The present decision shows that examples of patent applications should be drafted with care. Errors may prove fatal to the patent as a whole, as the patent proprietor had to learn in this case.
Claim 1 of the main request read:
A process for the production of microspheres containing pancreatic lipase or mixtures thereof with other pancreatic enzymes, one or more hydrophilic low melting polymers, and optionally excipients for pharmaceutical use, said microspheres having diameter comprised between 10 µm and 1500 µm and enzymatic title equal to or higher than 90% of the title of the solid mixture of their components, characterised in that a solid mixture formed by said lipase or mixtures thereof with other pancreatic enzymes, one or more hydrophilic low melting polymers, and optional excipients, is heated to a temperature equal to or higher than the melting temperature of said hydrophilic low melting polymer, in stirring condition, where said hydrophilic low melting polymer has a melting point between 20°C and 90°C.
Board 3.3.02 found this claim to be insufficiently disclosed:
[4.1] An invention is in principle sufficiently disclosed if at least one way is clearly indicated enabling the skilled person to carry out the invention over essentially the whole claimed range. The skilled person, trying to rework the invention defined in the main request, would first direct his attention to the examples, in which the invention is described in its most concrete form. The patent in suit contains four examples, of which examples 1 and 2 are reference examples and therefore irrelevant for the present invention.
Example 3 describes the preparation of pancreatin pellets using PEG 400 (polyethylene glycol) as hydrophilic low melting polymer. In view of the fact that according to document D12 PEG 400 has a melting point of 4 to 6°C, which was not contested by the respondent, example 3 is also not encompassed by the invention defined by the main request, which requires a hydrophilic low melting polymer having a melting point between 20°C and 90°C. Regarding the respondent’s argument that the reference to PEG 400 was an obvious error which the skilled person, knowing the melting point of PEG 400, would have immediately recognised as such and, as a consequence, would have understood PEG 4000 instead, the board notes that claim 1 as granted does not contain any lower limit regarding the melting point of the low melting hydrophilic polymer. The skilled person did therefore not have any reason to assume that example 3 was defective. He would rather have concluded that it was representative of the invention according to claim 1 as granted, but no longer relevant for the invention now defined in the main request. Therefore, he would have dismissed example 3 and turned his attention to example 4 in which PEG 4000 is used as low melting hydrophilic polymer.
The appellant argued that it was not possible to prepare pancreatin pellets by following the instructions given in example 4. The fact that the maximum rotation speed of the mixer-granulator Zanchetta Rotolab P-50 […] was limited to 315 rpm, so that the required 900 rpm […] was not obtainable, was offered as the principal reason for this failure. Reference was made to document D23.
The respondent counter-argued that example 4 involved two different mixers, namely a high-energy mixer-granulator Zanchetta Rotolab with a maximum rotation speed of 1150 rpm, mentioned in paragraph [0044] of the contested patent, and a mixer-granulator Zanchetta Rotolab P-50 depicted in paragraph [0045] of the contested patent. Paragraphs [0044] and [0045] related to two separate procedures involving two different mixers. As a consequence, the appellant, having erroneously used the mixer-granulator Zanchetta Rotolab P-50 for both procedures, had not correctly reworked example 4, so that document D23 was completely irrelevant.
However, the fact that paragraphs [0044] and [0045] relate to two separate procedures involving two different mixer-granulators is a piece of information which the skilled person is not able to extract from the wording of example 4. Paragraph [0044] describes the preparation of pancreatin pellets involving the steps of placing pancreatin and PEG 4000 in the tank of a high-energy mixer-granulator Zanchetta Rotolab, processing the mixture under the specific conditions described therein and finally unloading the pellets thus obtained. Then, at the beginning of paragraph [0045], example 4 continues with the wording “Using the described process, with a mixer-granulator Zanchetta Rotolab P-50 spherical pellets are obtained which are afterwards coated with a gastroresistant membrane formed by HP-55, triethylcitrate and talc.” The skilled person, reading example 4 as a whole, would necessarily assume that the same mixer-granulator is used, in the sense that the high-energy mixer-granulator Zanchetta Rotolab according paragraph [0044] is a generic denomination of the apparatus which is then specifically defined as mixer-granulator Zanchetta Rotolab P-50 in paragraph [0045]. Confronted with the problem that the mixer-granulator Zanchetta Rotolab P-50 does not allow a rotation speed of 900 rpm, he would conclude that example 4 was not enabling, as either said rotation speed of 900 rpm or the designation of the mixer-granulator Zanchetta Rotolab P-50 was incorrect.
