Position paper concerning the introduction of a grace period in Europe
Deutschland (BIO Deutschland), calls for the introduction of a grace period with the following key elements:
- Duration: 12 months
- Scope: Any prior disclosure of an invention does not destroy novelty provided that it was directly or indirectly made by the applicant or his legal predecessor
- Territorial field of application: the European Union and the member states of the European Patent Convention
Germany’s position as a hub of innovation is currently marked by ambivalence. On the one hand, its level of scientific and technological performance is very high, thanks to having an excellent research landscape and the highest proportion of innovative enterprises in the European Union.1 On the other hand, it is falling short of its potential in terms of leveraging technology to create new products. Germany has not become less competitive in the race for innovation, yet other countries are proving to be far more dynamic.
Creating favourable framework conditions that foster innovation is therefore crucial to Germany’s future success in the international competition to attract business investment. First and foremost, it is about quickly translating advancements in research and technology – especially in key areas such as biotechnology – into market advantages for the companies behind the innovations. This would require a competitive model of patent law, particularly at the EU level, that appropriately strengthens patent protection while countering the rising amount of intellectual piracy that is occurring in the form of counterfeiting and patent infringement.
An often neglected, but vital component of an innovation-friendly patent law is securing the results from basic research for real-world applications. Here there is a great deal of room for improvement concerning cases where inventors make novelty-destroying disclosures prior to the filing date.
A survey conducted by BIO Deutschland among its members revealed that 65% of these support the introduction of a grace period. In addition, patent research commissioned by BIO Deutschland shows that almost 7% of European and international patent applications filed by universities, research institutes and similar establishments that were published in 1999 and 2000 were subsequently abandoned or refused due to inventors making novelty-destroying disclosures in the 12 months preceding the filing date of the priority application and prior to the applicant being informed of the date of filing accorded to his application. This research does not include inventions for which applications were not filed at all due to the lack of a grace period. The number of these non-documented/non-researchable inventions for which applications were not filed due to the absence of patent protection in Europe is certainly high – probably at a similarly high rate as the proportion of patent applicants taking advantage of the grace period in the US (about 20%).
The introduction of a grace period in Europe, similar to that which has existed for a long time in other economically successful countries (e.g. in the US or Japan), can provide swift and cost-neutral relief. This holds significant potential for Germany in particular, as its strong basic research capacity generates numerous new ideas. In order to convert these scientific ideas into applications for the end-user, it is necessary to adequately protect research results.
Furthermore, recent legal developments in the area of clinical trials require data to be disclosed at an early stage, thus making it impossible to subsequently secure patents for the invention. This is another important reason for small and medium-sized enterprises (SMEs) and the pharmaceutical industry as a whole to help promote the introduction of a grace period in Europe (see further details in section 3.3).
The importance of cooperation between SMEs and large industrial companies is constantly growing in terms of overall economic significance. A study published by Accenture at the end of 2011 found that 60% of all innovations have their origins outside of large concerns. This proportion increases to 82% in the case of new biological therapeutics.2
Furthermore, the negotiations for a free-trade agreement between the US and Europe are giving added political momentum with regard to the strengthening of the international protection of intellectual property rights,3 as the German Chemical Industry Association (VCI) also noted in a statement in 2013.4 At the same time, the issue of international patent law harmonisation should not be left out of the debate on the introduction of a grace period in Europe (the US and Japan have such a system).5
For the reasons set out above, BIO Deutschland has developed a proposal that would incorporate the grace period in Europe into the existing legal system.
1 Eurostat press release, “Seventh Community Innovation Survey”, 11 January 2013, http://epp.eurostat.ec.europa.eu/cache/ITY_PUBLIC/9-11012013-AP/EN/9-11012013-AP-EN.PDF.
2 Accenture, “The Future of Pharmaceutical Innovation – Tackling the R&D Productivity Gap”, December 2011, p. 3.
3 This has also been observed by the International Association for the Protection of Intellectual Property (AIPPI). Ehlers/Hahner/Henke/Königer, Report of the German National Group for AIPPI’s Executive Committee meeting from 5-11 September 2013 in Helsinki, GRUR Int. 8-9/2013, p. 759 et seq.
4 German Chemical Industry Association (VCI), “Questions and Answers from the Chemical Industry Regarding TTIP”, 2 August 2013, p. 9.
5 This issue was pursued by the signatories to the Agreement on Trade-Related Aspects of Intellectual Property Rights (known as TRIPS) as well as the World Intellectual Property Organisation (WIPO).