From October 2016 to March 2017 the team is joined by Guest Kats Rosie Burbidge and Eibhlin Vardy, and by InternKats Verónica Rodríguez Arguijo, Tian Lu and Hayleigh Bosher.

Wednesday, 10 December 2014

Hurray for judicial sense on product by process claims - Birss triumphs in Hospira v Genentech

This Kat did not have time to get round to reading Hospira v Genentech when it first emerged, and did not immediately notice that it was an entire new case in its own right, and not simply a codicil to the decision that he reported here.  Now that he has had chance to read it, he is sorry that he did not get to it sooner.

Whilst first being pleased to notice that it is of medium length at only 250 paragraphs, as he started to read the judgment he was struggling to see what within it might be of interest to a wide audience.  This Kat was already transfixed from the technical point of view, because of key import was the role of trehalose as a lyoprotectant.  The stabilising (and unique) effects of trehalose were central to the case of Quadrant v Quadrant, which was this moggy's first experience of patent litigation when he was a little kitten, and was decided by Nicolas Pumfrey of blessed memory.  In the present case, trehalose is being used to stabilise lyophilised (freeze-dried - like your instant coffee - informs Merpel) preparations of herceptin, the (now) well-known anticancer drug.

But then, joy of joys, it turns out that Mr Justice Birss has, in a judicial first, cleared the fog and finally made sense of product-by-process claims.  These have long been a conceptual problem for European patent practitioners.  The reason is that the EPO interprets, for the purposes of assessing novelty, a claim that states "X obtained by process Y" as a claim to X as such, and will consider such a claim as lacking novelty if X as such is not new.  Incorrectly considering that they are applying the precept that claims must be interpreted for patentability in the same way as for infringement (and taking this to be a precept of the most fundamental level), some have taken the view that this means that such a claim, and in particular a claim "X obtainable by process Y", affords an inalienable monopoly in respect of X however it is produced.  The result is that a claim format that should only be allowable when there is no other way in which the invention can be defined is considered to give the patentee a monopoly of indeterminate scope, to the great detriment of third parties and alleged infringers.

This Kat understands that this expansive approach to construction of product-by process claims is the approach taken in Germany.  In the US, on the other hand, process features are considered limiting in product-by-process claims, and such claims are infringed only if the product is actually produced by the process defined in the claims.

In the UK, many practitioners have thought that the House of Lords decision in Kirin-Amgen supported this expansive view of product-by-process claims, but this is because they took what Lord Hoffmann said about novelty, and assumed that it applied to infringement as well, notwithstanding that when considering infringement Lord Hoffmann applied the restrictive interpretation and said that the claim was not infringed because the defendant's erythropoietin was not the product of the expression of a gene in a host cell as the claim required (while for novelty saying that the claims lacked novelty because urinary erythropoietin was the same thing as recombinant erythropoietin).

This Kat has long argued against the expansive interpretation, both as a matter of principle (where he prefers the US jurisprudence) and as a matter of what Kirin Amgen  actually stood for.  (It is not freely available, but he went so far as to write an article with Gregor Grant on the matter: The Protection Conferred by Product-by-­Process Claims; Grant, Gregor; Smyth, Darren; European Intellectual Property Review (2010), volume 32, issue 12, p. 635-643).  He has found very few people to agree with this view, however, because usually he receives back the mantra "claims have to be construed the same for infringement as for patentability".  This Kat has never had a good response to this, except - "Not necessarily, and there are more fundamental principles at issue".  What Birss J has now done is to say "The EPO approach to the interpretation is a novelty rule, not a construction rule, and Kirin-Amgen shows that to be so".  More specifically, at #147, he states (noting the second point):

I derive the following principles from this consideration of the EPO and UK authorities:
i) A new process which produces a product identical to an old product cannot confer novelty on that product. To be novel a product obtained or obtainable by a process has to have some novel attribute conferred on it by the process as compared to the known product.
ii) This rule is a rule of the law of novelty. It is not a principle of claim construction. Although in effect the rule treats "obtained by" language as "obtainable by" language, nevertheless as a matter of claim construction a claim to a product "obtained by" a process means what it says. That will be the relevant scope of the claim as far as infringement and sufficiency are concerned.
iii) Although normally a patent is drafted by the inventor "in words of his own choosing", the EPO will not permit overt product by process language unless there is no other alternative available. By no other alternative, they mean no other way of defining a particular characteristic of the product in question. 
Applying these principles to the construction of the claims, the judge held as follows:

