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Friday, 12 December 2014

More on Product-by-Process claims - what is the law, why is it, and what should it be?

My post on Wednesday morning has attracted a large number of comments, including many thoughtful contributions, and so I would like to follow up concerning the wider issue of product-by-process claims (independent of the specific Hospira v Genentech case), gathering up, and responding to, some of the comments.

In the meantime, readers interested in the decision itself may care to visit the report by Katfriend Suleman Ali (Holly IP) posted on the PatLit blog here, which has a more detailed analysis of the whole judgment and the claims actually at issue.

There is a lot of material, and so I will try to organise into subjects.

1) What kind of claim do you mean?

In my experience of discussing the law of product-by-process claims with a large number of people, it is important to have in mind the right kind of claim.  It won’t do if you are thinking of claim where the product is not actually new as such (such as erythropoietin in the Kirin Amgen case).  It may seem irrelevant, but actually I think that your legal instincts will be led astray if you are not actually thinking of a situation which satisfies the T 0150/82 criteria, namely:
Claims for products defined in terms of processes for their preparation (known as "product-by-process" claims) are admissible only if the products themselves fulfil the requirements for patentability and there is no other information available in the application which could enable the applicant to define the product satisfactorily by reference to its composition, structure or some other testable parameter.
This is the “EPO” standard that has been adopted in the UK.  Curiously, as one anonymous commenter helpfully pointed out, only the former of these two criteria appears in the corresponding EPO Guidelines, so at first instance at least the EPO seems to have resiled somewhat from the latter criterion.

Usually a product-by-process claim “X obtained/able by process Y” represents a novel subset of generic X.  It will necessarily have an ill-defined structure.  And pretty much always (I think), the claim will not define a single composition, but a genus of compositions, either because “process Y” itself contains a number of variables, or because “process Y” does not define absolutely all of the parameters that may affect the identity of the final product, and so by varying non-defined parameters, a number of products can be obtained.

A good example of the kind of claim that I think we should be considering was suggested by an Anon:
"A mixture of compounds obtainable by oxidising compound A under conditions x, y and z"
[This is now my comment, not Anon's] This may well produce a complex oxidised mixture that is difficult to characterise otherwise.  The claim is unlikely to define a single mixture, but, either because x y and z are defined with ranges, or because other conditions v and w also affect the outcome but are not specified, a number of mixtures are possible that fall within the scope of the claims.

The Anon went on to say
“Said mixture not being characterisable by techniques in common practice today, but identifiable by a 3rd party using their new fangled gadget, such that they are able to readily prepare said mixture quite easily.”  
I accept that this is possible in principle, and we should allow for the possibility, but I believe that in the majority of cases that would be unlikely to happen in the lifetime of the patent.

Some commenters pointed to the possibility of a claim to a single X, or something conceptually definable but not able to be structurally defined in particular circumstances.  One Anon stated:
I have a case to a new chemical entity that has been transferred post-drafting (getting my excuse in early). The claimed structure was in error, due to a re-arrangement taking place unbeknownst to the inventors. The characterising data all looked fine until recently when it was discovered otherwise.
New claims have now been drafted to the product obtainable by the disclosed manufacturing process. These claims, when granted, will be infringed by third parties making the same compound by a completely different route. Third parties will be well aware of the true structure because it is now in the public domain. In fact, third parties will only make this compound because they will be copying my client’s work once their product becomes successful. One day!
This approach may be successful on those specific facts (I don’t really want to adopt a view on that), but I don’t think it typical of the situation in general.

And I don’t think it should be overlooked that even when a product cannot be defined structurally, there are other means of characterisation that should be preferred over product-by-process definitions.

One Anon answered his own comment:
First comment:
Crystalline form of compound X obtainable by crystallisation from methanol, having crystal structure parameters a, b, c, melting point y, DSC peak at z, IR peaks at y1, y2, y3.
Fully characterised so that third parties can determine whether they fall within the claim when they make the same material by a different process.
e.g. Same crystal form obtained directly from the reaction mixture used to synthesise the compound, said crystal form crashing out of solution on work-up.
Follow up comment:
Question mark over my crystal form example would be whether the form is sufficiently characterised by the data, therefore not requiring the process step. However, we could add a functional feature not shown by all forms having the required data, yet would be testable by a third party to determine whether they infringe.
I think in general crystal forms can be defined without reference to process, and, even if a product-by-process limitation is additionally used, the spectroscopic characterisation in the claims allows third parties some greater clarity about whether an individual product infringes.

