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):
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:
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.
"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.