The claim is to a "lyophilised mixture". As a matter of language and applying the principles I have just discussed, that is limited to something which has actually been made by lyophilisation. It does not say "obtainable by" lyophilisation, it is a claim to a product "obtained by" lyophilisation. Air dried material which had never been lyophilised might anticipate the claim (but none is suggested to) but it could never infringe. 

At which this moggy rejoiced.

The judgment then went on to consider the meaning of "obtainable by" (which also appears in the claim at issue), and pointed out that for such a claim to be infringed is a different process is used, it "must have every single characteristic which is the inevitable consequence of that process" and:

"If something does not have all those attributes then it is not obtainable by the process. Even if only one attribute is missing, then it is not obtainable."

In other words, the patentee cannot select after the fact what features are characteristic of the process limitation.  The judge correctly noticed that "That may well make it hard to find the limits of the claim."  If the burden is on the patentee to show that the accused product meets the limitations of the claims, and if there are an indefinite number of features to be shown, in many cases it may practically be impossible to demonstrate infringement of an "obtainable by" form of claim if a different process is involved from that specified in that claim.

In the event, the judge refused amendment of the claims as granted to include a product-by-process feature requested by Genentech because he considered that the situation did not meet the EPO standard that there was no alternative product definition available.  He also considered that amendment resulted in an expansion of the scope of protection, and to involve added matter.

In any case, the claims as proposed to be amended were held to be obvious, because all the claimed aspects of the herceptin formulation, including the use of trehalose, "can be reached by the application of nothing other than routine approaches applied to excipients which were part of their common general knowledge".

Therefore, one of Genentech's patents was revoked (EP(UK) 2275119), while the other (EP(UK) 1516628) was restricted to some process claims that were not challenged by Hospira.

Pleasingly for a writer on a cat-themed weblog, the Birssian [an aside from Merpel - what should be the adjectival form of "Birss"?  "Birssesque?"  "Birssonian?"  "Birssacious?" At this point the IPKat intervenes to prevent Merpel going as far as "Birssilicious"] approach to the construction and analysis of product-by-process claims can be seen to be a kind of "anti-Angora Cat" situation, in which the claims are given a narrow construction, and in particular when applying the infringement analysis, but are considered product claims as such for the analysis of novelty.  Perhaps Professor Franzosi can come up with a suitable metaphor for this situation?


This Kat does not of course expect all our dear readers to share his particular joy at this decision, but he hopes that they will share his appreciation of a nugget of fundamental patent jurisprudence in a case that otherwise rather rests on its own facts.  He expects that not all will agree with this view of product-by-process claims and welcomes views either way.


52 comments:

Anonymous said...

Very nice article, thank you.

Anonymous said...

Good to see the UK following sensible EPO product-by-process jurisprudence - just a pity we still have to live with the inconsistency between novelty and infringement for 'obtained by' language. What's wrong with process claims and A64(2) for 'obtained by' protection?

Anonymous said...

I struggle with the concept that something described as a 'novelty rule' can have nothing to do with claim construction...

There are two principles at stake here:

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.

Michael Bates said...

This judgement truly made me excited:
1. it was clear,
2. covered a lot of ground; and
3. it used the EPO’s claim interruption policy to determine the outcome of the case (policy is important and often under appreciated - the EPO policy used: "obtained by" is interpreted as "obtainable by").

I am not sure whether such policy determinations would hold in other jurisdictions such as Australia (I have asked an examiner in IP Australia for their take on this EPO policy).

In Australia we have a “plain meaning” construction and interpretation of “product by process” claims where “obtainable by” offers broader scope for protection than an “obtained by” claim, which is limited to the products that are made by the process stated. This was addressed in SANKYO COMPANY LIMITED v. MERCK & CO INC. [1991] APO 28.

