Thursday, 4 September 2014

T 1570/09 - Getting both




In this examination the Board had to decide on a claim set that included both a Swiss type claim and a purpose-limited product claim under Article 54(5) EPC 2000. The two second medical-use claims were formulated as follows (emphasis mine)

Claim 1 in the main request before the board read:

1. Use of at least one member selected from the group consisting of alpha-ketoglutaric acid and pharmaceutically acceptable salts thereof, for the manufacture of a pharmaceutical preparation or a food or feed supplement for increasing plasma levels of high density lipoprotein (HDL) in vertebrates, such as birds and mammals, including man.
and Claim 4 read


4. A compound selected from the group consisting of alpha-ketoglutaric acid and pharmaceutically acceptable salts thereof, for use in increasing plasma levels of high density lipoprotein (HDL) in vertebrates, such as birds and mammals, including man.
The priority date of the application was 17.06.2004, thus before the decision G2/08 which abolished the Swiss type Claim. According to the minutes of the oral proceedings before the board both Claim 1 and Claim 4 were allowable.

The applicant would like to get both his two claims granted.


According to the applicant, it is accepted practice before examining divisions to allow both claim types together, since the entry into force of EPC 2000. Moreover, this would be needed because the interpretation of the two different claim forms by the national courts of the contracting states might differ from one state to another and also deviated from the EPO's practice.

This is what the board had to say about it:


Reasons for the Decision


(...)
4. Main request
4.1 It is generally known to the skilled person (see documents D5 to D7) that increasing plasma levels of high density lipoprotein (HDL) in human and animals is a medical indication for treatment, including prophylaxis, of several medical conditions and diseases.

The set of claims of the main request contains two independent claims (claims 1 and 4) concerning the further therapeutical use, defined as "increasing plasma levels of high density lipoprotein (HDL) in vertebrates, such as birds and mammals, including man", of the known substance alpha-ketoglutaric acid (and pharmaceutically acceptable salts thereof).

Therefore, claim 1 of the main request, which is drafted in Swiss-type form, and claim 4 of the main request, which is drafted as purpose-limited product claim, aim to seek protection for one and the same medical use of one and the same active drug.

4.2 The legal fiction in accordance with the praetorian rule introduced with Enlarged Board of Appeal decision G 1/83 (G 5/83, G 6/83), OJ EPO 1985, 60, has to be applied for conferring notional novelty to the subject-matter claimed in the Swiss-type claim 1 of the main request.

Enlarged Board of Appeal decision G 1/83 (G 5/83, G 6/83) introduced the "Swiss-type" form claim in consideration of the fact that the provisions of EPC 1973, and in particular of its Article 54(5), allowed purpose-related product claims only for the first (generic) medical use of a known substance or composition. In other words, in accordance with the provisions of EPC 1973, claims drafted in the form of a product claim directed to a substance or composition for use in a method referred to in Article 52(4) EPC 1973 are allowable if the first medical use of a known substance or composition is novel under Article 54(5) EPC 1973. In contrast to the first medical indication of a known substance or composition in the form of such "use-related product claims" under Article 54(5) EPC 1973, there was an absence of provisions in EPC 1973 allowing purpose-limited product claims for further specific medical indications (see G 2/08, OJ EPO 10/2010, 456, points 5.8 and 5.9 of the Reasons, and G 5/83, OJ EPO 1985, 64, point 15 of the Reasons).

4.3 Apart from this, a body of jurisprudence has been developed over the years by the Boards of Appeal which concerns the application of the praetorian rule introduced by Enlarged Board of Appeal decision G 1/83 (G 5/83, G 6/83) to particular situations in which the "invention" for which protection was sought relied upon a new use of a substance or composition in a method of treatment referred to in Article 52(4) EPC 1973 (Article 53(c) EPC 2000).

Thus, although Swiss-type claim 1 does not explicitly employ the term "medicament" the claim's wording is appropriate to the situation in the technical field underlying the present invention at the date of filing, where the term "medicament" has to be taken in a broader sense than the classical meaning in the year 1985, when the Enlarged Board of Appeal decision G 1/83 (G 5/83, G 6/83) was issued. Additionally, it has to be stressed that the "medicament" itself (and its definition in claim 1 of the main request) does not confer notional novelty on the claimed subject-matter. The notional novelty of the subject-matter claimed in claim 1 of the main request relies on the novelty of the medical indication specified in said claim.

Such a situation is referred to in Enlarged Board of Appeal decision G 2/08, OJ, EPO 10/2010, 456, point 7.1.1 of the Reasons, second and third paragraphs:

"Since the medicament per se was not new the subject-matter of such a claim was rendered novel by its new therapeutic application (cf. G 5/83, points 20 and 21 of the Reasons). This praetorian approach was a "special approach to the derivation of novelty" (cf. point 21 of G 5/83) and therefore constituted a narrow exception to the principles governing the novelty requirements which was not intended to be applied in other fields of technology.