2) How plausible is it that a different process will achieve the same product?

One issue that led to lively debate was whether the situation that “obtainable by” language would lead to a different outcome in infringement from “obtained by” was likely to be a common or a rare occurrence.  Perhaps there has been some misunderstanding here, so I shall set out my thoughts from the beginning.

As I stated above, the usual situation is that a product-by-process claim “X obtained/able by process Y” represents a novel subset of generic X.  The whole of X is not new, otherwise the limitation defined by the process would not be needed.  These situations are quite common.  I gave examples of “the products of processing or purifying complex mixtures, products of polymerisation, metallurgical compositions, and the like.”  A later anon added “oxidation process, re-arrangement reactions, extrusion processes, desalination processes, osmotic processes, filtrations processes, hardening, softening, annealing, centrifugation, mixing, stirring, blending, injecting, stretching, not-stretching, crystallisation, spray-drying, etc.”

If the test for infringement of an “obtainable by” claim is that set out by Birss J in Hospira v Genentech, namely that it "must have every single characteristic which is the inevitable consequence of that process", then I do believe with the greatest of respect to the Anon who clearly strongly disagrees with me, that the cases where a patentee may be able to prove infringement of an “obtainable by” claim, where an “obtained by” claim would not have been infringed, will be rare.  That is, I think it will be very difficult for a patentee to prove that the material produced by the infringer’s process is identical in all material respects to material that could be obtained by a different process that is defined in the claim.  That is not just from my experience, I think that there are conceptual reasons why this is likely to be so as well.

The product by process claim is in the domain X, that already encompasses some prior art compositions X(prior), which the process limitation excludes.  So the whole of X is not new, only the part that is effectively delineated by the process feature – let us call this X(claimed).  To prove infringement by the accused composition X(infringe), the patentee has to both a) prove that X(infringe) has every single characteristic which is the inevitable consequence of a composition of X(claimed) but also b) ensure that it does not stray close to X(prior).  If the process is completely different, I think that in most cases this will be an impossible task.

On the other hand, if the process is only slightly different from that defined in the claims (which I expect would be a more likely scenario) then there is a better prospect of demonstrating infringement.  However, in that case, I think that there is also a realistic prospect of infringement of an “obtained by” claim under normal principles of purposive construction.

In summary therefore, I think that situations where it will actually make a difference which language is used will be rare.  I have still not been persuaded otherwise.

3) What are the principles that are at stake?

An early commenter suggested two principles:
1) The 'Angora Cat' principle of construction, which neatly explains why the same interpretation of the claim should be adopted for infringement as for novelty. A patentee can't adopt a broad construction for infringement having argued for a narrow one for novelty (this protects the public) BUT, by the same token (and by general judicial principles: equal treatment of parties etc etc), one (in particular an infringer/challenger) should not be able to argue for a broader interpretation for novelty than for infringement - this protects the patentee. Deciding arbitrarily that a 'reverse Angora' scenario is fine is unjust and unfair on patentees/inventors.
2) The protection conferred by a patent should correspond to the patentee's contribution to the art. Post Kirin-Amgen, to be allowable, a product-by-process claim must be directed to a NOVEL product. The contribution to the art is hence the product per se, not the process, and the scope of protection should reflect that.
I would first point out that neither of these is a statutory principle.  The over-reaching statutory principle is Article 69 and the Protocol, to which I will return later.

Even though I referred to an anti-Angora Cat situation, actually the symmetry is not perfect, and so I don’t think that what has happened is “deciding arbitrarily that a 'reverse Angora' scenario is fine”.  There are cogent reasons why, in the special case of product by process claims, the symmetry between novelty and infringement is broken.  But there are already such situations – such as lack of enablement of the prior art (for example in the UK case of Synthon v SmithKline Beecham) – where the symmetry between novelty and infringement is broken, so actually this is not a fundamental principle at all.  (Other commentators may consider that the axiom that what infringes if later, anticipates if earlier was laid to rest even earlier, in the terfenidine case)

I don’t think it follows that just because the product has to be novel per se that the contribution to the art is the product.  On reflection over the last few days, I think actually what the contribution to the art is may not be the same for all kinds of product-by-process claims.  But at least in some cases, I think it will really only be the process, even if the product of the process does happen to be new.
My view of the applicable principles is probably easiest explained by reproducing exchange with Norman:

