12 Questions with Karin Seegert, COO Healthcare, Biotechnology and Chemistry, EPO

Karin Seegert

Karin Seegert, Chief Operating Officer for Healthcare, Biotechnology and Chemistry, EPO.

Karin Seegert studied pharmacy and received her PhD from the University of Munich in 1985. Following several years working in R&D in industry, she joined the EPO in 1991. During her time at the EPO, she has worked as Examiner and then beginning in 2002 as Director in the pharmaceutical area and as Director in Patent Administration. In 2010, Karin became Principal Director with responsibility for various technical fields, mainly in Electro Physics and Chemistry, before being appointed as Chief Operating Officer in 2017 she was leading the cluster Technical Chemistry (TeC).

The following interview was conducted via e-mail during June 2018.

1). Hello, Ms Seegert, could you please briefly tell me about yourself and your role at the EPO?

I am originally a pharmacist by profession and earned my PhD in Pharmaceutical Biology. For nearly 25 years, I have worked at the European Patent Office in a variety of positions starting as a patent examiner, then operational director, and finally, as principal director. Since July 2017, I have been the Chief Operating Officer (COO) for the Healthcare, Biotechnology and Chemistry sector.

2). Can you tell us a little more about what types of technologies your sector specifically covers? 

Well, the name Healthcare, Biotech, Chemistry is fairly self-explanatory on a broad scale but covers many different technological areas. The ones with the highest number of incoming patent applications include medical technology; diagnostics/treatment; pharmaceuticals; cosmetics; polymers; and industrial chemistry.

Development of inventions in the Biotech area is very active in the provision of diagnostic and therapeutic agents as well as methods to treat cancers, infectious diseases (including AIDS and other viral infections exhibiting haemorrhagic fevers), and all types of hereditary diseases.

The focus is on the development and application of new tools and methods, such as CAR-T cells for cancer therapy as well as genome editing (CRISPR-Cas) for the tailored treatment of hereditary diseases. We are now seeing a clear invention trend in the development of immunological methods and entities (e.g. new antibody formats). Another area gaining increasing importance is the field of bioinformatics.

3). In the U.S. there are certain sectors that deal with a variety of legal issues that are unique to those sectors. Does your area of technical concentration have any particular issues that other areas do not?

Generally speaking, we have had a particular way of handling medical treatment claims, not typically allowed at the EPO (Article 52(4) EPC), since they need to be reformulated into more acceptable wording. We also have had very sensitive cases in biotechnology relating to plants and animals, or cells. Furthermore, in the pharmaceutical area, there is always the issue of traditional knowledge.

Moving on to more concrete issues relating to the drafting of patent applications, in our area we have had specific issues with non-unity applications – often due to the sheer number of possible embodiments within one claim. This also overlaps with the issue of lack of support across the whole breadth of the claim and also whether the comparative tests provided are enough to support an inventive step across the whole range of the claimed invention. These will be discussed in the claim drafting workshop that we are holding here in Seattle alongside the AIPLA Spring Meeting.

Other challenges include parameters, ranges, selection inventions, functional features and clarity issues. On top of this, examiners in Biotech have had to sometimes deal with ethical issues and specific exemptions to patentability as well. Moreover, an increasing number of files in the medical technology area have had issues with computer implemented inventions, which I will touch upon later.

One challenge that has concerned the entire HBC area is the fact that these applications also have had hefty financial interests associated with them (e.g. pharmaceutical/plastics industries), which results in a substantial number of oppositions – around 8% annually- double the overall EPO rate. Consequently, this gives rise to a sizable compendium of field specific case laws addressing HBC issues.

4). Why has the EPO become more active in the US in recent years?

The US has been, in fact, our largest user community of EPO products and services. In 2017, 26% of our applications came from the US, 16% came from Germany and 13% from Japan. The EPO has been very active in the US for many years; as such, hundreds of EPO examiners visited industry and patent attorneys throughout the US in order to meet with users. A few years ago, we strengthened these ties by taking on an EPO Attaché to the US, our first and currently only attaché. In addition to these endeavours, the EPO is further developing our relations in the US alongside other important regions. The goal is to deepen contact with applicants, user groups, patent attorneys, paralegals, and others, with the aim to improve dialogue and ensure that the products and services we deliver are fit for purpose, both now and in the future.

Namely, this has involved being present at conferences, visiting companies, SMEs, start-ups, and universities to help people understand the patent system in Europe and learn how to utilise it most effectively. We are convinced that the EPO can contribute effectively to the validity and legal certainty of IP rights. This is because we have maintained a solid reputation for delivering the highest quality; this has been regularly confirmed by external benchmarks such as the IAM annual survey as well as our own User Satisfaction Surveys. Part of our strategy has included being here at the AIPLA in conjunction with the hands-on workshop which we will deliver after the AIPLA meeting is finished. It should be noted, however, that quality starts with the drafting of the patent application. With this improved relationship to our American users, we hope to improve the quality of incoming applications to the EPO. By increasing quality, the final product is not only better, the time is shortened, and the applicant spends less money overall due to “getting it right” the first time.

