Friday, 16 May 2014

T 1780/12 - Antibodies for cancer treatment - double patenting?



Photo by Dawn Huczek obtained via Flickr.

This is an appeal against the Decision of the Examining Division refusing a European patent application (herinafter "EP2"), with EP2 being a divisional application of a European patent application which has been granted (herinafter "EP1").


The Examining Division refused the divisional application under Article 97(2) EPC in conjunction with Article 125 EPC ("double patenting").

Claim 1 of EP1 read:
"1. Use of a composition comprising a biologically effective amount of an anti-aminophospholipid antibody, or antigen-binding region thereof, in the manufacture of a medicament for the treatment of cancer by killing tumor vascular endothelial cells of a vascularised tumor".

Claim 1 of the main request before the Examining Division read:
"1. A composition comprising a biologically effective amount of an anti-aminophospholipid antibody, or antigen-binding region thereof, for the treatment of cancer by killing tumor vascular endothelial cells of a vascularised tumor, inducing coagulation in tumor vasculature or destroying tumor vasculature."

In the decision under appeal the Examining Division held that:

"A claim directed to a second or further medical use claim under Article 54(5) EPC is considered to be directed to the same subject-matter as a Swiss type claim directed to the same medical use, in the sense that both these claims concern the same invention claimed in a different format".  The examining division also considered that "(…) double patenting is concerned with the substantial identity of claimed subject-matter and is not related to the (only potential) variance in the granted protection."

With its statement of grounds of appeal the appellant filed a new main request of which claim 1 was identical to claim 1 of the main request before the Examining Division.

The appellant requested that the decision of the examining division be reversed insofar as it resulted in refusal of this application. The arguments of the appellant:

"The claims of EP1 were formatted in accordance with decision G 5/83. It was widely accepted that this format of claim was a purpose-limited process claim. By comparison, the claims of the present application (EP2) were formatted in accordance with Article 54(5) EPC 2000. These claims were purpose-limited product claims, i.e. the product when packaged for that use. (...) The fact that these claim formats differed in scope was confirmed by the Enlarged Board of Appeal in decision G 2/08.

Decisions G 1/05 and G 1/06 referred to the same subject-matter. If the claims were not at least substantially identical in scope, they could not constitute the same subject matter. A process claim and a product claim could not be substantially identical in scope. For the reasons stated above, the claims were clearly distinguishable in scope and therefore were not directed to the same subject matter."

Reasons for the Decision

5. The examining division based its refusal (see section VII above) on established practice of the EPO departments of first instance (see Guidelines for Examination, C-VI, 9.1.6 and C-IV, 7.4) and decisions G 1/05 and G 1/06 of the Enlarged Board of Appeal (OJ EPO 2008, 271 and 307, respectively).

(...)

7. These passages of the Guidelines for Examination thus restrict the prohibition of double patenting to applications claiming the same invention, and more specifically to parent and divisional applications claiming "the same subject-matter". Thus, pursuant to the Guidelines, in order to determine whether or not the same invention is claimed, the claimed subject-matter has to be determined first.

(...)

10. Therefore, the board finds it appropriate to address first the issue of what constitutes the claimed subject-matter in the case under consideration.

Subject-matter


11. In decision G 2/88 (OJ EPO 1990, 93, see point 2 of the reasons) the Enlarged Board of Appeal was confronted with two points of law concerned with the interpretation and effect of patent claims. The Enlarged Board of Appeal considered (ibid., point 2.6 of the reasons) that: "(…) the subject-matter of a claimed invention involves two aspects: first, the category or type of the claim, and second, the technical features, which constitute its technical subject-matter."

(...)

13. In the board's judgement, it follows from decision G 2/88, supra, that the category of a claim and its technical features constitute its subject-matter and determine the protection conferred. This board is not aware of any different, commonly accepted definition of the term "subject-matter" in the context of a claim. While the board agrees with the examining division that EP1 and the present application relate to the same invention, the board concludes that the approach taken by the examining division when finding that the same invention eo ipso had to mean that the same subject-matter was claimed is neither supported by the Guidelines nor by the case law.

14. In the present case, what has to be considered and decided is whether or not the subject-matter of the claims, as defined by their categories in combination with their technical features, is the same for the claims granted for EP1 and pending for the main request.

15. The appellant disputes that the subject-matter of the claims granted for EP1 is the same as that of the main request (see section XVI above).

16. Claims 1, 24 and 25 of EP1 are formatted in accordance with decision G 5/83, supra, as so-called Swiss-type claims (see section III above for the complete wording of the claims). These claims take the form "Use of X for the manufacture of a medicament for the treatment of Y", i.e. they are purpose-limited process claims. The claims of the main request are formatted in accordance with Article 54(5) EPC (see section IV above for the complete wording of the claims). These claims take normally the form "X for use in the treatment of Y" and are construed as purpose-limited product claims. Thus, the categories of the claims granted for EP1 and of the claims pending as main request, respectively, are different.

17. As regards the technical features, both set of claims define the same compound and the same therapeutic use but the claims of EP1 comprise in addition the manufacture of a medicament while the claims of the main request do not (again, see sections III and IV above for the complete wording of the claims). The board concludes that the claimed subject-matter is different between EP1 and the main request.

Scope of protection


18. The examining division further held (see section VII above) that "double patenting is concerned with the substantial identity of claimed subject-matter and is not related to the (only potential) variance in the granted protection".

(...)

21. As set out in decision G 2/88 (supra, see reasons, point 3.3) the "(...) determination of the "extent of the protection conferred" by a patent under Article 69(1) EPC is a determination of what is protected in terms of category plus technical features (...)".

22. It follows from the above analysis (see points 16 and 17) that the claims under consideration belong to different categories, i.e. purpose-limited process claim vs. purpose-limited product claim and differ in addition in at least one technical feature. It is generally accepted as a principle underlying the EPC that a claim to a particular physical activity (e.g. method, process, use) confers less protection than a claim to the physical entity per se, see decision G 2/88 (supra, reasons, point 5). It follows that a purpose-limited process claim also confers less protection than a purpose-limited product claim. The scope of protection sought by the invention claimed pursuant the present main request is thus noticeably different from the scope of protection conferred by claims 1, 24 and 25 of EP1, see also decisions T 0795/06 of 18 March 2010 (points 6.3 to 6.4 of the reasons) and T 1635/09 of 27 October 2010 (points 14 and 15.1 of the reasons).

(...)

25. It follows from the above analysis that the subject-matter and the scope of protection conferred by claims 1 (...) granted for EP1 differ from the subject-matter and the scope of protection conferred by claim 1 of the main request. The board is thus satisfied that there is no manifest objective reason to deny the legitimate interest of the applicant in pursuing claims drafted in accordance with Article 54(5) EPC and thereby obtaining protection different from - albeit partially overlapping - with that of the Swiss-type claims of the parent patent already granted.

26. The board concludes that the grant of a patent on the basis of present claim 1 would not lead to double patenting. The appeal is thus allowable.

This decision has European Case Law Identifier:  ECLI:EP:BA:2014:T178012.20140130. The whole decision can be found here. The file wrapper can be found here.

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