UK: Report Of Recent EPO Decisions – June 2008

Patentability and Novelty (Articles 52 and 54 EPC)

T 1319/04 Nicotinic acid compositions for treating hyperlipidemia / Kos Life Sciences, Inc.

TBA Decision of 22 April 2008 (to be published in the Official Journal)

Chairman: U. Oswald
Members: J. Riolo, S. Perryman, A. Lindner and P. Mühlens

This case concerned an appeal by the applicant from a decision of the Examining Division to refuse its medical use patent application for lack of novelty. The application concerned a new dosage regime for a known pharmaceutical for the treatment of hyperlipidemia. The Examining Division had held that this dosage regimen reflected a medical activity excluded from patentability under Article 52(4) EPC 1973, and could not therefore be considered to represent a further medical indication from which novelty could be derived.

As the application was pending on the date on which EPC 2000 came into force, under the transitional provisions the application now had to be considered under the provisions of Articles 53(c), 54(4), and 54(5) EPC 2000 (following the decision in T 1127/05).

The TBA stated that it was not aware of any other case yet having been decided under Article 54(5) EPC 2000 and noted that it had no express equivalent in EPC 1973. However, it referred to the travaux préparatoires for EPC 2000, and decided that Article 54(5) EPC 2000 was intended to enshrine the decision of the Enlarged Board in G 5/83 on second medical use patents. The Board therefore considered the background to, and reasoning behind, the decision of the Enlarged Board in G 5/83.

Prior to G 5/83, it was understood in most contracting states to EPC 1973 that a known substance or composition which, as part of the state of the art, was no longer patentable in itself could be patented for a first use as a medicament, but that no patent could be granted for the discovery of a second possibility of using that substance as a medicament. However, the Enlarged Board concluded that the intention of Article 52(4) EPC 1973 was to free from restraint only non-commercial and non-industrial medical activities and that this exception to patentability should not be allowed to go beyond its proper limits. Therefore it was legitimate in principle to allow claims directed to the use of a substance for the manufacture of a medicament for a specified new and inventive therapeutic application, even where the manufactured medicament had previously been disclosed. However, the cases considered by the Enlarged Board in G 5/83 (and in the parallel decisions G 1/83 and G 6/83) concerned use of a known medicament to treat a new illness. There had therefore been no reason to distinguish between a use to treat a new illness and a use to treat the same illness with a different dosing regimen.

The Board then considered case law subsequent to G 5/83 on different categories of novel and inventive therapeutic uses in order to determine support for the patentability of novel dosage regimens. In particular, the Board referred to T 1020/03, in which a pure dosage regimen was recognised for the first time as not being excluded from patentability. However, the Board recognised that there was also a line of cases (followed by the Examining Division in the present case) which had reasoned that that pure dosage regimens were not patentable over the prior art, in part because the disclosure of the use of a medicament for treating a particular illness was deemed to make known all possible dosing regimens using that medicament to treat that illness. The justification for this view is that the assessment of the right dosage was so much a question between physician and patient that preservation of the physician's freedom to assess the right dosage must take precedence over any right to obtain a patent.

However, the Board in the present case held that this would require the attribution of a very special meaning to the prohibition of patenting "methods of treatment by therapy" in Articles 53(c) and 54(5) EPC 2000. The travaux préparatoires for EPC 2000 did not hint at any such special interpretation and therefore the Board considered that an authoritative interpretation was required, which only the Enlarged Board could provide. The Board also noted that this was an important point of law, as the situation arose quite frequently, and that if patenting of novel dosing regimens was excluded then applicants needed to know this for certain.

The Board therefore referred the following three questions to the Enlarged Board of Appeal:

1. Where it is already known to use a particular medicament to treat a particular illness, can this known medicament be patented under the provisions of Articles 53(c) and 54(5) EPC 2000 for use in a different, new and inventive treatment by therapy of the same illness?
   
   
2. If the answer to question 1 is yes, is such patenting also possible where the only novel feature of the treatment is a new and inventive dosage regime?
   
   
3. Are any special considerations applicable when interpreting and applying Articles 53(c) and 54(5) EPC 2000?
   
   

These questions are now pending under reference G 2/08.

Patentability

(Article 53(b) and Rule 23 b(5) EPC)

T 1242/06: Method for breeding tomatoes having reduced water content and product of the method / Unilever NV

TBA Decision of 4 April 2008 (to be published in the Official Journal)

Chairman: U. Kinkeldey
Members: R. Moufang and M. Wieser

This was an appeal from an interlocutory decision of the Opposition Division concerning a patent relating to methods of breeding tomatoes that produced tomatoes with a reduced water content. The central issue was the interpretation of Article 53(b) EPC because the decision under appeal had held that certain of the claimed subject matter was excluded under Article 53(b) and Rule 23b(5) EPC as an essentially biological process for the production of plants.

