Select Committee on European Scrutiny Twenty-Third Report


LEGAL PROTECTION OF BIOTECHNOLOGICAL INVENTIONS


(23146)
5379/02
COM(02) 2

Commission Report: 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.


Legal base:
Document originated:14 January 2002
Forwarded to the Council: 15 January 2002
Deposited in Parliament: 4 February 2002
Department:Trade and Industry
Basis of consideration: EM of 22 February 2002
Previous Committee Report: None
To be discussed in Council: No date set
Committee's assessment:Politically important
Committee's decision:Not cleared; further information requested



Background

  7.1  Directive 98/44/EC harmonises the patent laws for the protection of biotechnological inventions across the European Union. Article 16b required the Commission to provide the present report within two years of the Directive coming into force, so it was due by 30 July 2000. The Directive requires the Commission to assess "the implications for basic genetic engineering research of failure to publish, or late publication of, papers on subjects which could be patentable".

  7.2  This requirement was included in the Directive to take account of concerns expressed, particularly by academia, that the ability to patent inventions in this area might discourage or delay publication of results. As the Commission explains:

    "Research institutes, universities and small biotech companies, which are major contributors to innovation in the life sciences, may wish to file patent applications but at the same time they will want to disclose as quickly as possible the results of their research to the scientific community and/or investors. The conflict between these 'protection' and 'publication' strategies may lead to a delay in publication of scientific results and hinder the rapid dissemination of scientific knowledge, thereby slowing down scientific progress. On the other hand, the patent system ensures the publication of results that might otherwise have been kept secret."

  7.3  Before producing this report, the Commission conducted a survey of scientists who were carrying out research on genetic engineering to investigate the question of patenting and publication delay. They included people from academia, large and small companies, start-ups, and those involved in intellectual property rights issues, such as patent agents. It found that:

    "—  only a very small fraction of researchers and organisations actually experience a considerable delay in publication of research results that are the subject of a patent application, and this fraction is lowest for the most experienced users (10%) and highest for the less experienced users of the patent system (40%);
  • the public research sector strongly favours the introduction of a grace period and large industry strongly opposes it, with both positions being present in small and medium sized enterprises. There is no clear position among patent agents, which reflects the varied nature of their customers; and

  • the possibility of filing a provisional patent application also ranks high in importance, both with industry and academia, while understandably it is of low priority for patent agents. Researchers from academia consider support for patent filing as an important issue, while industry and patent agents consider awareness activities to be of some importance."

  7.4  Apart from asking whether there was any significant delay and what the implications were for basic genetic engineering research, the Commission asked what possible steps respondents considered appropriate to remedy possible negative effects. The report summarises the possible benefits and drawbacks of "grace periods" and "provisional patent applications" and discusses other alternatives and policy measures to prevent or minimise any delays in the publication of scientific papers which contain research results that could be the subject of patent applications.

  7.5  In her Explanatory Memorandum, the Minister for Competition, Consumers and Markets (Miss Melanie Johnson) notes that:

    "A 'grace period' is a period of time before a patent application is filed in which disclosure of an invention may not count in determining whether the invention is new or not. There is no such grace period in Europe (except for certain highly restricted circumstances involving breaches of confidence or some international exhibitions), but there are various forms of grace periods in other jurisdictions, notably the US.

    "The Commission refers to 'provisional patent applications' as applications used to obtain a filing date (for the purposes of novelty determination) without necessarily fulfilling all the formal requirements for a full patent application. Such applications are already accorded a filing date in the UK."

The document

  7.6  Summarising the results of the survey, the Minister notes that:

    "The responses showed that experienced users of the patent system, both in industry and academia, did not find the publication of their work delayed, or only encountered a marginal delay, in 80-90% of cases. The belief that the publication would be delayed by use of the patent system was strongest among academics who had not used the system.

    "The survey showed a clear preference among academics for a 'grace period', while large industry was strongly against the idea. The provision of a grace period might reduce any delays to publication. However, it might also create uncertainty, as it would not necessarily be clear where a certain disclosure was novelty-destroying and so prevented the grant of a patent. Adopting a grace period in Europe while there is none in other jurisdictions might also result in some applicants losing out on patents in those jurisdictions because they mistakenly relied on the grace period.

