T 1898/23 - Argon-containing plasma as medical composition

Key points

• Claim 1 of the main request reads as follows. "Cold atmospheric plasma for use in treating therapy-refractory actinic keratosis in a patient in need thereof, wherein the cold atmospheric plasma is an argon-containing plasma."
• Is this a valid second medical use claim?
• "it has to be considered: (a) whether claim 1 concerns a substance or composition within the meaning of Articles 54(4) and (5) EPC"
• The Board: "for the sake of argument and in the respondent's [proprietor's] favour, it is ... assumed that the alleged therapeutic effect is indeed caused by the parts of the claimed plasma that qualify as a substance or composition within the meaning of Article 54(5) EPC."
• The Board considers the claim to be obvious, even when assuming that is a valid second medical use claim.
• The Board, obiter, sets out the legal framework: - I omit the case law references from the quote:  "While this "subgroup of the larger group of 'products'" ... excludes medical devices ..., it does not seem justified to say that any product which does not qualify as a medical device because of e.g. a lack of shape automatically qualifies as a substance or composition within the meaning of Article 54(4) and (5) EPC ... . If that were so, any shapeless physical entity (e.g. electromagnetic radiation or ultrasound waves) could qualify as a substance or composition, regardless of whether it is a chemical entity. Having said this, the current Board agrees that whether something qualifies as a substance or composition within the meaning of Articles 54(4) and (5) EPC should be decided, in the first place, on the basis of what is claimed as such and not on the basis of its mode of action ... .
• The Board indicates it does not agree with T 1252/20.
• "In order to benefit from the notional novelty afforded by Article 54 (4) and (5) EPC, it must be a substance or composition - as opposed to other subject-matter not qualifying as such - which is used in a method referred to in Article 53(c) EPC,  ... . In the case at hand, where the method relates a treatment by therapy, it must thus be assessed whether the therapeutic effect can be ascribed to the chemical entities in the plasma or (only) to the other entities, such as the photons"

EPO 

The link to the decision is provided after the jump.

T 1909/23 - 2nd medical use claim for individualized RNA cancer vaccine

Key points

III. Claim 1 of the patent reads as follows:

"1. An individualized cancer vaccine for use in a method of treating a cancer patient, said method comprising the steps:

(A) providing the individualized cancer vaccine by a method comprising the steps:

(a) identifying cancer specific somatic mutations in a tumor specimen of the cancer patient to provide a cancer mutation signature of the cancer patient, comprising

(aa) ...  and

(b) providing an RNA vaccine featuring the cancer mutation signature obtained in step (a), wherein the RNA vaccine comprises RNA encoding a recombinant polyepitopic polypeptide comprising mutation based neo-epitopes; and

(B) administering the individualized cancer vaccine to the cancer patient."

• Claim 1 of the present patent [is very similar to] claim 1 of EP 2 714 071, dealt with in decision T 2168/21, [and differs from it] in the addition of steps (aa), (bb) and (cc) and in the absence of the further characterisation of the RNA vaccine as "featuring the mutation signature of the patient".
• T 2168/21 was published in June 2024. I missed it back then.

No cross-case res judicata effect

• "The decision in case T 2168/21 is formally not binding on the present board due to the independency of the proceedings between parent and divisional application(s). Neither has it an effect of res iudicata for the present proceedings due to the lack of identity of facts and claimed subject-matter (cf. e.g. T 1270/20, Reasons 3.8.2; T 2084/11, Reasons 1.3; see also Benkard, EPÜ (4th edition), Art. 76, Rn 10). However, in view of the very similar wording of claim 1 of both patents, the conclusions drawn in the present case and the reasoning of this decision are similar to those of T 2168/21."

Medicine preparation steps limiting

• “The claim relates to a purpose-limited product in the sense of Article 54(5) EPC. Both method steps (A) and (B), including the sub-steps (a) and (b), constitute characterising and limiting features of the claimed subject-matter because they form an integral part of the method of treating a patient, which is a method referred to in Article 53(c) EPC. Without these steps, the claimed "individualized cancer vaccine" cannot be implemented and would not be defined.”
• “The patient to which an individualised cancer vaccine is administered is therefore the same patient from which a tumour specimen for the identification of cancer-specific mutations originated giving rise to a cancer mutation signature of this very patient. Since these steps are mandatory to obtain the individualised cancer vaccine under consideration, the legal fiction of a purpose-limited product in accordance with Article 54(5) EPC applies at least to step (A), including the sub-steps (a) and (b), and step (B) of the method, which are thus limiting on the claim.”
  
  
  
• I wonder how infringement of this kind of claim will be evaluated. It seems to me there will not be any generic supplier of the vaccine? 

EPO 

The link to the decision is provided after the jump.

T 2199/22 - List of diseases and sufficiency

Key points

• "Claim 1 of auxiliary request 11 relates to a pharmaceutical or nutraceutical product comprising MK-7, administered at a dosage of 1 to 10 myg/day, with n-3 PUFA in the form of a marine oil, administered at a dosage of 5 g/day, for preventing or treating cardiovascular, bone, or cartilage diseases or disorders in both humans and animals. Claim 1 is thus drafted as [a] purpose-related product claim pursuant to Article 54(5) EPC."
•  For the requirement of sufficiency of disclosure to be met in the case of a claim pursuant to Article 54(5) EPC, the application as filed, when read by a person skilled in the art having the common general knowledge in mind, must establish the functional technical link between the claimed product and the claimed specific use within the meaning of Article 54(5) EPC, namely the prevention or treatment of at least one of cardiovascular-, bone- and cartilage-related diseases or disorders in humans and animals"
• " While the disclosure and evidence in the application as filed [...] may suggest a potential health benefit in terms of prophylaxis or prevention after a longer period of treatment for certain physical conditions, there is no evidence that the claimed combination affects the full range of cardiovascular, bone, and cartilage-related diseases or disorders, such as bone cancer."
• The claim does not recite bone cancer.
• The decision seems remarkable because most often, a long list of diseases to be treated is no problem; even less frequently is insufficiency found based on a subtype of disease that is not explicitly recited in the claims.  
• "The board concludes that the skilled person would not have considered that the claimed product achieves prevention or treatment of cardiovascular, bone, and cartilage-related diseases or disorders over the whole scope of the claim."
• 
  

EPO 

The link to the decision can be found after the jump.

T 0250/23 - Second medical use of bacteria

Key points

• This decision illustrates establihsed case law that bacteria are substances or compositions in the sense of Art. 54(4) and (5).
• Claim 1 in this case:   "Eubacterium hallii or relatives having at least 98% sequence identity with the 16S rRNA sequence of Eubacterium hallii, and/or Alcaligenes faecalis or relatives having at least 98% sequence identity with the 16S rRNA sequence of Alcaligenes faecalis, for use in preventing and/or treating insulin resistance and/or insulin resistance-related complications selected from metabolic syndrome, dyslipidemia, type 2 diabetes mellitus, and insulin resistance in endocrine diseases such as in obese subjects with type 1 diabetes mellitus, Cushing's disease and lipodystrophy syndromes"."
• The Board, on novelty: "As regards D6, it is uncontested that this document does not explicitly disclose the use of Eubacterium hallii in preventing or treating insulin resistance. Instead, this bacterium is described as a butyrate-producing bacterium in the context of energy metabolism. The only specific activity of butyrate-producing bacteria referred to in this document is that they are related to higher gut metabolic activity leading to overweight. In conclusion, there is not even an implicit disclosure concerning insulin resistance in D6."
  