Norman:
I don’t have a realistic example, but here is a conceptual example, just to make sure I understand your position. Suppose the patentee produces a new product by a certain process, and with the available technology, the product cannot be described by except by that process. The patentee claims the product “obtainable by” the process and separately “obtained by” the process. After grant, but before expiry, advances in the technology used to characterize products of that nature allows the product to be fully characterized and described by structure. Another party, armed with knowledge of the structure, then produces the exactly the same compound by a different process. Does that party infringe either of the claims? As a matter of policy, in your view, should it be considered to infringe?
Me:
In the situation that it subsequently becomes possible to structurally describe characterise the product, then I think under UK law as it stands, an “obtained by” claim is not infringed and an “obtainable by” claim is infringed.
I hope it will be clear to other readers that such a situation is difficult to imagine in reality. Usually things that cannot be characterised stay uncharacterisable for a long time.
But to answer your last point, as a matter of policy I think that it should be considered NOT to infringe. Essentially I suppose I am arguing that “obtainable by” language should not be able to be used by the patentee to expand the monopoly to cover things that only afterwards can be ascertained to infringe, because I think that it completely offends the Protocol to Article 69 – there is no certainty for third parties. It also offends the principle that the monopoly should be commensurate with the technical contribution – the real technical contribution is the process, even if the product is actually novel. (Here I completely disagree with ANON from Wednesday, 10 December 2014 at 10:12:00 GMT)
Otherwise, if “obtainable by” claims are allowed to cover the same product made by a different process, then the patentee has used his difficulty – “I cannot describe my product any other way” not only to get a product claim (rather than only a process claim), but to get a product claim that covers things that the patent itself gives no guidance as to whether they infringe or not. In your example, the patent has provided a process A, and an uncharacterised product X. Someone else, possibly the putative infringer himself, has to establish the structure X, the different process B, and that the different process B produces X, and not X’ or Y. In my view, the burden on third parties and the putative infringer is intolerable, compared with the little that the patent has contributed (really only A). If patentee’s difficulty to describe his product produces adverse consequences, these should be shouldered by the patentee, not by third parties.
It can even be framed as an estoppel point. To get the claim at all, the patentee has represented that the product cannot be described except by the process. But then to assert infringement, the patentee must represent that the product can be characterised in another way, necessarily not revealed in the patent, but only later. I don’t consider it far-fetched to say that the patentee should be estopped from this change in position, even if it is technically justified by interim developments.
Norman:
Your point regarding certainty for third parties is well taken. To expand my example, suppose that before the advance in characterizing technology, the second party develops the same product, but by an entirely different process. There will be no way for the second party to know whether it infringes, and indeed, the second party might also get an “obtainable by” patent for what is in fact exactly the same compound.
However, I’m not sure the principle that the monopoly should be commensurate with the technical contribution is offended, because I’m not convinced that the true contribution is necessarily only the process. I do agree that in some cases the true contribution would be only the process – eg where the desirability of isolating a compound is well known, and the patentee is the first to do it – and in such cases I agree that infringement should be limited to the particular process. But I’m not sure that is always the case. Suppose that the technical insight is that a certain plant compound has medicinal properties, and the only known way to obtain the compound is to extract it from the plant, but once the decision to extract is made, the extraction itself requires only well-known methods. The technology needed to characterize the product might subsequently advance by incremental unpatentable steps, until the point where the product can be readily characterized and synthesized, in which case the subsequent party would have contributed nothing inventive. Even if the characterizing technology or synthesizing technology were patentable, I would have no trouble with the subsequent party getting a patent on their particular novel process, but still, the thought of synthesizing the compound would never have occurred to them without the original invention. In this situation, I would say that the real technical contribution is the compound itself.
So, I don’t see this as a (relatively) easy case in which all policy considerations point in the same direction. It strikes me as a hard case where there is a real tension between the need for due notice to subsequent parties, and the need to reward the patentee for their contribution.
I would finally note that the disconnect between novelty and infringement has been endorsed in the USA by the CAFC in the case Amgen v Hoffmann-La Roche:
“In determining validity of a product-by-process claim, the focus is on the product and not on the process of making it”
“In determining infringement of a product-by-process claim, however, the focus is on the process of making the product as much as it is on the product itself”.
4) Words from another commenter (with whom I generally agree)
I was very grateful to Freddie Noble who expressed some principles clearly (and I think in a refreshing way), and I so I would like to repeat some of his contributions here:

