IP SPOTLIGHT OCT 23

Did the Delegate ask the correct questions?

The main concerns considered in the decision related to:

That no one had ever done it before, despite the obvious benefit of reducing side-effects, could point to the inventiveness of the claim. It is for this reason that we have reservations over the completeness of the Delegate’s reasoning on this critical point. Since these important questions were not asked, we believe that the Delegate may have been at risk of using hindsight to arrive at their conclusion of obviousness, having already been aware of the final solution and its benefits (i.e. reducing interference in combination vaccines) and neglected to acknowledge that interference in claim 1 of ‘535 was not relevant. Separately, consideration was also given to the term “substantially free” in the phrase substantially free of both (i) IgG and (ii) antigen-bound immunocomplexes. Whilst no clear definition was provided in the specification, the Delegate determined that sufficient evidence was provided in the examples and tables to allocate this term a clear, measurable, numerical value. Whilst this was resolved in the Applicant’s favour, this serves as a timely reminder to Applicants that including vague and imprecise terms such as “substantially” in the claims brings with it the risk of opening up such terms to attack. TAKEAWAYS This case highlights the dangers of combining proceedings in patent applications of similar subject matter. It is clear that the Opponent and the Delegate centred their line of questioning around issues which were not relevant to the claim in question and therefore should not have been discussed. It is also our opinion that the Delegate may have been prejudiced by matters which should have been considered later, and asked the wrong questions and potentially allowing themselves to be influenced by motivations discussed in relation to the other applications which should not have been considered until after a decision in the ‘535 application had been made. Lastly, this case serves as a timely reminder for Applicants that it is always prudent to clearly define each term in the claims, or to avoid vague terms completely, rather than hoping to rely on remedies in the examples and results. Zoetis have since filed a Notice of Appeal against this decision and we look forward to reporting the outcome of this appeal.

The Delegate’s decision states that:

– – was it obvious to produce a pig vaccine from the soluble fraction of the culture (rather than with the whole cells included)? Although not common general knowledge at the time, this was found to be obvious in light of the prior art – – was it obvious to remove neutralising antibodies and immunocomplexes from a pig vaccine to reduce interference? – – was it obvious to produce a combination vaccine? [Found to not be obvious] – – was it obvious to manufacture the combination vaccines in a one-bottle, ready-to-use single formulation, rather than as a multi-dose/multi-bottle vaccine? [Found not to be obvious]? Turning to question (2), in the Decision under the heading “The Problem”, the Delegate noted that the specification discusses the disadvantages of interference in prior art multivalent vaccines and this is where the Opponent focused their evidence. However, claim 1 of ‘535 is a single-target vaccine (where interference is not relevant) and there was no suggestion in claim 1 of it even being compatible with other antigens, so it is unclear as to why the discussion turned immediately to interference observed in multivalent vaccines (the concept of a multivalent vaccine was not introduced until claim 3). The Delegate found that it was obvious to remove non- specific antibodies from a single-target veterinary vaccine, despite there being no evidence of this having been done before in a pig vaccine (evidence in human vaccines was presented but not pig), and despite all the discussion around the possible motivation being directed to reducing interference in multivalent vaccines. When questioned how to produce the Applicant’s vaccine starting from the prior art, the Applicant’s expert provided a routine method of simply using a different serum which was less likely to contain antibodies in the first place. However, this response was again in relation to a question about reducing interference in multivalent vaccine production, rather than in response to a question about why one would want to remove the antibodies from a single-target vaccine where interference was not an issue.

I, therefore, find that from (the Okada documents) either using a separate step to remove immunocomplexes and IgG or to start with fetal serum would have been a routine step that the person skilled in the art would have done. Claim 1 of the ‘535 application does not involve an inventive step in light of the Okada documents and the common general knowledge. In our opinion, the questions should not have been was it obvious how one would arrive at the claimed invention from the prior art invention? or how would the skilled addressee reduce interference when producing a combination vaccine? , but rather why would one be motivated to arrive at the claimed invention in light of the prior art and CGK? If it was so obvious to remove non-specific antibodies from a vaccine, why had it not been done before in any single-target pig vaccine? It is these critical questions which we believe were not addressed by the Delegate. It is a well-known principle that if a claim solves a “long felt need”, there is a presumption that it is not obvious, as other inventors must have also tried to solve the need and not succeeded: “... the question of obviousness is probably best tested, if this be possible, by the guidance given by contemporaneous events. ... If an invention has resulted in the solution of a problem which has been troubling industry for years and achieves immediate success upon its introduction, then the suggestion after the event that the step was obvious inevitably rings a little hollow.” Solving a long-standing problem using a routine solution that no one had yet thought to implement is useful evidence to prove that the person skilled in the art would not be directly be led as a matter of course to try [the invention as claimed] in the expectation that it might well produce a useful result. We find it very curious that the Delegate did not address this in their considerations. No discussion was provided as to whether or not the evidence concerning human vaccines influenced the Delegate’s decision. Nor was the inventiveness of the purifying step discussed in relation to addressing the long-standing issue of side-effects. (Lucas and Another v Gaedor Ltd and Others [1978] RPC 297 at page 358).

DONNA MEREDITH Associate

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