T 2892/19 - Regen kits

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.

https://www.epo.org/law-practice/case-law-appeals/recent/t192892eu1.html

Reasons for the Decision

1. The invention

The invention relates to a process for the preparation of a cell composition for wound or tissue healing or regeneration treatments from whole blood.

Platelet rich plasma ("PRP") is obtained from the whole blood by discarding platelet poor plasma.

According to the patent, the PRP, possibly with the addition of certain specific cells of the body, may be used as an autologous treatment, i.e. a treatment of a person from whom the whole blood and the specific cells are obtained, for many kinds of diseases (paragraphs [0028] to [0039]) by promoting tissue regeneration. According to the patent, diseases which may be effectively treated include myocardial deficiencies, peripheral nerve damage or spinal cord injury, diabetes, urinary and anal incontinence, and gastroesophageal reflux.

According to claim 1 of auxiliary request II, the whole blood is centrifuged in a separation tube containing a thixotropic gel (a gel that becomes more fluid as a result of agitation or pressure - paragraph [0049] of the patent) and sodium citrate (an anticoagulant).

As a result of the centrifugation, performed at a given force for a sufficient length of time, a pellet containing erythrocytes (red blood cells) is formed at the bottom of the separation tube, on the top of which a supernatant (plasma) is gathered. The claim defines the separation between the red blood cells and the plasma as "a barrier". According to the claim, half of the plasma from atop of the barrier is removed to obtain "enriched platelet rich plasma". This is because the blood cells other than the red blood cells tend to gather towards the bottom of the plasma, proximate to the red blood cells (due to their weight). Table 1 of the patent provides an overview of how "enriched" the "enriched platelet rich plasma" may be compared to the complete plasma.

2. Admissibility of D200 and D201

D200 and D201 were filed by the appellant after the summons to oral proceedings. The respondent requested that they not be admitted into the appeal proceedings.

Under Article 13(2) RPBA 2020, any amendment to a party's appeal case made after notification of a summons to oral proceedings must, in principle, not be taken into account unless there are exceptional circumstances, which have been justified with cogent reasons by the party concerned.

The Board notes that D200 and D201 comprise legal arguments on the credibility of Kama Levi's witness statements which can be seen as a repetition or refinement of the appellant's arguments provided in the statement of grounds of appeal (points 25 to 27). The Board considers the references to foreign law in D200 and D201 an attempt to corroborate the alleged universal applicability of the legal arguments previously presented, rather than as a stand-alone analysis of that law.

In conclusion, in line with J 14/19 (point 1.11 of the Reasons), the Board does not see the filing of D200 and D201 as an amendment of the appellant's appeal case. Hence, D200 and D201 are taken into account in the appeal proceedings.

3. Prior use - availability to the public

In view of the conclusions in the impugned decision, 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.

More specifically, 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.

3.1 Evidence for the deliveries of the Regen kits and instructions does not lie exclusively within the sphere of the respondent. 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 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 (see "Case Law of the Boards of Appeal", 10th edn., III.G.4.3.2 a)).

3.2 Concerning whether Regen kits and instructions for use according to D127 and D129 were delivered to Levi Medical and from this company to clinicians in Italy before the priority date of the patent, the respondent provided a witness statement by Kama 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, Kama 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 shipping documents concern Regen kits identified as lot 0011, which is the same lot number appearing on the Regen kit in D127 (page 12) and in the instructions for use according to D129 (page 1). Contrary to the appellant's view, this is strong evidence that the Regen kits according to the shipping documents in D126 had to be the same as the one shown in D127, with instructions of use D129. The same lot number normally indicates a unique product, and the appellant failed to provide any evidence that this was not the case for the kits that it delivered to Levi Medical. The alleged contradictions in D62, D63, D64, D65, D67 and D68 relate to deliveries other than those of Regen kits and instructions for use according to D127 and D129 on the basis of the shipping documents in D126. Hence, these arguments are not relevant.

The appellant alleged that Kama 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 has noted Adelchi D'Ippolito's statements in D201. His considerations about Kama Levi's status and interests are to be considered in the evaluation of the submitted evidence under the principle of free evaluation of evidence applicable to the boards. However, such considerations do not render evidence or witness statements automatically inadmissible or unreliable in proceedings before the EPO. Rather, 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 Kama 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.

