept of ‘essentially biological’) are in need of further clarification / interpretation by EPO / the courts; Patents can be strong form of protection, stronger than PVRs; If you cannot stand the heat stay out of the kitchen.
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