This difference in jurisdictional interpretation of claims through patent office policy needs to be transparent, since as highlighted in this case, it is impacting on judicial interpretation of patents. This, in turn, may result in quite different hearing outcomes. Is this at odds with the international patent treaties and conventions?

Thoughts of others would be appreciated as to the claim interpretation policy used by their respective patent offices. Further, does this impact on patent hearing outcomes?

Anonymous said...

Birss's comments on 'formulation' cases are interesting: 'Formulation patents are one of the kinds of pharmaceutical patent sometimes called second-generation patents, because they do not relate to the drug itself. Such patents are sometimes criticised as an attempt by the pharmaceutical company to unduly prolong its monopoly, after the first generation patent for a drug itself has expired (so called evergreening)'

Anonymous said...

"the judge refused amendment of the claims as granted to include a product-by-process feature requested by Genentech because he considered that the situation did not meet the EPO standard that there was no alternative product definition available"

Is this really the EPO standard? The relevant EPO Guideline doesn't explicitly say that p-by-p claims are only allowed when no other definition is
possible (http://www.epo.org/law-practice/legal-texts/html/guidelines/e/f_iv_4_12.htm), it just says they have to be directed to novel products per se.

This tallies with what is often seen in practice - i.e. examiners will allow p-by-p claims, even if arguably another definition could be used instead, as long as they are novel (and clear).

On the other hand, the EPO IS explicit about how such claims should be interpreted:

"A claim defining a product in terms of a process is to be construed as a claim to the product as such. The claim may for instance take the form "Product X obtainable by process Y". Irrespective of whether the term "obtainable", "obtained", "directly obtained" or an equivalent wording is used in the product-by-process claim, it is still directed to the product per se and confers absolute protection upon the product (see T 20/94)."

Are we following the EPO or not?

Anonymous said...

In response to anon of 9:36 the problem with A64(2) protection is that it is unclear how far the protection of a direct product obtained by the process extends. When does a modification mean it is not longer the 'direct' product. There is much more certainty in having a product by process claim.

Anonymous said...

To Anon at 10:34 - we follow the EPO Boards of Appeal, not the Guidelines, and the relevant BoA decision is T 0150/82, which states:

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.

Anonymous said...

The combination of product-by-process claims (product not capable of being defined by technical features) and protection provided to the product of a process, in my view, covers all scenarios.

Badly drafted product-by-process claims will inevitably cause a problem as courts must limit the claims as the drafter's wording requires. The EPO did not err in demanding the drafter use specific, inappropriate, wording for their product by process claims.

Re the comment of anon at 10:39, the extent to whether a product is materially changed to the extent is no longer the direct product, is clearly a grey area. However, this issue does not apply to the present discussion.

Even with a standard product claim there would be a problem arguing for infringement by a materially-changed product.

Tim Roberts said...

Thank you, IPKat.

"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.

Freddie Noble said...

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.

Anonymous said...

More than "very slightly", I would suggest.

Freddie Noble said...

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".

Darren Smyth said...

Dear Freddie

Thank you very much for your clear and lucid explanations in your two comments. Agreeably, they are pretty much what I hope I would have written myself, although usually I tend to leave comments to others having already had my say, for better or for worse, in the main blogpost.

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.

Kind regards to all the commenters

Darren

Anonymous said...

The cases where it will have an effect would not be rare, far from it. Cases per se may be rare, but that would be because, hopefully, attorneys are drafting their claims correctly. The distinction in construction is not new as it is one of those things I learnt/was taught early on my training.

Darren Smyth said...

To Anon at 12:13 - I am with Freddie. I really struggle to come up with a technical field in which a patentable and valid claim of the "obtainable by" type could plausibly be proved by the patentee to be infringed by a product produced by a materially different process. If you have one in mind, it would be lovely if you could share it.

Kind regards

Darren

Norman said...

Dear Darren,

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?

Thanks for the very interesting post.

Norman

Darren Smyth said...

Dear Norman

Thank you for your kind and interesting comment.

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.