  
• On inventive step:
  "D2 is a scientific publication which addresses a wide range of beneficial effects on human health that butyrate has. In the paragraph headed "Obesity and insulin resistance" D2 discloses, based on a referenced publication, that dietary supplementation with butyrate can prevent and treat diet-induced obesity and insulin resistance in mouse models. The conclusion presented is that butyrate may have a potential application in the prevention and treatment of metabolic syndrome in humans. " 
• " In the following, an inventive-step analysis is carried out based on the teaching of D2 that calls for butyrate as the active component."
• "the paragraph in D2 that specifically mentions insulin resistance is restricted to oral administration of butyrate as such. How far the active substance to be administered can be modified is a question to address under obviousness."
• "the problem to be solved is to provide prevention or treatment of insulin resistance and/or insulin resistance-related complications"
• "  Starting from the closest prior art, the skilled person would have had to decide not to administer a palatable formula of butyrate. Then, they would have had to choose not to modulate the intestinal flora (e.g. by modifying the lumen pH) but to administer butyrate-producing bacteria. Finally, they would have had not to select the specific butyrate-producing bacteria mentioned in D2 - which are stated to represent the most important groups of butyrate producers in the human intestine - but to look for other butyrate-producing bacteria."" 
• " D2 itself does not mention the use of micro-organisms for managing insulin resistance, and the only micro-organisms mentioned in D2 are not the ones of claim 1. The skilled person would have had no motivation to turn to D3 or D4, which mention Eubacterium hallii among other bacteria. To do all this starting from the closest prior art is considered to encompass more than routine measures."" 
• The claim is held inventive.

EPO 

The link to the decision can be found after the jump.

T 1390/22 - Novelty of 2nd medical use based on omitting diagnostic step

Key points

• "Claim 1 as granted [reads]: "[pibrentasvir] thereof for use in a method of treatment for HCV, comprising administering an effective amount of Compound 1 or a pharmaceutically acceptable salt thereof to an HCV patient, regardless of the specific HCV genotype(s) that the patient has, wherein said patient is not genotyped for said treatment."
• "The assessment of the HCV genotype in treatment of HCV prior to the administration of antiviral therapy was standard practice at the time of the priority date for the patent. Document D19 indicates that such assessment formed part of the standard of care in order to select the appropriate type of antiviral therapy, including the dose of the medication and the duration of the treatment"
• "The intentional omission of the HCV genotyping as defined in claim 1 of the main request therefore represents a technically meaningful characteristic of the defined therapeutic treatment."
• "It follows from the considerations in G 2/08 (see Reasons 5.10.9), which refer to the wording "any specific use" in Article 54(5) EPC and confirm the seamless fit between the exclusion from patentability of methods of treatment by therapy and the special provisions regarding the novelty of a substance or composition for use in such a method, that this technically meaningful characteristic of the defined therapeutic treatment involving the use of pibrentasvir is suitable to characterize the claimed subject-matter in terms of a specific use as intended in Article 54(5) EPC."

EPO 

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

T 3122/19 - Functional compositions for second medical uses

Key points

• Claim 1 reads: "1. A compound having FGFR inhibitory activity or a pharmaceutically acceptable salt thereof for use in a method of treating or preventing cancer
  - in a patient who has been identified to express a fusion polypeptide comprising an FGFR3 polypeptide and a BAIAP2L1 polypeptide or to carry a polynucleotide encoding the fusion polypeptide, [wherein the polypeptide expressed in the patient has a certain sequence]
  - wherein the compound or a pharmaceutically acceptable salt thereof is capable of inhibiting a growth of a cancer cell expressing the fusion polypeptide or having a nucleotide encoding the fusion polypeptide."
• The compound is hence only defined in functional terms. 
• The Board: "Claim 1 (see section I.) is a purpose-restricted product claim directed to a compound having "FGFR inhibitory activity" for use in a method of treating or preventing cancer in a patient who has been identified as expressing a particular biomarker or as carrying a polynucleotide encoding it. This biomarker is a fusion polypeptide comprising an FGFR3 polypeptide and a BAIAP2L1 polypeptide, each polypeptide being defined by particular sequences. The claim further specifies that the claimed compound is capable of inhibiting the growth of a cancer cell expressing this fusion polypeptide or having a nucleotide encoding it."
• The Board, under sufficiency: "[the question is]  (1) whether the skilled person would have been able, based on the disclosure in the application as filed and/or on their common general knowledge, to obtain compounds as defined in claim 1 without undue burden. These compounds are defined by two functional features, namely that (i) they have FGFR inhibitory activity and that (ii) they are capable of inhibiting the growth of a cancer cell expressing the fusion polypeptide comprising an FGFR3 polypeptide and a BAIAP2L1 polypeptide."
• "in addressing issue (1), [the opponent] referred to the approach developed in particular in decision T 1063/06 (OJ EPO 2009, 516) in the context of so-called "reach-through" claims. The appellant [opponent] argued that the patent did not enable the skilled person to identify all compounds falling within the broad dual-function definition of the claim without undue burden and, accordingly, such alternatives were not available to the skilled person.

• " The board is of the opinion that the situation underlying decision T 1063/06 is not the same as that in the case at hand. The invention at stake in T 1063/06 was based on the discovery that a known illness (in this case cardiovascular disease) could be treated by compounds having the capability of stimulating the soluble guanylate cyclase enzyme independently of the heme group in the enzyme, i.e. the compounds stimulated both the heme-containing soluble guanylate cyclase enzyme and the heme-free soluble guanylate cyclase enzyme. No compounds having this capability were known in the art and such compounds could only be identified by means of a newly disclosed screening method as a new research tool. The claim under consideration in that decision was thus for the use of (hitherto unidentified and thus unknown) compounds, which were defined solely in terms of the specific new capability (function), for the manufacture of a medicament to treat a known illness.

• " By contrast, the invention underlying the case at hand relates to the identification of a subgroup of cancer patients which is susceptible to treatment with FGFR inhibitors. The inventors found that a known human cancer cell line (SW780), which was known to be susceptible to the antiproliferative effect of known FGFR inhibitors, expresses a fusion polypeptide of the FGFR3 polypeptide and the BAIAP2L1 polypeptide which was also identified in various other types of human-derived cancer cells. The claim under consideration is for FGFR inhibitors which have the capability of inhibiting the growth of cancer cells expressing a FGFR3-BAIAP2L1 fusion polypeptide for use in a method of treating cancer in patients who express a FGFR3-BAIAP2L1 fusion polypeptide. This is not the same situation as in T 1063/06, in which any kind of compound (without guidance in terms of chemical structure or other selection rules) would have to be screened for the desired enzyme-stimulating activity."

• "Numerous FGFR inhibitors were known from and made available in the art, and are also identified by their chemical names or structures in the application as filed. These constitute a large pool of candidates. Together with the general structural and functional requirements mentioned in the application as filed, this information would, moreover, have provided some orientation to the person skilled in the art for identifying further FGFR inhibitors, if required"

• "Testing for the second level activity against cancer cells (as described in the application as filed) would not have had to be carried out by trial and error on randomly selected compounds, but only on a limited selection of compounds, i.e. compounds chosen from the class of FGFR inhibitors. No evidence was provided to show that a large proportion of FGFR inhibitors would fail this test (in which case identifying active compounds would be an undue burden on the skilled person). "

• Regarding another decision:" In the case underlying T 1959/15, the invention resided in providing a further class of compounds for treating the disease; in the present case, the invention resides in the identification of the specific genetic make-up of a subgroup of patients who are particularly susceptible to treatment with a known class of compounds. For this reason alone, the findings in decision T 1959/15 do not directly apply to the facts and circumstances of the case at hand."

• In a way, we are patenting a diagnostic method, it seems.

• "unlike the conclusion in T 1959/15 for the claim at stake therein, for the reasons already set out in point 57. above this board takes the view that under the circumstances of the case at hand, the mere fact that claim 1 also covers compounds beyond those shown to be suitable for the therapeutic use does not automatically equate to an undue burden of screening arbitrary compounds. Moreover, this does not result in the claim being able to be classified as a "reach-through" claim."

