by Rachel Mumby

Bexsero, the Meningitis B vaccine marketed by GSK, has been the subject of many newspaper headlines in the UK over the last year, with parents seeking to persuade the UK Government to offer the vaccine to all children under the age of 11 as a matter of routine. Few will have been aware that Bexsero was also the subject of patent litigation in the UK, with GSK seeking the revocation of a patent owned by Wyeth (a subsidiary of Pfizer) and a declaration of non-infringement. Wyeth counterclaimed for infringement, but for public health reasons did not seek injunctive relief. Wyeth has developed its own Meningitish B vaccine, Trumenba, but this has not yet received approval in Europe.

In a lengthy judgment from Carr J, which provides helpful summaries of the law on the skilled addressee, common general knowledge, claim construction, plausibility, added matter, priority, novelty and inventive step (the application of each of which were hotly contested), the patent was found to be valid and infringed.

In order that the reader isn’t left wishing they’d just read the judgment themselves, the note below picks out some of the bigger points.

Common General Knowledge

Carr J applied the legal principles set out by Arnold J, and later approved by the Court of Appeal, in KCI Licensing v Smith & Nephew [2010], but also agreed with Sales J’s statements in Teva v AstraZeneca [2014] that the concept of common general knowledge needs to be kept up-to-date in the age of the internet and digital databases of journal articles. Carr J held that material which the skilled addressee knows to be available on-line and which is generally accepted as a good basis for further action (such as material which might be found off-line in a textbook or key journal article) may constitute common general knowledge. In doing so, Carr J poured cold water on any broader interpretation of Sales J’s statements, whilst acknowledging that the law has to keep up with the changing research practices of today’s scientists and engineers.

Plausibility – AgrEvo obviousness/insufficiency

There was no dispute over the principles to apply in relation to plausibility and AgrEvo obviousness/insufficiency, and once issues of construction had been dealt with, the AgrEvo obviousness allegation fell away. Carr J then considered that both experts more or less agreed that the disclosure of the patent was plausible. Indeed, both experts recognised that the disclosure of the Patent was very significant – even GSK’s expert acknowledged that the patent disclosed a vaccine candidate with promise, and of considerable interest (not therefore an arbitrary, implausible selection).

Carr J also rejected further plausibility arguments, for example that the skilled addressee would be concerned by the fact that data in the patent do not support the killing of some strains of meningococci by all compositions comprising a relevant protein with 100% homology with the equivalent protein of the tested bacterial strain. He held that the skilled person would not be surprised by exceptions to the general trend (especially considering the experiments had been carried out on complex biological systems) and would still consider the claims to the credible. In addition, whilst Carr J accepted that on the basis of the data in the patent, it would be preferable to select a lipidated rather than a non-lipidated protein, that did not make it implausible that a non-lipidated protein would give a bactericidal effect.

Added Matter

The main attack from GSK was that Wyeth had made a series of arbitrary selections from lists. GSK relied on EPO case law such as T 667/08 and T 12/08, together with the EPO Guidelines for Examination, and argued that since a selection from two lists can be novel for the purposes of patentability, then it will also constitute added matter if the selection was not to be found in the application as filed. In a paragraph which will be music to the ears of many patentees who feel scorned by recent harsh decisions on added matter, Carr J held as follows:

In my judgment, selections from two or more lists may well amount to impermissible added matter, but this is not a rigid rule. In order to see whether there is a new combination of independent features from two or more lists, the whole contents of the application as filed must be considered, including its general disclosure. It is necessary to avoid a mechanistic approach, and to compare the disclosures of the application as filed and the patent, through the eyes of the skilled person, in order to answer the overall question of whether the skilled person would learn new technical subject matter which was not disclosed in the application

Novelty

In relation to the first citation, patent application “WO885”, Carr J applied Dr Reddy’s v Eli Lilly [2010] and considered whether the prior art provided a sufficiently individualised disclosure. He acknowledged that this is a matter of degree. Carr J held that the prior art was in “books in the Bodelian” or “leaves in Sherwood Forest” territory, rather than being sufficiently individualised. WO885 included a list of potential antigens by reference to a series of other documents, including patent application “WO280”, and then later in WO885 there was a list of the antigens from WO280. He noted that the relevant sequence is not one that the skilled person is directed to by WO885 (or WO280). In order to pick the right antigen, the skilled addressee would be required to “pluck out” the relevant protein from a list of 1510 proteins from WO280, the references to WO280 in WO885 being no more than a reference to the document as a whole and with no technical information.