I don’t know if I have convinced anyone, and would welcome further comments.

Best wishes

Darren

Anonymous said...

I see an, um, obvious trap in the discussions here.

If you mean product A, then you do not mean product A'

Whether you are "close" or not, whether "every small detail" is present or not is the trap.

Logic is applied loosely, then tightly, instead of consistently.

As Freddie first says, if you claim a product, then for all intents and purposes - ALL of them - it is the product you are claiming.

To then parse the logic so finely as to say in essence the product is even so ever so different - because of the process - misstates the product claimed.

Darren, as to a realistic example, let me use pure water - H2O - and different inventions of the desalination process.

Any claim that matches the product on the front side of Freddie's example of "the important thing in the claim is the product itself" will necessarily be the water that will come from any other desalination process - or (as it should be obvious) the actual product from the other processes is not the same product.

Anonymous said...

How about a claim to "A formulation obtainable by lyophilising a mixture of A and B"?

Infringing material = air dried mixture of A and B.

Darren Smyth said...

Dear Anon at 19:52

I regret that I really don't understand the "trap" that you are identifying, or who you consider has fallen into it.

If you choose an example where the product is not new - water - still less a product that could not be defined in any other way than by its process of production - well, then that is not a "realistic example" is it?

Real examples are the products of processing or purifying complex mixtures, products of polymerisation, metallurgical compositions, and the like. I am sure that there are many more and I would welcome others. But they tend to be complex.

Do please feel free to clarify the point as I would like to understand it.

Best wishes

Darren

Darren Smyth said...

To Anon at 20:07 - I would expect a lyophilised mixture to be regarded as different from an air dried mixture for the purposes of construction of an "obtainable by" claim. the products are quite different, in appearance if nothing else. I don't see how they can be considered the same product at all.

I even think I can cite judicial precedent for this view, since the Quadrant case referred to in the main post emphasises the difference between the effect of the two processes.
Darren

Anonymous said...

"A mixture of compounds obtainable by oxidising compound A under conditions x, y and z"

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.

Anonymous said...

Compound A obtainable by extracting the coffee beans in my kitchen with my dirty bathwater.

Infringed by a smarty-pants synthetic organic chemist who can identify the compound and knock up a sample in their laboratory.

Anonymous said...

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.

Anonymous said...

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.

Freddie Noble said...

I think I may see the point made by Anon@1952 - though of course it is for them to confirm.

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.

Anonymous said...

Darren, you are determining the facts yourself rather than accepting different facts may apply in respect of my example of a lyophilised mixture. In my example, the facts are (not stated because it was an example) that the lyophilisation product is identical in every way (even appearance if such a technical feature for a life saving drug formulation is considered of value to you) to the air-dried mixture.

Anonymous said...

Water was chosen precisely because it is not a complex product, yet methods of desalination can be complex.

Not sure why you are having difficulties with understanding the logic.

If you want to focus on product, then that focus should receive the exact same scrutiny - and not the different levels as used by Freddie in his discussion wherein the first use was loose (a product, does not matter the process) and the second use was tight (a product, but must be exact per the process).

Plainly put (again), if your product is A' per the tight logic of exact per the process, then it is not A per the loose logic of the process does not matter.

In the discussion above, A and A' are used interchangeably when discussing loose logic and some A Ha! distinction is artificially injected with the application of the tight logic.

The A Ha is a fallacy of inconsistency.

Norman said...

Dear Darren,

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.

Norman

Freddie Noble said...

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.

Freddie Noble said...

Anon @2056 - I do not deny that different facts may apply to your example of a lyophilised mixture. That is partly because I understand the idea of a hypothetical example and partly because I know nothing about lyophilizing things.

But the hypothetical example has been done and understood - see Darren's comment@1919 -

"then I think under UK law as it stands, an “obtained by” claim is not infringed and an “obtainable by” claim is infringed."

I agree with that, but still have not been convinced that this is likely to happen very often, in real life.

Anonymous said...

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!

Anonymous said...