3.3 Concerning whether the deliveries of Regen kits according to D127 and instructions for use according to D129 made those Regen kits part of the state of the art, 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 Kama 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.

The Board in T 906/01 held that "a device having an investigational status, being implanted and tested within the restricted area of an hospital, under the responsibility of a surgeon operating within the frame of an investigator's agreement provided with a clause of confidentiality, must be regarded as a prototype device. Usually the development and testing phases of such products or devices are necessarily surrounded by secrecy as long as said products or devices have not been approved and commercialized" (point 3.5 of the Reasons). T 818/93 comes to similar conclusion in the case of a research project aimed at the fabrication and testing of an expandable graft (point 4.1 of the Reasons).

The appellant's line of reasoning is neither convincing nor in line with the conclusions in T 906/01. The statement in T 906/01 cited above, which refers to a lack of approval and commercialisation, only concerns devices as defined in the preceding sentence ("said products or devices"), i.e. to devices for which it has been established have "an investigational status" and are "tested within the restricted area" of a hospital. In the current case, the appellant has failed to establish such a prototype status. As the Board noted, the distribution agreement D63 supports the opposite, namely that the Regen kits were regular items of trade. For the same reasons, T 152/03 is not relevant to the current case either.

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. The alleged lack of clarity due to mistakes in the instructions for use according to D129 does not make the kits prototypes either.

Most importantly, however, as the respondent argued, the 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.

For these reasons, 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.

4. Prior use - novelty and inventive step

4.1 The respondent argued that the appellant's arguments according to which the instructions for use according to D129 did not disclose the method as defined in claim 1 of auxiliary request II should not be admitted into the appeal proceedings.

Under Article 12(4) RPBA 2007, which applies by virtue of Article 25(2) RPBA 2020, the Board has discretion to hold inadmissible facts, evidence or requests which could have been presented or were not admitted in the first-instance proceedings. The Board considers the appellant's arguments an appropriate reaction to the conclusions in the impugned decision, which deviated from the preliminary opinion sent in advance of the oral proceedings before the Opposition Division, and admits them into the appeal proceedings.

4.2 D127 and D129 refer to a separator tube called a Regen THT® Vacutainer. As the respondent correctly argued, D51, a general supply agreement between the appellant and Becton Dickinson AG, discloses that a Regen THT® Vacutainer tube as manufactured after October 2003 and with reference number 368924 (corresponding to the one visible on pages 14 and 15, annexes DPS-E5 and DPS-E6 of D127) contained a polyester-based thixotropic gel and 1.0 mL of an anticoagulant in the form of a buffered sodium citrate solution at 0.100 M (Schedule 2 of D51).

In D127 (pages 14 and 15, annexes DPS-E5 and DPS-E6), it is also visible that the Regen THT® Vacutainer tube contains sodium citrate ("NC") 1.0 mL. Hence, there is no reason to doubt that D127 is in accordance with the specifications of D51, i.e. the Regen THT® Vacutainer tube in D127 was manufactured according to the specifications valid at the time of its production. Whether D9, a brochure available on the internet in 2004, discloses that an anticoagulant other than sodium citrate could have been present in a Regen THT® Vacutainer tube with the same reference number, as argued by the appellant, is not decisive. As the respondent argued, D9 may have referred a theoretical version of a Regen THT® Vacutainer tube contemplated before the signing of D51, or it could simply contain a mistake.

4.3 The appellant argued that the instructions according to D129 were so unclear that the person skilled in the art would not know how to use the Regen kit. However, the inconsistencies in D129 to which the appellant pointed, such as the wrong mention of 10% CaCl2 in the preparation of PRP before application and of components not present in the Regen kit, are no real hurdle for the person skilled in the art in possession of the Regen kit and wanting to obtain PRP according to the instructions. Based on common general knowledge and the other instructions, which pertain to the use of components all present in the kit, the person skilled in the art would immediately recognise such inconsistencies as minor mistakes and ignore them.