Freddie:
I do like this decision. And I do not think it necessarily breaches the "Angora Cat" principle.
To start with you have a claim, and have to decide what it means. Fundamental to that is that is whether the claim is for a product or a process. If it is ambiguous in that respect then a clarity objection is proper.
Clearly this type of claim is for a product. So the question is - is the product novel? i.e. is it a new product? If the product is identical to a prior art product (albeit obtained by a different process) then the claim is not novel. I think this is what Birss means by a "rule of novelty" - notice there is no "construction" of "obtained by" at this stage, the "process" is just not relevant to the novelty of *the product*, apart from in so much as it defines the features of the product.
Then we come to infringement, and the question is "has the alleged infringer done what the claim says he must not do?" The "obtained by" claim says that the product, specified in terms of how it is manufactured, is the monopoly. If the product is not manufactured like that, then it does not infringe.
Alternatively, if the claim says "obtainable by" rather than "obtained by", then the alleged infringer has to make something which really is "obtainable by" the specified process. In other words, if it is made by a different process then it must be indistinguishable from the "obtained by" product.
The implication seems to be that it is (very slightly) better to say "obtainable by" than "obtained by" in your claim. And irrespective of whether the EPO might allow an "obtainable by" claim where there is an alternative, if there is an alternative way of defining the novel and inventive features of the product then that alternative is probably going to be better for the patentee.
Anon: “More than “very slightly” I would suggest”

Freddie:
Yes, you are right in that "obtainable by" instead of "obtained by" could make the difference between infringement and not, which in an important case could be worth an awful lot.
What I meant was that cases where it does make that difference are likely to be rare, bearing in mind the narrow definition of "obtainable by" - it "must have every single characteristic which is the inevitable consequence of that process".
Me:
I completely agree with you both in the sense that this is what the UK law is, following Kirin Amgen and as admirably now expounded by Birss J, and also as I think that it should be.
It is only at first blush that a fundamental precept of claim construction is breached; on careful consideration, as you have done, it is clear that this is not so.
Moreover, in my opinion, this approach is the only one that satisfies the Art 69 EPC requirement for an claim interpretation "which combines a fair protection for the patent proprietor with a reasonable degree of legal certainty for third parties". The "expansive" approach gives complete uncertainty for third parties, as Tim Roberts notes that such a claim is unconstruable.
What Tim Roberts wrote was:
"Product A obtained by process X" is a claim the scope of which can be decided by evidence (about the process used). What about "Product A obtainable by process X"? What does this include? It clearly includes cases (A') where A has been obtained by process X. But suppose A (A'')has been obtained by another process (Y,not X)? How do you tell whether A'' could have been been obtained by process X? In what sense could it have been so obtained, when it wasn't?
Clearly if the patentee can produce a product A''' produced by process X that is indistinguishable from A'', then A'' infringes. But suppose A''' and A'' differ slightly - or more than slightly? How do you construe the claim? Infringement (no doubt) is a matter of substance. But how do you tell what is an important difference and what is a trivial one? I would argue that the claim is unconstruable. It is no clearer than a claim to 'A substantially as described with reference to the description' - and we know what the EPO thinks of those.
[Clarifying the possible disconnect between novelty and infringement]

Freddie:
When novelty is being assessed, we deny that there is any construction of "obtained by" and instead say there is a "rule of novelty" which says that the product as such must be new. Part of the reason I gave for this was that the claim is either a product or a process - it can't be both - and if it's for a product then it is the novelty of the product which must be assessed.
Then when infringement is being assessed, we say that it is not enough for it to be the same product, it has to be really obtained by the process as stated. In other words, there is a "rule of infringement" which is not the same as the "rule of novelty".
There may well be some room to criticise this state of affairs - where infringement is assessed differently from novelty - but whether it is right or not I maintain that it is reconcilable with consistent construction of the claim, which is important.

As to whether all that is "right" in the sense that it should be the law, as well as in the sense that it is the law, well I think it is, because:
When we assess novelty of an "obtainable by" claim, we insist that the product is new, because it is the product which is being claimed.
When we assess infringement of an "obtainable by" claim, we insist that the infringing product really is obtainable by that process (which is really to say no more than that the infringing product has to be identical to the claimed product), because anything else leaves the scope of the claim uncertain and indeed subject to change in the face of new technology.
If it's an "obtained by" claim then, in certain circumstances (and still I have seen no convincing real-world examples) an identical product will not infringe, which might seem harsh, but then nobody forced the patentee to say "obtained by" instead of "obtainable by" , and if the anon comment @1213 is right, then the patentee has known very well for years that he had better say "obtainable by" to avoid that.
Thanks again to all the commenters for such excellent contributions.  I hope and expect that our dear readers may have further comments on this tricky and controversial topic where, perhaps surprisingly, the law is still not clearly fixed.

