T 0419/16 - First medical use and Art.123(2)

Key points

• " The [opponents] argued that the subject-matter of claim 1 (see section V) had no basis in the application as filed. In their view, the application as filed disclosed the claimed antagonist of IL-33 only for a specific medical use, but not for a first medical use [claim, i.e. "  An antagonist of IL-33 for use as a medicament"]." 
• " The board recalls that Article 54(4) EPC provides for claims directed to a first medical use of a per se already known substance or composition and that such a claim confers broad (albeit purpose-limited) protection for substances or compositions, covering any use in a medical method, even if only one specific use is disclosed in the application (see Case Law of the Boards of Appeal of the European Patent Office, 2019, I.C.7.1.1 and decision T 128/82, OJ EPO 1984, 164). It is the board's view that it follows from this case law that the disclosure in an application of a substance or composition for a specific medical use is a basis for a claim directed to a first medical use." 
• " Contrary to the appellants' submissions, the findings in decisions T 36/83 (OJ EPO 1986, 295) and T 128/82 do not support the view that a basis for a first medical use claim (in the sense of Article 123(2) EPC) can only be an identical or equivalent broad disclosure in the application as filed. In both decisions, it was held that a broad disclosure of a pharmacologically active substance for use as a medicament provided a basis for a corresponding broad (first medical use) claim. These decisions however did not consider other possible bases for such a claim nor rule out that the disclosure of a specific medical use can constitute a basis for a claim to a first medical use." 
• T 128/82 hn: " Where a known compound is for the first time proposed and claimed for use in therapy, the fact that a specific use is disclosed in the specification does not in itself call for a restriction of the purpose-limited product claim to that use" 
• To quote T 128/82 in the OJ translation from German,  further on Art. 54(5) EPC 1976 (now Art. 54(4) EPC): "[this provision] introduces, in respect of substances and compounds used in surgical and therapeutic treatment and in diagnostic processes carried out on humans and animals (hereinafter referred to briefly as "therapy"), a special concept of novelty unknown in other technical fields. This article was based on the French form of patent for medical preparations applying at the time of the Munich Diplomatic Conference. However, the history of Article 54(5) EPC does not reveal any uniform idea on the part of the negotiating States as to the breadth of the claim to be allowed for pharmaceutical inventions. The protection of inventions relating to therapy has under the EPC been incorporated in the general substantive patent law (Part II Substantive Patent Law, Chapter I - Patentability - Articles 52-57) and has thus been separately regulated, making it impossible clearly to decide which elements of the French form of protection for medical preparations it was intended to include in the EPC. On the other hand, the protection afforded by a French medical preparation patent was not restricted to a given pharmaceutical application (such as the combating of a certain disease). It is therefore impossible to derive from the travaux préparatoires any arguments in favour of limiting claim scope." 
• Still: T 128/82 "  If an inventor is granted absolute protection in respect of a new chemical compound for use in therapy, the principle of equal treatment would require that an inventor who for the first time makes a known compound available for therapy should be correspondinlyg rewarded for his service with a purpose-limited substance claim under Article 54(5) EPC to cover the whole field of therapy. Any other treatment would only be justified were Article 54(5) EPC absolutely to forbid a broad protective scope. The fact that Article 54(5) EPC does not contain any requirement that protection should be broad is of itself no reason for refusing to grant such protection. As a general rule the usual practice as it relates to new compounds should be followed." 
• " the practice of the European Patent Office hitherto has shown that substance and [pharmaceutical composition] claims [Stoff- und Arzneimittelansprüche] for therapeutically active compounds not limited to specific indications are allowed, even though as a rule only certain specific activities are [indicated] [note: i.e. in the description]." [obwohl in der Regel nur gewisse spezifische Aktivitäten konkret angegeben werden]
• As the present Board notes in r.27, by the same token, this applies also to Art.83:  an enabling disclosure of a single medical use, provides an enabling disclosure for a first medical use claim reciting "for use as medicament". It may be added that this  applies by the same token to the technical effect under Art. 56.
• The Board, citing T 128/82 later in the decision: " This objection fails because they are based on a misunderstanding of the first medical use claim format established by Article 54(4) EPC. As set out in decision T 128/82, Article 54(5) EPC 1973 (now Article 54(4) EPC) provides a special concept of novelty for any substance or composition, comprised in the state of the art, for use in a method referred to in Article 52(4) EPC 1973 (now Article 53(c) EPC), provided that its use for any method referred to in that paragraph is not comprised in the state of the art (see decision T 128/82, Reasons 9; confirmed by decision G 5/83, OJ EPO 1985, 65, Reasons 21). The decision further clarifies that "[i]f an inventor is granted absolute protection in respect of a new chemical compound for use in therapy, the principle of equal treatment would require that an inventor who for the first time makes a known compound available for therapy should be correspondingly rewarded ... with a purpose-limited substance claim under Article 54(5) EPC [1973 (now Article 54(4) EPC)] to cover the whole field of therapy" (Id., Reasons 10)." 
• The Board clarifies that the same holds for priority: "  A logical consequence of the availability of purpose-limited substance protection for a first medical use is that the disclosure of a single therapeutic use of a compound is both sufficient to meet the requirements of Article 83 EPC and to serve as a basis for such a claim in the sense of Articles 87(1) EPC and Article 123(2) EPC, respectively." 