4.4 Considering D129 in view of D51 and D127, the public prior use discloses a process for the preparation of a cell composition for wound or tissue healing or regeneration treatments (PRP according to the instructions) comprising the steps of centrifuging whole blood in a glass separator tube containing a polyester-based thixotropic gel and a buffered sodium citrate solution at 0.10 M (Regen THT® Vacutainer tube and section "Centrifuging" in D129), separating enriched platelet rich plasma from full plasma by removing part of the supernatant containing platelet poor plasma (by drawing off 2 ml supernatant after centrifugation - section "Preparation of PRP before application", point "a"), re-suspending the enriched plasma (homogenisation by inversion - section "Preparation of PRP before application", point "a"), with the centrifugation step being performed at a force of 1500 g in a sufficient length of time to form a barrier between plasma containing platelets lymphocytes and monocytes and a pellet containing erythrocytes (section "Centrifuging" and Figure 2 of D129), and with the enriched plasma being enriched in leucocytes, thrombocytes and adhesion proteins as compared to native whole blood.

4.5 The appellant submitted that D129 did not disclose a separation step made by collecting the supernatant from atop of the barrier in the separator tube. The appellant argued that, according to D129, the separation step did not necessarily take place by removing the supernatant from the Regen THT® Vacutainer tube where the barrier would have formed after centrifugation. The supernatant could first be entirely transferred to a Z tube, from which the removal of a part could take place afterwards.

However, according to D129, there are two possible options for obtaining PRP. The first involves only one centrifugation, and the second involves a second centrifugation of the Z tube. According to the first option, described in the section "Preparation of PRP before application", point "a", PRP may be transferred from the Regen THT® Vacutainer tube using a syringe ("to draw it directly in the Regen THT tube"). The same section discloses the removal of part of the supernatant to obtain PRP ("draw off 2 ml supernatant after centrifugation"). Hence, according to the first option, the removal of the supernatant is done from the Regen THT® Vacutainer tube. Hence, the appellant's argument that the whole content of the Regen THT® Vacutainer tube could be transferred to the Z tube before removing part of the supernatant must fail. This is all the more so because removing platelet poor plasma from the Z tube without a further centrifugation step would only be possible after an unreasonable waiting time needed for the plasma to set, as the respondent pointed out. It follows that D129 also discloses a separation step made by collecting the supernatant atop of the barrier in the separator tube, as defined in claim 1 of auxiliary request II.

4.6 The only remaining feature of claim 1 of auxiliary request II to be considered is the one according to which half of the supernatant is removed. The appellant argued that D129 taught to remove 2 out of 5 ml, and hence the removed part would not be half of the total.

The Board's view is that this claim feature is at least obvious in view of D129. Half of 5 ml is very close to 2 ml, especially in view of the necessary tolerances involved. According to D129, the removal is done by hand, and the user has to visually identify the removed quantity. Moreover, the patent provides no teaching that the precise rate of removal of the supernatant could bring about any unexpected effect. Clearly, the more platelet poor plasma removed, the higher the platelet concentration in the remaining PRP. Hence, based on the teaching of D129, the person skilled in the art would have removed half of the supernatant containing platelet poor plasma whenever circumstances made it desirable, without exercising any inventive activity.

4.7 It follows that 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.

Hence, the patent cannot be maintained for lack of inventive step (Article 101(3)(b) EPC).

5. Requests for apportionment of costs

Each party requested apportionment of costs in its favour due to alleged abusive behaviour of the other party.

The Board is of the view that each party must bear its own costs in line with the usual situation set out in Article 104(1) EPC. Persistently pursuing own interests in proceedings before the EPO does as such not amount to an abuse of procedure, and an abuse of procedure must be established without doubt (J 14/19, Reasons 13).

Each party argued that the other party made untrue statements, knowing that these statements were untrue. However, the Board notes that parties must enjoy ample freedom to put forward interpretations of quotations, legislation and business relations as they deem appropriate to make their cases. In the case at hand, both parties have made statements which are attempts to interpret facts from a perspective favourable to them, i.e. attempts to pursue their own interests. The Board cannot establish without doubt that a party has made an untrue statement knowing that it was objectively untrue, hence T 952/00 referred to by the respondent is not relevant here. Antoine Turzi's statement in D200 that "at the priority date of the patent, Regen Lab had no commercial relationship with Ms. Levi, as she was not our partner" may reflect Antoine Turzi's view that Regen Lab did not have direct commercial relations with Kama Levi in person but instead with the company Levi Medical. As regards the appellant's quotation from Lord Justice Floyd of the UK Court of Appeal and the respondent's submissions about the sales of Regen kits, these are also matters of subjective interpretation.

In conclusion, the requests for apportionment of costs must be rejected.

Order

For these reasons it is decided that:

1. The appeal is dismissed.

2. The requests for apportionment of costs are rejected.