The Technical Board hearing the appeal had referred two questions on the interpretation of these provisions to the EBA in T 83/05 which is currently pending as G 2/07 (see summary in the July 2007 Issue), and it decided to limit the oral proceedings to the issue of a possible further referral.

The TBA considered it would not be appropriate to decide on the scope of the exclusions with G 2/07 still pending. It was therefore left with the option of either staying the proceedings or, if appropriate, referring additional questions. Recognising that the case raised further issues of interpretation, it took the latter course. Previous caselaw of the EPO such as T 320/87 suggested that necessity for human intervention alone was not sufficient for a process to be deemed not "essentially biological". The patentee argued that this position had been changed by Rule 26(5) EPC, a provision introduced through implementation of the Biotechnology Directive (Directive 98/44/EC). However, the TBA considered that the mere fact that some kind of human intervention is required in a process does not, even in light of Rule 26(5), mean that a process necessarily escapes the exclusions; the crucial issue was what kind of human intervention is required for it to do so.

Accordingly, and in light of the particular issues before it, the TBA referred the following further questions to the Enlarged Board:

1. Does a non-microbiological process for the production of plants consisting of steps of crossing and selecting plants fall under the exclusion of Article 53(b) EPC only if these steps reflect and correspond to phenomena which could occur in nature without human intervention?
   
   
2. If question 1 is answered in the negative, does a non-microbiological process for the production of plants consisting of steps of crossing and selecting plants escape the exclusion of Article 53(b) EPC merely because it contains, as part of any of the steps of crossing and selection, an additional feature of a technical nature?
   
   
3. If question 2 is answered in the negative, what are the relevant criteria for distinguishing non-microbiological plant production processes excluded from patent protection under Article 53(b) EPC from non-excluded ones? In particular, is it relevant where the essence of the claimed invention lies and/or whether the additional feature of a technical nature contributes something to the claimed invention beyond a trivial level?
   
   

These further questions are now pending under reference G 1/08 and the EBA has indicated they will be considered in consolidated proceedings with G 2/07.

Claims (Article 84 EPC)

T 1808/06: Oxygen-absorbing label / Multisorb Technologies Inc

TBA Decision of 14 February 2008

Chairman: P. Kitzmantel
Members: W. Ehrenreich and M-B. Tardo-Dino

The claims of the patent in dispute in this case had been amended during examination with the patent being granted in amended form (see T 139/01). Then, during opposition proceedings, one of the opponents had argued that the description and the figures were not correctly adapted to the amended claims, and that the inconsistencies gave rise to an objection under Article 84 EPC. The Opposition Division, relying on Article 69(1) EPC, had adopted a less stringent approach to adaptation of the description than to the claims.

On appeal, the Technical Board of Appeal stated that in order to meet the requirements of Article 84 EPC that the claims be supported by the description, the adaptation of the description had to be performed carefully in order to avoid inconsistencies between the claims and the description which could render the scope of the claims unclear. The reliance by the Opposition Division on Article 69(1) EPC to justify its less stringent approach was wrong as Article 69(1) relates to the scope of the invention, and does not apply directly at the examination or opposition stage. The Board considered that the reference to Article 69(1) in the Guidelines to Examination, Part C, chapter III, point 4.3 was misleading. When removing inconsistencies between the description and the claims, the Board confirmed that only Article 84 EPC should be applied.

The Board also confirmed that it was only where the removal of inconsistencies between the description and the claims was not possible for procedural reasons (for example where no amendment was possible of the granted version) that Article 69(1) could, purely as an auxiliary construction, be invoked for an interpretation of the claimed subject-matter.

EPO Procedure (Rules 56 and 89 EPC)

T 1093/05: Verfahren und Schaltung zur Multiplikation eines Multiplikanden und eines Multiplikators nach dem Booth-Verfahren in iterativen Schritten (Method and circuit for multiplying a multiplicand and a multiplier by the Booth-method in iterative steps) / Infineon Technologies AG

TBA Decision of 13 June 2007 (to be published in the Official Journal)

Chairman: S. Steinbrener
Members: P. Schmitz, S. Wibergh, K. Bumes and G. Weiss

This was an appeal by the patentee against the Examining Division's notification not to correct a patent under Rule 89 EPC 1973.