Addendum 12 December at 21:45 to add this picture of Claim 2 of EP0309477B, referred to in the comments below


27 comments:

Anonymous said...

A slight variation on an earlier example:

"Compound A (single compound) obtainable by heating compound B (singe compound of known stucture) at 200 Celsius in a sealed, evacuated container, whereing said compound A has a melting point x, 1H NMR y1, y2, y3..., 13C NMR, z1, z2, z3....", IR spectrum, (etc), mass spec (etc)"

Facts: Compound A has an unknown structure at the time of filing. The manufacturing route is reproducible (100% yield every time producing the same material as can happen with such reactions).

The claim must be written in 'obtainable by' language because once the structure is eventually known it will be possible to prepare by alternative routes. 12 Months later a crystal is found in a sample tube suitable for x-ray determination. The structure is identified.

Q: Is this rare? Today, structural identification is far easier than before, however examples could actually be quite common. In fact, the structures of 'old' compounds are constantly being corrected. Today, even, if you can't get a single crystal of your individual isomer, you can't be sure of knowing which one you have. Filing a patent directed to a single isomer (defined by absolute configuration) when you are even 90% certain which one you have is a dangerous gamble. Always better to add a functional feature (e.g. optical rotation) to the claim.

All of my previous examples (by anon) where thought up on the fly while tuned in to the exciting TV broadcasts. The above example is a clear case (not rare) supporting the obtainable by language.

Other examples are all fact specific. For example, does rapid evaporation with heating in vacuo of mixture A, B and C (or just A alone in solvent) give rise to the exact same product as that obtained by slow evaporation at atmospheric pressure? In some cases, no, in other cases, yes.

A sufficiently defined claim will contain all features necessary to identify the product so nothing is left out. The 3rd party can slowly evaporate his mixture and determine whether he infringes by comparing with the claimed features. The 3rd party may say their product has a feature not mentioned in the claim that is different to that produced by the claimed process. However, if that feature is irrelevant to the clamed function of the product then it is irrelevant. This is no different to a product claimed directly, where an extra feature does not avoid infringement.

There are many clear examples where "obtainable by" is key, so the only argument would seem to be about the definition of rare. I have dealt with a few important examples, and can think of many more, so I settle for more common than not.

Anonymous said...

"I don’t think it follows that just because the product has to be novel per se that the contribution to the art is the product. On reflection over the last few days, I think actually what the contribution to the art is may not be the same for all kinds of product-by-process claims. But at least in some cases, I think it will really only be the process, even if the product of the process does happen to be new."

Not sure I can agree with this.

Product-by-process claims are directed to the PRODUCT, as at least one other commenter has noted. Just because they are defined as the product-of-a-process (perhaps because this was the only way to do so at the time) this does not change the fact that a new product has been made available to the public for the first time, by virtue of the inventor's efforts. The contribution to the art is therefore the product per se, as well as the process by which it is made.

Someone, later, finding an alternative way to make the exact same product infringes such a claim (let's assume it is drafted in 'obtainable by' language to avoid the construction debate for now). Surely this is fine - it is no different from someone claiming a new product structurally, which they are the first to make not because the product itself was not known about, but because no one could previously manage to produce it. Someone coming along later with their own new (possibly even inventive) method to make that same product will infringe: no one would have a problem with that. (esp. since e.g. Generics v Lundbeck).

It is unfair to deny the patentee protection for the product they have enabled, for the first time, just because they were unable to claim it other than using p-by-p language.

Darren Smyth said...

To Anon at 13:18

You say “The above example is a clear case (not rare)”, but I don’t even find it a plausible one. A chemist performs a reaction on a known compound, can completely characterise the product but has no idea what it is? But files a patent application anyway? I do not recognise such a situation as anything other than completely exceptional. I don’t accept that you need a crystal structure to know what you have got. Moreover, even if such an exceptional situation were to occur, I don’t think you need the obtainable by definition at all – it should be possible to claim with respect to spectroscopic properties only, as can be done for natural products of unknown structure (See for example EP 0309477). And even if you insist on putting in the product by process feature, it does not have to be defined so narrowly with respect to the process.

I still maintain that product-by-process claims that refer to a single product are not typical of the class, and to keep on harping back to them confuses the issue.

I think that you are referring to the lyophilisation vs air dried example as well. I agree that it is fact specific, but if lyophilised and air dried really produce the same thing, I do wonder what the lyophilised feature is doing in the claim at all.