Freddie, have you considered the possibility that your lack of knowledge of lyophilisation processes, possibly also some of the process listed below may be why you (and Darren) can't accept there could be many real-world examples? Could you both accept you may not be right here? Feel free to argue what you believe the law should be but that's a different issue.

Examples:

oxidation process, re-arrangment reacions, extrusion processes, desalination processes, osmotic processes, filtrations processes, hardening, softening, annealing, centrifugation, mixing, stirring, blending, injecting, stretching, not-stretching, crystallisation, spray-drying, etc.

Freddie Noble said...

Anon@2141

Yes I have considered that possibility, and accept that I might not be right. I thought I had made that clear already.

I still say that I am not convinced that it will happen very often. That is not the same as stubbornly asserting that it will certainly not happen very often.

I am inclined to be persuaded by Darren's comments, because he has technical expertise (according to his firm's website) in pharmaceuticals, agrochemicals... and that kind of thing. My kind of thing, on the other hand, is IT and telecoms, an area where I doubt this kind of claim is ever a good idea, or even a possible idea.

Anonymous said...

I have to say Freddie, in an attempt to provide constructive feedback, you need to gain additional experience in patents before coming to such firm conclusions about such matters.

Fabian said...

Thank you for this article and the subsequent discussion. I just came to read all this due to the very useful weekly wrap-up posted yesterday.

I would like to address a point that hasn't received much attention in this discussion: Everyone seems to agree that for the "rule of novelty" the claim is not novel when "the product is identical to a prior art product" (citing Freddie's first post). If infringement would be hard/impossible to prove because - in any given case - the "every single characteristic which is the inevitable consequence of that process" is practically impossible to demonstrate, I fail to see how anticipation by a prior art (assuming a different process) may ever be demonstrated by the Examiner or the Opponent for such a claim.

What else than the "every single characteristic which is the inevitable consequence of that process" criterion would be used when determining novelty? Am I right in assuming that there is no difference between the "rule of novelty" and the "rule of infringement" in case of a "obtainable by" claim?

Fabian

Anonymous said...

Freddie, I am in agreement.

You may be interested in a recent opposition division decision for EP1869035.

The EPO are not best placed for deciding such issues which are highly fact dependant and can be subject to argument amongst experts. In this case, benefit to the patentee may have been given.

To the best of my knowledge the claimed polymorph is the same as that produced by the prior art. This may get more interesting in the near future if this polymorph is of commercial benefit.

Still, all good fun.

Darren Smyth said...

Dear Fabian

Thank you for your comments. I don't think that the burden of proof works this way, although I can find no justification for this.

If the applicant claims "X obtainable by Y" and the examiner can find prior art X, then in practice (and I think this is justifiable) the burden shifts to the applicant to show that Y produces different X from the prior art X. It is not for the Examiner to show that the prior art has every single characteristic which is the inevitable consequence of Y. You may criticise this, but I personally consider it justified because the applicant is invoking a special mixed class of claim, and so should bear the responsibility of demonstrating the consequent novelty of the process-conferred feature.

The different commenters have different views as to whether the "rule of novelty" and the "rule of infringement" are the same or not; I personally don't think that the rules are different, but they do not play out in a symmetrical way, even for an "obtainable" type of claim. I think that is largely because of the respective burdens of proof, which is precisely the issue that you have identified.

Best wishes

Darren

Darren Smyth said...

To Anon at 21:02

Thank you for pointing out an interesting case, but I not sure about the point or the relevance to product by process claims - it is a crystal form characterised by its XRD pattern and like is it not? Or have I missed something?

Darren

Anonymous said...

Relevance to product by process claims =

Claim 1 is a product claim, which is said to be novel over the product produced by a prior art process, so the identification of the product of a process ("obtained by" in this case) requires similar consideration.

Claim 9 (allowed claims) is to "Micronized tiotropium bromide of claims...". Micronisation is a process step, so the claim is to a product obtained by a process.



Freddie Noble said...

Fabian,

I thought quite a lot about your comment and wrote a fairly long reply - which in the end I didn't quite believe so I deleted most of it.

In the end, I would just add to Darren's comment that the applicant, as well as having the burden to show that Y produces different X, also in practice needs to allege that "different X" has some sort of advantage / useful effect as compared to prior art X, if he is to satisfy the inventive step requirement.

