The patent relates to the prevention and treatment of secondary infections following viral infection, particularly in infants and small children.
Brief outline of the case
The patent was maintained in opposition according a MR.
The opponent appealed the decision.
The board decided that claim 1 as maintained was lacking IS. The same applied to AR 1-4.
The patent was thus revoked.
The decision in interesting in the way the board decided that post-published experimental data was not taken into account under G 2/21 and for the definition of the OTP.
The opponent’s point of view
The application as filed provided no experimental data, and the explanation it gave of the claimed composition’s postulated activity and therapeutic benefit remained hypothetical as it was a mere assertion to state that the co-administration of sialylated oligosaccharides and N-acetyl-lactosamine and/or oligosaccharides containing N-acetyl-lactosamine was “particularly effective”. Thus, the application as filed provided no plausible basis, either, for taking post-filed supplementary data, in this case, D15, into account.
Starting from the technical teaching of document D16, the OTP was to provide a suitable dosage form for administering sialylated oligosaccharides for preventing secondary infection following a viral infection.
The proprietor’s point of view
The proprietor did not contest that D16 was directed to the prevention of secondary bacterial infections following a virus infection. The document provided in vitro data that suggested the suitability of sialylated oligosaccharides for this purpose, but it did not disclose the therapeutic use.
The technical features distinguishing the claimed subject-matter from the disclosure of D16 were the combination of the sialylated oligosaccharide with two other mandatory components, the therapeutic use for preventing secondary infections, which is a functional technical feature of claim 1, and the chosen product form as a nutritional composition.
As the combination of the three active agents provided better efficacy than the use of sialylated oligosaccharides alone, the OTP should be defined as the provision of an improved composition for use in the prevention of secondary infections following a viral infection characterised by neuraminidase activity.
The technical effect of improved efficacy was made plausible by the mechanistic concept set out in the application as filed. The patent further explained that the oligosaccharides prevent pathogen attachment to host epithelial cells.
The advantage of particularly high efficacy was foreshadowed and also explained convincingly in the application as filed. The mechanistic concept provided justification for submitting additional evidence with D15. D15 could thus be taken into consideration to corroborate the alleged improved efficacy.
D15 did not compare samples containing two or three mandatory components of claim 1 with a sample containing only a sialylated oligosaccharide. Nevertheless, the experimental set-up in D15 still provided a fair comparison with the state of the art according to D16 in so far as a composition containing all three mandatory components required in claim 1 was shown to have better efficacy in inhibiting pathogenic bacteria than a composition containing only the sialylated oligosaccharide in combination with the probiotic component.
The bord’s decision
It was common ground that inventive step was to be assessed starting from the disclosure of document D16.
For the board, starting from the disclosure of D16, the technical problem to be solved is to provide a composition and route of administration, in other words, a specific product type or dosage form, for sialylated oligosaccharides for use in the prevention of secondary infection after a viral infection. This encompasses the secondary problem of identifying further suitable components for such a composition.
The board noted that the application as filed contained no experimental data since mechanistic concept relied on is not backed up by any corroborative data. Thus, the information provided in the application as filed did not amount to evidence of an “improvement” in comparison with the starting point in the prior art, i.e. D16.
D15 relates to a presumed synergistic effect that is independent of epithelial binding. Contrary to the proprietor’s view, the fact that a mechanistic concept of the antiadhesive activity of oligosaccharides is set out in the application as filed cannot justify introducing new experimental data that is manifestly based on a different mechanism of action.
D16 seeks to develop possible therapeutic uses of soluble oligosaccharide receptors as antiadhesive agents for respiratory pathogens. Among the oligosaccharides tested, D16 identifies sialylated oligosaccharides as the most promising candidates, which in vitro showed good antiadhesive activity against S. pneumoniae strains.
Claim 1 of the main request differs from the disclosure in D16 by combining the sialylated oligosaccharide(s) with two further components, and by requiring this combination to be provided in a synthetic nutritional composition.
Starting from the disclosure of D16, the technical problem to be solved is to provide a composition and route of administration for sialylated oligosaccharides for use in the prevention of secondary infection after a viral infection. This encompasses the secondary problem of identifying further suitable components for such a composition.
The test described in D15 does not represent corroborative evidence of the concept taught in the application as filed, but discloses entirely new information both on the mechanism of action and the pathogenic organism involved.
In order to be taken into account in the formulation of the objective technical problem, the alleged technical effect that is supposedly shown by the post-filed evidence must also be encompassed by the technical teaching of the application as filed, i.e. the technical effect in question must in the first place be disclosed or be at least derivable from the technical teaching of the application documents. The first requirement of G 2/21, Reasons 72, is not met in the case in hand.
Moreover, D15 cannot, in any case, provide a conclusive comparison of the claimed composition with the disclosure in D16, already because it cannot be verified on the basis of the available information that any of the tested compositions conform to claim 1.
The improvement alleged by the proprietor can thus not be taken into account in the formulation of the OTP.
Comments
Application of G 2/21
The decision makes clear that a mere hypothesis in the application as filed, without any experimental data supporting said hypothesis, is not enough to admit post- published evidence in the meaning of G 2/21.
If post-published evidence is not supported by the original disclosure, it cannot help defining the OTP.
