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Tuesday, 7 February 2012

What is obvious – the route or the destination?

When this Kat was an IPKitten, he learnt that, in the case of a product claim defined structurally (as opposed to functionally), the approach taken by patent offices such as the EPO to the analysis of inventive step was to investigate whether the structural features themselves were obvious, not to enquire whether the process of arriving at the structure was obvious.
For this reason, he was a little surprised by the EPO Board of Appeal Decision T 777/08 Atorvastatin Polymorphs (OJEPO 12/11).  This Kat has already blogged a factual note about this case, but, in essence, the Decision states that a claim to a crystalline form or polymorph of a compound [defined, for example, by its X-ray diffraction data] will in general lack inventive step over prior art disclosing the amorphous form of the same compound, unless in any particular case there is a technical prejudice or unexpected property of the polymorph discovered.  The main reason given was that screening for polymorphs is a routine procedure.
[Note for non-chemists – in a crystalline form the molecules of a solid substance are packed in a regular manner; if more than one such packing exists for the same substance it is termed polymorphism, and polymorphs have different X-ray diffraction data from each other; while in an amorphous form the molecules of a solid are not packed regularly.]
The counter view, following the reasoning to which this Kat has been accustomed, is that although it may be routine to look for crystalline forms, there is absolutely no way to predict what crystalline form(s) will be found, and therefore any specifically defined crystalline form is not obvious.

Last week this Kat was listening to Stephen Ingham’s CIPA Webinar on Antibody Patenting, in which technical field a similar dichotomy arises – the EPO since T 735/00 only acknowledges inventive step for an antibody (claimed structurally) “if and when there is evidence that a claimed monoclonal antibody prepared by routine methods shows unexpected properties”.

Stephen pointed out that this was inconsistent with the approach taken in the field of small molecule chemistry.  And now within the field of small molecule chemistry we have another inconsistency.
Which leaves this Kat pondering:

1)     Can there be any justification for applying the tests of obviousness differently in different technical fields?


2)     Should the patentability of a claim defined in structural terms be determined by reference to features other than the structural features recited?
What do our readers think?

22 comments:

Anonymous said...

"in the case of a product claim defined structurally (as opposed to functionally), the approach taken ... to the analysis of inventive step [is] to investigate whether the structural features themselves [are] obvious, not to enquire whether the process of arriving at the structure [is]obvious."

I'd agree that this is the correct test. But the reason it is the correct test is because the second enquiry, whether the process is obvious, will not provide a complete answer. It must be a necessary condition for a product claim defined structurally that any given process of arriving at that structure is non-obvious. But that is not a sufficient condition. A sufficient condition requires that ALL processes of arriving at the structure are non-obvious. So I agree with the Kat's learning as a kitten but I think it is being misapplied here. The EPO is in effect taking a short circuit to the answer by identifying whether there is an obvious process of arriving at the product and recognising that if the answer to that question is yes, then the product lacks an inventive step.

The point that one cannot predict which crystalline form will be found is analogous to the EPO case law following Agrevo, in which merely identifying a new chemical without specifying the advantage or purpose, does not identify an inventive step.

Anonymous said...

I am not sure that is how I read the decision. I do not agree that process features are read into the claim.

The process only becomes relevant in the final step of the problem-solution approach: what would the skilled person do to provide atorvastatin in a form with improved filterability?

He would crystallise it from different solvents to check for polymorphs. That's pretty routine. He would thus arrive at the claimed form in an obvious and straightfoward way.

The action of the skilled person is obvious, and so is its result. Seems fair to me. I do not see the inconsistency.

Mark Summerfield said...

Is this not just a standard variation on the 'obvious to try' test? If the skilled person, starting from something that is known, and applying precisely the same routine procedures that any such person would apply in the same circumstances, with reasonable expectation of success, would arrive at the claimed 'invention', then it is hardly the kind of thing for which a patent should be granted.

Even in Australia, where our standards are notoriously low (although hopefully soon to be improved) we do not grant patents for this sort of thing!

I do not see the enquiry as being about 'process' or 'structure'. It goes back to the fundamental statutory requirement for there to have been an 'invention' made.

