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Monday, 22 August 2011

MOPPing up selection patents: are you Reddy ...?

This Kat has always felt in his heart of hearts that selection patents were something of a kindly-intended exception to the rule that validity required an invention to require an inventive step. For this reason he has been taking an interest in the thoughts of Julie Carlisle (European Patent Attorney and Chartered Patent Attorney, Mewburn Ellis LLP) -- who has been taking a close look at how the obviousness of selection inventions is to be determined in the United Kingdom.  She writes:
"As reported on the IPKat here the UK Manual of Patent Practice (MOPP) was revised in October 2010. One of its revisions was the introduction of new guidelines for assessing the obviousness of 'selection inventions', in light of the Court of Appeal decision in Dr Reddy.

The new criteria applied by the UK Intellectual Property Office for an inventive selection can be found in paragraph 3.89 of the MOPP (emphasis added):
In order for there to be a technical contribution, and thus for the selection to be inventive, the following criteria derived from relevant statements in the EPO Board of Appeal decision in T 939/92 AGREVO/Triazoles 6 OJEPO 309 should be satisfied: 
(i) the selection must not be arbitrary but must be justified by a hitherto unknown technical effect; 
(ii) a technical effect which justifies the selection of the claimed group must be one which can be fairly assumed to be produced by substantially all the selected members; 
(iii) this technical effect can only be taken into account if it can be accepted as having been demonstrated in the specification as filed.
It seems to me that, while criteria (i) and (ii) can be derived from T939/92 (see points 2.5.3, 2.5.4 and 2.6 of the Reasons), and were expressly recited/approved in Dr Reddy (see paragraph 99, for example), criteria (iii) cannot be found anywhere in either of these cases.

The effect of criteria (iii) is quite serious - it means (and this has been confirmed to me by a UK examiner) that UKIPO policy is that post-filing data cannot be used to support inventive step. It will be ignored, even if it clearly shows that the claimed compounds have massively improved biological properties compared to the prior art.

So the fairly common scenario in the pharmaceutical field, wherein an original broad claim is narrowed down to focus on the eventual lead compound(s), will very often result in a refusal for lack of inventive step, unless the data that has made that/those compound(s) special and desirable was already available on filing and included in the application as filed. The timescale of R&D in the pharma field means that this data will very often NOT have been available at patent filing, so this approach is potentially concerning.

It is also almost exactly the opposite of the EPO approach, which the Court of Appeal said we should now be following.

In T939/92, explicit reference was made to the fact that the patentee could have filed further evidence (i.e. post-filing) such as experimental tests to prove that the technical effect asserted was possessed by the selected compounds (in that case they did actually not do so, hence no inventive step could be acknowledged). This is consistent with the current EPO approach to routinely allowing post-filing data showing a technical effect, in support of support inventive step:
EPO Guidelines for Examination
Chapter C-VI
5.3.5 Evidence

Under certain circumstances, however, later filed examples or new effects, even if not allowed into the application, may nevertheless be taken into account by the examiner as evidence in support of the patentability of the claimed invention. For instance, an additional example may be accepted as evidence that the invention can be readily applied, on the basis of the information given in the originally filed application, over the whole field claimed (see III, 6.3). Similarly a new effect (e.g. the one mentioned in VI, 5.3.4) may be considered as evidence in support of inventive step, provided that this new effect is implied by or at least related to an effect disclosed in the originally filed application.
In Dr Reddy as well, note the last sentence of paragraph 114, where the Court mentioned and appeared to approve the notion that evidence not present in the application itself can be used to support the presence of a new technical effect, as at the EPO:
"...at least in some cases, the Board appears to allow further evidence to support the validity; accordingly, although not referred to in the Patent, it may be appropriate to add that this conclusion is supported by the research reported in Chakrabarti 1980."
The UKIPO's justification for criteria (iii) apparently comes from older case law - especially that recited in paragraph 3.91 of the MOPP:
3.91 The “hitherto unknown technical effect” (i.e. advantage gained or disadvantage avoided) relied upon to justify a selection invention, and evidence to support that technical effect, should be clearly disclosed in the specification at the time of filing if it would not otherwise be apparent to a person skilled in the art. Otherwise it will not be possible to see that the technical effect has indeed been demonstrated. In Glaxo Group Ltd’s Patent [2004] RPC 43 (see also 3.30 and 3.31.1), the Patents Court held that unexpected bonus effects not described in the specification could not form the basis of a valid claim to a selection invention. If there is no statement of advantage, or indeed no evidence to support that statement, in the specification at the time of filing it may not normally be added later (see 76.14), since, as stated by Jacob J. in Richardson-Vicks Inc.s’ Patent [1995] RPC 568 at 581, in the context of synergy, demonstration of the advantage “by experiments conducted after the date of the patent cannot help show obviousness or non-obviousness … and it would be quite wrong for later-acquired knowledge to be used to justify the amended claim.”
BUT neither of these cases are actually concerned with selection inventions. ALSO both of these cases pre-date Dr Reddy, which did not cite either of these cases.

