Commission Report: An assessment of the implications for basic genetic engineering research of the failure to publish, or late publication of, papers on subjects that might be patentable

January 16, 2002

Brussels, 15 January 2002

REPORT FROM THE COMMISSION TO THE EUROPEAN PARLIAMENT AND COUNCIL
An assessment of the implications for basic genetic engineering research of failure to publish, or late publication of, papers on subjects which could be patentable as required under Article 16(b) of Directive 98/44/EC on the legal protection of biotechnological inventions [SEC(2002) 50] Full Text

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5. SUMMARY AND CONCLUSIONS

· Providing patent protection for results of genetic engineering research usually facilitates publication and avoids secrecy strategies. Papers are published after filing of the patent application(s), at the latest, through the publication of the patent application (up to 18 months after the application date).

· The public research sector has become a major user of the patent system. The conflict between the scientific "publication and dissemination" strategy and the "protection and exploitation" strategy may cause delays in publication of scientific results that might be the subject of patent applications.

· A survey among EU researchers and research organisations from both industry and academia has shown that publication delays do occur, but less so with more experienced users of the patent system. With experienced users significant delays occur in less than 20% of all cases (20% for academic institutions and 8% in industry).

· Almost half of the surveyed researchers from academia that have no previous experience with the patent system but intend to use it in the future are of the opinion that considerable delays will occur. There is a need for awareness actions and support activities to counteract these (inaccurate) perceptions and to help researchers to become more familiar with the patent system itself. This should be done on all levels - regional, national and European.

· The survey showed a clear preference of the academic sector for a grace period in order to avoid and/or minimise any delays of publication of research results that may be the subject of a patent application.

In contrast, large industry is strongly against a grace period and favours rather the introduction of a provisional patent application (PPA) into European legislation. The replies received from medium sized industry and from independent patent agents did not show any consistent opinion on the merits of a grace period. In particular patent agents stressed the needs for awareness activities, assistance and support measures.

A comparably high level of importance was attributed to the PPA by both industry and academia.

· Experience has shown that the level of detail required in a patent application, i.e., to demonstrate the 'proof of concept' is less than that required for a successful scientific publication. Thus scientists with experience of both processes should learn to make the patent application at an earlier stage than the submission of the scientific paper for publication and thus avoid any delay in publication of the scientific paper.

· Despite a number of studies, no precise figures are available which quantify the economic effects for industry, or which assess the value in practical terms for academia, of the introduction of a grace period. Throughout the member states of WIPO, different concepts of a "grace period" have developed (e.g., in US, JP), all of which should be investigated in detail concerning the balance they provide between the interests of the academic sector and those of industry. The US structure involving a "grace period" coupled with the "first-to- invent" system provides the highest level of "legal uncertainty" and should not serve as the "best practice" example.

· In view of the increasing internationalisation of research, in particular in the genetic engineering sector (both public and private sector funded research), and also given the fact that the public research sector has become a more experienced and major user of the patent system, efforts to define and harmonise the concept of the `grace period' should be considered. However, this concept will only work at a global level and will only be effective if it provides `legal certainty', which is the major concern of industry. This should be taken into account during the current discussions by the Standing Committee on Patent Law (SCP) of WIPO on the possible introduction of a grace period.

· In 1991 WIPO discussed the inclusion of an article into the first draft of a "Treaty on Harmonisation of Patent Law" concerning the introduction of a grace period into national laws. This was rejected based on the grounds that a grace period would be counter to education and awareness campaigns among academic researchers concerning the proper use of the patent system. These arguments clearly no longer hold good today.

· The legal framework conditions should be further optimised to ease the use of the patent system by academics and small and medium sized enterprises.

These should include, among others:

­ the introduction of a provisional patent application in all member states in line with Article 5 of the Patent Law Treaty, adopted in Geneva on June 2, 2000.

­ support and advice for academic bodies and SMEs in the proper use of the patent system and the strategic use of intellectual property rights as well as teaching and training on these issues.

­ a simple and cost-effective patent system, as will be provided through the proposed Community Patent.

Brussels, 14.01.2002 COM(2002) 2 final

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