T 0424/21 - First medical use claims revisited

Key points

• In this opposition appeal, claim 5 reads:  "The antibody or Fc fusion protein according to any one of claims 1-[] for use as a medicament." 
• The Board gives a tutorial on first medical use claims, i.e. claims reciting "for use as a medicament".
• " Claim 5 is formulated in the form of a first medical use ("for use as a medicament") according to Article 54(4) EPC ("for use in a method referred to in Article 53(c)"). In view of the above finding with regard to the sufficient disclosure of the antibody and Fc fusion protein as such, it remains to be analysed whether those compounds are suitable for use as a medicament."
• " The patent shows that the PGLALA mutations can be introduced into known therapeutic antibodies having a human IgG1 Fc region and that an antibody of this kind provides relevant medical effects such as reduced Fc receptor affinity and reduced effector function, known to be useful in several therapeutic contexts " 
• " the only remaining question is whether claim 5 should be restricted to these particular therapies."  
• "The case law of the boards of appeal concerning the question of sufficiency of disclosure of a first medical use is not very extensive " 
• The Board observes that it is irrelevant that in this case, the compound (antibody) of claim 1 is also novel.
• " In decision G 5/83, Reasons 15, the Enlarged Board of Appeal stated: "Thus the inventor of a 'first medical indication' can obtain purpose-limited product protection for a known substance or composition, without having to restrict himself to the substance or composition when in a form technically adapted to a specified therapeutic purpose. The appropriate protection for him is, therefore, in its broadest form, a purpose-limited product claim. No problem arises over its susceptibility of industrial application, within the meaning of Article 57 EPC." The board interprets this statement to mean that the Enlarged Board, although not commenting explicitly on Article 83 EPC, also saw no general issue of sufficiency of disclosure for a broad first medical use claim and did not see the need for the inventor to "restrict himself ... to a specified therapeutic purpose"." 
• " Before decision G 5/83, decision T 128/82 had followed the same line of thinking: "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 correspondingly rewarded for his service with a purpose-limited substance claim under [Article 54(4) EPC 2000] to cover the whole field of therapy"
• The reasoning indeed appears to be " Argumentum a maiori ad minus", with the tacit observation that a product claim covering all possible uses of the product, even uses still to be invented, is considered to be sufficiently disclosed by an enabling disclosure of the preparation method.
• " With regard to Article 84 EPC, [T 128/82 ] stated [in r.12]: "The mere fact that there are [no] instructions concerning all and any possible specific therapeutic applications does not justify limiting the scope to the therapeutic application actually mentioned. This would not be in accord with the general practice of the European Patent Office concerning therapeutically active compounds" []. Thus, although Article 83 EPC is not mentioned, this decision does not require a limitation to a specific therapeutic use either." 
• " This board cannot derive any requirement from the EPC whereby a patent would have to show that a compound is suitable for each and every disease in order for a first medical use to be sufficiently disclosed. Instead, it is sufficient to show that the compound is suitable for at least one particular medical use, as is the case in the patent at issue" 
• T 128/82 further states that: " the practice of the European Patent Office hitherto has shown that substance and medical preparation claims for therapeutically active compounds not limited to specific indications are allowed, even though as a rule only certain specific activities are stipulated." "As a general rule the usual practice as it relates to new compounds should be followed [for first medical use claims]."
• Hence, the EPO's practice was (and is) to allow compound [and composition] claims for new (and inventive) compounds (and compositions), also if it concerns new therapeutically active compounds, even though generally only certain specific activities are disclosed in the description. These compound claims are not limited to specific uses (or medical indications). 
• The same Board 3.3.04 briefly touched on the same point recently in T 0419/16:  "  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." It may be added that a single inventive therapeutic use of a compound is also sufficient to meet the requirement of inventive step of such a first medical use claim. 

EPO 

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/t210424eu1.html

36. The case law of the boards of appeal concerning the question of sufficiency of disclosure of a first medical use is not very extensive and generally relates to the situation where, unlike in the case in hand, the substance or composition is part of the state of the art (in accordance with Article 54(5) EPC 1973 corresponding to Article 54(4) EPC 2000). However, for the question of whether the "medical use" aspect of the claim is sufficiently disclosed, this distinction is irrelevant as the skill required to use a known substance or composition in medicine is the same as that required for a substance or composition provided by the patent for the first time.

37. In decision G 5/83, Reasons 15, the Enlarged Board of Appeal stated: "Thus the inventor of a 'first medical indication' can obtain purpose-limited product protection for a known substance or composition, without having to restrict himself to the substance or composition when in a form technically adapted to a specified therapeutic purpose. The appropriate protection for him is, therefore, in its broadest form, a purpose-limited product claim. No problem arises over its susceptibility of industrial application, within the meaning of Article 57 EPC." The board interprets this statement to mean that the Enlarged Board, although not commenting explicitly on Article 83 EPC, also saw no general issue of sufficiency of disclosure for a broad first medical use claim and did not see the need for the inventor to "restrict himself ... to a specified therapeutic purpose".

38. Before decision G 5/83, decision T 128/82 had followed the same line of thinking: "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 correspondingly rewarded for his service with a purpose-limited substance claim under Article 54(5) EPC to cover the whole field of therapy" (see Reasons 10). With regard to Article 84 EPC, the decision stated: "The mere fact that there are not instructions concerning all and any possible specific therapeutic applications does not justify limiting the scope to the therapeutic application actually mentioned. This would not be in accord with the general practice of the European Patent Office concerning therapeutically active compounds" (see Reasons 12). Thus, although Article 83 EPC is not mentioned, this decision does not require a limitation to a specific therapeutic use either.

39. In decision T 604/04, sufficiency of disclosure of a claim to a monoclonal antibody "for use in therapy or diagnosis", i.e. a first medical use, was denied because "the mere disclosure of a monoclonal antibody against the polypeptides of Figure 4 or 5 without identifying a diseased state caused by the 'misfunctioning' of these polypeptides is not sufficient to acknowledge a use in therapy for the monoclonal antibody" (see Reasons 25). The case in hand, however, is different from the situation underlying decision T 604/04 because the patent discloses that established therapeutic antibodies and Fc fusion proteins can be modified as claimed in order to reduce the effector function without affecting the therapeutic effect. Common general knowledge about antibodies and Fc fusion proteins and their therapeutic function(s) thus provides the basis for acknowledging a use in therapy.

40. This board cannot derive any requirement from the EPC whereby a patent would have to show that a compound is suitable for each and every disease in order for a first medical use to be sufficiently disclosed. Instead, it is sufficient to show that the compound is suitable for at least one particular medical use, as is the case in the patent at issue (see point 34. above).