28 June 2013Biotechnology

Quality control: biotech at the EPO

What is your role and responsibility at the EPO?

First, I’m a member of the management team for the biotechnology cluster. The operational part of the EPO, which is called DG1, is composed of 14 clusters of all different technical fields, and biotech has its own cluster. It’s composed of nine directorates, each composed of 25-30 people.

All directorates have specific technical fields, and I’m one of the nine directors dealing with biotech in the biotech joint cluster. I coach and manage a team of qualified engineers working as patent examiners. The cluster produces about 10,000 searches per year and delivers approximately 6,000 granted patents and hears about 200 oppositions annually.

What is your background?

I studied molecular biology at the University of Strasbourg—I worked there for a bit and very quickly afterwards I joined the EPO. That was in 1990. I started as patent examiner in Munich—I did that for 10 years. I did some quality audits for four years in the field of biotechnology. Then I became a director in 2006. The job of a patent examiner is to search, examine and grant patents.

This is done in three languages: English, French and German. The examiner applies the regulations of the European Patent Convention— examiners are experts in the technical and legal aspects in the procedure of patent granting. We have about 230 examiners in biotechnology, spread between Munich and The Hague.

Is it easy to recruit the quality of the people, given the technical demands?

It is a challenging task. The examiners we have recruited over are very good—the selection was at a very high level. About 90 percent of our examiners have a PhD; they are all scientists. The difficulty is to develop their skill on the legal side of the patent procedure. We have to train them to the necessary level on the legal challenges.

What are the other major challenges?

One of our key challenges is to continue improving the operational quality—our stakeholders say that we offer the best quality—our office has the reputation of being the best patent office in the world. Of course, if we are complacent we are not good enough, so we always try to improve not only the quality of our day-to-day work, but our efficiency in core tasks as well.

We have many operational quality projects, focused on all the different aspects of the patent procedure. We also have an internal quality control, and we perform user satisfaction surveys—with those tools we try to analyse and detect where improvements can be made. This is the general policy of the EPO.

We apply the basic principles of ISO9001 quality management. We continuously apply a loop where we identify shortcomings that have to be remedied and/or areas that can be improved, implement the improvements, verify results and go back to the beginning of the loop. We also invest a lot in training examiners. We send them on technical missions and courses. Our president, Mr Battistelli, has emphasised improving the quality. We always try to strive for excellence.

More specifically in biotech, we have many challenges, because it is well known to be a very complicated field. We normally have thicker files, with more claims than in other fields. In particular, there are a lot of issues related to the exceptions to patentability, morality, bioethics and so on.

An examiner who starts working usually has no training in those aspects, so we have to make sure of the training. Quite often, when the press talk about the EPO, they concentrate on what the biotech cluster is doing, which stresses the importance of training in these aspects for the examiners in this field.

On the work itself, we have developed tools for the search, including those related to sequence listings; here we invested a lot to be the most efficient. Also tools for the examination itself. IT is one of the areas where a lot of money has been invested over the years, and this will be the case in the future. Not only to improve quality, but also the timeliness to ensure we can deliver in the expected time. These are the key challenges.

Is it clear in Europe what can be granted in terms of morality and ethics?

We are dealing with patent applications, and new techniques are developed. You never know what you will get in an application tomorrow. We have to adapt and to seek clarification if something is not clear in our guidelines. We have publically available guidelines for examination, where most aspects have been dealt with and are clear.

The examiners know what they have to apply, through the EPC and then the guidelines for examination. These have been drafted on the basis of the interpretation of the EPC given by our Boards of Appeals. When we do not have a clear indication in the guidelines, we follow the case law, and then we have to adjust our practice when required.

This is a constant enterprise for the EPO in the biotech area particularly. We are faced with the morality problems, and we sometimes have to push our boards of appeal to take decisions in order to clarify the practice we need to follow. With human embryonic stem cells, for example, we are lucky because here there was a decision of the enlarged board of appeal. This is applied on a case-by-case basis, and we know what objections we can raise. This is the way to progress and to apply the right practice.

Twenty-seven percent of biotech applications result in grant, according to the EPO figures. Does that seem a low figure, or is it to be expected?

This is something we can expect. I don’t think that our examination practice in biotech is too strict—it’s just that the problems we face in biotech are often different in other fields. There is morality, of course, but we are also faced with many exceptions to patentability, and we just apply the EPC. We have also integrated the EU biotech directive into our legal framework and the EPO practice carefully follows the case law of the EU Court of Justice.

It’s also due to having many withdrawals in biotech. This is a field where there are no real commercial products at application and, due to the financial crisis, it’s maybe due to the lack of money, or a policy decision to withdraw claims, especially more speculative claims in the application. That combination [difficulty of the field and the nature of the companies applying, as there are lots of SMEs] means the rate of withdrawal is quite high.

Is there a problem with harmonisation in this area, given the different attitudes to the morality question across the world?

That is of course what the EPO tries to do. The concept of morality, of ordre public, which we have in our convention (in Article 53a), has been interpreted by our boards of appeal. The morality concept which is applied at the EPO reflects the totality of the accepted norms which are deeply rooted in the culture inherent in European society and civilisation.

It is generally accepted that the concept of ordre public covers the protection of public security and the physical integrity of individuals as part of society. We apply what is usually acceptable in European society. According to the EPC, the assessment of whether or not a particular subject matter is to be considered contrary to either ordre public or morality is not dependent upon any national laws or regulations.

Conversely and by the same token, a particular subject matter shall not automatically be regarded as complying with the requirements of Article 53(a) EPC merely because its exploitation is permitted in some or all of our contracting states. Thus, approval or disapproval of the exploitation by national law(s) or regulation(s) does not constitute per se a sufficient criterion for the purposes of examination under Article 53(a) EPC.

What about on a transatlantic or international basis, with other offices?

The ideal situation would be to have the same approach, but it’s not always the case. Here work is also done, but now we are talking about patent practice. We cannot change the morality concept in those countries. At the level of patent examination there are constant consultations between the big five patent offices to harmonise this. On the question of morality, this is of course quite challenging.

What advice would you give to applicants? What mistakes do applicants make?

I’d come back to quality. We have a lot of work to deal with the quality of applications that are filed at the EPO, because of the number of claims and the way they are drafted. Of course, most applicants try to file the best quality application, but especially in biotech we are faced with problems. The best quality applications will also provide the best quality patents that we can grant. If a further effort is made by our applicants, the easier it makes it for us to grant the quality patents.

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