Intellectual Property (IP) Management for Marine Bioprospecting

Rationale and objectives

The overall objective of WP 8 is to maximize the impact of the Micro B3 project by facilitating (a) efficient technology transfer and (b) rapid exploitation of results. To realize this objective, it is important to strike an appropriate balance between (a) efficient dissemination of materials, software, data and published results to a wide range of science communities and other users / stakeholders (b) appropriate IP protection and management (including patent, copyright and trade secrecy issues) (c) measures for compliance with the provisions of the Nagoya protocol on access and benefit sharing with a view to involve resource states in the R&D activities and contribute to the protection and preservation of the marine biodiversity.

The main paradox to be addressed in this work package is the contradiction between the tremendous potential benefits for society of bioprospecting and the fact that, in the current state of affairs, “Bioprospecting is still largely neglected and rudimentary” (E. O. Wilson, Foreword to Chiviani and Bernstein, 2008). Indeed, as shown also in WP 7 new methods for culturing microbial organisms, molecular biology, and computational methods for large-scale genomic, metagenomic and environmental data mining hold immense potential for the development of new commercial applications from marine microbial biodiversity and for understanding basic biochemical processes in the marine microbial world. For example, over the last five to ten years, marine microbial drug discovery has been clearly established as one of the most exciting research frontiers in natural drug discovery, with more than 100 papers published in the scientific literature each year and with some products already going into the clinical test phase, such as an antitumor agent from the deep-sea bacterium Salinispora [1].

To fully realize the potential of bioprospecting for society a number of obstacles must be overcome. Two of these obstacles are especially relevant in the context of Micro B3:

1. Disappearance of / lack of continuous access to collection sites and valuable marine environments. For example a US National Cancer Institute project came to a halt because re-collection of the marine species Diazona containing a new class of antitumor agents failed, until it was rediscovered on another location many years later in deep coral reef caves [2].
2. Pressures on facilitated and continued access to pre-competitive research data and research materials. To realize the full potential of large-scale collaborative marine microbial research, rapid and continued access to collected research materials and the wealth of related data is needed. However, in the current situation, many developing and transition countries implement increasingly restrictive Access and Benefit Sharing (ABS) legislation, without special exceptions for non-commercial pre-competitive research. India for example is pushing for a reach-through right on data produced in bioprospecting enterprises. These and other measures treat every single organism and related data as potentially of high commercial value, even if in reality only a tiny proportion of the wealth of research data and research materials are used in commercial applications. The vast majority of research data and research materials are pre-competitive, that is of unknown and/or unlikely commercial potential, but are treated under the same conditions and procedures as materials and data of known commercial value. On the other hand, in the developed economies, examples of patenting of upstream and general purpose research materials and methods – such as recently the Myriad patent on a gene involved in breast cancer diagnostics – continues to generate concerns from developing and transition countries, who ask to benefit in a fair and equitable manner from the progress of scientific innovations with materials collected in their jurisdictions.

In view of these obstacles WP 8 is set out to design a set of balanced and simple rules for fostering maximum exploitation of research results produced in the Micro B3 project, with the goal to

1. ensure intellectual property protection on downstream commercial applications
2. while alleviating obstacles to facilitated access to pre-competitive research materials and associated data and
3. adopting appropriate access and benefit sharing rules which can promote R&D activities in resource countries and generate funding for biodiversity conservation through a multilateral approach most appropriate for marine bioprospecting (cf. article 10 of Nagoya Protocol on Access to Genetic Resources and the Fair and Equitable Sharing of Benefits Arising from their Utilization to the Convention on Biological Diversity).

To take into account the difference between the IP regimes governing microbial genomic data and information on the one hand, and microbial materials on the other, the rules and agreements for facilitated access to pre-competitive research data and materials are dealt with in two different tasks under this work package. IP rules and the plan for the exploitation of the project results with direct high potential commercial value are part of a third task assisted by an IPR Task Force formed within Micro B3 as a multi-disciplinary advisory committee.

Recent Progress:

WP 8 finalized Micro B3 model agreements on access to marine microorganisms and benefit sharing. The model agreements can be used for pre-competitive utilization/research; for competitive research and for hybrid situations. The agreement is characterized by an innovative distinction between research and development for the public domain and research and development for proprietary purposes. Also the concept of a viral license is introduced for transfer to third parties of genetic materials, according to which transfer of materials and data to third parties is possible only if the initial obligations contained in the access agreement are binding on third parties. The figure below illustrates all the legal steps that need to be considered in the whole pipeline of the Ocean Sampling Day from the sampling activities to the release of the data.

The two main outcomes of WP 8 in the first 18 months, the model agreements and the Data Policy for the Ocean Sampling Day, are meant to guarantee that all the activities within Micro B3 are in conformity with international, European and national legislation. They also are consistent with the objective of Micro B3 to provide an innovative legal framework and model contracts for the protection and sustainable use of marine genetic resources.

Legal workflow of the whole pipeline in Micro B3. Some abbreviations are explained in the text and more in the public deliverables of WP 8, which include the model agreement.

Progress towards the objective “design of model agreements for marine bioprospecting” was made by drafting and finalizing model agreements for pre-competitive and competitive research on access to marine microorganisms and benefits sharing. This document was endorsed by the Extended Executive Board of Micro B3 on 8 May 2013 in Bremen and can be downloaded below.

The Micro B3 Agreement on Access to Marine Microorganisms and Benefit Sharing is now available to the public (PDF, 434 kb, updated December 17, 2013).