An integral element of implementing this strategy is to ensure that our users (whether inside or outside Europe) can fully understand what the EPO offers and how to make use of our services in the most efficient way. Similarly, we have sought  out occasions on which we have been able to receive input and feedback from our stakeholders. We have been able to successfully do that within Europe via major conferences such as PATLIB, EPOPIC and our annual user days, but other regions should also benefit from the latest information. We have now organised two conferences in the US specifically to enhance user knowledge of patent application processes at the EPO in Information and Computer Technology. We are now adding a third in Seattle after the AIPLA Spring meeting and a fourth event will be organised in September back-to-back with the IPO Annual Conference in Chicago where the focus will be on mobility. The goal is to equip users with the latest information on how to draft applications so they have the best possible chance of achieving a granted patent quickly and with the highest level of legal certainty. For both the user and the EPO, given the potential savings in time and costs, it was an initiative in efficiency and quality that received positive feedback from those attending.

Efficiency and quality are fundamental principles at the EPO and now more important as ever, as reiterated by our President when he spoke at the Intellectual Property Owners Association in Manhattan recently. Applications from the US have increased heavily in the past few years, but we have more than kept up with the increasing number of applications and have effectively managed our backlogs.

5). How has the EPO decreased pendency times to process patents?

In the last few years, the Office has taken major strides to decrease pendency times of applications and increase overall quality. We have successfully addressed these issues with an initiative called “Early Certainty”. The main goal here is to provide early legal certainty to users by respecting strict time limits as mentioned in the European Patent Convention or PCT. Nowadays, we can guarantee that a search + written opinion will be delivered within 6 months of receipt, regardless of the route chosen. For examination and oppositions, our goals are – on average – 12 months and 15 months respectively for standard cases by the end of 2020. I am proud to report that we are well on target to meeting these challenging deadlines. In fact, certain technical areas have already achieved these targets. Of course, these time limits apply to European applications but we also deal with applications filed under the PCT at the same pace. Notably, this is an interesting feature also for US applicants. The early delivery of high-quality products, in particular under the PCT or “PCT Direct”, allows for further exploitation via the PPH to, currently, 15 other countries with which the EPO has agreements. Please also bear in mind that a European patent is not only valid in our 38 Member States. We have two additional countries, Bosnia-Herzegovina and Montenegro, the so-called Extension States, where a European patent can become valid. A fairly new programme, launched in 2015, allows for a European patent to become valid in Cambodia, Moldova, Morocco and Tunisia thereby opening up further possibilities for applicants. Taken together, protection from a single European patent can be given in a cumulated population of some 700 million in 44 countries. This new “Validation” programme is likely to expand further in the future as many countries have shown an interest in this scheme.

6). How have you been able to achieve this so quickly without affecting quality?

Successful mastering of the EPO’s increased workloads is due to three main components. The first is increased capacity, through recruitment and also by instructing our examiners to focus on core tasks. The second is increased efficiency of our examiners through training and on the job knowledge transfer as well as in the concentration of technical fields. Moreover, the newly adopted career system promotes employees based on merit instead of on seniority. The final component is the rapid improvement in the tools available to examiners, enabling them to achieve results more efficiently than in the past.

In terms of quality, it is worth emphasising that the EPO has a very comprehensive, solid quality management system in place. At every level, there is a high commitment to quality and we are the only one of the IP5 Offices to be fully ISO 9001 certified for the entire patent granting process. As such, quality at the EPO remains assured as all our Key Performance Indicators demonstrate. At the EPO we are unique among the global IP Offices in that we do not outsource any of our core processes; moreover, we deploy three examiners for every file. These files are then further checked by team managers and then directors. Along with our highly experienced and trained examiner core, documentation and search tools are key to providing high-quality products and services. To name a few statistics, examiners have access to over 1.3 billion technical records, over 100 million patent documents, over 3 million standards documents; all are key to providing high quality.

7). There has been a flood of patents emanating from Asia – especially China – how has the EPO dealt with those in particular?

Indeed, the sheer number of applications from around the world in many different languages is something we have had to address. As you know, the applications of today become the prior art of tomorrow; these need to be easily retrieved when we conduct our prior art searches.

One area where we are seeing a wholescale turnaround of a market is in pharmaceuticals from India and China. In the past, they used to focus more on generics rather than R&D and new drug design. Now they are moving into this market; we need to not only be aware of this but also be able to use these documents actively in our search and examination work.

