Key points
- "The Board has to consider first whether Regen kits and instructions for use according to D127 and D129 belong to the state of the art."
- "it has to be established whether such Regen kits and instructions were delivered to Levi Medical and from this company to clinicians in Italy before the priority date of the patent and, if so, whether the deliveries made these Regen kits part of the state of the art."
- "Evidence for the deliveries of the Regen kits and instructions does not lie exclusively within the sphere of the respondent [opponent]. Rather, both the appellant and the respondent had access to this evidence since the deliveries under scrutiny are for material which originated from the appellant [proprietor] and which was the subject of a distribution agreement between the appellant and Levi Medical (D63). Hence, the applicable standard of proof is the balance of probabilities"
- "the respondent provided a witness statement by [person] Levi (D126) according to which a Regen kit as shown in D127 including instructions for use according to D129 had been found at her home. In D126, [person] Levi produced shipping documents as evidence of the delivery of nine Regen kits to different clinicians in Italy before the priority date of the patent."
- "The appellant alleged that [person] Levi was an unreliable witness, also on the basis of D200 and D201, mainly because she had an interest in the invalidation of the patent in suit and was involved in criminal proceedings."
- The Board: "it is not exceptional in opposition proceedings that a piece of evidence or a witness statement stems from an interested person or even a party to the proceedings."
- "In view of the strong documentary evidence provided in addition to [person] Levi's witness statements and the fact that the appellant has not pointed to any substantial contradictions in these witness statements about the deliveries of Regen kits and instructions for use according to D127 and D129, the Board is convinced, on the balance of probabilities, that Regen kits according to D127 and instructions for use according to D129 were delivered to Levi Medical and clinicians in Italy before the priority date of the patent."
- "the Board notes that it is the appellant which initially has the burden of proof to establish the existence of a confidentiality agreement (T 473/13, point 11.2 of the Reasons)."
- "The respondent provided [person] Levi's witness statements to the EPO and the UK High Court of Justice, according to which purchases and sales by Levi Medical of the appellant's products were not confidential. The witness hearing before the UK High Court of Justice remained unchallenged (points 20 and 88 of D137). The witness statements are supported by distribution agreement D63, which does not include or hint at any confidentiality agreement for the Regen kits. On the contrary, D63 clearly indicates that these kits were normal items of trade, explicitly defining the relationship between the appellant and Levi Medical as one of vendor and vendee, the latter of which has to maximise the sales of the product and actively demonstrate it to potential customers (paragraphs 3, 8 and 10). There is no reason to assume that the lack of confidentiality derivable from D63 should not extend to the deliveries of the Regen kits to Levi Medical and clinicians in Italy, especially because the appellant provided no explicit evidence that those deliveries had been made under a confidentiality obligation."
- "The appellant only argued that the deliveries had implicitly been confidential as the Regen kits had not been approved for commercialisation in Italy and therefore were for test purposes only. To support this argument, the appellant referred to T 906/01 and T 818/93."
- "Even if the Italian Ministry of Health had to be informed before the selling of the kits in Italy and even if this information had not been provided, this does not imply that the Regen kits were prototypes. The fact that the appellant may have had a significant interest in obtaining patent protection does not render the kits prototypes either. Mistakes in this respect happen. As regards the allegedly small number of deliveries according to D126, this is not evidence that the Regen kits were prototypes. As concluded under similar circumstances in T 1464/05 cited by the respondent (point 4.2 of the Reasons), the deliveries could have been for promotional purposes, for instance. "
- "he Regen kit shown in D127 and the instructions for use according to D129 bear a CE marking, which conveys the information that the kit was a final product that could be sold in the EU. Even if the Regen kit should, as argued by the appellant, not have had such a CE marking for legal reasons, the mere fact that this marking was actually on the product speaks strongly against customers considering it a prototype."
- "the Board is convinced that the deliveries of Regen kits according to D127 and instructions for use according to D129 to Levi Medical and clinicians in Italy before the priority date of the patent made those kits part of the state of the art."
- "the subject-matter of claim 1 of auxiliary request II, i.e. the only claim request on file, is not inventive (Article 56 EPC) over the prior use of Regen kits and instructions for use according to D127 and D129."
EPO
The link to the decision is provided after the jump, as well as (an extract of) the text of the decision.
source http://justpatentlaw.blogspot.com/2023/07/t-289219-regen-kits.html