Sufficiency of disclosure must be assessed on the basis of the patent as a whole. As a consequence, the absence of enabling examples does not necessarily mean that the claimed invention is not sufficiently disclosed. If, however, as in the present case, where the process in question involves the processing of an instable enzyme under relatively harsh conditions (high rotational speed, elevated temperatures) without any significant loss of its activity, the claimed invention is of a complex nature, then the skilled person is in need of clear and precise instructions. These are lacking, on account of the deficiencies in examples 3 and 4 mentioned above. Trying to carry out the invention only on the basis of the general teaching of the description would, taking into account the technical complexity of the present case, amount to an undue burden. As a consequence, the requirements of A 83 are not met.
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15 comments:
I have not yet read the entire decision but am interested in polling the views of readers on the following issue.
It seems to me that the Board is assuming the role of the person skilled in the art. It simply announces its own opinion, whether the skilled person would have found the disclosure sufficient to enable the invention, as a fact.
In a civil law jurisdiction, nothing special here. The distinction between fact and mere attorney argument goes unrecognised, most of the time.
But such a decision would be impossible in a jurisdiction which has English law, that is, the UK, the USA and the former British Empire countries, because the court there cannot pretend itself to be the skilled person. What the skilled person knows is a fact. Opinions are cheap but facts are precious. In litigation, facts have to be proved by evidence.
Thus it is, that litigation under English law is inherently expensive, because it values more highly what are the true facts on which the Decision falls to be made.
Thoughts?
Just a note to highlight the fact that the Patentee has filed a Petition for Review: R6/13.
So-- basically the Board said that skilled practitioners are unable to switch the between polymer microspheres of different molecular weights and between different types of mixers.
The alleged basis for this conclusion is that a no significant loss in activity should occur, even though this doesn't appear in the claim.
It looks like the Board just wanted to go home early rather than have to think.
Based on the summary, not having read the decision, the Board said that the Patent as a whole, not just the Examples, lacks guidance regarding how to obtain the claimed microspheres. Seems ok to me.
@MaxDrei - you have summarised quite nicely why I am always slightly nervous/apprehensive whenever the EPO (ED upwards) raise insufficiency as a terminal problem. Whilst in "normal" examination I can see (and indeed support) the basic requirement for the ED to assume the mantle of the skilled person in reality they are not. The question of insufficiency in my mind should require a "genuine" skilled person in the field in question and not a fictional construct as sufficiency is a question of fact and sometimes the EPO should accept they are not best placed to answer that question.
Some years ago I heard a talk by a senior EPO person where he very clearly stated that Examiners (and the EPO in general) really, really, really don't like being told what the skilled person would have thought. The message was that the Examining Division *is* the skilled person. This may have been in relation to inventor declarations but my memory of it is a little hazy now.
Of course, the problem with finding a "genuine" skilled person is that they'd have to be from the filing date, with no knowledge of the content of the application.
As I've shown above regarding the talk I can't quite remember, memory is a tricky thing.
Thanks for the comments thus far.
The point about evidence in England is that it comes from witnesses who can be cross-examined in court, in front of the judge. This makes every witness very very careful what they report in their written statements that are given in evidence, some weeks before the trial.
Take the typical case, in chemical litigation. The Professor of Organic Chemistry from Oxford swears that he faithfully followed the instructions in the patent yet cannot get Example 4 to work. The other side have the professor from Cambridge University as their witness. He swears in his written report that he was able to get the experiment to work.
Each such expert witness is cross-examined in court, on the content of their respective Expert Report. Your barrister's questions to their Professor have of course been carefully structured, with the help of your professor. In effect, each chemistry professor is cross-examining the other.
Typically, the process of cross-examination takes more than a day, with the intervening evening being spent poring over the transcript of the preceding day's cross-examination, to sharpen the questions for the next day. The cross-examination process takes place in front of the judge who is closely watching the face of the witness the whole time, from a vantage point less than 2 meters away from the witness. When an expert witness is exposed as unreliable, there is not only huge embarrassment and loss of the case but also the prospect of a broken reputation, even career.
