The application relates to a vascular embolic system comprising compositions comprising solutions of specific peptides for use in the treatment of three different conditions, namely (i) cancer, (ii) patent ductus arteriosus (PDA) or (iii) major aortopulmonary collateral artery (MAPCA).
Brief outline of the case
The applicant appealed the refusal for lack of N.
During appeal proceedings the applicant filed new claim sets as MR and AR 1-8.
The board held that the requirement of Art 54(4) or (5) is fulfilled when a substance or composition is present.
It was undisputed that the amphiphilic peptides defined in the claim, aqueous solutions thereof, as well as hydrogels formed therefrom, are already known from D1 and D2.
The case was eventually remitted to the ED for further prosecution.
The case is interesting in that it attemps to define what is understood under a substance or composition in the meaning of Art 53(c).
The ED’s point of view
In its decision the ED 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 Art 54(5), their mode of action being purely mechanical.
The ED referred in particular to decision T 1758/15 to support this view. This decision is also referred to in the Guidelines for Examination, G-VI, 7.1.1.
Since the N exception under Art 54(5) did not apply, the claim had to be construed as claiming a device, suitable for being used in the method defined in the claim.
The peptide solutions were known from D1 and D2 and they were suitable for the method defined in the claim. Thus, the independent claim of the MR lacked N. Similar considerations applied to the claims of the ARs on file.
The applicant’s point of view
The applicant brought forward various arguments emphasising the chemical nature of the peptide solutions defined in the claims. It argued that the embolizing effects were due to the better adhesion of the hydrogel formed.
The better adhesion, in turn, could be attributed to the chemical structure of its components or to the chemical structure of the hydrogel once assembled inside the body of the patient, or even to the self-assembly process.
It thus submitted arguments why the peptide solutions defined in the claim did qualify as “substance or composition” within the meaning of Art 53(c) and 54(4) and (5). The N exception in Art 54(5) should thus apply, and since the therapeutic methods defined in the claim were not disclosed in D1 or D2, the claimed subject-matter was new.
The conclusions drawn in the appealed decision, based on the reasoning in case T 1758/15 and the cited part of the Guidelines G-VI, 7.1.1, would thus not apply to the present claims.
The arguments of the ED and also the reasoning in T 1758/15 appear to be directed more to the lack of chemical character of the mode of action. In other words, the main objection to the claimed peptide is not really the device character of the resulting hydrogel plug, but the fact that the therapeutic effect is not achieved by means of a chemical interaction with the human body.
The board’s decision
The claim defines the use of a solution containing one of three specific peptides in a concentration effective to form a hydrogel under physiological conditions to allow at least partial blockage of the biological vessel to effect embolism or necrosis.
Substances or compositions may still be considered novel if claimed for use in a method referred to in Art 53(c), i. e., in “medical” methods practised on the human or animal body. Importantly, this N exception can only be invoked for substances or compositions, not for other products, e. g. medical devices.
Apart from being derivable from the wording of Art 53(c), 54(4) and (5) this limited applicability of Art 54(5) is consistent case law of the Boards of Appeal, see e. g. T 1099/09, headword, T 2369/10, Reasons points 7 and 8.1, or T 1758/15, Reasons points 5.2.1 and 5.2.2. This was not a disputed issue in the present case and the board saw no reason to call this into question.
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. From the analysis of Articles 53(c) and 54(4) and (5) 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 Art 54(5) also emphasised that the application of the special approach to N through the intended use is strictly limited to claims that are directed at substances or compositions intended for use in methods stipulated by Art 52(4) EPC 1973, corresponding to Article 53(c) EPC.
Analysis of the existing case law
T 1758/15 in turn relied on the findings of T 2003/08 and the criteria developed in it. It concerned a ligand for immunoglobulins which was immobilized on a support in a column used for extracorporeal removal of immunoglobulins from blood.
The Board first stated that G 5/83 required the substance or composition to be responsible for the therapeutic effect, in the wording of T 2003/08, it had to be the “active agent“.
Then it concluded that in order for a material to be considered a substance or composition in the sense of the applicable provisions, it was decisive to establish
(a) the means by which the therapeutic effect was achieved and
(b) whether that what achieved the therapeutic effect was a chemical entity, or a composition of chemical entities.
The board came to the conclusion that the decisive agent was the ligand, which was a chemical entity responsible for the therapeutic effect. The ligand was thus considered a substance or composition.