I do not find it at all surprising that different tests apply to varying extents in different technical fields. To take a more extreme example, it would be relatively rare that this type of test would even be applicable in the mechanical arts. What are the routine methods for going from one arrangement of gears to another?!

Anonymous said...

"Even in Australia, where our standards are notoriously low (although hopefully soon to be improved) we do not grant patents for this sort of thing!"

Not so fast Mark.

The last time I looked, the AU equivalent of the EP patent that was the subject of the TBA decision referred to in this blog post (EP 0848705 B1 = AU 725424 B2) was on the AUSPat register, with its status as "Sealed".

It looks like, notwithstanding your comments, you do grant patents to precisely this sort of thing in Australia.

Anonymous said...

It's old news Mr Kat. Obviously things have moved on since your day! There is no inconsistency. The test for obviousness will always be whether something is "non-obvious to a person skilled in the art". All of the 'obviousness' tests are merely created by judges to help them explain their own decisions to themselves. They are of course useful, but usually arise based on the facts of a particular case. And, as we all know, facts change on a case by case basis.

'Obvious to try' must always be subject to a 'reasonable expectation of success' otherwise there would be very few inventions deemed patentable. It would be like saying the copmplete works of Shakespeare are obvious because the skilled person (the monkey) would eventually arrive at the works by combining and re-arranging the words in a dictionary.

In the case of polymorphs, it is now, in fact, routine for the skilled person to conduct a polymorph screen using available techniches. The skilled person 'would do' a polymorph screen and 'would reasonably expect' to find new polymorphs. Those polymorphs would be expected to have different properties in relation to solubility, stability, dissolution rate, stickiness, etc. These are the properties the skilled peron is looking to improves and therefore seeks out the polymorph having the best profile overall. It cannot (yet) be predicted in advance which particular polymorph will be produced having the desired range of properties, but the skilled perosn would expect, in advance, to find it should it exist.

The product is therefore obvious because the skilled perosn would be expected to find it, subject to their using standard techniques.

If, on the other hand, new, non-standard techniques are used to identify a polymorph that would not have been found using standard techniques then the product would be non-obvious. [There is a slight analogy here with some of the relatively recent enantiomer decisions where the desired enantiomer was an obviously-desirable goal, but no obvious process was known at the time for its preparation].

The antibody case, to the extent it is reported her, appears to mirror the reasoning of the polymorph cases and therefore seems appropriate.

The way to obtain patent protection for such novel, but obvious products, is to identify a non-obvious use on which to hang the cap of patentability. The invention lies in what the skilled person would do to find a solution to the problem at hand (as determined with reference to the closest prior art) and if that solution was not expected to be found by performing a polymorph screen of a known compound, or generating monoclonal antibodies, then their invention cannot be consdered obviousness.

I don't see an analogy with Agrevo here as there are defined advantages and purposes with a polymorph claim. In Agrevo, the product claimed was simply A.N. Other compound(s) which were obvious to prepare and did not have the advantageous properties claimed.

Anonymous said...

RE Anon at 11:02 - They may get granted but get invalidated in court - see the Astrazeneca omeprazole salt case form a few years ago.

If we took what was granted as watertight we would accept that the German way was the best way for the unitary patent, because (so it is claimed) they have a rigorous, watertight, examination system resulting in patents having inarguable validity.

The Australian examination system, however, has a very long way to go before it gets to the level of other nations. They are still a young 'examination nation', bless 'em.

MaxDrei said...

A number of thoughts occur:

1. Inconsistent with THE approach to obviousness in small molecules, is it, Mr Ingham? Whose "approach" would that be, please?

2. Paul Cole has observed that the randomly generated number on a winning lottery ticket is definitely not obvious. Like Mr Smyth writes here, there is no way to predict the winning number, but is that enough to render a winning lottery ticket, as such, patentably inventive (despite the enormous "effects" it will deliver for its possessor) ?

3. The claim is freighted with a load of X-ray diffraction data, but none of it is relevant for non-obviousness. So, for Art 56, let's strip it out. What are we left with? Atorvastatin, characterized in that it is crystalline.

4. How about the observations of Hugh Laddie in the Brugger case, on whether Form IV is inventive over the other crystalline forms?

5.I'm with Anonymous at 10:16am. In what way is T777/08 breaking new ground?