Nobody in the EPO who has been through such litigation in England would dare to announce, on the basis of his opinion alone, what patent specification is or is not enabling. Ask those in DG3 with experience of English patent litigation, such as Christopher Rennie-Smith.
With no Binding Precedent, I think that a Board of DG3 just uses whatever tool comes to hand, to get to the end result that their collective gut tells them is the right result.
But perhaps that is the optimal way to decide cases quickly?
Thoughts?
Facts have to be proven by evidence, but it is not always the ED or the Board that has to establish something as fact.
Art. 83 is complied with if the skilled person, based on the information contained in the application and his common general knowledge at the filing date of the application, can carry out the claimed invention.
Since in general it is not possible to prove that the skilled person does not know something, i.e. that a particular fact is not in the common general knowledge, it is normally sufficient for an ED or Board to explain why on the basis of the application alone (plus some basic skills) the skilled person is not able to carry out the invention. It is then up to the applicant to provide evidence of common general knowledge that fills up the gaps in the application. It is the applicant that relies on such facts, so he has to prove them.
Regarding the "inventor declarations": one can of course not expect to convince an ED or Board by a declaration of the inventor that he was able to carry out the invention on the basis of the description.
Examiners and Board members do not (or at least should not) pretend to be skilled persons. But they are technically trained, so they are in a position to judge technical arguments that are put forward (by technically trained attorneys) and to assess the technical content of technical documents. This is a difference with national litigation where the non-technically trained judges necessarily must rely on expert evidence.
I don't see a problem with this decision for the reasons given by the third Anonymous.
Well thank you Myshkin. We agree on a lot. The technical background of the board members allows them to weigh the technical evidence.
Thus, here, the Opponent adduced evidence that they just couldn't get the Examples to work. Well, he would say that, wouldn't he?
As you say above: "one can of course not expect to convince an ED or Board by a declaration of the inventor that he was able to carry out the invention on the basis of the description." But fair's fair. Why should the Board take the opponent at his word, that try as hard as he might, he just couldn't get the experiment to work. He is biassed, isn't he. He is trying his hardest to get it NOT to work.
The Board admits this late-filed evidence then proceeds to announce that the claimed invention is "complex" so that the skilled reader is not enabled until he has "clear and precise" instructions. As the instructions in the patent do not rise to that level, the patent's teaching is so insufficient that the skilled reader cannot without "undue burden" enable the claimed subject matter. It was the typo that killed the patent. What would have been the outcome, had there been no such typo?
In my experience, in engineering cases, it doesn't matter what deficiencies of teaching the patent displays. The Board happily announces that it is satisfied that the skilled person can make something within the scope of the claims.
It all leaves me uneasy, that Boards decide on gut feeling.
But I accept that parties should stop grumbling and start filing evidence. Members of Opposition Divisions and EPO Boards of Appeal are smart enough, and specialised enough, to get to the right end result, if the parties simply file relevant evidence.
@MaxDrei
Well in this case the patentee tried to file evidence regarding the types of rotomixers available at the priority date (to counter the opponent's experimental evidence), but it wasn't admitted. This is apparently why they've filed a petition for review.
Yeah! Indeed! At the EPO the timing is very important, just when to file your evidence. Here, the Opponent seems to have timed it just right.
@MaxDrei:
Why should the Board take the opponent at his word, that try as hard as he might, he just couldn't get the experiment to work.
The logic of point 4.1 in respect of example 4 is as follows:
- The opponent provides document (23) as evidence of the fact that the maximum rotation speed of the mixer-granulator Zanchetta Rotolab P-50 is limited to 315 rpm, and provides reasoning why this causes example 4 not to work
- The proprietor does NOT dispute this fact. Instead, he argues on the basis of paragraphs 44 and 45 that the fact proven by document (23) does not contradict the example.
- The Board carefully reads paragraphs 44 and 45 and concludes that the proprietor's reasoning does not hold up.
I see nothing problematic here. Certainly the Board is not simply taking the word of the opponent (which btw is a different gripe than the one you started with).