These criteria (a) and (b) were further developed in T 1758/15. In this case, the macroscopic 3D-structure of the solidified implant material, rather than its chemical composition, was considered responsible for the therapeutic effect.
According to this decision, in such a case the means to achieve the effect were not chemical, as required by criteria (a) and (b) of T 2003/08 and the filler material defined in the claim was not considered a substance or composition in the sense of Art 54(5). In the wording of T 1758/15, “[t]hat the material has some indirect influence on the characteristics of the resulting solid structure does not make the material the active principle“, see Reasons 5.2.8, third paragraph.
Similar considerations were made in case T 2136/15 concerning a self-gelling injectable alginate, and in T 1345/18 concerning a filler material for the root channel of a tooth. Also in the latter case the cement-like filler material was not held to be a “substance or composition” in the sense of Art 54(5). Its effect, the blocking of the root channel, was considered to be based on the macroscopic structure of the hardened cement rather than on the chemical properties of the material.
This line of case law imposes restrictions to what may fall under the definition of “substance or composition” in the sense of Art 54(5) 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 Art 54(5) since once inside the body they acted as a device.
In T 264/17 a claim directed to an inert substance as a replacement for synovial fluid was allowed. Although no classical active agent was present, the chemical properties of the material were still considered to be responsible for the achieved therapeutic effect.
In the present case
The board was convinced that the peptide solutions defined in the claim must be considered a “substance or composition” in the sense of Art 54(5).
The claim does not define the material by any technical features which would be characteristic for a device, e. g. its shape. As also apparent from the explanation of the invention in the description, it is in liquid form that the material is administered to the patient. When administered, the material does not yet have the crucial shape of the plug fitting to the blood vessel, which will in the end result in the therapeutic effect aimed at.
Thus, for the board, the material defined in the claim is evidently a “substance or composition”. It is a shapeless liquid mixture of chemical entities and, already for this reason alone, it is not a device.
It is another matter that the peptide solution will, once used as defined in the present claim, transform itself into something which may act as if it were a device.
The main objection to the claimed peptide was not really the device character of the resulting hydrogel plug, but the fact that the therapeutic effect is not achieved by means of a chemical interaction with the human body.
When analysing G 5/83, the board came to the conclusion that 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 Art 54(5).
This 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.
The board also considered that none of Art 54(4), 54(5) or 53(c) require a material to act via a certain mechanism in order to be considered a “substance or composition”. The board further considered it not derivable from G 5/83,that mode of action as the relevant criterion for judging whether a material is a “substance or composition”.
Comments
The present case is interesting in that the board made great efforts so that it could define what should be understood under a substance or composition to be used in a method according to Art 53(c). The need of a reaction with the human or animal body is not necessary to qualify a substance or compostion in the meaning of Art 53(c).
G 5/83 and its genesis
I do however have difficulties in following the board, especially when looking at the genesis of G 5/83.
My recollection of the genesis of G 5/83 is somehow different. G 5/83 aimed at render possible the protection of further medical uses with so-called Swiss-type claims. Swiss-type claims were clearly aimed at protecting new therapeutic uses and are clearly involving a chemical reaction within the body. Since Art 53(c) does not differ in substance from Art 52(4) EPC73, it appears difficult to claim that Art 54(4) and 54(5) do not require a chemical reaction within the body in order to be qualified as substance or composition.
I therefore cannot share the board’s view that, according to G 5/83, 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 Art 54(5). On the contrary, the essence of G 5/83 clearly relates to a chemical interaction in the human or animal body.
There is another important aspect: when using the known substance or composition in a therapeutic method, the substance or composition disappears once it has been used and cannot be reused. It is due to the chemical reaction within the body that the substance or composition cannot be reused. This is a fundamental difference with a device which does not disappear once it has been introduced in the human or animal body. This aspect has been ignored in the present decision and in T 264/17, as the substance or composition is not consumed through its use. On the other hand, T 2369/10 was clearly relating to a device.
Diverging case law
The present decision is aligned on T 264/17. Both decisions actually consider that a chemical reaction in the body is not necessary to consider a substance or composition in the meaning of Art 53(c).
On the other hand, T 1758/15, T 2136/15 and T 1345/18 actually consider that a chemical reaction in the body is necessary to consider a substance or composition in the meaning of Art 53(c). In my opinion, the peptides of the present invention are comparable to the gelling alginate in T 2136/15, or the filler material in T 1345/18.
