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In 2012 Member States and the European Parliament agreed on the "patent package" - a legislative initiative consisting of two...

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Product-by-Process Claims

When one has an allowable patent claim for a new and inventive process, is there any need to also claim the product of that process, in a product-byprocess claim?

If the product is itself new, a claim to the product as such, independent of any process steps, would be very useful, but can a patent be granted for the product of a process merely because the product derives novelty from the process by which it was made?

These questions arise again and again in a wide variety of fields from expression of proteins by recombinant DNA techniques to semiconductor manufacturing techniques and the resulting devices.

Product-by-process claims come in many forms. A common formulation is "product X formed by the process of claim 1". Such a claim may be allowable provided that product X is in some way new. Other formulations mix product features with process steps (e.g. "A machine element comprising at least one fitting member pressure-fitted on a shaft as in the Nippon Piston Ring appeal, T0059/97, discussed below). EPO Guidelines only permit product-by-process claims "where the product cannot satisfactorily be defined by reference to its composition, structure or other testable parameter".

A claim to a patented process extends, under Article 64(2) EPC and national law equivalents, to "products directly obtained by such process", so one might take the view that claims to "product X formed by the process of claim 1" are unnecessary. Clearly, until the Enlarged Board of Appeal says otherwise, the claims in the Broccoli and Tomatoes cases are exceptions - in those cases the processes are excluded from patentability and the question remains whether the products of the processes ought to be excluded also.

More generally, device or product claims that include process steps may suffer from the same evidentiary burden as process claims. To prove infringement, one may still have to obtain access to the alleged infringer's process to establish that the product was made by that process. The process limitations cannot be disregarded, and complex issues surrounding infringement of such a claim may arise.

Nevertheless, product-by-process claims will continue to be useful in those cases in which the product cannot be described by its structure as such. Steels and alloys are an example.

A problem with relying on Article 64(2) is that such protection is limited to the direct product, which has been narrowly construed in the UK and Germany to exclude products with any intervening steps. It provides protection only where the process is claimed right to the very end.

If the invention lies in, say, motion capture, this would require describing and claiming the subsequent rendering, recording onto a digital medium or printing onto celluloid etc in order to claim the process right up to the finished product which is put on the market. Moreover, such a claim would be narrow and infringement would be uncertain, because an infringer might add some extra step along the way.

The leading UK authority on whether a product is obtained "directly" by means of a patented process is Pioneer Electronics Capital Inc v. Warner Music Manufacturing Europe GmbH [1997] RPC 757, which (following German case law) establishes that the product obtained directly by means of a patented process is the product with which the process ends and it does not cease to be such a product if subjected to further processing which does not cause it to lose its identity. Further processing does not cause the loss of identity where the product retains its essential characteristics.

The evidentiary problem of proving infringement of a product-by-process claim is illustrated in the lengthy UK Court of Appeal judgement in Medimmune v. Novartis, in which many pages are devoted to the question of whether the ranibizumab sold by Novartis was a direct product of Medimmune's patented process.

As can be seen, lawyers can raise many defences under Article 64(2) EPC, but applicants will still wish to protect their products with a product claim. Decision T150/82 recognises, for example, that whether the importation of products made by a patented processes is prohibited under Article 64(2) EPC when the manufacture has taken place in another country is a matter which must be decided by national courts. Accordingly, there will continue to be a demand for product-by-process claims.

This brings us to our second question - what if there is some vestige of evidence in the product itself indicative of the process by which it was made? The product could be claimed in terms of its features, independent of the process steps. Such a claim would surely be valuable. Can such a claim be granted merely because the product derives novelty and inventiveness from the process by which it was made?

It is well established both at the EPO and before the UK Court and indeed the Courts of Germany that a claim to a product must be new and that a difference in the method of manufacture of a product that is otherwise identical to the prior art does not make it new. We discussed this point in our Autumn 2004 edition of this newsletter, when the House of Lords ruled in Kirin-Amgen v. TKT.

EPO case law goes further and says that the "product-by-process" claim must be interpreted in an absolute sense, i.e. independently of the process, and that even if the product is new it still does not involve an inventive step merely because the process for its preparation did so. It appears that this question has not yet been put to the test before the UK Courts, and indeed EPO case law is not as settled on this point as it might seem. Decision T0059/97 Nippon Piston Ring draws a distinction between chemical products and other fields and the mechanical field in which the method of manufacturing a product "often does leave its mark on the finished product".

This causes us to raise the question as possibly unsettled as to whether a product that has some vestigial feature resulting from the process by which it was made, a feature that is novel but perhaps imparts no advantage to the product, might be patentable because (a) it is novel and (b) there is no rationale why a person skilled in the art would create such a product. Indeed, the product solves a technical problem, albeit that the problem lies in a better way of manufacturing the product.

EPO examining divisions apply inventive step analysis to the product claim independent of the process. We speculate that the Board of Appeal will do so too.

In the case of the Nippon Piston Ring, the product in question was "a machine element comprising at least one fitting member pressure-fitted on a shaft" and was thus a claim to a product made by a certain process step, and the Board of Appeal identified at least one difference between the finished product and the prior art, which was the diameter of the shaft adjacent the fitting member. Clearly the product was novel. Was it also inventive? The problem was defined as "finding a way around the difficulties associated with the camshaft assembly of the prior art" and the solution lay in the relative dimensions of the inner surface of the bore and the protrusions on the shaft. The product was easier to form and it was no longer necessary for the fitting member to be harder than the shaft. The Board of Appeal merely concluded that the person skilled in the art would not have been led from the prior art camshaft towards the claimed solution, so it was not obvious.

Note that in Nippon Piston Ring, there is a certain nexus between the process and the novel feature in the product, viz. the pressure fitting process and the relative sizes of the bore and shaft. Each can be said to solve the problem in the prior art. Note also that Nippon Piston Ring can be distinguished from other product-by-process cases in that the product claim was interpreted by the Board of Appeal as a claim to two parts (the fitting member and the shaft) and to instructions for assembling these parts.

By contrast, if the vestige of the process that "leaves its mark" on the product does not in any way make the product a better product, is it enough that it might, for example, be a cheaper product by virtue of its process of manufacture?

Strictly speaking, the determination of the "technical problem" for EPO inventive step analysis does not necessarily imply that the technical solution is a technical improvement over the prior art (Guideline G, VII, 5.2 seventh paragraph), but in practice EPO Examiners expect product claims to exhibit some technical advantage. We look forward to seeing a case in the mechanical, or perhaps the semiconductor field, of a claim to a product that is novel merely by virtue of vestiges of its process of manufacture, where those vestiges are the direct and unambiguous result of the process but do not themselves impart any advantage other than the advantage derived by the process.

In the meantime, those drafting patent applications, especially PCT applications that may be processed at the EPO, should avoid relying on device claims defined in terms of steps by which the device is made. To do so risks being caught on the horns of a dilemma. The claim may be refused for lack of clarity, because one cannot tell whether the device is made directly by the process steps, and clarification by replacing the process steps with features that define the product exclusively by its physical attributes may be impermissible without raising an objection of added subject matter under Article 123(2).

In practice, if the process steps can be replaced directly and unambiguously with the resulting characteristics of the product, the amendment to the claim should be permitted and indeed the necessary nexus should be established between the inventiveness of the process and the inventiveness of the product (or in the words of the above-cited Guideline "all claimed embodiments exhibit the technical effects upon which the invention is based"), but it is so much better to avoid these uncertainties by clearly demarking product claims from the outset by the avoidance of process steps.

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