That praetorian ruling found its cause in the fact that a claim directed to the use of the substance or composition for the treatment of the human body by therapy had to be regarded as a step of treatment (see point 18, in fine of G 5/83). A claim of that kind was forbidden. On the other hand only the first medical indication of a known composition in the form of a medicament was by virtue of Article 54(5) EPC 1973 (Article 54(4) EPC 2000) entitled to be drafted in the form of a purpose-related product claim. And since the intention of the legislator was clearly not to exclude second therapeutic indications of a known medicament from the field of patentability the so-called Swiss-type claim constituted the adequate but exceptional solution."

4.4 Moreover, following the rationale of Enlarged Board of Appeal decision G 2/08, as expressed in paragraph 7.1.2 of the Reasons:

"Article 54(5) EPC now permits purpose-related product protection for any further specific use of a known medicament in a method of therapy. Therefore, as mentioned in the preparatory document (MR/24/00, point 139) the loophole existing in the provisions of the EPC 1973 was closed.
In other words "cessante ratione legis, cessat et ipsa lex", when the reason of the law ceases, the law itself ceases.

The cause of the praetorian approach ceasing, the effect must cease."

In the present case the appellant has been able to formulate under Article 54(5) EPC 2000 an allowable purpose-limited product claim (claim 4 of the main request) which seeks protection for the same medical indication of the same substance as in the Swiss-type claim 1, and the notional novelty of claim 1 is not derived from the "medicament" itself. Therefore, there is no longer an objective reason for justifying the simultaneous presence of both claims in the set of claims to be proposed for grant. Allowing such a set of claims would cause the contradictory legal situation that the old provisions in Article 54 EPC 1973 together with Article 52(4) EPC 1973, and the new provisions in Article 54 EPC 2000 together with Article 53(c) EPC 2000 would apply simultaneously to one and the same set of claims.

Enlarged Board of Appeal decision G 2/08 announced the official end to the praetorian rule set out in G 5/83, OJ EPO 1985, 64, in its answer to question 3 as follows:

"Where the subject-matter of a claim is rendered novel only by a new therapeutic use of a medicament, such claim may no longer have the format of a so called Swiss-type claim as instituted by decision G 5/83.

A time limit of three months after publication of the present decision in the Official Journal of the European Patent Office is set in order that future applicants comply with this new situation".

Fixing an official time limit for the end of the praetorian rule merely solved any possible problems derived from the fact that at the time of the publication of G 2/08 in the OJ EPO (October 2010) many applications for which the transitional provisions governing the entry into force of EPC 2000 applied were still pending and the abolition of the praetorian rule should therefore not create a retroactive legal effect (G 2/08, point 7.1.4 of the Reasons).

However, G 2/08 does not give applicants an absolute right to draft two independent claims in one single set of claims for one and the same medical indication of one and the same substance, one claim following the praetorian rule introduced in view of the old provisions of EPC 1973, and the other claim following the new provisions in Article 54(5) EPC 2000.

4.5 The appellant submitted that including both claims in a single set of claims served to protect its legitimate interests, since it was to be expected that different national courts would decide divergently on patentability of claims seeking protection for a further use in a method referred to in Article 53(c) EPC 2000.

Apart from the fact that such argumentation would rather justify the filing of two separate sets of claims (one with claims in the form of Swiss-type claims, the other with claims in the form of purpose-limited product claims) depending on the contracting states for which particular national jurisprudence was applicable, the appellant did not cite any such national decisions to support its argument.

The relevance for the present appeal case of a theoretical possibility of supposedly conflicting national decisions cannot be seen. Moreover, Article 4(3) EPC confers on the European Patent Organisation the authority to grant European patents.

The issue is whether it is allowable in view of the Enlarged Board of appeal decisions G 1/83 (G 5/83, G 6/83) and G 2/08 to have two independent claims directed to the same known substance for use in the same further method for treatment formulated in accordance with EPC 1973 on the one hand, and in accordance with EPC 2000 on the other hand. It is thus an issue of the transitional application of the law as authoritatively interpreted by the Enlarged Board of Appeal.

4.6 Under the circumstances depicted above, the appellant's argument that Swiss-type form claims and purpose-limited product claims confer different scopes of protection under Article 69 EPC at national level cannot succeed as a valid justification for allowing the main request. The answer given to question 3 in G 2/08 confirms that the theoretical possibility of different interpretations of the scope of protection conferred under Article 69 EPC at national level is not stated as a reason for prolonging the life of Swiss-type form claims in those cases where there is no longer any legal reason for applying the praetorian rule in accordance with the old law (EPC 1973) instead of Article 54(5) EPC 2000.

4.7 The appellant also asserted that there was a practice followed by the EPO examining divisions, after the entry into force of EPC 2000, of granting both forms of claims in the same set of claims. However, the boards of appeal have to comply with the provisions of the EPC and are not bound by the interpretations and practice of the examining divisions (Article 23(2) EPC 2000).