At least it can be said that there is a divergence in case law. Whether it is worth a referral to the EBA remains to be seen.
Even if a patent should be granted on the basis of the present decision, an opposition will be possible. As an OD is not bound by the decision of the ED, the problem might arise again.
Amendment of the Guidelines
As there are actually only two decisions disagreeing with the Guidelines G-VI, 7.1.1, it is not to be expected that the Guidelines will be amended. There are enough decisions confirming T 1758/15 mentioned in said Guidelines.
https://www.epo.org/en/boards-of-appeal/decisions/t201252eu1
Comments
17 replies on “T 1252/20 – Substance or composition in the meaning of Art 53(c)”
It seems to me that, in some way, the Board is attempting to avoid drawing distinctions between:
(a) substances or compositions that qualify as an “active substance”; and
(b) substances or compositions that qualify as a “medical device”.
This is perhaps not such a bad thing as, even for regulators, the borderline between the two can be fuzzy. Therefore, whilst I understand the motivations behind prior case law that attempts to draw distinctions between (a) and (b), I am not sure that heading down that path can possibly lead to a clear and predictable test for identifying “substances or compositions” in the sense of Art 54(5).
Indeed, it strikes me that, for some diagnostics, the medicinal product approved by regulators contains a substance or composition that:
– is assessed (and designated) as an “active substance” by the regulators; but
– has a mode of action that relies upon “physical” (as opposed to “chemical”) means.
It would be a great shame if the EPO derived a test under Art 54(5) that disincentivised the development of DIAGNOSTIC second medical uses of known substances or compositions. After all, such uses are just as deserving of patent protection as are therapeutic uses. For this reason, I am inclined to support the Board’s decision in this case.
@ Doubting Thomas alias Proof of the pudding
I can certainly follow your reasoning with respect of substances used in diagnostic methods. They should indeed although receive patent protection under Art 54(4 and 5).
Take for example substances or compositions used for contrast enhancement in X-ray imaging, in US- or MR-Imaging. Those substances do certainly not have a therapeutic effect as they are not meant to cure an illness and are thus not medically active.
However, those substances, once injected, are nevertheless eliminated by the body, be it in the form of metabolites or other similar mechanisms. In this respect, those substances and compositions can well be considered as substances or compositions in the meaning of Art 53(c).
Although I can understand the intention of the board, I cannot share its views on G 5/83.
I would claim that a clear and predictable test for identifying “substances or compositions” in the meaning of Art 53(c) is
– firstly, that they disappear when used and
– secondly, they are eliminated by mechanisms proper to the body.
Whatever happens those substances or compositions cannot be reused and are eliminated by the body itself.
I am however not convinced that the hydrogel of the invention underlying T 1252/20 will disappear by mechanisms proper to the human body.
@Daniel X. Thomas, alias “…”
I see no reason to include your proposed test. Article 53(c) provides no indication that the wording “substances or compositions” should take a meaning other than the plain meaning of those words.
As you have presumably noted, there are three prongs to the trident of A.53(c): methods of treatment by surgery, methods of treatment by therapy and diagnostice methods. The EBA in G4/83 only considered one of these, methods of treatment by therapy in connection with therapeutic or pharmaceutical substances or compositions. That forty years of case law have misapplied the teaching of G4/83 such that a second medical use exemption should require a therepeutic effect does not lead to your interpretation of the EPC being the correct one. The Board in this case is to be congratulated on going back to basics.
@Kant
The limits are not that clear. See T 558/20 relating to a bone regenerating material for use in a combined therapeutic treatment and surgical step for the treatment of osteoporotic patients.
@ Kant alias …@….
I accept your point of view, but you cannot expect that I share yours. In view of the case law, and especially of G 5/83 we are further than the plain meaning of the words in Art 53(c).
I disagree that “forty years of case law have misapplied the teaching of G 4/83 (I would rather speak of G 5/83 which comes to the same conclusion, as G 4/83 and cannot be found in the list of decisions of the EBA) such that a second medical use exemption should require a therapeutic effect. G 5/83 was nevertheless clearly directed towards therapeutic effects.
I invite you to look at T 655/92 which relates to the “use of a magnetically responsive material for the manufacture of a diagnostic contrast agent for use in a method of in vivo nuclear magnetic resonance imaging of a subject, …. such that said particles in said nuclear resonance imaging of said subject cause relaxation time changes resulting in a visualisable ‘black hole’ contrast effect””.