MaxDrei said...

Should Mr Smyth run the facts of this case through the EPO's Could/Would test procedure? Is there anything in getting to the claimed matter that the skilled person could have done but, actually, would not have done? Or is it all stuff that, of course, he would have done, and routinely at that? If so, is that not enough to render plainly obvious the subject matter of the claim?

I still think it useful to compare obviousness in patents with descriptiveness in trademark registrability. Is BATHTUB descriptive for i) caravans or for ii) lorry bodies? With marks, you need to know the goods. With patent claims, you need to know the technical field and what problem the skilled person was addressing. Was the blue squash ball obvious or inventive? Might it not depend on what objective problem it solved?

Anonymous said...

Dear Kat, the worrying thing about this decision is its headnote. It reads as if the EPO now wants to see both a prejudice and an unexpected property for inventive step. Unexpected properties per se are not enough anymore.

It this is intended, it would be new and not in line with the PSA.

If there is any justification for this decision, it can at best reside in that drying and filtering properties have something to do with crystallinity. If that is the ratio behind it, it will be one of many decisions where the headnote is far too general.

If, however, T777/08 realy means what it says in the headnote, inventive step will be much more demanding.

Darren Smyth said...

Thank you very much for all the comments so far.

In response to all of the 8 comments above - the issue as I see it is: what is to be considered as the "Invention" in relation to which the inventive step analysis - could/would, obvious to try, it doesn't really matter - is to be performed?

If the invention is defined at the level of "any crystalline form of atorvastatin" (or "any antibody to a known antigen"), ignoring the structural parameters in the claim, then the invention will be considered obvious (probably irrespective of what standard for inventive step is adopted). If the invention is defined at the level of "Atorvastatin Form IV" (or "an antibody having specific defined CDRs"), including the structural parameters in the claim, then the invention will I think not be considered obvious. So how should the invention be defined?

In most small molecule chemistry, the invention is defined including the structural features in the claim (at least by the EPO, if not necessarily by UK courts). Therefore, I do think that there is an inconsistency here. I am not particularly advocating either view.

Darren Smyth said...

Previous comment was written before post of Anon at 2.43, to whom this:

I think the headnote is intended to mean that either a prejudice, or an unexpected property, could justify inventive step. In the case under consideration, neither prejudice nor unexpected property was found, so inventive step was not acknowledged.

MaxDrei said...

Bit of a stretch isn't it, that last Anon? You read a Headnote that says what happens absent prejudice and absent anything at all that is unexpected, and you conclude from it that a plausible tale of that good old standard, the "surprising and unexpected" result is no longer going to do the trick. Are you not worrying unnecessarily?

Anonymous said...

Dear Mr Smyth, I cannot share your optimism. The polymorph was shown to have some unique properties. If unexpected properties alone were enough, then this would mean that these properties were to be expected. However, the TBA did not present any evidence that would support such an expectation.

All the TBA had was the general idea that one may look at polymorphs and that they may have useful properties vis a vis the amorphous form. This is no basis for any specifc expectation, is it?

Anonymous said...

Please at least read the Headnote properly!

"It reads as if the EPO now wants to see both a prejudice and an unexpected property for inventive step" No, no, no!

Read it more carefully:

"in the absence of any technical
prejudice and in the absence of any
unexpected property".

For those that believe this case is offering something new, I hope to put it down to it being outside your technical field of competence. This has been settled practice for years.

Darren Smyth said...

To anonymous at 4:57 - the Board of Appeal does not publish in the Official Journal of the EPO cases which relate to "settled practice for years".

MaxDrei said...

Can I reconcile Mr Smyth with Anon, on OJEPO publication? I suggest that inclusion of this Decision in the pages of the Journal is intended as a contribution to the effort to "raise the bar" of legal certainty, without imposing on inventors any obviousness hurdle that is higher than the one that has been "settled practice" for years.

Anonymous said...

Well Darren, they did this time!

Mark Summerfield said...

I see that it is 'condescend to the Aussie' day. Must be due to envy of our robust economy and strong currency!

But anyway, good-natured ribbing aside, I cannot let the misconceptions and inaccuracies in the Anonymi at 11:02 and 11:24 go unanswered, lest readers be misled about the position in Australia.