4.8 Summarising, Article 54(5) EPC 2000 applies to the present case (Article 1(3) of the decision of the Administrative Council of 28 June 2001 on the transitional provisions under Article 7 of the Act revising the European Patent Convention of 29 November 2000, and thus the purpose-limited product claim 4 of the main request is allowable for seeking protection for the further (specific) medical indication of alpha-ketoglutaric acid (and pharmaceutically acceptable salts thereof).

The Swiss-type form was conceived as an exception under the old law (EPC 1973). Therefore, since Article 54(5) EPC 2000 applies to the present application and claim 4 of the main request is allowable in view of a new medical indication of a known substance, there is no longer any legal reason in the present case for allowing Swiss-type claim 1 in the set of claims of the main request. Accordingly, the main request is not allowable.

4.9 As regards the appellant's general comments relating to the fact that a request to the Regulatory Authorities has to be submitted before commercializing products in the medical field, this situation applies to both Swiss-type claims and purpose-limited product claims. Moreover, the provisions in the EPC concern the requirements to be fulfilled in order that a patent can be granted, which are different requirements to, and independent from, those that have to be fulfilled for a product to obtain marketing authorisation from a Regulatory Authority.


This decision has European Case Law Identifier:  ECLI:EP:BA:2014:T157009.20140516. The whole decision can be found here. The file wrapper can be found here. Photo by Andreas Kambanis obtained via Flickr.


5 comments :

  1. The Boards seem divided, Board 3.3.08 came recently in T0879/12 to the opposite conclusion, following T1780/12. Strange that the Board in this decision T1570/09 does not even acknowledge that it does not follow T1780/12 (which had a "B" publication code).

    ReplyDelete
  2. T 1780/12 and T 879/12 dealt with Swiss-type and Art. 54(5)-type claims in the context of double patenting. The question was whether they were identical in scope.

    This decision deals with a single set of claims comprising both a Swiss-type claim and an Art. 54(5)-type claim. It does not seem to conflict with T 1780/12 and T 879/12, as it does not state that the two claims have identical scope.

    The applicant in this case, who is now getting the Art. 54(5)-type claim granted, can still pursue the Swiss-type claim in a divisional. Double patenting is not an objection (provided T 1780/12 and T 879/12 are followed), and I don't see how the fact that he can in principle draft an Art. 54(5)-type claim (as he has in fact done in this "parent" application) would prevent the applicability of the transitional rule of G 2/08. In view of this I have some doubt about this decision. Where does G 2/08 not give applicants an absolute right to having the praetorian rule of G 1/83 applied to them for applications filed during the transitional period?

    The board seems to require a specific "legal reason" applicable to the present case for allowing the "praetorian rule" of G 1/83. But:
    - this rule was established for EPC 1973 by the EBA in G 1/83 (G 5/83, G6/83);
    - this rule has been maintained for EPC 2000 by the EBA in G 2/08 for a transitional period.

    G 2/08 did not state that the transitional period does not apply where the applicant happens to be able to draft an Art. 54(5)-type claim. It does say "the cause of the praetorian approach ceasing, the effect must cease", but it is still the EBA that made the rule cease... after a transitional period.

    Imho, the board should either have followed G 1/83 and G 2/08, or referred a question to the EBA.

    The decision isn't very clear in stating the legal ground for refusing the main request (which can only be lack of novelty).

    ReplyDelete
  3. It seems an astute observation that the Board does not state the legal ground for the rejection. I won't guess lack of novelty, rather A 84 (conciseness of the claims). For instance, the Baord suggests in 4.5 filing separate set of claims for different countries, which in this case would nog help to restore novelty (and neither be possible under R 138 and A 118). However, if the ground was indeed lack of novelty, then I agree that T 1780/12 and T879/12 are less relevant. Althoug in those cases, either of the two claims causing (possible) double patenting should be novel.

    ReplyDelete
  4. At the start of the reasons I thought the board mainly had lack of conciseness in mind (e.g. see 4.1). This makes more sense to me. If the two claims have identical scope, then you need only one. Also the minutes state explicitly that any one of the two claims was allowable; but not both.

    Near the end of the reasons the argument seems to veer towards lack of novelty.

    This would lead to the strange situation that if this applicant wasn't able to formulate a purpose limited claim, then the Swiss format would be novel. But now that he can, it isn't.


    ReplyDelete
  5. Lack of conciseness seems unlikely, as the board never mentions Art. 84 in this decision, nor the word conciseness. Plus, if lack of conciseness had been the legal ground it would not have been necessary to discuss whether the "praetorian rule" applies to this case.

    I admit that the board is not clearly reasoning towards a lack of novelty either. Both the minutes and the decision seem to suggest that deleting either claim would have overcome the objection. It is difficult to understand how deleting one claim could have overcome a lack of novelty of another claim.

    So there is no clear legal ground. There is evidently a "dislike" of claim sets comprising both claims, possibly fed by the idea "you don't need both". But that's not enough to refuse a request.

    ReplyDelete

Statcounter