• There are more interesting issues in the case, e.g. making the claim novel and inventive by adding "wherein said patient is a human patient"

EPO 

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

T 1941/21 - Clinical trials; Novelty after inventive step

Key points

• "D4 discloses the protocol and design of a clinical trial for evaluating the efficacy and tolerability of [the compound] TUDCA in the treatment of ALS, wherein TUDCA is administered at 1g b.i.d (2g daily) for a year to 18-75 years old Caucasian male or female ALS patients who had first symptoms of ALS by no more than 1.5 years and were in treatment with a steady regime of riluzole and vitamin E for a minimum of three months (see D4: title; page 6, arms and interventions; page 7, outcome measures; page 7, eligibility). Further, document D4 describes in detail the rational for using TUDCA in these clinical trials. It mentions in particular that TUDCA is endowed with antioxidant, antiapoptotic and neuroprotective activities and describes the detailed pharmacological mechanisms of action for each activity (see D4, pages 5-6). The results of the trial announced in D4 have not been made available to the public."
• I.e., D4 discloses the method features of the second medical use claim at issue (""1. Tauroursodeoxycholic acid [TUDCA] or a pharmaceutically acceptable salt thereof for use in the treatment of a neurodegenerative disorder in a mammal, characterized in that said neurodegenerative disorder is amyotrophic lateral sclerosis."')
• "The problem [solved by the claim over D4] was defined by the opposition division in its decision as the provision of an effective treatment for ALS. "
• "The problem appears to be solved in view of the examples of the contested patent in paragraphs [0028]-[0038]. The patent shows for instance that the baseline-adjusted absolute ALSFRS-R score was significantly higher in TUDCA-treated than in placebo-treated patients "
• Note:  "This study shows that one year of treatment with TUDCA at the prescribed dose was associated with slower deterioration of function in ALS patients. This disease modifying effect is additional to that of riluzole, as both treatment groups [i.e. "placebo" and TUDCA] were under riluzole and vitamin E treatment. " (patent, para. [0036]
• "Clinical trials are usually initiated on the basis of encouraging results from preclinical experiments. Thus, the announcement of a phase II clinical trial protocol for a particular therapeutic agent and a disease may provide the skilled person with a reasonable expectation of success. "
• "Such reasonable expectation of success is, however, to be denied in a situation where a skilled person would have been discouraged from carrying out the clinical trials, such as when the state of the art provides the skilled person with reasons for not pursuing the solution envisaged in the clinical trial or provides the skilled person with an expectation of failure. Consequently, "a reasonable expectation of success" is linked with the specific circumstances of the case and requires a case-by-case evaluation of all the facts at hand at the priority date of the contested patent. In the present case, the Board holds that the state of the art suggested to the skilled person a clear expectation of failure."
• "The disclosure of document D9 demonstrates indeed that the skilled person could not base any reasonable expectation of success of the use of TUDCA in treatment of ALS on the announcement in document D4 of a phase II clinical trial for the treatment of ALS with TUDCA.

  D9 is a scientific article published in 2012 which gives a general review of the treatment of amyotrophic lateral sclerosis (ALS) at that time. D9 mentions 89 different drugs which, before the filing date of the opposed patent, had been used in clinical trials for ALS based on allegedly promising preclinical data [...]. 

• "Importantly, [D9] discloses that, for all the drugs listed in the document, promising preclinical data, such as biochemical or cellular assays, have been provided, but nevertheless the majority of the clinical trials failed"

• "Accordingly, the Board concludes that, starting from document D4 and in view of the further cited prior art, the skilled person would not have arrived at the claimed subject-matter in an obvious manner and that the subject-matter of claim 1 of the main request involves an inventive step."

Novelty after inventive step

• "D8 [EP 2 422 787 A1, being prior art under Art.54(2)] relates to compositions comprising low doses of diazoxide for use in the treatment of a mammal afflicted with ALS, in particular a human (see D8, claims 1 and 3). Further, D8 discloses in claim 9 that diazoxide can be combined with "an additional therapeutic agent useful in the treatment of amyotrophic lateral sclerosis" including TUDCA, which constitutes a single selection from a list. Consequently, a composition comprising diazoxide and TUDCA for use in the treatment of a mammal afflicted with ALS is derivable directly and unambiguously from D8."
• "Accordingly, even if D8 does not provide any in vitro or in vivo experiments with regard to the efficacy of TUDCA in the treatment of ALS, D8 provides an enabling disclosure for a combination treatment based on diazoxide and TUDCA, in view of the explicit disclosure in D8 of the efficacy of diazoxide. "
• "D8 supports the utility of low dose diazoxide in the treatment of ALS with experimental results, in particular in Example 2. This example shows that low doses of diazoxide improve survival in the SOD1-G93A transgenic mice model for amyotrophic lateral sclerosis. The utility of diazoxide in treatment of ALS described in D8 has not been disproved."
• Note, for D8, a pre-clinical experiment (animal study) is sufficient for an enabling disclosure. Cf. the remarks about D9 above.
• "As a general rule, a claim to the use of a known compound for a particular purpose or to a product for use in a particular medical purpose, which is aimed at obtaining a technical effect described in the patent, should be interpreted as including that purpose as a functional technical feature, and is accordingly not open to objection under Article 54(1) EPC provided that such technical feature has not previously been made available to the public. This functional feature has however been made public in the present case."
  
  
• "In the Board's view, the discovery of a new property of a particular ingredient of a known composition, i.e. here TUDCA in the composition comprising diazoxide and TUDCA, used for a known and identical general purpose, i.e here the treatment of a mammal afflicted with ALS, can indeed not confer novelty to the particular ingredient used for the same general purpose, namely TUDCA for the treatment of ALS. Novelty can only be recognized if this new property is applied in a new use."
• The claim does not specify "a composition comprising TUDCA for use in the treatment of ALS". The Board's reasoning is difficult to follow.
• Consequently, the disclosure in D8 of treatment of ALS based on diazoxide and TUDCA, wherein the efficacy of diazoxide is supported by experimental data and has not been disproven, anticipates the subject-matter of claim 1 of the main request.
• " Claim 1 of auxiliary request was amended by the addition of the feature " in a human, characterized in that it is administered for at least 30 weeks".
• "Since there is no disclosure of any duration of treatment in D8, the subject-matter of claim 1 of auxiliary request 2 is not anticipated, and auxiliary request 2 meets the requirements of Article 54 EPC."
• As a comment, there is no discussion at all of why the added feature of administration of 30 weeks provides for an inventive step over D8. I don't understand why, except that the opponent had no inventive step objections starting from D8. I understand ALS is a chronic disease?

EPO 

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

T 2074/22 - Disclaiming medical uses

Key points

• "In claims 11 and 17, the expression "non-therapeutic" was introduced by way of an amendment as an undisclosed disclaimer in the sense of G 1/03." (the amendment was made before grant, I understand).

• Claims 11 and 17 "relate to the non-therapeutic use of an agent, or a food or drink, [having  a certain composition] for the prophylaxis or improvement of frailty in an elderly person,  wherein the frailty is at least one kind of symptom selected from the group consisting of  decrease in walking speed, decrease in the amount of physical activity and loss of motivation."

• It is established case law that a disclaimer "non-therapeutic" allows for the exclusion of therapeutic uses from a claim encompassing both therapeutic and non-therapeutic uses in such a way that they are substantively separable, so that the remaining subject-matter is no longer covered by the exception to patentability under Article 53(c) EPC. However, such a disclaimer cannot be employed to define as non-therapeutic a use which necessarily includes one or more therapeutic steps.

• The Board decides that in the case at hand, the recited claims are directed to a use which necessarily includes one or more therapeutic steps, see further below.

• "Since present claims 11 and 17 concern a use which is necessarily therapeutic (i.e. at least prophylactic), the exclusion from patentability of methods for treatment of the human or animal body by therapy under Article 53(c) EPC also applies to the subject-matter of claims 11 and 17, despite the introduction of the disclaimer "non-therapeutic"."

• So, the claims are not allowable under Art.53(c) EPC even if reciting "non-therapeutic".

• "Additionally, in both T 1635/09 (see point 5 of the reasons, last paragraph) and in T 767/12 (see point 2.), a disclaimer intended to restrict the claim to "non-therapeutic" methods was in analogous situations considered unallowable for lack of clarity under Article 84 EPC since it rendered the scope of the claim void. This [i.e. clarify of the claim] is however a condition for allowing undisclosed disclaimers according to G 1/03 (see Headnote, point 2.4). " 
• Headnote 2.4 of G 1/03 only says that : "A claim containing a disclaimer must meet the requirements of clarity and conciseness of Article 84 EPC.". I wonder if a disclaimer that is present in the claims as granted can be examined for clarity (G 3/14) under headnote 2.4 of G 1/03. 
• "Considering also that, in the present case, the undisclosed disclaimer "non-therapeutic" contradicts the original disclosure according to which the prophylaxis or improvement of frailty aims at maintaining health (see 1.3 above), this undisclosed disclaimer is also considered to infringe Article 123(2) EPC."
• I'm not exactly sure what requirement of G 1/03 the Board is applying here. Headnote II.4 reads: "A claim containing a disclaimer must meet the requirements of clarity and conciseness of Article 84 EPC". It does not refer to the third requirement of Art. 84 (support) and does not indicate that lack of clarity becomes an issue under Article 123(2) under this headnote. 