The Court of Appeal's decision in the Dr Reddy case should now be the definitive word on what the criteria for selection inventions are in the UK, and it does not place any limitation on the nature of the technical effect, or on when it has to be proven.

The question of whether a selected group of compounds has a special technical property is surely a question of fact - either the compounds have (e.g.) an improved activity compared to the wider group of prior art compounds from which they are notionally selected, or they don't. Whether it is expressly proven in the application as filed should not matter.

Provided there is basis in the application for claiming the 'selected' class (i.e. basis for narrowing to the compounds which have the advantageous property, if necessary) it should be possible to claim these disclosed compounds since, fairly clearly, they represent a contribution to the art...

So I have come to the conclusion that criteria (iii) as set out by the UKIPO must, simply put, be wrong".
Julie wonders if any of the readers of this weblog has any further thoughts on this. She would also be personally very interested in hearing from anyone who has successfully navigated the new guidelines, and who has had a chemical selection patent granted at the UKIPO.

Selection patents: a personal overview here

16 comments:

Julie Carlisle said...

Thank you Jeremy. As a postscript to this I have since spotted that the Glaxo case (cited in MOPP) actually states (see paragraph 113):

…There is a limited class of cases in which the patentee has identified an advantageous feature possessed by some members only of a class otherwise old or obvious, has described the advantageous effect in his specification and has limited his claim to the members of the class possessing this advantageous feature. Such a claim may be justified on the basis of what is called selection.

Note - 'identified' and 'described', not 'demonstrated'.

So far from providing basis for criteria (iii), this case actually singles out selection inventions as an exception to the idea that post-filing data cannot be used to support inventive step...

Julie

Anonymous said...

I understand the term “demonstrated” in the third criteria to mean “identified” or “indicated” or “described” or “implied” etc. “Demonstrated” in this context cannot be interpreted as “providing evidence”. When narrowing down an originally filed broad claim, the new narrow claim must have basis (clearly identified technical advantage) in the specification as filed. The basis cannot be one where no technical contribution is identified (otherwise it would be a mere arbitrary selection at the time of filing and fail criteria 2). Without the third criteria three, a pending patent application may well be amended to cover subsequent drug discovery, which obviously is an absurd outcome. New evidence and data may be used to support an argument about contribution which is at least implied in the application as filed. It may not be used to justify the merits of a selection that was apparently arbitrary at the time of filing.

Rich H

Julie Carlisle said...

@Rich H

The problem is that the UKIPO are not interpreting 'demonstrated' in the way you suggest. It is not enough that the technical effect be 'described' or 'implied' (as it would be at the EPO). They are looking for explicit demonstration, i.e. proof, in the spec.

Hence (an example from my personal experience) they will not take into account post-filing data showing that a biological activity which was recited in the spec as being possessed by the compounds of the invention (in general) is greatly improved in the compounds of the new claim (narrowed to restore novelty over a piece of prior art - i.e. to make it a novel 'selection' therefrom) as compared to the compounds in that prior art i.e. the evidence that notional 'selection' from the prior art is not arbitrary must be present in the application as filed.

This means that if you are faced with a situation where your eventual claim is a notional 'selection' over prior art that you were not aware of when drafting the case, you are almost certainly scuppered by criteria (iii).

Julie

Anonymous said...

I agree that selection inventions are a bit of an oddity. Suppose A finds that part of a known range provides a new and unexpected result, and says so and puts in a claim to that part; while B puts in a claim to a different part which has no unexpected effect. A can get a patent, while B's range is considered obvious. But the test of obviousness is supposed to be what the skilled person would find obvious given the prior art; and there seems no logical justification for saying that he would find B's range obvious but not A's.