On the procedure
The CPA=D16=Infection and Immunity 66(4), 1439-1444 (1998) was not mentioned in the ISR established by the EPO.
Lack of IS for the first component was decided by the bord on the basis of D16+D17 (reference [16] in D16) which was the first document classified as X,Y in the ISR established by the EPO.
As far as the other components are concerned, the board referred to D1=WO 2007/101675 or D9=US 2006/0018890, whereby both documents were not found in the ISR established by the EPO.
https://www.epo.org/en/boards-of-appeal/decisions/t210887eu1
Comments
6 replies on “T 887/21 – Application of G 2/21 when the application as filed does not contain any experimental data”
Interesting case applying G2/21. Regarding your comment below “Application of G2/21”, it seems that the board did not accept the post-published evidence since it did not relate to the mechanism of action disclosed in the application as filed. On the post-published data, the Board stated that “This is not corroborative evidence of the concept taught in the application as filed, but entirely new information both on the mechanism of action and the pathogenic organism involved.” (2.15.3).
In other words, a hypothesis not backed up by data on filing could be supported by post-published data, provided that such data is related to the hypothesis (the “encompassed” threshold of G2/21?). Do you agree with this interpretation?
Thanks for providing such good analysis of case law!
Dear Trainee,
Thanks for your interesting question. I would nevertheless not agree with your interpretation, but for a different reason.
There is no need for an invention to divulge any theory behind it. It has however to be enabled or in other words, the skilled person should be able to reproduce it.
If the technical effect of an invention is relying on a hypothesis which is not verifiable at the moment of filing, then the invention was not enabled at this moment and was purely guess work. Post-published evidence will thus not help to confirm the hypothesis.
In the meaning of G 2/21, the invention might be encompassed within the originally filed technical teaching, but I would say that it is not embodied in the originally disclosed invention. Just take the example of a perpetuum mobile, The inventor might have a theory according to which it can generate more energy than is input. I could well imagine a clever inventor coming up with post-published evidence, showing that it works. Would you then grant a patent on it? I would not.
G 2/21 is applicable to all technical domains, but it is clear that its primary use lies in the chemical/pharmaceutical/biotech field. If a substance or composition is meant to cure a certain illness, the technical effect is stated in the claim. In such a situation, the problem is not IS but enablement. It ought to be shown at filing that the effect is achievable irrespective of the theory behind it. Otherwise purely speculative patents would have to be granted.
In the case at stake, the independent claim relates to a synthetic nutritional composition for use in the “prevention of secondary infections following a viral infection”. The effect is part of the claim=”prevention of secondary infections following a viral infection”. In the absence of any experimental data, the problem is then less IS than enablement. I refer here to G 1/03 and T 2001/12.
Any claimed therapeutical effect has to be originally disclosed and supported by evidence available at the date of filing, unless the gap in information can be covered by common general knowledge.
Thanks you for another interesting analysis, I wonder what the difference would have been if the
Thanks you for another interesting analysis. I wonder if the conclusion would have been different if the PCT application had contained data supporting the hypothesis disclosed in the priority application (which did not contain supporting data). Would the patent only be entitled to the effective date of the PCT filing seeing as the priority application was not supported?
Please see my reply to Trainee.
In my humble opinion, the invention was not enabled, be it at the filing date or at the priority date. A valid priority cannot be claimed from a non-enabled priority application. See for instance T 107/09 or T 521/10.
More in line with your question is T 903/05.
In T 903/05, the board held that the content of priority document and application mainly differ in that the former lacks experimental results contained in the latter.
The selection of specific peptides from the disclosure of the priority document does not result in in novel subject-matter since the selection is made from only one list of entities. Hence G 2/98 is respected.
As an obiter dictum, the board saw no legal basis for imposing additional criteria such as the presence of experimental data in the priority document which makes plausible the invention would work.
I am not sure that this decision and the obiter dictum would hold in view T 107/09 or T 521/10.
As far as G 2/21 is concerned, I would not dare to say something.
With apologies for going off topic: as you say, where the technical effect is recited in the claim (e.g. a second medical use claim), the problem is not IS but enablement.
The achievement of the technical effect as expressed as a feature of the claim could be the basis for patentability over art that does not. The difference could be that the former contains supporting data whereas the latter contains none (e.g. perhaps just a hypothesis).
But then should the same criteria be applied to the scenario put forward by “Jack of all”? Say, if the priority document does not contain data whereas the later filed application does, then should that mean that where the technical effect is expressed as a claimed feature, the priority document is not enabled and the claim to priority is lost?
The decision in T903/03 relates to the old Swiss claim style. The board rejected arguments whether priority document made the claimed invention “plausible” as being related to IS and irrelevant to priority. This decision seems wrong.
It also seems to open the door to abuse. What’s to stop an applicant repeatedly filing and withdrawing a priority application to e.g. a second medical use, based on some hypothesis, and only claim priority once it finally has some decent data? The applicant would unfairly gain up to a year over its competitors, and since any withdrawn priority applications are never published, the competitors would be none the wiser.
I have lost sleep over T903/05. Perhaps it is bad law. But it is prominently there is the case law book, and is frequently cited as authority.
(great blog, by the way!)