• The Board considers "the prophylaxis or improvement of frailty in an elderly person" to be inherently therapeutical because it is directed to maintaining health.
• "Considering that the prophylaxis or improvement of frailty leads at least to the maintenance of health in the elderly patient according to the patent itself, no distinction can be drawn between a therapeutic use and a non-therapeutic use, even in the context of the further limitation to the symptoms defined in claims 11-18. Even if these symptoms (decrease in walking speed, decrease in the amount of physical activity and loss of motivation) may not necessarily be as such constitutive of an illness, the prophylaxis or improvement of these manifestations of frailty necessarily aims at maintaining health."
• " it is not possible to carry out the method of present claim 11 on a subject which is neither in a pathological state nor likely to develop one, because claim 11 precisely defines the subject as an elderly suffering from or likely to develop symptoms of frailty."
• "even if the symptoms of frailty in elderly people are not necessarily considered an illness as such (see paragraph [0036] of the patent), the prevention of these symptoms necessarily aims at least at maintaining health in the patient. The description makes clear that the prophylaxis of frailty is [] prevention of its symptoms from being developed, and the improvement of frailty includes bringing these symptoms to fall within a normal range, as well as preventing the progression or exacerbation of the disease (see paragraph [0039]). It is also explained that the prophylaxis of frailty leads to the prevention or delaying of a transfer to a condition in need of nursing care and increases health expectancy (see paragraph [0003]). 
  
  
• "The Board additionally notes that the appellant - proprietor's argumentation on novelty and inventive step of claim 1 of the main request ["composition for use in the prophylaxis or improvement of frailty in an elderly person"] rather contradicts their position regarding the non-therapeutic nature of the use of claim 11. The appellant - proprietor submitted that claim 1 relates to the prophylaxis or improvement of frailty, and that the present invention is aimed at preventing and alleviating the ill effects that would otherwise arise in elderly populations, so as to maintain health, such that claim 1 should be considered to be a use limited product claim in accordance with Article 54(5) EPC "

 

 

EPO 

You can find the link to the decision and an extract of it after the jump.

T 1252/20 - A solution for forming a blockage in a blood vessel

Key points

• Claim 1 is directed to " A composition for use in reducing ... cancerous cells in a subject by forming at least a partial blockage, ... in a blood vessel to deprive a tumor in the subject of blood supply, ...  the composition comprising: a solution comprising an amphiphilic peptide in an effective amount and in an effective concentration to form a hydrogel under physiological conditions to allow at least a partial blockage of the biological vessel to effect embolization or cell necrosis therein, ..."
• The question is whether this is a valid second medical use claim. 
• " In its decision the Examining Division came to the conclusion that the peptide solutions defined in claim 1 of the applicant's main request did not qualify as "substance or composition" in the sense of Article 54(5) EPC, their mode of action being purely mechanical. The Examining Division referred in particular to decision T 1758/15 to support this view. " 
• " The Board, however, is convinced that the peptide solutions defined in the claim do qualify as "substance or composition" in the sense of Article 54(5) EPC, and that thus the claimed subject-matter is novel over D1 and D2 due to the specific use defined therein. This will be reasoned in the following." 
• "  The question of what can be considered a "substance or composition" in the sense of Articles 54(4) and (5) EPC regularly emerges in cases before the Boards of Appeal. From the analysis of Articles 53(c) and 54(4) and (5) EPC as explained above it follows that not every object can be read on this definition, although of course every object, also a medical device, is in the end made up of substances and/or compositions. The decision G 5/83 which established the patentability of second medical indications and in fact served as the basis for Article 54(5) EPC (see T 1758/15, Reasons 5.2.5) also emphasised that the application of the special approach to novelty through the intended use is strictly limited to claims that are directed at substances or compositions intended for use in methods stipulated by Article 52(4) EPC 1973, corresponding to Article 53(c) EPC (G 5/83, Reasons 21, last sentence)." 
• " [Established] case law imposes restrictions to what may fall under the definition of "substance or composition" in the sense of Article 54(5) EPC based on its mode of action. Whereas the materials underlying these cases, collagen fillers, alginates or bone glue, would, in everyday language, be seen as substances or compositions, they were not considered "substances or compositions" in the sense of Article 54(5) EPC since once inside the body they acted as a device." 
• " [The Board] is convinced that the peptide solutions defined in the claim must be considered a "substance or composition" in the sense of Article 54(5) EPC already for more fundamental reasons. In the following, for reasons of brevity, also where only "substance" is mentioned, it is understood that a "substance or composition" within the meaning of Article 54(5) EPC is meant."
• I recommend reading the entire decision.  
• " the exceptional approach to novelty of Article 54(5) EPC (and equally of Article 54(4) EPC) is not only applicable in case of therapeutic treatments, but also for treatments by surgery and for diagnostic methods. Decision G 5/83 addresses exclusively a therapy where a medicament is administered and its active agent achieves some therapeutic effect, such as treating an illness. The claim category endorsed by G 5/83 was also explicitly directed at the "use for manufacture of a medicament". However, with the adoption of the EPC 2000 it became clear that the novelty exception now generally encompassed all uses of a substance falling under Article 53(c) EPC, e. g. also surgical treatments and diagnostic methods, meaning that the the scope of Article 54(5) EPC is broader (G 2/08, Reasons 6.5). This already speaks against a too narrow interpretation of "substance or composition", possibly limiting it to such uses where the mode of action is exclusively or at least predominantly chemical. In particular, the use of a substance in a surgical or diagnostic method may possibly involve various mechanisms of action which may not immediately appear comparable to a classical "chemical" reaction triggered by a medicament." 
• " There is no legal basis for the mode of action as a criterion for qualifying a material or object as a substance or composition under Article 54(5) EPC. " 
• " In addition to the lack of a legal basis, the use of the mode of action as the decisive criterion seems problematic for several other reasons. First of all, the material acting inside the body may not be the same than the material the claim is directed to. The material defined in the claim and the material acting inside the body may differ in composition or in some other relevant property. This is clearly so in the present case. The claim requires the presence of a peptide solution. Already for this reason the claim is not directed to any particulate or spheric form of a hydrogel formed from the peptide solution inside the body. The question to be asked is whether the peptide solution defined in the claim is a "substance or composition". This question is to be decided irrespective of whether any solidified macrostructure formed from the substance, upon application in a specific way, can also be considered a substance or composition, or should rather be seen as a device. In other cases even the chemical structure of the substance may not remain the same during the therapeutic use. The Board notes that there are classical drugs which are administered as inactive prodrugs, the active species only being formed in the body by metabolic processes. However, second medical use claims under Article 54(4) and (5) EPC are generally directed to the administered substance. Since it is this substance which is used in a method excluded under Article 53(c) EPC, such a claim drafting is entirely in line with Articles 54(4) and (5) EPC."
• "The Board does not overlook the fact that distinguishing devices from substances for the purposes of Article 54(5) EPC is indeed required, and this article should not be used to circumvent the usual assessment of novelty of devices. A pacemaker or a surgical scalpel made of a particular stainless steel alloy do not qualify as a "substance or composition", even if they are claimed for use in an arguably novel therapeutic or surgical method. However, there is no apparent reason to disqualify a solution of a peptide, i. e. a shapeless liquid defined without any device-like features, from the scope of Article 54(5) EPC."

EPO 

The link to the decision is provided after the jump, as well as (an extract of) the decision text.