To Anon at 15:48

What I was trying to say is that it is an error to suppose that the technical contribution to all claims of the same class is the same. Even for product claims, the technical contribution is not necessarily the product. In last week’s case Idenix v Gilead, the technical contribution of the compound claims was held not to be the compounds as such, but compounds having anti-Flaviviridae activity. That being the case, I don’t see how it can be axiomatic that for a product-by-process claim the technical contribution will always be the product as such. It will depend on the specific case. Deploy Generics v Lundbeck with caution, as in that case the patent was claiming a single compound, and that fact is critical to the ratio. I have explained in detail why I don’t think this is unfair, and I won’t repeat it again.

Anonymous said...

Darin,

Please take a moment and realize how your statement reads in plain English:

Even for PRODUCT claims, the technical contribution is not necessarily the PRODUCT.

Sorry, but I cannot accept the logic of this statement.

As I posted - you either have the product or you do not. You cannot use two different types of logic, one loose and one tight to reach a different conclusion.

Darren Smyth said...

To anon at 18:01 You are welcome to your opinion, but it is not the law of England and Wales, as reflected in the judgment that I cited.

Anonymous said...

Darren,

Thanks - I do not doubt that there are laws that are not logical.

But discussions of said laws should not hide behind a gloss statement like yours.

If there be error in my view, I would rather have you point out that error. If you can not point out any error, I would appreciate you acknowledging this and then advancing a suggestion as to how an errorless view and the illogical law it addresses can be brought together - if such should happen. If such should not happen (in your view), then I would enjoy SOME rationale as to why an illogical law should be kept on the books.

Anonymous said...

"A chemist performs a reaction on a known compound, can completely characterise the product but has no idea what it is? "

erm... YES. Speak to a chemist or two.

"files a patent application anyway"?

Again, yes, just like your EP reference.


"it should be possible to claim with respect to spectroscopic properties only"

Really?

EP0309477: The claimed compound is not claimed with respect to spectroscopic properties only.

You might not be convinced Darren, but news just in is that you don't have a monopoly on patent opinions in the chemical field.

Darren Smyth said...

To Anon at 19:39 In response to your statement that "The claimed compound is not claimed with respect to spectroscopic properties only" I have added an image of claim 2 of the patent as granted, which is representative. What other limitation do you see?

Anonymous said...

The limitation I see is "Ecteinascidin 743..."

I accept it is in black and white, but that doesn't make it a spectrocopic property in my humble opinion.

The best objection to this is that the name adds nothing to the claim at all. However, it would have been pointless to include it had this been the case, although patent agent are free to draft poor claims. However, in this case, I would suggest the name is crucial to determining the scope of the invention. Ultimately, I may even suggest the name is mere shorthand for "A compound obtainable by the process of extraction of the marine turnicate........"

Even more ultimately, this EP supports my case that even with significant characterisation, determining the absolute structure (including configuration) of a molecule is not a done deal. 1987 was not that long ago.

Anonymous said...

It is an old argument that the contribution made by a novel product is not the product.

I don't buy it and neither do patent offices or the courts.

I haven't ploughed through Idenix yet, but according to the conclusions, no compound claim was determined to be novel and the "no contribution to the art" objection is in respect of medical use claims.

Anonymous said...

Darren, I wanted to point out a biotech example where product by process claims are crucial:

'Protein X which has post-translational modifications obtainable by expressing it in bacterium Y.'

Here the process bit is very narrowly defined with reference to deposited bacterium Y. The modifications I have in mind are glycosylation which is difficult to characterise structurally. Many other bacteria would give the same results, but we haven't deposited them so cannot refer to them in the claim. I think this example is interesting because we can define it as being restricted to only one feature resulting from the process. Unlike the situation Birss was faced with we don't need to try to identify all the features that result from the process - only post-translational modifications.

Anonymous said...

What I find interesting - and a bit of a disconnect - is reading the decision, and then reading the posts here that seem to take the decision as an endorsement of what is on its face a forced schism in logic.

I read the decision as recognizing the schism, but by no means whatsoever endorsing it.

Anonymous said...

What a relief to read some solid patent theory (and practice) as a contrast to the very controversial present EPO issues. Thank you!

Best wishes,


George Brock-Nannestad

Ashley Roughton said...

Darren

VV interesting points - TY. Can I ask a question?

In relation to EP ...477B and claims like the one you cited, do you know of any infringement or validity cases where the accuracy of spectroscopic (or magneto resonance or chromatographic) data has made a difference? I only ask because it is likely that the cost associated with a proper magnetic, chromatographic and spectroscopic investigation is going to be vast. I see at least 10 means of analysis here. I would have thought that the court is likely to require fairly strict compliance on proof.