T 655/92 refers to G 5/83 and it is thus possible to say that G 5/83 applies not only to substances used in therapy, but also to substances used in diagnostic methods. There is thus nothing new with respect of substances used in diagnostic methods.
The method at stake was considered diagnostic as it transformed the NMR imaging from a non-invasive to an invasive technique.
In T 655/92, the board added that “the present diagnostic process, when considered in its totality, comprises at least one step essential for the desired diagnostic result, which cannot fall under the exclusive responsibility of the technician skilled in NMR technology. While for a process whose steps as a whole are non-medical but technical it is legitimate not to derive the in vivo diagnostic character from its final diagnostic purpose, this does not apply to a process for a diagnostic purpose which is to be implemented in its essential steps by medical staff or under the responsibility of a doctor. A different interpretation would be in clear conflict with the spirit of Article 52(4)”, now Art 53(c).
The magnetic particles were injected in the body and could not be reused. It does not appear wrong to considered that those magnetic particles were eventually eliminated from the body in one way or another.
I further allow myself to refer to T 558/20. The substance or composition in T 558/20 acts as a bone regenerative material that is resorbed by the body over time and replaced by newly generated bone material, cf. § [0011]. Being resorbed by the body, it can be considered that it disappears or is dissolved in the broadest sense, as body bone material is eventually generated. Here, the substance or composition is used in a surgical method. That T 558/20 does not refer to G 5/83 does not change this fact.
I therefore maintain the test I have proposed. It might not been perfect, but it has the merit to be rather simple and corresponds to the spirit and scope of G 5/83. It certainly goes further than the plain meaning of the words in Art 53(c).
It can apply to other substances used for contrast enhancing in X-ray imaging. It can also apply for instance to substances and compositions used methods of surgery in which the injection of specific substances renders tumours visible under lighting of a specific wavelength, so as to better spot and destroy them.
“The operators of this website take the protection of your personal data very seriously. We treat your personal data as confidential and in accordance with the statutory data protection regulations and this privacy policy.” Ho hum
Dear Daniel,
Using the fact that a substance/composition 1. disappear when used and 2. is eliminated by body mechanisms as relevant features for creating a cut-off between substance and device can become tricky in other situations.
For example, by using these features as a cut-off, dissolvable stitches could be considered a substance/composition instead of a device (which they clearly are, in my opinion). Other examples are bioabsorbable devices/prothesis.
I am not saying that I agree with the instant decision, however the borderline between substance/composition and device can become very blurry, as science advances. Thus, finding a clear distinction between substance and device is not trivial and more aspects should be considered than the above.
Keep your great work, I really appreciate your posts here!
@Trainee
You are quite right to mention devices/prothesis. This is the case in T 558/20 relating to a bone regenerating material for use in a combined therapeutic treatment and surgical step for the treatment of osteoporotic patients. As far as I understand the method, the bone material once implanted after the surgical step is not dissolved and in addition body bone material is eventually generated. T 558/20 was commented on a previous post on this blog.
Dear Trainee,
You certainly have a point, but having been working for nearly 15 years in medical devices/medical physics, I have a different view when it comes to devices you mention.
To me, dissolvable stitches are clearly belonging to the category “devices”. The same applies to dissolvable stents, which also exist. I do not remember merely seeing claims for substances or compositions for use in such dissolvable devices. I do however agree that it may become difficult to make a distinction between substance and device as science advances.
It remains, that in general the interest lies in the devices and less in the substance used in those devices. Devices most probably bring more money than the substances or compositions as such.
If my blog fosters a vivid exchange of views, I am quite pleased. We do not have to agree, but looking at things from a different angle is in general profitable to all.
Thank you for your comments, Daniel and Francis!
Dear Mr Hagel,
Thanks for reminding of my post about T 558/20.
The substance and composition in T 558/20 was indeed used in a surgical/therapeutic method.
I would however consider that the substance or composition in T 558/20 cannot be reused at it ends up with forming new bone material.
The substance or composition in T 558/20 acts as a bone regenerative material that is resorbed by the body over time and replaced by newly generated bone material, cf. § [0011]. Being resorbed by the body, it can be considered that it disappears or is dissolved in the broadest sense, as body bone material is eventually generated.
Contrary to your comment addressed to Kant, and as far as I am concerned, the limits are clear. No possibility to reuse the substance or composition whereby the substance or composition is transformed, resorbed or eliminated from the body.