Before grant of the patent application, the Examining Division gave notice of the amendments to the patent claims and description that it intended to adopt in the granted version pursuant to Rule 51(4) EPC 1973. The patentee did not agree with these amendments and submitted an amended version of the description with a request to grant the patent based on this description and the claims as filed. However, the Examining Division then granted the patent with the amendments included in the Rule 51(4) notification which were different to the version the patentee had asked for. Notably, the decision to grant the patent contained the following statement: "The amendments requested by the applicant and received by the EPO on 00.00.00 have been considered."

The patentee had then applied for a correction of the decision pursuant to Rule 89 EPC 1973 on the basis that a error had been made, but this request was rejected by the Examining Division. The Examining Division stated that the applicant's request for amendments had not been received by the day of the decision and the Examining Division was therefore of the opinion that the decision to grant the patent did not contain an obvious error. Consequently, it could not be corrected on the basis of Rule 89 EPC 1973, and could only be appealed by the patentee.

It was the Examination Division's decision to reject the correction under Rule 89 which was considered by the TBA in this case. The patentee argued that it appeared that the Examining Division had granted the patent with the requested amendments but had forgotten to insert the correct date. The date "00.00.00" constituted an obvious error in the sense of Rule 89 EPC 1973.

The TBA upheld the decision of the Examining Division. It considered that Rule 89 EPC 1973 only provides for linguistic errors, errors of transcription and obvious mistakes to be corrected. It took the view that, as the decision to grant the patent referred to the notification according to Rule 51(4) EPC 1973, the grant of the patent was based on those amendments. It is the established practice of the EPO that the electronically generated form for granting a patent always contains the sentence "The amendments requested by the applicant and received by the EPO on 00.00.00 have been considered" if no amendments have been submitted or if they have not been considered. In such circumstances, no concrete date is inserted but only the figures "00.00.00" are shown. As decisions of the EPO have to be interpreted from the point of view of how a knowledgeable addressee participating in legal relations with the EPO would have understood the decision in good faith, this practice of the EPO was regarded as known to such an addressee. In any event, the lack of a concrete date indicated a mistake had been made.

Since the patent had been granted in a form to which the patentee had not consented, the TBA like the Examination Division consider this to be a material procedural mistake which could only be rectified on appeal.

J 0003/06: Über Viadukte geführter Oberbau für schienengebundene
Fahrzeuge (Railway track on viaduct) / Heitkamp Rail GmbH et al.

LBA Decision of 17 December 2007 (to be published in the Official Journal)

Chairman: B. Günzel
Members: W. Sekretaruk and C. Rennie-Smith

This was an appeal by the patentees against a decision of the Receiving Section of the EPO which dismissed the patentees' application to claim 10 January 2004 as the date of filing of its application and to rescind the Receiving Section's notice of loss of priority rights from the patentees' related German patent application.

The patentees had filed the application on 10 January 2004 submitting a description, claims and drawings. Upon examination, figure 3 of the drawings was found to be missing. The Receiving Section notified the patentees that, upon re-submission of the missing drawing in due time, the date of filing would be deemed to be the date of the re-submission pursuant to Rule 43 (2) EPC 1973. A decision was then made to that effect.

The patentees appealed the decision. They were of the opinion that the Receiving Section should have kept 10 January 2004 as the date of filing based on Rule 56 (3) EPC 2000. The new provision stipulates that, if the missing drawings are filed within the due period, and the application claims priority from an earlier application, the date of filing shall remain the date on which the requirements for the date of filing were fulfilled, provided that the missing drawings were completely contained in the earlier application. With respect to the applicability of Rule 56 EPC 2000, the patentees argued that it refers to Article 90 EPC 2000 which applies to all pending applications at the entry into force of EPC 2000. Thus, in its view, the same should hold true for Rule 56 EPC 2000.

However, the LBA shared the Receiving Section's view that Rule 43 (2) EPC 1973 and not Rule 56 EPC 2000 was applicable. It emphasised that EPC 2000 generally only applies to applications filed after EPC 2000 came into force, unless the Administrative Council had decided otherwise. As to the rules of the Implementing Regulations to EPC 2000, they apply to all applications as far as they are subject to the provisions of EPC 2000. It is therefore important to know which particular Article of EPC 2000 is implemented by which particular rule.

It was the LBA's opinion that Article 80 EPC 2000 rather than Rule 56 EPC 2000 implemented Article 90 EPC 2000. As Article 80 EPC 2000 is only applicable to applications having been filed after EPC 2000 entered into force, the same applies to the corresponding Rule 56 EPC 2000. Thus, the LBA considered that the old regime applied, according to which the day on which the missing drawing is submitted is considered to be the filing date.

It should be noted that the LBA has also confirmed that these principles apply in relation to the applicability of these and other EPC 1973 / 2000 articles in J 0010/07.