The EPO has been actively working on accessing and using Asian documentation fully for many years. As such, there is an Asian Patent Expert Group (APEG) for this purpose, which is a network of all the people in the EPO who have been working with Asian Documentation. For over 10 years now, they have focussed on this topic and transformed a problematical issue for the EPO into one of its major selling points. They have systematically acquired documentation and designed tools to access it and trained all the examiners office-wide in its importance and how to handle it. Almost a quarter of our patent citations are only available in an Asian language (Chinese, Japanese and Korean). In fact, counting all Asian origin citations, around 150 000 originate from Japan and roughly 30 000 each from Korea and China. This means that 47% of our search reports contain at least one patent of Asian origin (Chinese, Japanese, Korean). We search our “Asian only” documents mainly using English language machine translations –which have rapidly improved in quality during recent years – and with the advent of AI, will improve even more quickly in the future.

In addition, together with our partners, we have developed with the USPTO, a cooperative patent classification system (CPC) based on EPO’s own classification system ECLA, which has now become an accepted and actively used standard. Currently, 26 patent offices are classifying or have indicated that they will classify, in CPC. Amongst those are the Chinese and Korean patent offices. The CPC harmonises patent classification and achieves new levels of precision which give us better access to the prior art. During talks with SIPO, we were able to assess how vast and rapidly-rising amounts of Asian prior art are being effectively managed by the use of the CPC. There are now 6 million documents classified by SIPO (4 million) and KIPO (2 million) into the CPC

Given all the tools we have and the training that examiners receive, we would say, for us, it is almost as easy to find and cite a Chinese or Korean patent as it is to cite a European patent.

8). Coming back to the CII that you mentioned earlier, what is the expected evolution of CII files in your sector and what are you doing about it?

Recently, the EPO released a report on 4IR patents in relation to CII. Clearly, with Industry 4.0, based on the 4th industrial revolution, there are increasingly more inventions that are related to computers. They are pervasive throughout practically every technical area now, and we in HBC are not immune. I have already mentioned medical technology and bioinformatics. Furthermore, one way we have dealt with this is to reorganise the examiner environment into three business sectors which more effectively mirror the technical world outside the EPO. This has effectively brought technologies that are now related even closer whereas they used to be completely separate in the past. With this structure, we are also ready to deal with the informatics and AI era that is now upon us. My sector has heavily relied on the experience of the ICT sector to help us build upon their expertise through awareness and training. We are also taking transfers from their area, retrain our examiners and offering advanced CII courses. In the meantime, we have established a CII network with one expert per operational directorate who can advise on CII matters or escalate further where needed. This guarantees a harmonised approach within the sector and across the whole of the EPO.

9). Can you tell us a little about how software in HBC is examined at the EPO?

Firstly, we prefer to talk about CII instead of software as it is more precise. As I said in my previous answer, our approach in HBC is consistent with every other area of the EPO dealing with this subject matter too. Our decisions are based on thorough guidelines and reinforced by stable and consistent case law. Moreover, in HBC, CII mostly contributes to solving a technical problem and is therefore patentable. This is perhaps something that is not so well known in the US and is one of the key messages we are bringing over. We are now in the 4th year of a program to annually revise our CII Guidelines, broadening and deepening them to take new technology using CII into account. These will soon include specific examples from biotech and healthcare.

10). What are the main differences between the EPO and the USPTO approaches to CII?

As I mentioned in my last answer, perhaps it is not as well known in the US that you can get patents for Computer-Implemented Inventions at the EPO. We use a two hurdle approach which is relatively easy to understand: the first hurdle is the eligibility of the claims. The exclusion under Article 52(2) and (3) EPC is overcome if at least one feature is technical in character; the real discussion is based around the second hurdle: the inventive step (Article 56 EPC) and necessitates a technical problem that must be solved

11). If this is the case, why have there been so many unsuccessful US applications – how can the applications be drafted for a higher likelihood of grant at the EPO?

Well, I think that it clearly is a matter of understanding the differences between the two systems of the EPO and USPTO. A couple of common mistakes can be remedied as follows:

  • Ensure the algorithmic steps contribute to producing a technical effect serving a technical purpose.
  • Claims are often too vague or descriptions too detailed – ensure that there is full and appropriate disclosure in the original application and especially of intermediate generalizations as fall-back positions, which can be remedied by using multiple dependencies of claims rather than relating all claims back to claim 1. By doing so, this often solves the issues US applicants have with added subject matter (Article 123(2) EPC).

12). Is there anything else you’d like to say to our readers?

Yes, I think that the EPO’s new strategy to further reach out to users is something that is driving us in the right direction. It increases our presence outside Europe and brings us closer to our key stakeholders more frequently than ever. This means that we can enhance our products and services to ensure that they suit the needs of all our applicants. In parallel, we are also able to inform our American user community of the practice at the EPO thereby allowing for better patent applications to be drafted. Our stakeholders have been asking, and in some cases pleading for closer cooperation. Well, we are now delivering! I am convinced that this close and continuous interaction serves the IP system at large and is fully aligned with the EPO’s mission to contribute to innovation and economic growth.


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