Regarding AU725424 (the Australian equivalent patent), of course I did not go looking for the equivalent Australian case before making a general comment on the law of inventive step. But even if I had, it would not have been pertinent to the issue at hand.

Three things must be noted. First, it is not only the Australian Patent Office that granted a patent on the alleged invention, so did the EPO. The TBA decision relates to an opposition. The Australian patent was not opposed, and thus the kind of prior art and other evidence which only a competitor is likely to bring to proceedings was not available.

Second, as readers will be aware, there are mixed issues of fact and law in obviousness cases. The factual enquiry requires the decision-maker to determine the state of the prior art and common general knowledge (CGK) of the relevant person skilled in the art (PSA). This forms the base from which the legal analysis is conducted as to whether or not the claims involve an inventive step. Thus even if the same legal principles apply in different jurisdictions (or before different tribunals in the same jurisdiction), the availability of different prior art and/or CGK may lead to a different result.

Thirdly, the law relating to the admissibility of prior art information and CGK is very different in Australia to that in Europe, and was even more so in 1996 when the application in question was filed. The Australian decision-maker will always be starting from a lower base when assessing inventiveness (and this is the aspect of the law which will hopefully soon be improved).

So, to spell out my point more explicitly: 'even' in Australia the law of obviousness encompasses a 'routine steps' analysis so that, assuming you start from the same base of prior art and CGK, the same result should be reached, and I see nothing surprising in the TBA decision under discussion.

Which brings us to the second Anonymous, who most kindly took it upon him/her self to bless our examination youth. The omeprazole formulation case to which Anon-2 refers is presumably Aktiebolaget Hassle v Alphapharm Pty Ltd [2002] HCA 59.

However, contrary to what is stated by Anon-2 above, the patent in question was ultimately upheld by the High Court. The issue here was the state of the law, and had nothing to do with the standards of the Australian examination system. (Additionally, the omeprazole patent was granted under the 1952 Australian Patents Act, which set the baseline for inventive step analysis even lower than the current Act.)

It is the omeprazole case which, in fact, provides us with our current 'routine steps' test for obviousness. The principle (paraphrased from paragraph [53] of the decision) is:

Would the PSA, at the relevant date, in all the circumstances, which include a knowledge of all the relevant prior art and CGK, directly be led as a matter of course to try the combination of integers or steps making up the claimed invention, in the expectation that it might well produce a useful alternative to, or an improvement upon, the prior art?

Even so, the claims were found to involve an inventive step, due to the very limited scope of the admissible prior art under the law at the time. If I recall correctly, the opposite result was reached in corresponding litigation in the UK. However, a US District Court reached the same conclusion as in Australia, after finding that an 'obscure' item of Japanese prior art was not relevantly 'available to the public' under US law.

Anonymous said...

Those generalists dabbling in the pharmaceutical arts may find this EPO presentation from 2006 helpful.

http://www.pcb.ub.edu/centredepatents/pdf/cursos/dillunsCP/papathoma_polymorphs.pdf

Gellie gave a more recent one (hideous use of powerpoint)

http://www.pcl-workshop.com/uploads/Gellie.pdf

MaxDrei said...

This generalist finds the Gellie Paper a cracker. Vielen herzlichen Dank, that Anonymous above, for providing the link.

Striking is how closely the language coming out of DG1parallels that of the DG3 Decision discussed here. Some EPO people are a tad too smug for my taste but a high degree of pride is fair enough, that the EPO is teaching the world how to get legal certainty in patent law, and how to deliver a fine balance between the interests of the patent owner and those of the opponent. Of course, with 24 competing Boards handing down more than a thousand Decisions each year, it would be surprising if by now, after 30+ years, a consistent line had not been distilled out of all those thousands of disputed validity cases.

Anonymous said...

£1 will buy me $1.46 AU. That makes the pound stronger in my book! And at least we don't have to check under the toilet seat for deadly spiders, or is that a myth designed to scare us off?

MaxDrei said...

Thank you Mark for revealing to EPO geeks that over on the other side of the world, in Australia, "PSA" is not a reference to any sort of Approach, Solution or Problem, whether medical, technical or otherwise.

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