T 1203/19 - Novelty of second medical use claims, and credibility of prior art

Key points

• The decision was taken on 26.04.2022 and was notified in writing on 18.07.2023. The minutes were forwarded on 06.05.2022. No communications under Art. 15(9) RPBA are visible in the (public) online file.
• A petition for review is pending.  
• 
  
• " claim 18, is directed to the therapeutic use of an oncolytic adenovirus"
• "Use of the oncolytic adenovirus comprising a sequence encoding a hyaluronidase enzyme inserted in its genome for the manufacture of a medicament for the treatment of a cancer or a pre-malignant state of cancer, in a mammal including a human."
• "If the claimed subject-matter pertains to a use in connection with a medical treatment, for the requirement of reproducibility to be regarded as fulfilled it is necessary that the disclosure in the prior art document is such as to make it credible that the therapeutic effect on which the method of treatment relies can be achieved (see decision T 1457/09 of 17 January 2014, point 36 of the Reasons which refers to decision T 609/02 of 27 October 2004, point 9 of the Reasons). The therapeutic application of the present patent is based on the finding that the expression of a sequence encoding a hyaluronidase enzyme inserted in the genome of an oncolytic adenovirus improves the distribution of the virus through the tumour mass, increases its antitumour efficacy and induces tumour regression (see paragraphs [0017] and [0060] to [0064] and Figures 7 to 9 of the patent)."
• "Document (13) [WO 2005/018332]  does not include any experimental results whatsoever showing expression of the hyaluronidase sequence in tumour cells infected with the described adenovirus, either in vitro or in vivo, nor improved distribution of the described genetically engineered adenovirus within a tumour or tumour regression induced by administering the adenovirus. As a matter of fact, none of the examples of document (13) involves the use of an adenovirus, let alone an oncolytic adenovirus comprising a sequence which encodes a hyaluronase enzyme. Hence, document (13) itself does not provide anything of substance that makes it credible that the genetically engineered adenovirus described therein is in fact suitable for the treatment of cancer."
• "In the board's view, in the absence of relevant experimental data in the document which may support a therapeutic effect, the common general knowledge of the skilled person at the publication date of document (13) becomes highly relevant. Therefore, only if - in the light of this common general knowledge - it was credible that the genetically engineered adenovirus described in document (13), which comprises a sequence encoding a hyaluronidase, was suitable for treating cancer in a mammal, it can be concluded that the skilled person derives this technical teaching from document (13). The board considers that - in view of the common general knowledge set out below - the skilled person would have had serious doubts in this regard and that, therefore, this technical teaching cannot be seen as being derivable from document (13)"
• Regarding inventive step: "As stated above in connection with novelty, document (13) is not considered to be enabling for the use of the oncolytic adenovirus as defined in claim 1 for the treatment of cancer. If, as the respondent contended, the problem to be solved starting from this document were to provide an adequate treatment for cancer, the statements in document (8) (see page 12, last sentence of the second paragraph) would not suggest to the skilled person the use of an oncolytic adenovirus comprising a sequence which encodes a hyaluronidase, but rather the co-administration of an oncolytic adenovirus and hyaluronidase enzyme in the tumour."
• "It follows from the above that the subject-matter of claim 18 is not obvious to a person skilled in the art in view of document (13) combined with common general knowledge. Hence, inventive step is acknowledged."
• Hence, this second medical use claim appears [*] novel and inventive over a prior art document literally apparently disclosing the second medical use.
• [*] - It is not entirely clear to me what the relevant paragraphs of D13 are. The Board's decision does not seem to contain pin-point citations, as D13 is dismissed as not making certain statements credible. 

The link to the decision is provided after the jump, as well as (an extract of) the text of the decision.

T 0558/20 - Compound for surgical method

Key points

• The patentee appeals. Claim 1 of Auxiliary Request 2 reads as follows: 
  " A bone regenerative material comprising calcium sulfate [or some other compounds] for use in a method of treating a patient suffering from a degenerative bone condition that can be characterized by a loss of bone mineral density (BMD), the method comprising: forming a channel into the interior of a localized area of intact bone, using the channel as access, forming a void of dimensions greater than the channel in the localized area of intact bone by clearing degenerated bone material and optionally removing a portion of the degenerated bone material, at least partially filling the formed void with a bone regenerative material that facilitates formation of new, non-degenerated bone material in the void." 
• The feature in italics is added compared to the main request.
• As a comment, I note that the claim specifies " the method comprising ... filling the formed void with a bone regenerative material", not "the bone regenerative material" . 
• The OD found that "The method defined in the claim did not involve a new technical teaching, as required by decision G 02/08, and was thus not novel. Therefore the claim had to be read as defining compositions suitable for this method. Since the materials defined in the claim are well-known ... the claim was then held to lack novelty" 
• In connection with the Main Request, the Board notes that "it was uncontested that the material used in D3 is according to the claim. It was likewise uncontested that the method used in D3 is according to the claim."
• " D3 states clinical trials to be under way, however, no results of any such trial are on file." 
•  "  The appellant [proprietor] defended novelty of the claim arguing that D3 failed to disclose the formation of "non-degenerated bone material" as required by the claim." This argument fails. 
• "The description of the patent does not support the interpretation of "non-degenerated bone material" as exclusively referring to bone material corresponding to a 30-year old healthy subject, or bone material having certain physical characteristics relating to the BMD or T-score. The feature "new, non-degenerated bone material" may as well be interpreted as relating to newly formed bone material not yet affected by degenerative processes, as brought forward by the respondent [opponent]. In that sense the respondent's argument that newly formed bone material is, by definition, non-degenerated, has some merit."
• On the general interpretation of second medical use claims:   After assuring that the method defined in the claim falls under the exclusion of Article 53(c) EPC, the use and the method steps are considered as limiting features of the claim. Following this approach it then has to be examined whether the specific use of the substance or composition defined in the claim is novel or not. If this specific use is already known, the claim is not novel over the document disclosing the specific use of the substance or composition defined in the claim."
• "The approach proposed by the appellant, i. e. reading the claim as it is drafted, assuring that the method falls under Article 53(c) EPC, then considering the use and method features as limiting and assessing whether the specific use defined by them is already known from the prior art is, in the Board's view, aligned with the wording of Article 54(5) EPC and follows its logic. ... This approach is also the one generally used by EPO departments when assessing patentability of second medical use claims, and the Board will adhere to it in the present decision."
• Turning to AR-2: "D3 does not disclose forming a channel and using this channel as an access to form a void greater than the the channel in the bone. In D3 a hole is drilled, and nothing more, see figure 3."
• "Requiring additional surgical steps clearly provides a new technical teaching compared to the disclosure of D3 already because additional physical actions must be undertaken. The method defined in the claim is thus not just verbally different from the method disclosed in D3, but differs in tangible, physical method steps."
• On inventive step: "A skilled person, reading D3, would have had no reason to create a bigger void inside the bone, using the channel as an access. There is no indication anywhere in D3 that the drill hole alone could not accommodate the bone graft material injected into the bone, or that the amount of injected material was considered insufficient. "
• "The least ambitious technical problem that can be formulated starting from D3 is the provision of an alternative treatment of bone degenerative diseases."
• The Board does not expressly reject the more ambitious problem.
• The claim is considered to be inventive.
• By way of brief comment: a claim for a device for a surgical method does not benefit from Art.54(5) as a device is not a substance; and some other decisions reject claims for a gel for a medical use because the gel had no therapeutic activity in the method. This claim escapes all traps. 

EPO 

The link to the decision is provided after the jump, as well as (an extract of) the text of the decision.

T 3048/19 - Suitable for killing P. salmonis

Key points

• Claim 1 is directed to "Propyl-methyl-phenol compound, or composition comprising a propyl-methyl-phenol compound for use in the treatment and/or prophylaxis of Salmonid rickettsial septicemia (SRS) and/or diseases caused by Piscirickettsia salmonis, and/or for the use in killing, combating or controlling Piscirickettsia salmonis."
• The Board: "Purpose limited product claims, formulated in accordance with Article 54(5) EPC, are limited by their reference to methods of Article 53(c) EPC. However, "killing, combating or controlling" is not restricted to methods for treatment of the animal (including human) body by therapy and includes disinfection of water, as also indicated in the description of the patent which states "said propyl-methyl-phenol compound is applied to a locus to be protected from said bacteria or virus" (see paragraph [0020] of the patent in suit). In this case, the killing, combating or controlling of PS/SRS or ISA/ISAv may occur outside the fish."
• "Consequently, the compounds and compositions comprising the compounds of the second alternative defined in claims 1 and 2 ("for the use in killing, combating or controlling") do not profit from the purpose limitation under Article 54(5) EPC but are to be construed as compounds and compositions merely "suitable for" the intended use"
• In D10, "Paragraphs [0043] to [0062] list a number of non-volatile or volatile bioactive compounds. Among the non-volatile compounds, phenols, including propyl-methyl-phenols such as thymol or carvacrol, are an option (see paragraph [0044])."
• "Based on the claim construction above (see point 2.1), any prior-art compound "suitable for" killing, combating or controlling PS/ISAv, i.e. inherently possessing the claimed physiological properties, will take away novelty of the claimed composition."
• "Document D10 discloses a composition comprising thymol or carvacrol (see paragraph [0044]), i.e. propyl-methyl-phenol compounds, suitable for killing, combating or controlling PS and ISAv. It is inherent that the composition has been manufactured. "
• "Thus, the second alternative "for the use in killing, combating or controlling" of claims 1, 2, 14 and 15 is anticipated by the disclosure of document D10 within the meaning of Article 54 EPC. The main request is not allowable."
• 
  

EPO 

The link to the decision is provided after the jump, as well as (an extract of) the text of the decision.