The second novelty citation was to the prior use of a Cuban Vaccine. However, Carr J found that on the balance of probabilities, this vaccine did not contain the relevant protein pre-priority. Even if he was wrong on that, after carefully considering the House of Lords case of Merrell Dow v Norton [1996] (which he noted to be consistent with the EBA in G1/92), Carr J found that there would have been no enabling disclosure. Carr J held that if the Cuban Vaccine could not be analysed to identify the presence of the relevant protein, then the supply of that vaccine and its administration to patients conveyed no information which would have enabled anyone to work the invention. For the Cuban Vaccine to anticipate, it must have been possible for the skilled person to identify the presence of the relevant protein in the vaccine and to reproduce it without undue burden – Carr J found that GSK had not proved that it would have been possible to identify the relevant protein either at all or without undue burden. In addition, the relevant protein was in such low abundance in the Cuban Vaccine that it would have made no material contribution to the immune reaction (thus not anticipating claims 18-20 mentioned above).

Inventive Step

Carr J once again set out the relevant legal principles and, following the trend in recent cases, criticised GSK’s expert for hindsight. GSK’s expert had come to the cited prior art with knowledge of the protein of significance to the case. He had obtained this from reading 885 (and 280), the patent application cited for novelty in this case – yet again showing the importance of giving the expert the documents in the right order.

Conclusion

This will be a comforting decision for patentees facing attacks on all possible grounds, and wondering whether it will be possible to fight all of them off without being squeezed on multiple fronts into any traps. Carr’s non-mechanistic approach will also be welcomed by the patentee community. However, with quite so many points in issue, and GSK only needing to win one of them to get a different outcome, we expect to see an appeal.

A link to the decision can be found here

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5 comments

  1. II would like to comment on added matter.

    Whether one likes it or not, added matter and novelty are the two sides of the same coin. One is not available without the other. Some decisions of the Boards of Appeal might seem harsh, but at least a coherent system has been set up by the latter.

    Citing T 12/08 in the context of added-matter appears difficult to follow, as Art 123(2) did not play a role in this decision, see Point 2 of the reasons.

    Next to T 667/08, it is worth mentioning T 2619/11, which aimed at a more “intelligent” look at the claim structure.

    In T 1363/12, the BA made clear that decisions on Article 123(2) EPC are very case-specific and care should be taken in applying statements of Boards of Appeal made in the context of particular factual situations to other factual situations. T 1362/12 made as well clear that the Boards of Appeal were not willing to water down their position on added matter.

    I fail to appreciate why J. Carr’s statement on the selection in multiple lists should be music to the ears of many patentees. It merely confirms what was said in T 1363/12.

    Without pointer to one element of one list towards an element in the other list, we are in presence of an arbitrary selection which brings in added subject-matter. As an example, if some members of one list are “preferred”, then a combination of “preferred” elements from each list could then well be considered as directly and unambiguously disclosed in the originally filed documents. But the combination of “preferred” members of one list, with non-preferred embodiments of the other one cannot be said to be originally disclosed. The same applies mutatis mutandis to combinations of “preferred” elements of a single list. But then all “preferred embodiments have to be combined, not just some.

    The criterion to be used is indeed novelty, and what matters is not what the person skilled in the art could have envisaged in view of his general knowledge, or looked plausible and was thus worth attempting, but what has been directly and unambiguously disclosed.

    It is however correct to state that a mechanistic approach in added matter is not what should be done.

  2. The comment from DX Thomas just leaves me even more impatient to read the Decision in full. But I see no Link. And these days I find the BAILII route frustrating. What have they done to its search function? It has been degraded, no?

    So, can the Blog, the writer of the piece, or another reader, kindly provide a Link that works? Hope so.

    1. You need to be a specialist in biotech to be able to follow the reasoning on added subject-matter in the decision. There are probably pointers from one list to another, but you need to be acquainted with the matter to decide whether this is the case or not.
      Drawing some conclusions which go further than the actual case seems a bit daring. I maintain my earlier comment.

      May be Max Drei will shed some light on the matter?

      1. Sorry D X Thomas, that I cannot do much to illuminate. In London, the judge will decide what is clearly and unambiguously derivable by following the course of cross-examination, two meters in front of his nose, of the two different technical experts appearing as witnesses, one for each of the opposed parties. The judge is bound by this evidence, when coming to a conclusion. I think it is not like this in any mainland European civil law jurisdiction.

        Each of these technical experts has put in a lengthy written expert opinion some weeks before the trial and it is this on which he or she is cross-examined. You can probably guess how hard it is, under questioning for a day and a half in the witness box, fielding questions formulated by the other side’s technical expert, if there is anything in your expert opinion that is other than rigorously defensible. One needs to bear in mind too, that each of the experts has it heavily impressed on them, from the outset, that their duty of truthfulness is not to their paymaster but to the court. You can imagine how jealous professors of chemistry from the Universities of Oxford and Cambridge are, when it comes to burnishing their reputations for intellectual rigour. Against attacks on their position launched by the rival professor from the other university, they are going to be extremely cautious and circumspect, in the evidence they give. After all, the game they are laying is to get the judge to go with their line, and not that urged by the expert on the other side.

        All this makes it relatively easy for the judge to discern what was, and what not for the hypothetical skilled person “directly and unambiguously derivable”.

        Daniel, have you watched a patent case in London, I wonder. The x-exam of the experts is enormously exciting, at least when you have an interest in the outcome.

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