EPO T 0419/16

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/t160419eu1.html

Main request

Amendments (Article 123(2) EPC)

Claims 1 and 2

7. The appellants argued that the subject-matter of claim 1 (see section V) had no basis in the application as filed. In their view, the application as filed disclosed the claimed antagonist of IL-33 only for a specific medical use, but not for a first medical use.

8. The board recalls that Article 54(4) EPC provides for claims directed to a first medical use of a per se already known substance or composition and that such a claim confers broad (albeit purpose-limited) protection for substances or compositions, covering any use in a medical method, even if only one specific use is disclosed in the application (see Case Law of the Boards of Appeal of the European Patent Office, 2019, I.C.7.1.1 and decision T 128/82, OJ EPO 1984, 164). It is the board's view that it follows from this case law that the disclosure in an application of a substance or composition for a specific medical use is a basis for a claim directed to a first medical use.

9. Contrary to the appellants' submissions, the findings in decisions T 36/83 (OJ EPO 1986, 295) and T 128/82 do not support the view that a basis for a first medical use claim (in the sense of Article 123(2) EPC) can only be an identical or equivalent broad disclosure in the application as filed. In both decisions, it was held that a broad disclosure of a pharmacologically active substance for use as a medicament provided a basis for a corresponding broad (first medical use) claim. These decisions however did not consider other possible bases for such a claim nor rule out that the disclosure of a specific medical use can constitute a basis for a claim to a first medical use.

10. Claim 1 therefore meets the requirements of Article 123(2) EPC.

[...]

Priority (Article 87(1) and 89 EPC)

24. Since document D1 is relevant to novelty, it is necessary to decide on whether or not the claimed subject-matter can validly claim priority from US provisional patent application 60/545,730.

25. The appellants pursued several lines of argument to demonstrate that the claimed invention differed from that disclosed in the priority application.

Same invention

26. The first was that in view of the opposition division's finding that subject-matter relating to an anti-IL-33 antibody for use in treating arthritis (claim 4(d) as granted) had no basis in the priority application since this rather disclosed that anti-IL-33 receptor antibodies exacerbated arthritis. Thus, the subject-matter of independent claim 1 must also lack a basis in the previous application, at least partially.

27. This objection fails because they are based on a misunderstanding of the first medical use claim format established by Article 54(4) EPC. As set out in decision T 128/82, Article 54(5) EPC 1973 (now Article 54(4) EPC) provides a special concept of novelty for any substance or composition, comprised in the state of the art, for use in a method referred to in Article 52(4) EPC 1973 (now Article 53(c) EPC), provided that its use for any method referred to in that paragraph is not comprised in the state of the art (see decision T 128/82, Reasons 9; confirmed by decision G 5/83, OJ EPO 1985, 65, Reasons 21). The decision further clarifies that "[i]f an inventor is granted absolute protection in respect of a new chemical compound for use in therapy, the principle of equal treatment would require that an inventor who for the first time makes a known compound available for therapy should be correspondingly rewarded ... with a purpose-limited substance claim under Article 54(5) EPC [1973 (now Article 54(4) EPC)] to cover the whole field of therapy" (Id., Reasons 10).

28. A logical consequence of the availability of purpose-limited substance protection for a first medical use is that the disclosure of a single therapeutic use of a compound is both sufficient to meet the requirements of Article 83 EPC and to serve as a basis for such a claim in the sense of Articles 87(1) EPC and Article 123(2) EPC, respectively.

29. In view of the above considerations, claims 1 and 2 relate to the same invention as disclosed in the previous application in the sense of Article 87(1) EPC.