G 2/21 - The Enlarged Board on sufficiency

Key points

• "[The] referred questions do not require an answer to the issue of sufficiency of disclosure and Article 83 EPC. However, as the terminological notion of plausibility relied upon by the referring board [] is mainly to be found in the case law of the boards of appeal with regard to the patentability requirement of sufficiency of disclosure, the Enlarged Board accepts the appropriateness of a comparative analysis and comparative considerations in this regard."
• "Indeed, a technical effect, which in the case of for example a second medical use claim is usually a therapeutic effect, is a feature of the claim, so that the issue of whether it has been shown that this effect is achieved is a question of sufficiency of disclosure under Article 83 EPC"
• To rephrase this statement slightly:  if technical effect ... is a feature of the claim, the issue of whether it has been shown that this effect is achieved is a question of sufficiency of disclosure under Article 83 EPC. This was also noted in G 2/03. 
• "Hence, because the subject-matter of second medical use claims is commonly limited to a known therapeutic agent for use in a new therapeutic application, it is necessary that the patent at the date of its filing renders it credible that the known therapeutic agent, i.e. the product, is suitable for the claimed therapeutic application.  The Enlarged Board explained the legal and historical background to the patentability of further medical uses in its decision G 2/08." [r.74.3]
• In other words, it is necessary under Art. 83 for second medical use claims that the patent (or patent application) at the filing date renders it credible that the known therapeutic agent, i.e. the product, is suitable for the claimed therapeutic application. 
• Note, the Enlarged Board does not say that the opponent must show that it was not credible on the basis of the patent application (as filed) on the filing date the recited therapeutic agent was suitable for the claimed therapeutic application.
• Clearly, it is the application as filed, as understood by the skilled person on the filing date in the light of common general knowledge of the skilled person on that date, that must render it credible that the recited therapeutic agent is suitable for the therapeutic application specified in the claim under examination. 
• Note, the Enlarged Board does not say that the application as filed must provide full proof that the recited therapeutic agent is suitable for the therapeutic application specified in the claim under examination. 
• Note, the Enlarged Board says, "renders it credible". A purely verbal statement that a compound is suitable for treating disease X may not always be sufficient to meed this requirement (in fact, may often be insufficient) even though (at least under currently prevailing case law) such a statement would be fine as disclosure under Art. 123(2) for a corresponding second medical use claim.
• Note, the Enlarged Board's requirement logically extends to allegedly novelty-destroying prior art for second medical use claims. 
• The requirement, probably, also extends to non-medical use claims ("use of compound X for purpose Z"), and to first medical use claims ("compound X for use as medicament"), for the latter the application as filed must render it credible that the recited compound is suitable for a therapeutic application.
• The Enlarged Board does not mention serious doubts substantiated by verifiable facts, i.e facts to be adduced by the opponent. Because the Enlarged Board specifically mentions that "it is necessary that the patent ... renders it credible", the Enlarged Board's holding appears to be directed not in the least to opposition proceedings. 
• The Enlarged Board's reasoning to arrive at this conclusion regarding sufficiency is remarkably brief, though building on the preceding extensive review of the case law on inventive step in the decision. The Enlarged Board observes that "the technical effect ... is a feature of the claim", and then the above-cited r.74.3 follows. This paragraph is followed by a summary of some decisions of Technical Boards of Appeal on sufficiency. 
• The precise function of the reference to G 2/08 is not entirely clear to me. It might be noted that G 2/08, r.5.3 mentioned that "the exclusion from patentability of [medical methods]  seemed actually to be based on socio-ethical and public health considerations."

EPO 

The link to the decision is provided after the jump, as well as an extract of the decision text.

T 0752/19 - Pharmaceutical composition comprising a computer program

Key points

• "Claim 1 of the main request reads as follows: "Ticagrelor for use in a treatment of Acute Coronary Syndrome or myocardial infarction, in combination with acetyl salicylic acid and a computer program product comprising instructions causing a computer to perform a method comprising the steps - providing a patient with a set of questions according to a question schedule, ... providing said feedback information to the patient"
• The Board: "The subject-matter of claim 1 of the main request differs from D3 in that it further includes an interactive computer program."
• As a comment, apparently, a second medical use claim can validly recite a computer program.
• Note that a second medical use claim directed to a medical device is not permitted. 
• I acknowledge that the claim at issue is of the kit-of-parts type second medical use claim. "In T 9/81 [25.01.1983]  the board held that combined preparations, the individual components of which represented known therapeutic agents, might be protected in a formulation corresponding to Art. 54(5) EPC 1973 (now Art. 54(4) EPC) even when claimed as a kit-of-parts, [provided that] those components formed a functional unity (true combination [)] through a purpose-directed application. " CLBA 9th ed. I.C.7.1.3. (note, these claims were a kind of second-medical use claims avant la lettre (G 1/83 being issued 05.12.1984). However, the Board therein required that " the individual components of which represented known therapeutic agents".
• The Board, on inventive step: " It thus has to be assessed whether the computer program according to claim 1 interacts with the technical features of claim 1, namely the combination of ticagrelor and acetylsalicylic acid, to bring about an overall technical effect."
• "improved patient compliance could be recognised as the overall technical effect of the distinguishing features of claim 1 only if it were shown to arise objectively in an unbroken technical chain from the intrinsic properties of the claimed pharmaceutical formulation. In general, in a pharmaceutical formulation exhibiting improved patient compliance, the intrinsic properties of the improved pharmaceutical formulation either lead to fewer side effects or make the administration of the pharmaceutical formulation into the patient's body easier, thus objectively lowering the risk of discontinuation or interruption of the therapy regimen."
• "In the case at hand, the pharmaceutical composition is indeed not new. Since the computer program of claim 1 does not interact with the intrinsic properties of the pharmaceutical composition, it can be ruled out that it leads to an overall technical effect in terms of improved patient compliance. Any improved patient compliance in the case at hand, as apparently demonstrated by D4 or D5, is instead the result of a "broken technical chain" (see T 1670/07, point 11 of the Reasons), namely an alleged chain of technical effects starting with information provided to a patient which is then broken by the patient's mental activities."
• 
  

EPO T 0752/19

The link to the decision is provided after the jump, as well as (an extract of) the text of the decision.