I think that this has an effect on the issue you identified. I have tried and failed to exactly articulate what that effect is, but would be interested in comments.

Anonymous said...

"If the applicant claims "X obtainable by Y" and the examiner can find prior art X, then in practice (and I think this is justifiable) the burden shifts to the applicant to show that Y produces different X from the prior art X."

If the examiner finds prior art X then the claim to "X obtainable by Y" lacks novelty. If different X is produced by Y then X is not X, but Z. Z would be novel, because it is not prior art X.

Z must also be inventive because no-one would ever consider producing Z as the skilled person is actually trying to make X to solve their problem. Unless, of course, the skilled would inevitably stumble upon Z while trying to make X, which would lead to a lack of inventive step for Z if Z is for the same use as X.

If Z is claimed for different use to X, then Z must be inventive, because the skilled person attempting to solve the problem solved by Z would not try and make X, which is known only for a different use.

One effect of this practice is that third parties seeking to solve the same problem as X may inevitably stumble across Z; Z being obvious. However they would be prevented from using this obvious development in their field because Z has been patented by another working in a different field.

To comment on Fredies point: Inventive step is assessed in all cases and would be fact-dependant.

At 21:02, I mistakenly (very) stated I was in agreement with Fredie. I meant to say I was in agreement with Fabian.

Freddie Noble said...

>>"If the examiner finds prior art X then the claim to "X obtainable by Y" lacks novelty. If different X is produced by Y then X is not X, but Z. Z would be novel, because it is not prior art X."

I don't think that's right - see Darren's follow-up comment and in particular section 1 "What kind of claim do you mean?":

"Usually a product-by-process claim “X obtained/able by process Y” represents a novel subset of generic X."

In other words, X is not new, but a special type of X, obtainable by Y, is new and may be patentable.

If you can write some description Z which accurately specifies the special new type of X, then there is no need for a product by process claim at all.

Anonymous said...

Sorry, but I've know idea what a special type of X is, could ever have been, or could ever be.

There is a reason why you are not getting this Freddie, and it is simply because it isn't your field of expertise. Never put your finger in a live electrical socket when you can pay an electrician to it properly.

Anonymous said...

On the contrary Anon at 15:05, it is you who show, again and again, that you have no idea.

Anonymous said...

Really Darren? Pray tell!

Anonymous said...

As not a single person has contradicted any of my comments with any explanation and as every single one of the questions posted in reponse to my comments has been simply answered without any further comment, I fail to see on what basis anon at 17:03 has come to the conclusion that I have no idea.

I am always happy to debate if said anon would like to come out and play, rather than throw a limp-wristed punch and then run away to momma.

Darren Smyth said...

Dear Anon at 19:13

I don’t really know where to begin. I don’t really want to engage with you as you are not interested in a proper debate: your comments are a mixture of “bait and switch” misrepresentation of the position that you are arguing against, and condescending ad hominem attacks that have no basis. The problem is that you are sowing confusion in a field that requires careful thought, and I think it would be a disservice to our readers not to point this out.

I don’t know how many of the anon comments are you, but attributing all those in the same tone as you, it seems from a review that every single comment of yours has been comprehensively rebutted either in this or the later thread, usually before it was made, every example that you put forward has been shown not to stand up. (It would help if you signed your comments – it does not have to be your real name, but it would be polite. I, as you see, am using my real name, and I stand publicly by what I write.) Just because the answer does not appear in the next comment to what you wrote, does not mean that “not a single person has contradicted any of my comments with any explanation”.

Your last couple of salvos at 9:43 and 15:05 are breathtaking. If you don’t see that “X obtainable by process Y” is not the same as “X”; that such a claim only makes sense if “X” as such is not novel; then you have not understood product by process claims at all. In fact, you have not understood claims at all, because in claims two integers combine to define a space that is more restricted that that defined by either integer alone. Usually. Of course there are exceptions to everything, but if we keep digging around in the exceptions we never get anywhere. You have alleged product by process features where none exist, and you have denied the force of the limitation where it is clearly there.