When looking at the hydrogel in T 1252/20, it is difficult to say that it will be resorbed by the body, but I accept to be proved wrong as I am not a chemist.
@ Kant alias …@….
I was expecting reaction of this kind and I was not disappointed.
You have no reason whatsoever to complain.
Why did you find the necessity to address your comment @Daniel X. Thomas, alias “…”?
I respected your anonymity as I did not publish your whole e-mail address.
You have not treated my personal data as confidential as you made an association of my name with a pseudo.
You got thus the reaction you deserved. “Wie man in den Wald ruft, hallt es zurück”.
In other words, “As one calls into the forest, it echoes back”.
For the rest, I strongly deny that D.X. Thomas has anything to do with “…”.
I hope you will stop here. If not, moderation will take place, what I do not wish, and any incorrect entry will be forwarded directly to “Trash”.
If you stop your nonsense, you will be addressed as follows @ Kant
I expect a reply is substance going further than simply alleging that “forty years of case law have misapplied the teaching of G 4/83”…, which is actually not the case. The forest and the echo also apply to this allegation of yours.
DXT, that is a flagrant breach of data protection rules. “ I respected your anonymity as I did not publish your whole e-mail address.” holds no weight. You are a data controller and need to act accordingly.
Kant was simply mirroring the way you have been addressing others. If you can’t take it, don’t dish it out.
And finally, if you think we believe that you’re not …, you are deluded. The writing style and opinions are identical. It is well known by regulars on the blogs. You’ve also used other pseudonyms, which I won’t hesitate to share if you don’t fix what you’ve done.
If “D. X. Thomas” is not “…” as he claims, how can it be a breach of his confidentiality if somebody publicly associates those two names together?
@DXT alias “…”
I can keep going.
Aside from the dispute over data protection, I fail to understand what was so offensive about Kant’s remarks about G 4/83.
Kant asserted that this decision has been misapplied or misinterpreted for 40 years. That is Kant’s opinion and it is Kant’s right to hold and express that opinion. The fact that the opinion is not to Mr Thomas’ liking, and that he cannot agree with it, is neither here nor there.
I do not see anything offensive in the way that the opinion is being expressed. Certainly it is a strong opinion but there is nothing wrong with that, even if it might be preferable for people disagreeing with a line of case law to explain why they disagree with it.
It seems that Mr Thomas is, perhaps, feeling offended on behalf of the Boards. That he feels a need to defend them against what he sees as an unjustified attack on their competence or integrity. I would like to suggest, gently, that such offence-taking is misplaced. After all, has Mr Thomas himself not also frequently disagreed with decisions of the Boards? I am not sure that we want an unspoken rule that says only he is allowed to disagree with the Boards and that it is offensive for anyone else to do so.
@ Kant, Bemused, La marmotte, Anonymous etc…
Considering the association of two pseudos’ as a breach of confidentiality cannot be taken seriously. No person is endangered in any way. It is at best unpleasant, but does not harm anybody.
On the contrary, associating a pseudo with a real person by giving its name is a clear breach of confidentiality. It cannot be taken as joke as it directly and unambiguously might harm the person named.
It is getting worse, when the threat is expressed to divulge further pseudos’, what has actually happened. This is clearly going too far and by no means acceptable. What is going on in the head of those people? Have they such a dislike of my person and my ideas, or have they simply lost their marbles?
Could all those having come up with the stupid idea of associating my name with a pseudo try to reflect seriously on the consequences of their doing?
I see in associating my name with a pseudo the clear intention to harm myself and a total lack of respect towards my person. Would some people want me to give up my blog, they would not act differently!
I did not start a blog in order to get harmed. I wanted the blog to be a forum of discussion, even harsh discussions, but with mutual respect. That pointing on some problems is taken as criticism, so be it.
But this does not allow an anonymous writer to claim that “forty years of case law have misapplied the teaching of G4/83”. This a mere allegation not supported by any evidence. This is, in my opinion, simply going too far, and on top of it not true. I am still waiting for a reply on the explanations I have given Kant about the application of G 4/83.
It would be pretentious for me to claim that I am offended for the sake of the boards in particular, or for the EPO in general. That some boards deserve to be criticised is a matter of fact. But I do this not in hiding behind a pseudo, but with an open helmet.
I do not wish to see anymore comments about secondary, actually unimportant, aspects, but only about substantial matters. It was never my intention to only publish comments after moderation as it is standard on all other IP blogs I know off, but if it continues as it was the case here, I see no chance to avoid moderation.