T 2344/19 - Weight gain related adverse events

Key points

•  Claim 1 is directed to: " 1. [vortioxetine] for use in the long-term treatment of depression or anxiety in a patient who has previously received medication for the treatment of said disease which medication was ceased due to weight gain related adverse events, wherein long-term treatment refers to a treatment period above 12 weeks." 
• The question is whether the feature in italics can provide for novelty, i.e. whether it specifies a valid second medical use under Art. 54(5) EPC. More in particular, whether the feature defines a patient group.
• The Board: " The indication that the previous treatment was stopped due to weight gain related adverse events establishes the fact that the group of patients under consideration is known to develop weight gain related side-effects when administered medication active in the treatment of depression or anxiety. The development of certain side-effects reflects a certain physiological and/or pathological status of the patients concerned. The development of these side-effects during treatment for depression or anxiety creates a link between the patients, their physiological and/or pathological status, and the therapeutic treatment. The patient group under consideration is thus a technical feature of the claims." 
• As to inventive step, D7 " describes weight gain as a common adverse effect of psychotropic drugs (abstract). In the concluding passages, it states that medication should be switched to another drug if weight increase due to a psychotropic drug cannot be stopped or reversed by measures relating to proper nutrition and eating habits, physical exercise and behaviour modification " 
• " The difference between the subject-matter of claims 1 and 3 as granted and the disclosure of document (7) is the use of vortioxetine as the switch drug." 
• " In view of the disclosure of document (7) []and the objective technical problem, it is clear that the person skilled in the art would have avoided the administration of any psychotropic drug for which long-term weight gain related side-effects had not been excluded. They would also have avoided any treatment potentially worsening the overall physiological condition of the patient, or, when leading to non-compliance, worsening the underlying psychiatric condition and potentially leading to relapse, hospitalisation or even fatal consequences. " 
• " In summary, the person skilled in the art would have needed to count on success or, put differently, have a strong expectation of success. Any treatment undertaken with a mere hope to succeed, in the present case a treatment where short-term side-effects had been excluded but nothing was known on long-term side-effects, would not have been envisaged by the person skilled in the art." 
• " Consequently, since no information on long-term weight gain related side-effects was known for vortioxetine, the person skilled in the art would not have considered vortioxetine for solving the technical problem stated above, and thus would not have arrived at the claimed subject-matter." 
• 
  

EPO T 2344/19

The link to the decision is provided after the jump, as well as (an extract of) the text of the decision.

T 2056/17 - Co-marketing as 2nd medical use?

Key points

• Claim 1 is, arguably, a second medical use claim and reads: “"1. A pharmaceutical combination for use in the prevention, alleviation or/and treatment of epileptic seizures, which comprises a separate dosage form comprising (a) a first composition comprising lacosamide and (b) a second composition comprising levetiracetam, wherein the compositions (a) and (b) are provided in distinct preparations (separate dosage forms), which are administered simultaneously and/or subsequently, wherein said separate dosage forms are co-presented in separate packaging, or are separately packaged and available for sale independently of one another, but are co-marketed or co-promoted for simultaneous and/or subsequent administration."
• “D2 discloses a pharmaceutical combination for use in the treatment of epileptic seizures which comprises a separate dosage form comprising (a) a first composition comprising LCM and (b) a second composition comprising LVT, where the compositions (a) and (b) are provided in distinct preparations, i.e. packaged separately, and administered simultaneously and/or subsequently.”
• “Regarding the feature in claim 1 that the actives are available for sale independently of one another but are co-marketed or co-promoted for simultaneous and/or subsequent administration, the board notes the following. The effective treatment of epileptic seizures according to both claim 1 and D2 is achieved by the simultaneous and/or subsequent administration of the separate dosage forms of LCM and LVT. The fact that these dosage forms are available for sale independently of one another but co-marketed or co-promoted for simultaneous or subsequent administration does not render the therapeutic treatment in claim 1 different from that in D2. In both cases, the therapeutic effect is the same, it is achieved on patients having the same physiologic and pathologic state, using the same combination of active ingredients, administered by the same route and with the same dosage regime. In other words, claim 1 and D2 relate to an identical clinical situation which is treated with the same therapeutic measures. Therefore, claim 1 does not define a new specific use within the meaning of Article 54(5) EPC.”
• As a comment, one may ask if “are co-marketed or co-promoted for simultaneous and/or subsequent administration” is a technical feature at all. 

EPO - T 2056/17 -

Link to the decision after the jump, as well as an extract of the decision text.

T 2218/16 - Gene therapy and result to be achieved

 Key points

• Claim 1 is a second medical use claim directed to basically an AAV vector comprising a therapeutic gene for use in a method for treating a motor neuron disorder in a subject. The AAV vector is further specified, as well as the mode of administration. The therapeutic gene is defined as “wherein the therapeutic gene is operably linked to a promoter specific or functional in motor neurons”. The claim further specifies a functional feature described below.
• Novelty over D2 is considered. “Document D2 discloses the same scAAV9 vector, therapeutic genes, motor neuron disorders to be treated ...  including the same mode of administration as referred to in claim 1 ... Document D2 further discloses ubiquitous promoters, like CMV ... which as shown in the patent, are functional in motor neurons too.”
• “It was contested between the parties whether or not document D2 discloses motor neurons transfected by the scAAV9 vector.”
• "The claim inter alia specifies that the administration of these vectors cause "infection of spinal cord motor neurons and expression of the gene in spinal cord motor neurons". Accordingly, the claimed use of the scAAV9 vectors is defined by a functional feature that indicates the desired result to be achieved, namely the transfection of spinal cord motor neurons as a necessary prerequisite to achieve a therapeutic effect. According to the case law, functional features are technical features of the claim (see Case Law, II.A.3.4., II.C.7.2.). As set out above, document D2 does not disclose the transfection of motor neurons. Thus, the "result-to-be-achieved" feature in claim 1 relates to a new technical effect."
• “ document D2 is silent on directly transfecting motor neurons, and relates to the transfection of other target cells that, after secretion of a therapeutic product, have an indirect effect on cells involved in the development of particular diseases, inter alia, SMA. The respondents did not dispute that a scAAV9-based therapy that did not directly transfect motor neurons was not suitable for treating SMA. In these circumstances document D2 provides a non-enabling disclosure for the treatment of SMA. Since for the reasons outlined above, the new mechanism of action creates a new clinical situation, the board concludes that the situation in the present case differs from that underlying the decisions T 433/14 and T 406/06.”
• The claims are found to be novel, inventive, and allowable.

T 2218/16 - 

https://www.epo.org/law-practice/case-law-appeals/recent/t162218eu1.html

Claim 1 of the main request reads:

"1. An AAV vector comprising a therapeutic gene for use in a method for treating a motor neuron disorder in a subject, wherein said AAV vector is administered by by intraperitoneal (i.p.), intramuscular (i.m.) or intravenous (i.v.) injection, preferably intravenous injection, to said subject, said administration causing infection of spinal cord motor neurons and expression of the gene in spinal cord motor neurons, wherein said AAV vector is:

- a double-stranded self-complementary AAV9 vector, or

- a pseudotyped AAV vector comprising a double-stranded self-complementary AAV genome derived from an AAV serotype different from the AAV9 serotype and a capsid derived from an AAV9 capsid; and

wherein the therapeutic gene is operably linked to a promoter specific or functional in motor neurons".

Reasons for the Decision

Novelty

40. In a first line of argument, the appellant submitted that the subject-matter of claim 1 lacked novelty over documents D1 and D2. Since, as the appellant further submitted, the disclosure of both documents is "very similar, if not identical", in the following reference will be made to relevant passages in document D2 only.

40.1 Document D2 discloses the same scAAV9 vector, therapeutic genes, motor neuron disorders to be treated (e.g. SMA, amyotrophic lateral sclerosis (ALS), or Kennedy's disease), including the same mode of administration as referred to in claim 1 (see for example page 1, first paragraph; page 6, lines 1 to 3, 17 to 19; page 12, lines 3 to 10 and 15 to 23). Document D2 further discloses ubiquitous promoters, like CMV (see page 9, lines 17, 27 and 28), which as shown in the patent, are functional in motor neurons too. The board is therefore not convinced by the respondents' argument, that document D2 discloses a promoter subset that is different from the "functional" promoters cited in claim 1.

T 1345/18 - Bone adhesive not a second medical use substance

Key points

• Claim 1 is directed to (in translation) a bone adhesive comprising calcium phosphate ... for use in a method of treating bone lesions, i.e. in a dental method.
• The question is whether this is a valid second medical use claim, in particular whether the recited compound is a substance or composition in the sense of Art. 54(5) EPC.
• The Board, in translation: “The question of what falls under the terms substance or composition within the meaning of Article 54 (5) EPC was the subject of several decisions by the boards of appeal (see in particular T 1758/15, Reasons 5.2; T 2136/15, Reasons 1; T 2003 / 08, reasons 17, 18). In summary, the boards came to the interpretation that it must be a substance or a composition that has an effect in the claimed method, which is new as such. The effect must be brought about by the substance or the mixture of substances itself, not by a macro-structure created from the substance or the mixture of substances.”
• In the present case, there is a direct and an indirect medical effect. The direct medical effect is the adhesive effect. The Board: “However, this effect corresponds to the well-known effect of any such bone glue. For this reason alone, this effect cannot produce any novelty in the sense of a second medical use.”
• I think this reasoning is quite remarkable.
• The indirect effect is sealing plug effect. However, “the sealing plug consists of a substance or composition, as can also be the case with any other product. However, it is not the substance or the composition that has the effect, but the macro-structure formed from this substance or composition”
• Thereby the second medical use format does not lend novelty to the claim.