Given that to prove infringement one would need to carry out experiments, each one of those numbers in the claim is option limiting. I think that the degree of nit picking involved (which always happens where experiments are concerned)might make the exercise costly. Whereas if you say, chemical X obtained by pouring hot A over cooler B then the costs of proof are likely to be considerably lower.

Ashley

Anonymous said...

Ashley,
the costs of running the analyses to produce the characterizing data is minimal (less than £2K). In the example provided by Darren, third parties would certainly have the funds to cover the work. In other fields (e.g. food technology) there may be a burden on small outfits, but in their cases the kinds of analyses would differ from those above and would be much cheaper.

In the example, I would consider that at least one of the measurements would show a variation, as well as having a clarity issue, so proving infringement may be a problem, even if all other limitations are met. I would have preferred the agent used "product obtainable by" language, with fallbacks and independent claims covering the data.


GEORGE: I agree. No-one wants to discuss such theories anymore. It is becoming a dummed-down profession.

Darren Smyth said...

Dear Ashley

Thank you for your question. I don’t know of a case where claims defining a compound by spectroscopic means have been tested in court. I agree with the subsequent anon that this is not likely to be that costly. Chemistry papers quote these characterising details for all new compounds prepared, and in principle it is supposed to be how we determine whether the compound that we have prepared is the same compound reported in a previous paper. In practice of course it is not that simple and I would expect that there would be some quibbling about how precise the correspondence needs to be to count as the same “stuff”, which presumably be resolved by expert evidence. Speculatively, I wonder whether putting more characterising data in the claim may allow more wriggle room in the claim, because if one measurement did not quite match, it could be compensated by others that did.

If you say “chemical X obtained by pouring hot A over cooler B” then provided the infringer is also pouring hot A over cooler B then it is relatively simple. Where I think it becomes unacceptably complex is if you say “chemical X obtainable by pouring hot A over cooler B” and the infringer is pouring hot C (different from A) over cooler B. Then were are in the realms of multiple experiments as to whether what the infringer has obtained is actually within the scope of the claims.

The patent I quoted was a natural product. Here the structural determination is much harder than for a synthesis from a known starting material under defined conditions, because you don’t have the information about how you made it. This very much limits the possibilities for what the thing could be. Classically, synthesis was the gold standard of structural proof; nowadays it is crystal structure, where this is possible.

“Product by process” features that ARE limited by the process are ubiquitous and so common that we hardly notice them moist of the time – every past participle in a claim might be one – terms that often escape notice such as “extruded”, “cast”, “moulded”. Provided that the infringement is also extruded etc, there is rarely occasion to stop and notice that in principle it is a product by process feature.

Best wishes

Darren

PS George – thank you for the kind comment.

Anonymous said...

Excellent and interesting discussion.

My comment's on Birss J's statement that an "obtainable by" claim "must have every single characteristic which is the inevitable consequence of that process".

Darren: A few times now this has been short-handed to say the infringing product must be identical to the claimed product. I think the scope of monopoly here may be broader than you think. "Inevitable consequence" seems a rather high hurdle. Are there not many characteristics that could be changed by varying process conditions or adding steps that aren't specified in the claim? The list of characteristics that are truly 'inevitable' may be very small indeed.

Darren Smyth said...

Dear Anon at 18:01

Thank you for your comment. I think that you may be approaching from one direction something that I have been trying to point out from another. Namely, I have been trying to emphasise that a product by process claim normally defines a genus of products, not a single product, and I have been trying unsuccessfully to steer the discussion to such situations (“And pretty much always (I think), the claim will not define a single composition, but a genus of compositions, either because “process Y” itself contains a number of variables, or because “process Y” does not define absolutely all of the parameters that may affect the identity of the final product, and so by varying non-defined parameters, a number of products can be obtained” in the main post, and “I still maintain that product-by-process claims that refer to a single product are not typical of the class, and to keep on harping back to them confuses the issue” in a later comment.)

I agree that, in the case of a usual product-by-process claim, there are a large number of products that can be explicitly obtained according to the claimed process, by varying or adding steps that are not specified in the claim. I think that Birss’s “must have every single characteristic which is the inevitable consequence of that process” does not equate to “is identical to the claimed product”. But I think it does equate to the, not very different, “is identical to a product that could have been obtained by a process according to the claim”. This will usually equate to a large number of products.

I therefore think that we basically agree. But perhaps I have misunderstood the thrust of your comment.