Commentary the the ABS agreement (PDF, 506 kb, released January 09, 2014)

The first 12 months focused on analysing the legal framework and the practice for accessing genetic resources, sharing the benefits (ABS) and exchanging of data. On the basis of this in-depth analysis model agreements could be drafted through intense team collaboration and the following deliverables produced: D8.1 a report on literature review for pre-competitive access to microbial materials; and D8.2 a report on literature review for pre-competitive access to large-scale microbial genomic databases. 

The following six months focused on the analysis of the draft agreements and on the preparation of semi-structured interview to better understand the practices of exchanges of materials and data in research consortia. As a result WP 8 produced deliverable D8.3 a report on the model agreements for pre-competitive access to microbial research materials. The targeted stakeholders for the questionnaires have been identified also in conjunction with the multi-stakeholders outreach workshop held in Brussels in February 2013. The stakeholders’ workshop gathered representatives from other FP7 projects dealing with marine biotechnology: BlueGenics, PharmaSea and SeaBiotech. Synergies and collaborations between these projects within future activities are planned.

Summary of Deliverable 8.1.1 Part 1: Review of relevant legislation on pre-competitive access to marine microbial resources and exchange of material and data; synthesis report on model contracts on pre-competitive access to marine microbial resources and exchange of material and data.

In a study on the regulation of access to microorganisms in the marine realm two international treaties have to be taken into focus: The United Nations Convention on the Law of the Sea (UNCLOS) and the Convention on Biological Diversity (CBD). The earlier adopted treaty was the UNCLOS in 1982. At that time it was a prevailing desire to establish a comprehensive regulatory system addressing the use of the ocean space within different maritime zones. Although the convention was primarily tailored to regulate conflicts on exploitation of mineral resources, oil and fish, the legal terms are broad enough to offer solutions for questions on access to marine microorganisms.

In taking account of the growing interest in research and development of genetic resources the CBD, which entered into force in 1993, an equitable approach was specifically introduced, balancing the interests of users and providers of terrestrial and marine genetic resources: the Access and Benefit-Sharing (ABS) mechanism.

UNCLOS differentiates between “marine scientific research” and “marine scientific research with direct significance for exploration and exploitation” and attaches different access conditions to these activities. The regulatory regime also differs in relation to where the activity takes place (territorial sea, exclusive economic zone or ABNJ).

The CBD and especially the Nagoya Protocol (NP) (not yet in force) distinguish between the general “utilization of genetic resources” and “research for non-commercial purposes” the latter being profiteer of simplified access conditions. Both conventions can be understood to build on more or less the same categories although using different terminology.

Although they lack precise definitions the decisive criterion in our opinion is the function of R&D activities: are the R&D results intended to be put into the public domain (open access to the public) or into the private domain (limited access for the public, protection by intellectual property rights) In the WP 8 Model Agreement on Access to Marine Genetic Resources we call this in the former case, “research and development for the public domain”, and in the latter case “proprietary research and development”.

Both conventions acknowledge sovereign rights of the coastal state to require prior informed consent for the taking and utilization of genetic resources from its territorial sea and exclusive economic zone, and to ask for the sharing of non-monetary and monetary benefits. However, they somewhat differ concerning the duty to simplify access conditions for research for the public domain. While both conventions oblige coastal states to simplify access in the exclusive economic zone, in the territorial sea the coastal state has unlimited discretion according to UNCLOS but not according to the NP. However, the difference is not essential because even under UNCLOS the coastal state is subject to a general obligation to support marine scientific research. Thus, both conventions can be read to establish about the same ABS regime. This facilitates the elaboration of Model Agreements on Access to Marine Genetic Resources.

Summary of Deliverable 8.2: IP Model Agreements for Pre-Competitive Access to Large-Scale Microbial Genomic Research Databases

The WP 8 team has recently worked on researching literature on existing agreements on biodiversity-related IPR. We have mapped model IP agreements for pre-competitive access to microbial research data generated in marine bioprospecting missions. Further work on proposing legally valid provisions concerning data for the model Access and Benefit Sharing Agreement has also been done. These efforts are aimed at enabling the pooling of data from large-scale community resource projects and fostering rapid pre-publication data releases, thereby creating a robust public domain for research and innovation.

The public Deliverable 8.2 provides a review of the relevant legal and policy framework, both at international and European levels, i.e. covering five initiatives for early release of genomic reference data:

• Bermuda Principles of 1996
• Fort Lauderdale Principles of 2003
• Toronto Statement of 2009
• EC recommendation C/2008/1329
• OECD guidelines for access to research data from public funding.

After presenting several data policies and main challenges, the main features of UNCLOS in regard to marine data, copyright and database rights as well as existing data license agreements are described.

Finally two interesting case studies are provided, one on the database of the British Oceanographic Data Centre and the other one on the BONUS EEIG Data Policy.

All of these have been analysed by the project team and illustrate open access efforts with regard to large scale databases.

It was also discussed how the key aspects of the model agreement were included in the model Access and Benefit Sharing Agreement, developed under Deliverable 8.1. The report concludes by outlining some of the important future steps, particularly the development of specific MICRO B3 data policy guidelines based on this work.

The public Deliverable 8.3 surveys and summarizes selected agreements and other legal instruments (already in force or templates) for pre-competitive access to microbial research materials.

The aim is to assess how stakeholders have organized their transactions, mostly in regard to access to the material and/or related to exchange of genetic materials. The objective is to understand and map how stakeholders - like researchers, policy makers, and public institutions - regulate the access to and the exchange of microbial research material in pre-competitive research.

A questionnaire was designed for the purpose of better understanding the stakeholders’ practices to regulating access and exchange of microbial material. It aims at eliciting the preferences and motivations of the involved parties.

Lead: Tom Dedeurwaerdere, Université catholique de Louvain