T 0419/16 - Inventive step of first medical use

Key points

• The decision deals with inventive step of a first medical use claim in the format of Article 54(4) EPC.
• "The purpose given in the claim is "for use as a medicament". The board also notes that according to the patent, the claimed antagonist is useful specifically in the treatment of "a disorder or condition selected from the group consisting of asthma; allergy; multiple sclerosis; or arthritis" (see paragraph [0011] and claim 4 of the patent as granted). "
• Claim 1 is, moreover, a functional antibody claim: "1. An antagonist of IL-33 for use as a medicament, wherein the antagonist comprises a binding composition from an antibody that specifically binds to IL-33."
•  The opposition division came to a positive decision on inventive step, assessed solely when starting from the disclosure in document D6 representing the closest prior art. The appellants [opponents] however consider the disclosure in several (different) documents (documents D3, D4 or D6/D10) as starting points for assessing inventive step."" 
• "Although assessing inventive step only from one closest prior art disclosure may constitute an efficient approach to address the situation where multiple similar disclosures were presented as starting points for the assessment of inventive step, it is, however, not an appropriate approach if the alternative starting points represent alternative and different routes to the invention, as they do in the case at hand. In such a situation, each starting point needs consideration because under Article 56 EPC, in order for an inventive step to be acknowledged, the claimed invention must not be obvious to a skilled person having regard to the state of the art, i.e. any prior art disclosure with the exclusion of documents under Article 54(3) EPC (see T 694/15, Reasons 13 to 15, T 816/16, Reasons 3.7.1 and T 261/19, Reasons 2.5)."
• For inventive step over D6: "the difference between this [antibody of D6] and the claimed antibody is the target (ST2/IL-33 receptor) and its medical use(s) both in general and the specific uses identified in the description of the patent (treating asthma, allergy, multiple sclerosis and arthritis)."
• "The objective technical problem that arises out of the above differences and their technical effects can be formulated as the provision of a medicament, e.g. for treating asthma, allergy, multiple sclerosis and arthritis."
• The decision is interesting because for inventive step of product claims, we normally consider only at the use mentioned in the description. 

EPO 

The link to the decision and an extract of it can be found after the jump.

T 0197/22 - First medical use claims

Key points

• "in case of a claim for a composition for use under Article 54(4) EPC [first medical use claim] it is not generally required for compliance with Article 83 EPC that a patent discloses the therapeutic suitability of the defined compositions in treatment of a plurality of diseases (see T 424/21, reasons 40)."
• A totally uncontroversial statement until you compare it with the May 2024 PTAB USPTO decision  (APR pane) Ex parte Chamberlain, Appeal 22-1944 where a claim directed to " a method of treating a patient by administering an anti-C5 antibody [, said antibody] comprising ..." was considered and found to be invalid as lacking sufficient support by the description". Moreover, the decision comes directly from the USPTO Director, along with the Commissioner for Patents and the Chief Administrative Patent Judge. (Patently-O).
• "However, as claim 1 of the main request defines a composition for use in therapy, the patent must provide the skilled person with sufficient instructions for applying the compositions within the scope of the claim in some form of therapy without undue burden. In line with the considerations in G 2/21 (see reasons 77) this requires that the patent must substantiate the therapeutic utility of the claimed composition if in the absence of experimental data it would not be credible to the skilled person that any therapeutic effect is achieved."
• "Claim 1 of the main request defines the composition to comprise mRNA encoding a functional protein or enzyme. '" 
• "The patent demonstrates in examples 7 and 8 with in vivo experiments in mice that mRNA encoding firefly luciferase (FFL) may be effectively transfected and expressed using a liposomal transfer vehicle as defined in claim 1 of the main request. As recognized by the patent proprietor during the oral proceedings, the expression of FFL luciferase serves no purpose in any therapy. According to the proprietor, examples 7 and 8 provided nevertheless with the use of FFL proof of concept that the defined transfer vehicles allowed for the effective transfer and expression of therapeutically useful proteins."
• "if the term "functional protein or enzyme" in claim 1 of the main request is understood as functionally restricted to a protein with a feasible therapeutic utility, the Board considers that the patent does not provide the skilled person with a sufficient disclosure to generally enable the therapeutic use of the claimed formulation comprising the mRNA encoding for an accordingly defined protein. "
• " the mere detection of an unquantified level of expression of FFL using a particular formulation for gene transfer does not credibly disclose the general suitability of such a transfer vehicle for use in gene therapy, because in view of documents D64 and A106 serious doubts prevail that such a formulation allows to generally achieve therapeutically effective levels of expression of the contained mRNA. The Board is therefore not convinced that the patent provides actual proof of concept regarding the suitability of the claimed formulations for use in therapy."
• "whilst document D39 thus may describe with the mentioned experimental results the in vivo expression of the administered mRNA encoding hEPO in a quantity which could indicate the described compositions to be therapeutically useful, the patent fails to disclose such a quantitatively adequate expression of mRNA from the compositions as defined in claim 1 of the main request. In accordance with the considerations in G 2/21 (see reasons 77) a lack of sufficiency of disclosure cannot be remedied by post-published evidence. The patent proprietor's argument relying on the post-published document D39 is therefore not considered persuasive.  Accordingly, the Board concludes that the main request does not comply with Article 83 EPC."
• The composition defined in the claim was as follows: " at least one mRNA molecule ...  encapsulated in a liposome having a size of less than 100 nm, wherein said liposome comprises one or more cationic lipid(s), one or more non-cationic lipid(s), and one or more PEG-modified lipid(s)," 
• EPO 

The link to the decision and an extract of it can be found after the jump.

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.

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.