Kind regards

Darren

Anonymous said...

From a US perspective, I found the thin comments in the decision concerning "consisting of" and "comprising" to be rather confused and confusing.

There is a world of difference between those two terms here, and the decision seems to hand wave them as being equivalent.

Am I missing something in the translation?

Anonymous said...

That's Google Translate for you.

I wouldn't necessarily put too much weight on the works of Mr Birss, just yet. He isn't addressing ground-breaking issues in the chemical field, which have, for he most part, been dealt with by his more eminent predecessors.

Anonymous said...

Anon at 18:01 here:

I think perhaps the slight difference in opinion is whether Birss J's 'inevitable consequence' test results in a large decrease in scope for product by process claims compared to 'normal' product claims. I think that if the product by process claim is well drafted (thinking of Anonymous@13:13's point here), perhaps it won't.
On the 'genus of products' point, I totally agree but I don't think there's anything controversial about this or peculiar to product by process claims - the scope of monopoly of most/all patent claims define a genus in one way or another. The fewer criteria specified in the claim, the larger the genus.

Where I think we disagree is the potential breadth of “is identical to a product that could have been obtained by a process according to the claim”. You could imagine additions to the process of e.g. purification steps.

E.g. a claim to "A compound obtainable by oxidising compound A under conditions x, y and z" where the process results in an uncharacterised mixture of different oxidised compounds, would have within its scope a purified composition of the one oxidised form subsequently shown to be the active agent, let's call it B. And if the claim reads onto to this purified B, then it could also cover purified B obtained via a completely different process that resulted in a different mixture of initial compounds so long as it also included B. The "inevitable consequence" test would perhaps then only apply to any impurities resulting from the claimed process that were completely impossible to remove from B and weren't present at all in the new process.

Darren Smyth said...

Dear Anon at 18:01 and 13:46

Please let me clarify whether I have understood you. I think you suggest that "A compound obtainable by oxidising compound A under conditions x, y and z" that leads to "an uncharacterised mixture of different oxidised compounds", let us call them B, C, D, E and F, might be infringed by purified B alone resulting from the purification of this mixture? (Provided that it is has the impurity profile, for example, that came from this preparation process).

I come back to the one statutory principle - the Protocol to Art 69 EPC - and I do not see how such an expansive construction provides any certainty for third parties. How are they possibly to know what such a claim covers, if it is interpreted as broadly as that? I don't agree with this approach personally, and I find it difficult to imagine a UK court coming to such a conclusion.


Anonymous said...

Anonymous @ 13:46,

Yes !

And that is why I find the gossamer treatment of "comprising" and "consisting of" unsatisfying.

The two terms remain distinct - and importantly so (comprising, being open-ended necessarily means that there is no - and can be no - "exact" match).

I find it odd that such an "exact match" is being fussed about with a Product by Process when the exact same fallout occurs with a straight up product claim (with a "comprising" term).

Darren Smyth said...

Dear Anon at 14:44

Again (because I think it is the same as previous Anon) I find myself not understanding the point you are getting at, this time concerning "comprising" and "consisting of". The judgment says at 122:

"Genentech's fall back position is to replace "comprising" with "consisting of". It cures this defect. The effect of the change is as follows. The word "comprising" allowed for other ingredients to be present. The term "consisting of" in these claims has the effect of limiting the composition to the particular ingredients referred to and no others."

What is not to like?

Darren

Anonymous said...

Preferred language in this regard is "consisting essentially of". These definitions have important differences in construction in different jurisdictions.

Anonymous said...

Anon @ 18:01 here

Yes, I think purified B could infringe under those circumstances, but I think this is very much in keeping with Protocol on Interpretation of Art 69.

If the patentee discovered that a compound resulting from that process treats a disease, but hadn't yet characterised the chemical formula at time of filing, why should a competitor who goes to the next (perhaps trivial, perhaps not) step to purify the active agent be able to take advantage of the patentee's advance without infringing. By analogy, isn't this the same principle as when a patentee patents a chemical (A compound according to formula X), and then someone comes along and finds that a particular stereoisomer or crystalline form is the active agent. Most would agree that the sale of the particular stereoisomer would infringe - isn't the same principle at play here?

Anonymous said...

A claim to:
"A compound obtainable by oxidising compound A under conditions x, y and z"
simply lacks clarity and would never be granted. No need to apply the Protocol.

When I say "never be granted" I am being nostalgic regarding EPO examination. Today, it will be rushed through to grant without comment because clarity is confusing to the current crop of examiners.

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