Friday, 9 October 2015

T 1021/11 - Two independent claims for same medical use


In this examination appeal, the main request comprises two independent claims for the same medical indication of the same substance, one claim drafted in the Swiss-type format (use of substance X for the manufacture of a medicament for the treatment of disease Y) and the other claim following the provisions in Article 54(5) EPC (substance X for use in the treatment of disease Y).

In a telephone conversation with the rapporteur, the applicant was invited to comment on the presence of two independent claims for the same medical use in the same set of claims in this request.

The applicant commented that he has a legitimate interest to pursue both claim types in one set because determining the scope of those claims in potential infringement proceedings was a matter for national courts, as confirmed in decision G 02/08. 

In addition, both claim types were deemed allowable by the applicant since the patent application was pending when G 02/08 was issued (and thus the Swiss-type format was allowable) while the transitional provisions concerning the revised Convention Article 54(5) EPC applied to the present application.

Summary of Facts and Submissions (selected paragraphs)

I. The appeal lies from the decision of the examining division to refuse European patent application No. 06 850 366 which was filed as an international application and published as WO 2007/094893 (the application as filed).

XII. Claims 1 to 9 of the main request read:

"1. An immunogenic composition for use in a method of preventing lymphadenopathy associated with PCV2 infection in swine, wherein the composition is to be administered once in swine, said composition comprising 4 myg to 200 myg of recombinant PCV2 ORF2 protein as the antigenic component and 100 myg to 10 mg adjuvant per dose, wherein said recombinant PCV2 ORF2 protein has been obtained in that (a) susceptible cells are infected with a recombinant baculovirus vector containing PCV2 ORF2 DNA coding sequences, (b) PCV2 ORF2 polypeptide is expressed by said recombinant baculovirus, and (c) the expressed PCV2 ORF2 polypeptide is recovered from the supernate [sic] by filtration and the baculovirus vector inactivated.

8. Use of an immunogenic composition comprising 4 myg to 200 myg of recombinant PCV2 ORF2 protein as the antigenic component and 100 myg to 10 mg adjuvant per dose, wherein said recombinant PCV2 ORF2 protein has been obtained in that (a) susceptible cells are infected with a recombinant baculovirus vector containing PCV2 ORF2 DNA coding sequences, (b) PCV2 ORF2 polypeptide is expressed by said recombinant baculovirus, and (c) the expressed PCV2 ORF2 polypeptide is recovered from the supernate by filtration and the baculovirus vector inactivated, for the manufacture of a medicament for the prevention of lymphadenopathy associated with PCV2 infection in swine, wherein the medicament is to be administered once in swine.

IX. In a telephone conversation with the rapporteur on 16 December 2014, the appellant's representative was informed of issues of clarity and inventive step concerning the main request and was invited to comment on the presence of two independent claims for the same medical use in the same set of claims in this request.

XIV. The appellant's arguments relevant to the decision can be summarised as follows:

Second medical indication - allowability of "Swiss-type" and "Article 54(5) EPC-type" claims

Both a purpose-limited product claim and a claim in the Swiss-type format for the same medical indication were allowable in the present set of claims.

The Swiss-type format was allowable for applications having a filing date before 28 January 2011, in accordance with the "Notice from the European Patent Office dated 20 September 2010 concerning the non-acceptance of Swiss-type claims for second or further medical use following decision G 2/08 of the Enlarged Board of Appeal". The Enlarged Board of Appeal had in decision G 2/08 intentionally introduced a transitional period during which Swiss-type claims could still be pursued while the revised EPC was already in force. This clearly indicated that the Enlarged Board of Appeal saw no "contradictory legal situation" between the provisions of Article 54 EPC 1973, which led to the allowability of Swiss-type claims as the exceptional solution provided in decision G 5/83 and the provisions in Article 54 EPC.

