Early Certainty: “Quality first!”

Interviewees:

• Dr. Jürgen Dressel, Head of Global Patent Litigation Strategy at Novartis Pharma
• Dr. Helmut Buschmann,?Head of Chemistry, Pharmaceutical Development and Patent Affairs at AiCuris
• Dr. Rainer Wessel,?Managing partner at MIM Germany
• Andrea Sparwasser,?Manager R&D and IP at Sphingotec GmbH

EuroBiotech
What is the early certainty initiative about?

Andrea Sparwasser (Sphingotec)
With the ECI, the EPO aims to improve and speed up its services. In a first step termed Early Certainty from Search, the EPO has reduced the time of patent search to six months on average, which was widely applauded by the life science sector. This year, the EPO started to extend early certainty to opposition, cutting time for the procedure from the current 26 months for cases with no specific legal complications down to just 15 months. However, concerns are related to a third element dubbed “Early Certainty from Examination,” which the EPO has adopted most recently. Patent applications will be concluded, on average, within 12 months after the start of the examination procedure. The prosecution deadline is no longer optional, as under the current PACE programme of the EPO, but mandatory. This might affect life sciences companies negatively.

EuroBiotech
What problems could arise for pharmaceutical companies from a plan to grant an EU patent 12 months after an application? Early certainty and rapid results sound good.

Jürgen Dressel (Novartis)
In principle, nobody can be negative about the Early Certainty Initiative. If certain conditions are met, everybody is interested in getting a patent early. However, we in the pharmaceutical sector are in a special situation. Though we have very long development times and a 90% risk of Phase I candidate drugs failing before market approval, we must file our patent applications at a very early stage. This situation implies that we don’t know exactly when applying for a patent where its future focus will be and which embodiment of the invention is the most valuable. Hence, there is a range of situations, in which we are interested in our patent being granted later, as we aim to protect our invention as effectively as possible. So, it is crucial to find the right balance between broad and specific IP protection, to assure that the right invention is protected, even when the broad patent shield is fragmented. It would be fatal if we received a patent after 12 months of examination for something that is not longer of interest for us. 

EuroBiotech
Does this also apply to biotech SMEs?

Helmut Buschmann (AiCuris)
The impact of Early Certainty for Examination depends on the patent strategy and, particularly, whether core patents are affected. If core patents are concerned, it could have advantages or disadvantages, as there is a fast decision on whether the patent is granted or refused. On the one hand, time is too short to provide data that may support the invention. On the other, after the patent is granted, significant, cumulative “nationalisation“ costs are due, which must be factored in. For complex biotech patents, that could be a five-digit euro amount in the first year when a company applies in all EU countries. This might affect patent strategies: companies will only apply for inventions with high chances of business success, so there will be more patents with a narrow focus leading to another cost explosion.

Rainer Wessel (MIM Germany)
Another problem, which might affect both biotech SMEs and academic tech transfer offices, affects licensing. If patents are rushed to granting in a mandatory way at an early development stage, before clinical proof of concept can be demonstrated, there will be a greater risk that the most effective drug is not protected by a claim. It will be fairly impossible, then, to find licensees. At the same time, validation costs must be paid at a development stage, when there is no chance to commercialise the invention. This could affect the whole value chain, from universities over biotechs, to licensees from the pharma sector. But don’t get me wrong. In principle, it makes sense to have the opportunity for accelerated examination, particularly for applications regarding diagnostics or life sciences research products. The problem is to make rapid examination mandatory for all companies of all industrial sectors with their very different needs, but not optional, as under the previous PACE programme of the EPO. It would be better to keep it as is.

EuroBiotech
The EPO wants to speed up the time for examination but also to remain a top player concerning quality. Isn’t this an apparent contradiction?

Buschmann
Currently, quality is very high. However, if the pressure increases on patent examiners to examine as many applications as possible, quality will suffer. Quality of patents is relevant when it comes to litigation. Biotech investors will assess how robust the patent portfolio is when it is challenged.

Wessel
Patent examination is complex and requires a lot of experience, particularly in the case of complex life sciences patents. So, when timelines are reduced without hiring experienced patent examiners at the same time, it is highly probable that the high level of quality can’t be maintained. 

Sparwasser
According to information published on the EPO website, current plannings of the patent office foresee the hiring of a high number of young patent attorneys right out of the university, in order to fill the gap and reduce the pressure on patent examiners. 

Dressel
If this holds true, it might have two effects that could affect the excellent international reputation of patents granted by the European Patent Office, which plays an important role in litigation. On the one hand, there could be many additional, unexperienced patent examiners at least initially; on the other hand, experienced patent examiners, who will be responsible for their training, would have less time for the substantial assessment of our complex patents. This might imply that formal aspects will play a major role when it comes to accelerated examination. It would be bitterly disappointing for an applicant, who is totally dependent on a high-quality assessment of his invention, to get a quick refusal based only on formal reasons such as lack of clarity.

EuroBiotech
What would be the best solution for life sciences companies with regards to early certainty?

Buschmann
For biotechs, it would be ideal to have the right to choose an accelerated examination, as under the existing PACE programme. The Early Certainty Initiative just provides an apparent certainty. Unfortunately, there was no stakeholder dialogue prior to the rapid establishment of the Early Certainty Initiative by the EPO. Many life science companies were caught unawares by the development and now have to find a way to deal with it. 

Dressel
From a pharma applicant’s standpoint, the PACE procedure is sufficient to create legal certainty. If there is a third party interest apparent, for example, from Third Party Observations, now, the EPO already switches automatically to accelerated examination.

Sparwasser
For the future, it would be highly appreciated to have a process that suits both third parties and applicants in the technical field with short product life cycles, and those in  the life sciences with long development times. For us, quality comes first, and fast timelines, second.