T 1345/18 - 

https://www.epo.org/law-practice/case-law-appeals/recent/t181345du1.html

1.6 Die zweite Voraussetzung für die Anwendung des Artikels 54(5) EPÜ besteht darin, dass es sich bei dem beanspruchten "Knochenkleber umfassend Kalziumphosphatzemente und deren Granula" um einen Stoff oder ein Stoffgemisch im Sinne dieses Artikels handeln muss.

1.7 Die Frage, was unter die Begriffe Stoff oder Stoffgemisch im Sinne von Artikel 54(5) EPÜ fällt, war Gegenstand mehrerer Entscheidungen der Beschwerdekammern (vgl. insbesondere T 1758/15, Entscheidungsgründe 5.2; T 2136/15, Entscheidungsgründe 1; T 2003/08, Entscheidungsgründe 17, 18). Zusammenfassend kamen die Kammern zu der Auslegung, dass es sich dabei um einen Stoff oder ein Stoffgemisch handeln muss, das in dem beanspruchten, als solches neuen Verfahren eine Wirkung entfaltet. Dabei muss die Wirkung durch den Stoff bzw. das Stoffgemisch selbst bewirkt werden, nicht durch eine aus dem Stoff bzw. dem Stoffgemisch entstandene Makrostruktur.

1.8 Der Beschwerdeführer brachte vor, dass der beanspruchte Knochenkleber ein unmittelbare und eine mittelbare medizinische Wirkung auf den Zahnhalteapparat entfalte.

1.8.1 Die unmittelbare medizinische Wirkung des Knochenklebers sei darin zu sehen, dass er Knochenläsionen fixiere.

Diese Wirkung entspricht jedoch der wohlbekannten Wirkung eines jeden derartigen Knochenklebers. Diese Wirkung kann somit bereits aus diesem Grund keine Neuheit im Sinne einer zweiten medizinischen Verwendung herstellen.

1.8.2 Die mittelbare Wirkung beruhe auf der Ausbildung einer Verblockung im Sinne eines Verschlusstopfens. Die Positionierung des Verschlussstopfens im apikalen Bereich verhindere, dass das nachträglich eingebrachte Wurzelfüllmaterial aus dem Wurzelkanal in apikaler Richtung austreten könne. Dadurch würden Reizungen und Infektionen prophylaktisch verhindert.

Der Verschlussstopfen besteht zwar aus einem Stoff- bzw. Stoffgemisch, so wie das auch bei jedem anderen Erzeugnis der Fall sein kann. Es ist jedoch nicht der Stoff bzw. das Stoffgemisch, welches die Wirkung aufweist, sondern die aus diesem Stoff bzw. Stoffgemisch gebildete Makrostruktur (vgl. dazu: T 2136/15, Entscheidungsgründe 1.1 ff und insbesondere 1.6 sowie T 2003/08, Entscheidungsgründe 17, 18).

Insbesondere liegt die vom Beschwerdeführer geltend gemachte Neuheit speziell in der Länge des Verschlussstopfens von maximal 1/10 der Wurzelkanallänge. Dies stellt ebenfalls keine stoffliche Eigenschaft des Knochenklebers dar.

Die mittelbare Wirkung der Verblockung ist daher im Sinne der oben wiedergegebenen Auslegung keine Wirkung des Stoffs bzw. des Stoffgemisches und kann nicht als Basis dafür dienen, dem beanspruchten Knochenkleber umfassend Kalziumphosphatzemente und deren Granula Neuheit gemäß Artikel 54(5) EPÜ zuzuerkennen.

1.9 Der Gegenstand des Anspruchs 1 gemäß Hauptantrag ist daher nicht neu.

T 2232/17 - New subgroup but no special therapeutic effect

 Key points

• “Independent claim 1 of the main request reads: "1. Use of natalizumab or an immunologically active fragment thereof for the preparation of a medicament to be administered to a human subject in a steroid sparing effective amount to reduce and/or eliminate a need for steroid treatment in the human subject with a disease selected from the group consisting of inflammatory bowel disease, asthma, multiple sclerosis, graft versus host disease, host versus graft disease, spondyloarthropathies, and combinations thereof, wherein the human subject is under treatment with steroids."”
• “the board considers that "to reduce and/or eliminate a need for steroid treatment", does not define a different clinical situation to that in which this feature would be absent. This is because reducing the need for treatment only defines a situation which may or may not lead to a difference in treatment. The underlying medical use defined in claim 1 is therefore not different from the administration of natalizumab in the absence of any considerations about the need for steroid treatment. In other words, the feature "to reduce and/or eliminate the need for steroid treatment" does not limit the subject-matter of the claim.”
• In AR-2, claim 1 additionally specifies that: “ that the human subject to be treated is further defined as "refractory, intolerant or dependent on steroids" ”
• “It is established case law of the boards of appeal that the use of the same compound in the treatment of the same disease for a particular group of subjects can represent a new therapeutic application, provided that it is carried out on a new group of subjects which is distinguished from the known group by its physiological or pathological status (see e.g. T 19/86, OJ EPO 1989, 24, point 8 of Reasons; T 893/90, point 4.2 of Reasons; T 1399/04, point 35 of Reasons and T 734/12, point 24 of Reasons). In the present case, the board has seen no evidence that patients suffering from MS and who are "dependent on steroids" differ in their physiological or pathological status from the general group of MS patients, in particular with respect to their suitability for being treated with natalizumab. The patent contains no data on the treatment of MS patients with steroids and/or natalizumab. Moreover, even if the patent was taken as disclosing a sub-group of "steroid dependent" patients, no special therapeutic or pharmacological effect of natalizumab in this sub-group is disclosed in the patent. Thus, even if the patients disclosed in document D4 were not considered to be dependent on steroids, this feature would not establish novelty.”
  
  
• The OD did not admit an auxiliary request. “As a further reason, the opposition division referred to the long duration of the oral proceedings and the late point in time (21:35 hours) when the appellant attempted to file the sets of claims of alternative auxiliary requests 3 to 5 (see point 27.1 of the decision). The board however notes that the appellant had attempted to replace all auxiliary request at an early stage of the oral proceedings (see minutes, point 4., "New Main Request") which was not permitted by the opposition division. Also this reason is therefore not considered pertinent.”
• Also the other reasons given are not convincing for the Board. “In view of the above, the board considers that the opposition division exercised their discretion in an unreasonable way, preventing the appellant from pursuing alternative auxiliary claim requests 3 to 5 which were intended to address issues with regard to sufficiency of disclosure, novelty and inventive step.”
• The case is remitted.

T 2232/17 - 

https://www.epo.org/law-practice/case-law-appeals/recent/t172232eu1.html

Independent claim 1 of the main request reads:

"1. Use of natalizumab or an immunologically active fragment thereof for the preparation of a medicament to be administered to a human subject in a steroid sparing effective amount to reduce and/or eliminate a need for steroid treatment in the human subject with a disease selected from the group consisting of inflammatory bowel disease, asthma, multiple sclerosis, graft versus host disease, host versus graft disease, spondyloarthropathies, and combinations thereof, wherein the human subject is under treatment with steroids."

Reasons for the Decision

Main request and auxiliary requests 1 and 2, all submitted with the statement of grounds of appeal

Admission in the appeal proceedings (Article 12(4) RPBA 2007)

1. Pursuant to Article 12(4) RPBA 2007, the board has the power to hold inadmissible requests which could have been presented in the proceedings before the opposition division even though they have been submitted with the statement of grounds of appeal. In the board's opinion, the provision applies a fortiori to requests which were presented in opposition but subsequently withdrawn because, as in the cases explicitly addressed in the provision, the opposition division was likewise prevented from taking a decision on these requests.