Furthermore, an applicant had a legitimate interest to pursue both claim types in one set because determining the scope of those claims in potential infringement proceedings was a matter for national courts. Which exact scope would in future be attributed to each of these claim types by any specific national court was yet to be determined, as confirmed in decision G 02/08 of the Enlarged Board of Appeal which stated that "It appears that the rights conferred on the patentee by the claim category under Article 54(5) EPC are likely broader, and could, in particular, lead to possible restrictions on the freedom of medical practitioners to prescribe or administer generics. However, in view of the clear provisions of Articles 53(c), second sentence, and 54(5) EPC and the intention of the legislator, the Enlarged Board has no power to broaden or reduce in a praetorian way the scope of these provisions. If deemed necessary, the freedom of medical practitioners may be protected by other means on the national level".
Reasons for the Decision
Applicability of EPC 1973 and the revised EPC

1. The present application has a filing date of 28 December 2006. Thus, on 13 December 2007, the date of entry into force of the revised version of the European Patent Convention, the present application was pending.

2. Pursuant to Article 7(1), second sentence, of the Act revising the EPC of 29 November 2000, the revised version of the Convention does not apply to such applications, unless otherwise decided by the Administrative Council of the European Patent Organisation. By the decision of 28 June 2001 on the transitional provisions under Article 7 of the Act revising the European Patent Convention of 29 November 2000 (see special edition No. 1, OJ EPO 2007, 197) the revised version of the EPC was ordered to be applicable to pending patent applications with regard to a number of provisions.

3. In the following, "EPC" and "EPC 1973" will be used in order to specify whether reference is made to the revised EPC or to its previous version.

(...)

Second medical indication - allowability of "Swiss-type" and "Article 54(5) EPC-type" claims

34. The main request comprises two independent claims (claim 1 and claim 8) for the same medical indication of the same substance, one claim drafted in the Swiss-type format (use of substance X for the manufacture of a medicament for the treatment of disease Y) and the other claim following the provisions in Article 54(5) EPC (substance X for use in the treatment of disease Y).

35. In decision G 2/08 (OJ EPO 2010, 456), the Enlarged Board of Appeal considered the consequence of the revised EPC on claims in the Swiss-type format. The Enlarged Board decided that since "Article 54(5) EPC now permits purpose-related product protection for any further specific use of a known medicament in a method of therapy 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" (see Reasons 7.1.3). In view of the fact that patents had been granted and many applications were still pending seeking patent protection for claims of this (Swiss) type, the Enlarged Board considered that a transitional arrangement was necessary to ensure legal certainty and to protect the legitimate expectations of applicants. It therefore set a time limit of three months after publication of its decision in the Official Journal of the EPO for future applications to comply with the new situation. In this respect the relevant date for future applications was ordered to be their date of filing or, if priority has been claimed, their priority date (see Reasons 7.1.4).

36. Hence, in applications not covered by the transitional arrangement, protection for second medical indications may no longer be sought in the Swiss-type format where the claimed subject-matter is rendered novel only by a new therapeutic use of a medicament. However, for applications covered by the transitional arrangement, no restriction has been set by the Enlarged Board for the use of Swiss-type claims.

37. The present application was pending when the decision G 2/08 (supra) was issued and it therefore belongs to the category of applications in which the Swiss-type format may, as a general rule, still be used. Thus, it follows that the Swiss-type format may be used in the present application.

38. At the same time, pursuant to the transitional provisions concerning the revised Convention Article 54(5) EPC applies to the present application (cf. Article 1 point 3 of the decision of the Administrative Council of 28 June 2001, loc. cit.).

39. As both claim formats - Swiss-type and the format according to Article 54(5) EPC - are available for the present application and claims of both formats are present in the main request, the question arises whether both claim types may be present in a single set of claims.

40. Decision G 2/08 (supra) does not deal with this question. This board therefore concurs with the conclusion reached in decision T 1570/09 of 16 May 2014 that decision G 2/08 (supra) did 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 in the Swiss-type format and the other claim in the format in accordance with Article 54(5) EPC (see decision T 1570/09, reasons 4.4, last paragraph). However, it appears to this board that no prohibition of the coexistence of such claims in one claim set can be deduced from G 2/08 (supra) either, as it is silent in this respect.

41. In decision T 1570/09 (supra), the competent board did not consider a set of claims comprising the two claim formats to be allowable. Against the background that an allowable claim pursuant to Article 54(5) EPC could be formulated and was present in the claim set and that the Swiss-type form was conceived as an exception under the EPC 1973, the board held that there was no longer an objective reason which justified 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" (see T 1570/09, reasons 4.4, paragraph 4).

42. The present board, having carefully examined the reasoning given in decision T 1570/09 (supra), has several considerations which prevent it from raising an objection against the presence of claims in the two formats in one single set of claims in the present case.

