Plausible Pharmaceutical Solutions

Article from our Winter 2008-2009 edition of InsideIP.

In June 2005, a biotechnological Board of Appeal (BoA) of the EPO handed down a decision with potentially far-reaching implications for those seeking to file patent applications in other areas, not least in the pharmaceutical sector. More than three years on, it is now appropriate to review the impact this decision has had on case law since and to question whether filing strategies should be altered accordingly.

A Plausible Solution

The decision in question, T 1329/04, related to the discovery of a new polypeptide GDF-9. This polypeptide was claimed to be a new member of a particular family of polypeptides, the TGF-B family. The application as filed only characterised GDF-9 structurally. Unfortunately this structural data strongly suggested that GDF-9 was in fact not a member of the TGF-B family. Thus, in spite of laterfiled evidence showing that GDF-9 was a member of the family by virtue of its biological activity, the BoA refused to acknowledge the presence of an inventive step on the grounds that it was not credible at the date of filing that the problem of the provision of a further member of the TGF-B family had been solved.

Whilst the fundamental issue in this case appears to be the contradictory nature of the evidence in the application as filed, in reaching its decision the BoA stated that it must be ‘at least made plausible by the disclosure in the application that its teaching solves indeed the problem it purports to solve’ and that ‘supplementary post-published evidence … may not serve as the sole basis to establish that the application solves indeed the problem’.

In the context of the facts of the case the above statements may seem reasonable enough, however their potential impact when applied to other cases is immense. In particular the question arises of just what is meant by ‘plausible’, i.e. how much evidence should be supplied in the application as filed?

When filing applications in the pharmaceutical sector drawn to, for example, new compounds, new formulations or new polymorphs, it is not uncommon forvery little or even no evidence of the efficacy upon which the arguments for the presence of an inventive step rely (e.g. biological activity, stability or dissolution rate) to be included in the application as filed. Traditionally, the EPO has allowed such evidence to be submitted at a later date provided that any effects demonstrated are at least hinted at in the application as filed. In the worst case scenario, however, T 1329/04 suggests that this may no longer be allowed, leaving vast numbers of applications irreparably compromised.

The Consequences to Date

As of yet none of the technical BoAs relating to the pharmaceutical or chemical sectors have considered T 1329/04 in their decisions, thus its precise impact in these sectors is hard to deduce. The decision has however been discussed in 11 other BoA decisions to date, all in the field of biotechnology.

Regrettably there seems to be no clear-cut common ground between these decisions as to when supplementary post-published evidence will or will not be allowed and what is meant by ‘plausible’. A number of decisions have followed T 1329/04 and refused to allow supplementary evidence, some even when there is no apparent contradiction in the application as filed, whilst others have ignored T 1329/04 and allowed supplementary evidence to be submitted. In spite of the above, there are a number of trends which appear to be emerging from the case law as a whole. In particular, it seems that where the application as filed apparently contradicts itself, such that there is serious doubt in the mind of the skilled reader that the alleged effects will in fact be displayed, this will prove fatal.

It also seems for the most part that where there is at least some evidence of efficacy in the application as filed, even if that evidence relates to a substance similar to but not actually falling within the claims, then supplementary evidence will be allowed.

What is less certain however is whether or not the EPO will allow supplementary evidence when there is no evidence whatsoever of efficacy in the application as filed. Whilst some of the BoA decisions appear to lean towards the position that at least some evidence of efficacy must be included in the applications filed for an invention to be ‘plausible’, this approach has not been universally adopted. Furthermore, some criticism of this approach has been  forthcoming from the national courts, most notably in the recent UK House of Lords judgement in Conor Medsystems v Angiotech (discussed at length by Eimear Ward in a recent news article, see http:// www.vennershipley.co.uk/show-news-id-37.html).  In this case, a stent coated with a specific drug (taxol) was considered inventive in spite of the fact that the application as filed included no evidence demonstrating that the drug would exhibit the alleged efficacy (the prevention of restenosis). Thus there is clear pressure on the EPO not to require that at least some evidence of efficacy must be present in the application as filed.

Strategic Implications

Faced with the above uncertainty, anyone filing a pharmaceutical patent application drawn to a new compound, formulation, polymorph or similar and relying on some biological, physical or other effect in support of inventive step is faced with an unenviable choice. Do you file the application without any evidence of efficacy and risk the EPO refusing the application for a lack of inventive step, or do you wait until you have obtained some evidence of efficacy and risk your invention being anticipated in the intervening period?

The answer to the above question will depend very much on the facts of the case, and of course any of the pharmaceutical specialists at Venner Shipley will be more than happy to guide you in this respect. As a general rule however, unless the evidence of efficacy is already available or can be obtained particularly quickly, we would normally recommend filing a priority application at the earliest possible opportunity, especially in highly competitive fields.

However it is of course prudent to try and include at least some evidence of efficacy (however slim) before the end of the priority year and at the latest in any subsequent patent application claiming priority from the initial application. In so doing, the applicant will then have captured the earliest possible protection in any subsequent patent application claiming priority from the initial application. In so doing, the applicant will then have captured the earliest possible priority date for his invention whilst also ensuring as a fall-back position that there is some evidence of efficacy in the application as filed, even if not in the initial priority application.

Finally, it must be stressed at this point that there is no particular need for alarm amongst those who have applications pending but no evidence of efficacy. It is still very strongly arguable, particularly in view of the lack of any BoA decisions in the chemical or pharmaceutical sector considering T 1329/04, previous EPO practice in this regard, and the UK House of Lords judgement, that supplementary evidence of efficacy should be allowed before the EPO.

We at Venner Shipley will of course continue to monitor the situation as the case law in this area develops.

Allie Elend 13 Feb 2009

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