That said, in your case, Julie, you make it sound as though the right result was reached. The originally-claimed wide range was not novel. The narrower range may be better but the specification as filed apparently did not say this. So you are seeking protection for an invention which was not there in the spec as filed, or at least was not supported by saying why that particular range was special. In effect you're trying to get protection for an invention that you didn't come up with till later.

MaxDrei said...

In haste (please forgive, if I have missed the point), but:

I'm thinking of the Conor stent case, and the notion of making an effect "plausible". In the app as filed, you have to include enough "evidence" to make "plausible" the effect on which you rely for patentability.

Is that not so? Is that not it, both at the EPO and in the UK?

Anonymous said...

Very useful post, many thanks indeed. I was wondering if it might be possible to mention infringement of selection patents in a future post or post a link to a relevant case concerning infringement? I suppose my point is that if you have a patent for a narrowed range of compounds, who could sue a potential infringer? Could both original and selection patent holder sue an infringer? Also, would the holder of a selection patent be able to perform their invention whilst the original patent was in force?

Julie Carlisle said...

@MaxDrei: Yes, I think that is how it should be, but the UKIPO seem to have made a special case out of selection inventions which requires a much higher standard of disclosure to show the necessary 'technical effect' i.e. it must be 'demonstrated', not just made plausible, that the selected compounds have the technical effect. See paragraph 3.91 of MOPP, quoted above.

@Anonymous: I disagree - the original broader range claimed was disclosed as a genus of compounds having a particular biological activity - inhibitors of target enzyme X, say. This range of compounds turns out not to be novel over a prior art document that discloses a broader, or overlapping, range of compounds, but does not say or suggest that they inhibit enzyme X - enzyme X is not even mentioned. We narrow our claim to a subset of the original genus - a subset which is disclosed in the original application (i.e. there is basis for the narrowing amendment). This subset are the best at the activity that we have disclosed for them - and can be shown to be significantly better inhibitors of enzyme X than the examples in the prior art (which now fall outside our claim). It is still the same invention, just a narrower embodiment of it that avoids the prior art examples.

But at UKIPO this narrower claim will only be acknowledged as an inventive selection if the evidence showing that the new subset are better than the prior art was presented in the application as filed.

The EPO on the other hand would generally accept post-filing data to show such an improvement, provided that the effect in general terms was disclosed in the application - because they realise that the applicant cannot be expected to know of all the prior art in advance, and so may not have presented what turns out to be the crucial comparison (i.e. with the closest prior art).

Julie

Anonymous said...

I'm with anonymous of 10.36 on this one. Julie's example appears to be a case of trying to claim an invention that wasn't known about on filing, which shouldn't be allowed in my opinion. If the specification had said on filing that the particular sub-set was expected to have greater activity then I would expect the UK IPO to allow post-filing evidence to support that assertion. If the specification makes no mention of the particular range having improved activity then why should the applicant be able to later discover that it does and then use that discovery to get a patent for an invention that they hadn't made on filing?

None of the above is based on a consideration of the law though, just what I think is fair.

Anonymous said...

Selection inventions are inherently 'unfair' in a sense, because they work on the basis that it is OK to re-claim part of something that has previously been given to the public as part of the prior art, provided that in return there is a contribution to the art i.e. in principle the earlier disclosed genus now belongs to the public, but if you discover something amazing (+ hitherto unknown) about one member of that genus, you are entitled to claim that member, provided it is novel.

Cosmictrout said...

Hmmm....

Imagine the extreme case of a selection invention i.e. where the claim is to a single compound, which falls within a broad genus of compounds previously disclosed.

Say a patent application is filed disclosing a group of compounds defined by a generic formula, which are said to be useful as anti-cancer agents. Several specific example compounds are shown, and their synthesis described, but biological data is only available for a few of these at the time of filing. However, there is more than enough to pass the 'plausibility' threshold (Conor v Angiotech).

Post-filing, it turns out that one of the specifically disclosed compounds, but not one for which biological data was given in the application, is far and away the best compound - kills cancer cells with sub-nanomolar potency, and minimal side effects, etc.

In a patent office search, prior art is then uncovered that turns out to disclose generic formulae overlapping with the original genus claimed. At least one such prior art genus encompasses the magic compound. However, the magic compound itself is not exemplified anywhere - it is therefore a novel 'selection' from that prior art genus.

As the compound was specifically disclosed on filing, there is basis to write a claim directed to that specific compound alone. Its synthesis was described, so it is unquestionably enabled. Its potential use was also disclosed. It is a non-arbitrary selection because it has the hitherto unknown properties described above (but which were not explicitly demonstrated in the application as filed).