The problem is, I think that you do see this. I think that you are perfectly aware of the fallacy of your arguments, and I don’t think for one second that you believe them. So I conclude that you are writing drivel in the comments just for a bit of fun. Well good for you. Actually, it seems that most of our readers understand this, because almost no-one is engaging with you. As I said, it is a bit difficult to see who “you” is, but as far as I can tell, in general, a small number of us disagree with you, no-one at all supports what you have said, and most of our readers are wisely just ignoring you. I should probably do the same, but I am concerned about the person who visits this website in all good faith to find decent information, and finds the waters muddied by your interjections.

There is room for a debate about product by process claims. My view happens to correspond pretty closely to the law in the UK supported by Lord Hoffmann and Mr Justice Birss; it is also the law in the USA according to the CAFC. It is not as I understand it the law in Germany although there are no very clear cases. There is scope for debate on the point but that is not what you are doing. About that, I am sorry.

Anonymous said...

"I think it would be a disservice to our readers not to point this out."

That is very big of you Darren, but you are not the final word on chemistry patenting. Sorry to disappoint you.

It is factually incorrect to state that my points have been answered. You have made quick rebuttals, without explanation, simply "I say so therefore you are wrong." Alternatively, every example I, and others (I am far from being the sole poster who disagrees with you) provide is labelled as an exception. Whenever I have responded to your criticism or answered specific questions you have gone quiet.

E.G. Do you not believe a claim to a micronised product is a product by process claim? I believe it is, but am very happy to reconsider if an alternative argument is put forward.


I have no need to sign off with a name because the arguments speak for themselves and I am not attempting to publicise myself for business development purposes, so I have no need to convince everyone that I am infallible. Nor do I have the power to start a new thread on the blog to advance my cause and bury the contradictions of other commentators.

My reference to Freddie's knowledge is not an ad hominem attack (something that clearly turns the Kats' milk sour), imply an observation that chemistry is not his area, which I understand was admitted. An understanding of these issues requires a thorough understanding of the chemical sciences, even an expert understanding in specific areas.



My comment at 9:43 was written very much tongue-in-cheek, but the argument still stands. If you read it calmly and with an appreciation that there is knowledge within others, you will see that I didn't say:

"If you don’t see that “X obtainable by process Y” is not the same as “X”.

I don't think it takes that much effort to work this out.

Personally, I have no objection to ad hominem attacks made in my direction, but it would me more worthwhile if the points were also debated. Of course, I'm sure the whole of the IPkat community takes your side in criticising me if we take the view that silence means agreement with you. I understand President BattyStelly has just made the same argument.

Darren Smyth said...

In amongst all that I can see only one actual point. I accept that "micronised" is a product-by-process feature. It falls pretty much in the category that I mentioned on the other thread:

'“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.'

But the example that you cited is particularly uninstructive since the feature is in a dependent claim (modifying a crystal form already considered novel by the OD, even though not apparently by you) and nothing whatever seems to turn on it. So I come back to - what was your point?

In fact all of your examples have been implausible, fringe, or beside the point. That is why I do not believe that you are actually trying to debate.

Chemistry may not be Freddie's area, but he has shown himself capable of intelligent and relevant comment. I have yet to see that from you.

Anonymous said...

I thought I'd suggested you calm down before re-reading my post.

In the EP example, which was posted due it being hot of the press, I also mentioned the fact that this covered novelty in respect of product by process of the prior art. Not relevant? This was the reason it was provided for the interest of the other commentator (yes there are others). The mention of claim was honestly mentioned as an answer to your comment, even though it was a supercilious comment.

As for my example only being a dependent claim, what happens when claim 1 is knocked out in court? Do all dependent claims fall automatically, or are they assessed independently? Is Mr Birss not going to consider the effect the process step has on the product?

And are you really trying to tell your loyal fanbase that "micronised tiotropium" is not novel over a disclosure of "tiotropium"? Is it fair to Freddie to teach him this?



Subscribe to the IPKat's posts by email here

Just pop your email address into the box and click 'Subscribe':