Early Certainty Initiative Of The European Patent Office – Flexibility For Biotech Needed

By Michael Kahnert, legal counsel, BIO Deutschland

In 2016, the European Patent Office (EPO) introduced a streamlined opposition procedure that should simplify opposition proceedings and deliver decisions faster, while giving parties more time to react to summons and prepare for oral proceedings. This new initiative, called early certainty, aimed to cut down the overall duration of granting new patents and to tackle the backlog in patent granting within the EPO.

BIO Deutschland welcomes the intention of the EPO to enhance the efficiency of the patent application process and to achieve more legal certainty for third parties. In the past, the EPO already launched a number of measures that aim to speed up the patent application process (see table EPO early certainty initiatives). Currently, Early Certainty in Examination is being discussed, meaning that grant of a patent will be concluded on average within 12 months after the start of the examination procedure.

In 2015, the average duration of the patent application process was close to 27 months^[1]. The EPO 2016 Quality report stated that the median search time has been reduced to 5.1 months and the median examination pendency has been reduced to 23.3 months. Reducing the median examination pendency to 23.3 months is a “first step” (in the words of the 2016 Quality Report). EPO and its president Benoît Battistelli emphasized that delivering high quality/legally solid patents is the first priority in the patent granting process. On the other hand, flexibility in the patenting process especially for patent applicants who develop products in the area of cutting-edge technology is needed. To tackle this issue, Benoît Battistelli commented in an interview that applicants should still have adequate opportunities to be heard – 12 months should be adequate in general and in specific cases it should be possible to extend the examination period up to 36 months and still meet the Paris criteria.[2]

Reducing the application process to 12 months implies that much faster work is expected from patent examiners to maintain the same quality of patent examination. In complex sectors such as biotechnology, the shortening of the patent application process would also lead to higher costs at an early stage, because of the extensive examination procedure. Especially small and medium sized enterprises (SME) in the research and development sector usually have a high need for capital to assure cashflow. Therefore, these companies will be additionally affected by a cost burden early on. To attract investors and partners, SME as well as academic institutions often cooperate to advance their research and development and share sensitive information in the process. In order to maintain the possibility of pursuing specific aspects of the patent application at a later time, more divisional applications would be necessary and cause significantly higher costs. Therefore, the proposed shortening of the patent application process leads to a disadvantage for research-driven SME.

In research-intensive sectors, such as biotechnology, a patent application for companies at an early stage is needed to assure that they are able to assert themselves in international competition. Research and development of a new biopharmaceutical product takes more than ten years in general. At the early stage of patent application, it is often not clear which main aspects should exactly be covered by the application. Applicants therefore intend to defer decision and costs to a later stage, when, e. g., first clinical data are available and a candidate for development is determined.

Responding to the early certainty in examination initiative of EPO, BIO Deutschland and other industry associations called for the possibility to apply for exemptions to carry out the patent examination outside of the Early Certainty in Examination (“De-PACE” procedure) in order to meet the specific requirements of high-tech SME. It should be possible to defer the proceedings pending at the request of an applicant.

Recently EPO started a new initiative taking into account these arguments. The so-called user-driven early certainty includes the possibility for applicants to postpone the start of substantive examination for a limited period of time. This proposal of the EPO clearly has some advantages especially for patent applicants developing products in the area of cutting-edge technology which is highly needed to gain sufficient flexibility in order to foster innovation in Europe.

Michael Kahnert is acting Corporate Counsel at BIO Deutschland (Biotechnologie-Industrie-Organisation Deutschland e.V.) in Berlin since August 2008. From 2012 until 2014 he was also the Managing Director of EABP. Before that he worked as lawyer at the German Federal Labour Market Authority and in several law offices for insolvency law and civil law. Michael Kahnert holds a degree in law from the University of Rostock and successfully completed his legal clerkship in Berlin and Los Angeles.

[1]  See http://documents.epo.org/projects/babylon/eponet.nsf/0/4C30F69F33211B6EC1257F6A0049308F/$File/quality_indicators_en.pdf

[2]  http://www.maucherjenkins.com/news-and-publications/articles/European-Patent-Office-Attacks-its-Examination-Backlog

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