Clearly, this compound is worthy of patent protection?

But if the view of the two Anons (@10.36 and 10.46) and the UKIPO were followed, however, they would not get a patent for it because only with post-filing data can it be proven to have the necessary technical effect.

And as it has now been disclosed, they can't claim it anywhere else.

If we are talking about fairness, then how is it fair that no patent would be possible for that compound, which must be considered to be a contribution to the art?

Anonymous said...

I wonder if the UKIPO isn't trying to 'import' similar recent US case law in which it was determined that the Description must not only enable the invention to be recreated, but must also demonstrate that at the time of Application the inventor 'possessed' the invention (and thereby avoiding a claiming what has not yet been invented situation rightly objected to by Anon@10.46).

Following this logic to satisfy (iii) it is not enough for the Applicant to suggest a particular selection might work, rather they must demonstrate in the Specification that it does as claimed work, i.e. demonstrate broadly the technical effect thereafter relied upon to support patentability.

Contrarily, if one cannot demonstrate the 'inventive' technical effect at the time of Application is there not a danger that the selection is made not to define a patentable invention but to avoid irritatingly anticipatory prior art! In so doing there may indeed be invention, but not as of the filing date. If such 'new' selection invention is to be claimed a new filing adding required subject matter may need to be filed albeit with consequential unfair loss of the original priority.

Julie Carlisle said...

Anon @10.46:

"If the specification makes no mention of the particular range having improved activity then why should the applicant be able to later discover that it does and then use that discovery to get a patent for an invention that they hadn't made on filing?"

But the 'improvement' is part of the notional 'selection' - over prior art of which we might not have been aware on filing.

It is important to remember that a 'selection invention' does not generally arise from any kind of real-life selection process (where you look at the prior art and then pick the best bit from within that). It is a device to justify novelty/non-obviousness for an invention which happens to form part of an earlier generic disclosure (as implied by Anon @2.04), but which has something special over and above that earlier disclosure that makes it inventive in its own right.

We are not claiming an invention we hadn't made on filing, we are claiming the same invention, but in a narrower way in order to overcome said prior art. The applicant should be entitled to narrow their claim (provided they have basis for the narrowing).

One could argue that disclosing that the compounds disclosed (generally) are inhibitors of X, and providing basis for a fallback to a subset of compounds, at least implies that those subset might be preferred in some way, in any case.

Julie

Anonymous said...

Julie - my post at 10.46 was made before your post of 10.19 was visible and I had assummed that the prior art had disclosed the biological activity and that you were therefore relying on the improved activity for inventiveness over the prior art. I see now that is not the case.

Myshkin said...

@Anon of Aug 22, 10:36PM:
"But the test of obviousness is supposed to be what the skilled person would find obvious given the prior art; and there seems no logical justification for saying that he would find B's range obvious but not A's."

B's range is obvious because ANY arbitary range is obvious. If the skilled person is given the task of selecting an arbitrary range, there is no skill - let alone inventive ingenuity - involved in randomly choosing a begin point and an end point.

However, once the selected range has a _technical_ effect, the technical problem becomes not to select an arbitrary range, but to modify the closest prior art so as to provide that technical effect.

No layman would consider that there is an invention worth of a monopoly in coming up with two arbitrary numbers that nobody before has disclosed. Only a mechanical application of the rule "no suggestion in the prior art, therefore inventive" can lead to another conclusion. However, this is rightly not a rule of European patent law.

Anyway, T 939/92 explains it very well.

Anonymous said...

@cosmictrout - anon@10.46 doesn't say post-filing data shouldn't be allowed. In fact says the opposite, that it should be allowed to support plausible assertions in the spec (as you specify in your example) so you'd be fine. This is also what Max Drei is saying I think, that it must be plausible.

UK IPO seems to be taking a different approach, that it must be plausible and actually demonstrated. Didn't Conor v Angiotech say that there was no requirement to prove your invention worked??

Anonymous said...

The EPO approach seems fair - you can rely (entirely, if necessary) on post-filing data showing a new or surprising technical effect, as long as the effect you are thereby showing is closely enough related to or implied by the original inventive concept you disclosed i.e. not plucked out of thin air ex post facto (so-called 'bonus effects'). It shouldn't need to all be in the application as filed - as long as the existence of such an effect is plausible to the skilled person, that should be enough, as it is for 'normal'inventions.

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