Novelty does not necessarily mirror infringement: product-by-process claims

Author: Darren Smyth (EIP)

Hospira UK Ltd v Genentech Inc [2014] EWHC 3857 (Pat), Patents Court, England and Wales, 21 November 2014

Journal of Intellectual Property Law & Practice (2015) doi: 10.1093/jiplp/jpv030, first published online: February 21, 2015

Mr Justice Birss expounds, interprets and applies the law on construction, novelty and infringement of patent claims that have a ‘product-by-process’ feature.

Legal context

It is frequently held as a fundamental tenet of patent law that, according to the ‘post-infringement’ test for novelty, tests for novelty and infringement must mirror each other: ‘what infringes if after, anticipates, if before’. This was affirmed under pre-1977 law in the UK by the Court of Appeal in Windsurfing International Inc v Tabur Marine (Great Britain) Ltd [1985] RPC 59, which stated ‘the notion behind anticipation is, as we understand it, that it would be wrong to enable the patentee to prevent a man from doing what he has lawfully done before the patent was granted’. However, there are in fact recognized under the current Patents Act 1977 many situations where the novelty test does not mirror the infringement test. For example, it was confirmed by the House of Lords in Synthon BV v Smithkline Beecham plc [2005] UKHL 59 that it is necessary, when considering novelty, for the prior art to have enabling character, whereas there is no equivalent requirement in the infringement test.

The European Patent Office (EPO) interprets a ‘product-by-process claim’—that is, for example, a claim in the form of ‘Substance X obtained/obtainable by process Y’—as a claim to the substance as such. If X is not novel, and if process Y does not necessarily impart some novel feature to X, then the claim is held to lack novelty. This is so whether the language used is ‘obtained’ (on the face of it a narrower wording) or ‘obtainable’ (on the face of it a broader wording).

The question that therefore arises is whether a product-by-process claim should be given a similarly expansive construction for the purposes of infringement.

Facts

The dispute underlying the case concerned two patents, EP (UK) 1 516 628 and EP (UK) 2 275 119, belonging to Genentech, which are divisionals from the same parent. They both relate to lyophilized (ie freeze dried) formulations of trastuzumab, the antibody that is the active ingredient in the well-known anti-cancer drug Herceptin.

Claim 1 of the 628 patent had two product-by-process features, one of the narrower type, ‘lyophilized mixture’, and one of the broader type, ‘obtainable by lyophilizing’ a particular solution. The scope of both the narrower and broader expressions in relation to both novelty and infringement was considered.

Analysis

The leading case previously concerning product-by-process claims is the House of Lords decision in Kirin-Amgen Inc v Hoechst Marion Roussel [2004] UKHL 46, which relates to recombinant erythropoietin. In that case, on the matter of novelty of the product-by-process claim (Claim 26) Lord Hoffmann held (as Birss J summarized) that

a difference in the method of manufacturing did not make a product new and that was so as a matter of law. On that basis the claim could only be novel if the process definition gave the product a new characteristic of some kind.

Because recombinant erythropoietin (rEPO) was not shown to be distinguishable from naturally occurring urinary erythropoietin (uEPO), the claim was held to lack novelty. Thus, on the issue of novelty, Lord Hoffmann aligned the UK approach with that of the EPO.

However, as Birss J observed, this holding in Kirin-Amgen was not a rule of ‘mandatory claim interpretation’, but rather one of novelty. That is because

the House of Lords also decided that the defendant's rEPO did not infringe the patent because it was not the product of the expression of a gene in a host cell … Thus Lord Hoffmann was applying the process feature as a relevant limitation which was not satisfied for the purposes of (non-)infringement but ignoring it for the purposes of novelty. That can only be on the basis that the product by process rule is a rule of novelty law, not claim construction.

This disjunction between novelty and infringement in Kirin-Amgen only emerges from a very careful reading of the judgment and is easily missed. Birss J perhaps had a special understanding of the case from having acted as counsel in the proceedings. He accordingly distilled the following principles from the UK and EPO authorities in relation to product-by-process claims:

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.

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. 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. On this basis, when construing the claims for infringement, the narrower formulation was construed 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.

In contrast, in relation to the ‘obtainable by’ language, Birss J pointed out that for such a claim to be infringed if 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.

Thus, even for the broader language, it may practically be very difficult for a patentee to demonstrate infringement of the claim by a product prepared using a different process from that specified in the claim.

Practical significance

Mr Justice Birss's approach to novelty in this decision accords with that of the EPO, as the UK law on novelty has consistently been under both Synthon and Kirin-Amgen. There is no EPO law on infringement, as that is a matter for national courts. German courts have, for example, tended to take an expansive approach to infringement of product-by-process claims, analogous to that adopted by the EPO for novelty, and have considered that a product can infringe if produced by a different process, in principle irrespective of whether ‘obtained’ or ‘obtainable’ language is used, provided that the product has the same ‘fingerprint’ as that produced by the process of the claim. Even though the present decision arguably only makes evident what was always the case under Kirin-Amgen, for the first time there is clearly a divergence between the UK approach and that of other European jurisdictions.