    "Industry and academia both endorsed the value of provisional patent applications in avoiding publication delays. The low-cost UK application system is highlighted in the survey results by some respondents as making a specific provisional patent system unnecessary."

  7.7  The report provides statistics which show that:

    "Europe on average has a high quality science base (measured through the rate of publication) but that it is weak in its technological and economic exploitation (as measured through patenting activity). This 'European paradox', which is typical also in other sectors and seems to indicate a weakness of the EU innovation system, has been analysed and discussed in detail elsewhere".[19]

  7.8  Commenting on the different strategies employed to manage intellectual property generated through public and private research, the report notes that there are basically three different strategies:

    "To publish the results and thereby obtain 'copyright' or other 'authors' rights' on the published subject matter, while in most cases leaving the inventions themselves unprotected (public domain approach). Public research organisations and the scientific community largely pursue this strategy of rapid publication and the 'publication' list usually determines the reputation of a researcher, the quality of his/her work and the career development.

    "To patent the results or obtain another form of industrial property right. In return for a limited period of exclusive protection in the country or countries concerned, the inventor agrees to the publication of the details of his invention, usually after a period of 18 months. This allows third parties to improve the patented invention or invest alternative solutions, thereby advancing the state of the art. This strategy is largely used by commercial entities in order to protect investments in further research and development or the commercialisation of the patented invention. It is also increasingly used by public research institutions for the exploitation of research results through licensing or spin-off generation.

    "The 'secrecy' strategy, i.e., to keep the results secret thus strongly restricting the use and dissemination of these results. It is often used for results that cannot be protected, or sufficiently protected, through the use of intellectual property rights. This strategy is used mainly by commercial entities in order to obtain and maintain a competitive advantage."

  7.9  The Commission comments that the value of the patent system is that, though it may lead to a delay in publication, it does avoid complete failure to publish results. Publication of the patent application is mandatory after 18 months in EU Member States. There are possible conflicts between the "publishing" and "patenting" strategies, particularly for researchers from the public research sector, as they are obliged to disclose their results rapidly to the scientific community. What is needed is a public research policy that establishes framework conditions to help prevent a conflict of interest.

  7.10  The Minister draws attention to two particular points made by the Commission:

    "—  the need to secure funding for a patent application as a possible cause of delay in application (and hence publication). The Commission argues that a cost-effective Community patent system would reduce these costs, and hence help to tackle this issue; and
  • a lack of understanding of the patent system as a factor leading to delays in applications and publication. The Commission emphasises the need to provide support and advice for academic bodies and SMEs in particular in the proper use of patents and intellectual property rights in general."

The Government's view

  7.11  Addressing the policy implications of the report, the Minister comments:

    "The report makes clear that providing patent protection for results of genetic engineering research usually facilitates publication and avoids secrecy strategies. It makes no suggestion that there is a need to reconsider the patenting criteria for biotechnology as a result of its findings.

    "There is a need to consider the question of whether the adoption, on an international basis, of some form of grace period, would be beneficial, and the Government is actively consulting on this issue.

    "In the current negotiations on the Community Patent, the Government continues to stress the need for the Community Patent to be cost-effective for users, the importance of which is highlighted in this report.

    "The report also highlights the need to ensure that academia and SMEs are aware of how to effectively use the intellectual property system. The Government is committed to this aim; for example in December it published guidelines for public sector research establishments on the management of intellectual property.

    "The Government is currently conducting a consultation on the possible introduction of a grace period, which can be accessed through the Patent Office website http://www.patent.gov.uk. The consultation runs until 30 April 2002."

Conclusion

  7.12  The Commission has conducted a thorough examination of the issue and explained in clear terms the situation and options for future action.

  7.13  We ask the Government to inform us of the results of its consultation and meanwhile do not clear the document.



19  European Commission, "2nd European Report on Science and Technology Indicators", December 1997. Back


 
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