43. Firstly, it is noted that a single set of claims may be governed by provisions of the EPC 1973 and the revised EPC at the same time. This is the result of the transitional provisions adopted by the Administrative Council and can be seen, for instance, from the application of provisions from both versions of the EPC to the present case (see in particular Article 1 points 1 and 3 of the decision of the Administrative Council of 28 June 2001, loc. cit.). A specific provision does not apply in both versions at the same time, with either the old version or the new version of the provision applying.

44. Secondly, there might no longer be a need for patent protection for second or further medical indications to be sought in the form of Swiss-type claims from the time of entry into force of the revised EPC since the new format is at an applicant's disposal. However, in the board's view the continued existence of the Swiss-type format, in parallel to the provisions of Article 54(5) EPC, is a direct consequence of the transitional arrangement provided for by the Enlarged Board in decision G 2/08 (supra). The gap in the EPC 1973 regarding patent protection of second or further medical indications was closed in a praetorian way by the Enlarged Board by the introduction of Swiss-type claims and the special approach for assessing the novelty of such claims. As the cause of this praetorian ruling ceased to exist with the creation of a legal provision in the revised EPC by the legislator, the Enlarged Board decided to abandon the special approach on novelty for Swiss-type claims. However, in order to avoid a retroactive effect on pending applications or granted patents, the Enlarged Board ordered that the Swiss-type claim format may no longer be used as of the specified cut-off date. It thereby created a time period in which both the old and the new format for claims for second and further medical indications could be used.

45. Thirdly, the board sees no reason to prevent an applicant from choosing both available formats during the interim period and considers it justified to do so in one set of claims. Even though the claims in both formats provide patent protection for the same medical indication, there is a difference in the subject-matter of the claims due to their category, in combination with their technical features: The Swiss-type claim is a purpose-limited process claim whereas the claim pursuant to Article 54(5) EPC is a purpose-limited product claim. Moreover, in addition to the definition of the compound and the therapeutic use present in both claim formats, the Swiss-type claim comprises the feature of manufacturing a medicament and therefore differs also in this respect from a claim formulated according to the provisions of Article 54(5) EPC (see T 1780/12 of 30 January 2014, reasons 11 to 17; T 879/12 of 27 August 2014, reasons 7 to 11). It is because of this difference in subject-matter that, in a situation in which a patent was granted with (only) a Swiss-type claim and protection is then sought using a purpose-limited product claim pursuant to Article 54(5) EPC for the same medical indication, in a patent application of the same applicant, designating the same contracting states and having the same effective date, the issue of double-patenting does not arise (see also decision T 1780/12 (supra), reasons 25 and 26 and T 879/12 (supra), reasons 15 and 16).

46. Thus, by filing two patent applications having the same effective date (two parallel applications or parent/divisional or priority/subsequent application) it is possible for an applicant to obtain patent protection for the same second or further medical indication in both available claim formats.

47. Allowing the coexistence of two patents from the same applicant, having the same effective date, one including a claim in the Swiss-type format and the other including a claim for a purpose-limited product, does not seem to be materially different from accepting the two claims in one set of claims. The result is that in both cases, patent protection is available for the same second or further medical indication in both available formats.

48. The board therefore does not object to the presence of both formats in a single set of claims, as both formats are applicable to the present application. The board notes that no objections were raised in similar previous cases (see e.g. decision T 396/09 of 27 February 2013 and decision T 1869/11 of 22 March 2013), even if the issue was not discussed in these decisions.

49. Thus, for the reasons set out above, the present board is of the opinion that independent claim 1, drafted following Article 54(5) EPC and independent claim 8, drafted as a Swiss-type claim, as instituted by decision G 5/83 (OJ EPO 1985, 64), are both allowable in the same set of claims.

Order

For these reasons it is decided that:

1. The decision under appeal is set aside.

2. The case is remitted to the examining division with the order to grant a patent on the basis of claims 1 to 9 of the main request filed with the letter dated 18 December 2014, with a description and figures to be adapted thereto.


This decision T 1021/11 (pdf) has European Case Law Identifier:  ECLI:EP:BA:2014:R001613.20141208. The file wrapper can be found here. Photo "Hogs Outside" by the United Soybean Board obtained via Flickr under CC BY 2.0 license (no changes made).

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