Myshkin I don't want to get into an argument with you, because I lack the time or the motivation to study the case in enough detail to plead it before a member of DG3 who evidently has no appetite to hear me, but nevertheless I feel compelled to write that I remain sceptical about the Board's treatment of the Art 83 issue.
The claimed process requires heating a solid mixture to a temperature above the melting point of the polymer. The Board observes that PEG 400 melts at 4 to 6°C but then finds as a fact that the skilled reader nevertheless had no reason whatsoever to doubt the teaching in Example 3 to use PEG 400.
Now PEG 400 is liquid, not solid, at any temperature above 6°C. If you want "solid" then, you have to cool it down to less than 4°C. At room temperature what you've got is liquid, not the "solid" of the claim. When the claim recites solid, I think it means solid.
Is that not something that might genuinely prompt a reader of Example 3 to doubt whether the "solid" polymer really is PEG 400?
No, says the Board. That is because, you see, claim 1 of the B1 has no numerical lower limit on the MP of the polymer.
Once again, somebody at the EPO muddles up what a claim covers with what a patent discloses. The patent discloses "solid" and "heating". The independent claim requires "solid" and "heating". For me, an MP of 4-6°C simply does not fit. Simply saying that Claim 1 of the B1 imposes no numerical lower limit of temperature on the MP of the PEG is for me not persuasive, not conclusive and not fair to the patentee.
I have no dog in this fight. I don't care one jot whether or not this particular patent lives or dies. But I do care about DG3's reputation for quality. To my mind, the skilled reader having a synthetical propensity would judge that something is wrong with Example 3.
Yet the Board says that the skilled reader would find it perfectly fine and the reasoning that it uses to get there leaves me disappointed. Sorry Myshkin, but for the time being my dissatisfaction with this decision on Art 83 remains unassuaged.
As far as I'm aware this is not an argument but only an exchange of arguments.
I'm mainly concerned with the legal structure of the reasoning, with which I see nothing wrong.
I've already commented on your doubts about the Board's treatment of example 4.
You also mentioned the typo. This relates to example 3. I must admit I find the reasoning for example 3 not immediately convincing. The mere fact that it falls outside claim 1 does not seem to be enough reason to completely dismiss it for the question of disclosure. Maybe the skilled person would recognise that its techniques can also be used to carry out the invention as defined by claim 1, for example.
However, it seems the Board is of the view that example 3 discloses how to carry out the invention as defined by claim 1 as granted, and supposedly the amended claim 1 achieves some extra effects that example 3 does not. I would have to study the description to understand this better. But if it is true that example 3 makes complete sense when you take claim 1 as granted, then isn't it true that the skilled person has no reason to believe that PEG 400 is a typo? (I would think it is even better to look at claim 1 as filed.) For sure the applicant's argument that the skilled person would spot the mistake in example 3 because the _present_ claim includes the range 20-90°C is not a very good argument.
That the assessment of Art. 83 in other fields is usually very different is not strange. For example, if the invention can be shown in a drawing, or can already be carried out based on the wording of the claim, then it does not matter what else is in the application.
In this case it seems quite clear that precise instructions really are needed to carry out the invention. Apparently example 4 does not work if you are limited to 315 rpm. Without any examples one would really be at a loss. So the only thing that could have saved the proprietor is the argument that the skilled person, based on the information provided by examples 3 and 4, would eventually figure out a way by trial and error. That might indeed be too much to ask.
"Perhaps" Myshkin our discussion has gone on long enough. "Maybe" what the skilled person derives from the description is not what I suppose it to be, what you suppose it to be, or what the Board supposes it to be. The Board needs high quality evidence, from both sides, before it can judge a sufficiency issue fairly.
You write:
"...if it is true that example 3 makes complete sense when you take claim 1 as granted, then isn't it true that the skilled person has no reason to believe that PEG 400 is a typo?"
and in that text I quarrel with the first word "if". You see, what I was trying to get across in my earlier written submission was that it is "solid" in the independent claim that deprives of any sense (for a skilled mind that is willing to, and wants to, understand) the specific PEG 400 teaching of Example 3.
I concede that I should better have taken Claim 1 of the WO as my reference. But I just checked. It also recites "solid".
I think we have done this topic to death now, don't you?
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