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INTELLECTUAL PROPERTY: WHO-WIPO-WTO BOOK

Chapter 3: Medical technologies: the innovation dimension

 

E. Sharing of influenza viruses and access to vaccines and other benefits

Key points

  • The WHO Pandemic Influenza Preparedness (PIP) Framework for the Sharing of Influenza Viruses and Access to Vaccines and other Benefits provides a global approach to the sharing of influenza viruses with pandemic potential. It also enables the sharing of benefits derived from such viruses, including the management of related intellectual property (IP).
  • The Standard Material Transfer Agreements (SMTA) agreed under the PIP Framework stipulate that participating laboratories should not seek to obtain intellectual property rights (IPRs) on PIP biological material. In addition, these agreements provide for a range of options for biological material recipients, such as influenza vaccine manufacturers, to enter into benefit sharing agreements.

A highly significant development in itself, given its central role in preparing for a potential pandemic, the PIP Framework also serves to illustrate many of the points made in earlier sections of this chapter relating to the role of public-sector institutions and networks, capacity-building in medical innovation, sharing of benefits of the fruits of innovation, and dealing with IP in a public health context.

1. WHO Global Influenza Surveillance and Response System

The WHO Global Influenza Surveillance and Response System (GISRS) (formerly known as the Global Influenza Surveillance Network) was created in 1952 to advise WHO member states on influenza control measures. This system monitors the evolution of seasonal influenza viruses and other subtypes of influenza viruses that infect humans sporadically. Among its many responsibilities, the GISRS selects and develops candidate influenza viruses for development and production of seasonal and other influenza vaccines, including pandemic vaccines. The GISRS also serves as a global alert mechanism for the emergence of influenza viruses with pandemic potential. Its activities have contributed greatly to the understanding of influenza epidemiology, and have facilitated effective, internationally coordinated responses, to outbreaks of seasonal, H5N1 and other influenza virus subtypes with pandemic potential.

The system comprises different categories of laboratories with National Influenza Centres (NICs) forming the backbone of the GISRS. Under their WHO terms of reference, NICs are requested to regularly ship representative clinical specimens/virus isolates to WHO collaborating centres for in-depth antigenic and genetic analyses. To fulfil its role as a global alert mechanism for the emergence of influenza viruses with pandemic potential, the GISRS relies on its members to share in a timely manner all influenza viruses with pandemic potential.

The re-emergence of highly pathogenic avian influenza A(H5N1) in 2003 highlighted the risk of an influenza pandemic. The inability of developing countries to secure safe and affordable access to pandemic vaccines was underscored by the global limitation of influenza vaccine production capacity. In early 2007, this situation prompted one country to announce that it would stop sharing its A(H5N1) viruses with the GISRS until it:

  • provided greater transparency of its activities
  • enabled increased access by developing countries to the benefits derived from the use of such viruses, notably vaccines.

This event led to the adoption by the May 2007 World Health Assembly of a resolution which became the basis for negotiations on a framework for the sharing of influenza viruses and other benefits.1 Two issues were central to the discussions:

  • improving the transparency of the activities of the GISRS
  • improving fairness and equity of access to influenza vaccines and other benefits derived from the work of the laboratories in the WHO system.

Box 3.18. WIPO Patent Search Report on PIP Related Patents and Patent Applications

In 2010, WHO member states requested information from WIPO on PIP-related patents to support the WHO Open-Ended Working Group of Member States on Pandemic Influenza Preparedness: Sharing of Influenza Viruses and Access to Vaccines and other Benefits (OEWG). WIPO prepared this report, and presented it at the meeting of the OEWG in April 2011.

The patent search report highlights several critical points:

  • In the pool of patent information assembled and analysed in this report, no patent documents were identified that included claims having, as a sole and/or single element, either a complete native virion, a native viral strain, a native viral genome in its entirety, or a complete assembled complement of native viral proteins from a specific virus.
  • The report discusses in detail certain patent families, represented by patent applications, where the scope of the claims is broad and could potentially be construed as covering known viral sequences, processes and compositions of matter. It is well established that issued patents frequently have narrower claims than the corresponding patent applications. Therefore, the scope of the claims in the patent applications identified and analysed in this search may very well be restricted during the patent application prosecution and grant process.
  • While some patent applications from members of the WHO Global Influenza Surveillance Network are identified as falling within the scope of the search, the report does not analyse to what extent collaborations, licences and technology transfer are taking place between these and other entities, including between and among developed and developing countries.
  • A number of patent applications were identified from companies based in industrialized countries that are now co-owned by companies of developing countries. This is arguably one form of technology transfer and should be seen in the light of emerging models that facilitate broad access to new technologies, including in health, by developing countries.2

2. Intellectual property rights in the context of PIP negotiations

The role of patents, and more specifically the rules regarding the rights of the GISRS laboratories to seek patent protection on inventions developed with viruses contributed to the GISRS, was a core issue throughout the negotiation process. Technical papers prepared by the WHO in response to a request by member states found that: “There are no significant patent barriers to the manufacture of any of the marketed types of influenza vaccines. Some patents protect specific processes or products, but for each of the types of marketed vaccines, there is sufficient FTO to permit manufacturers in developing and emerging economies to make the vaccine of their choice. For future vaccines based on new technologies, there are potential intellectual property barriers; however it is not known which, if any, of those technologies could make marketable vaccines that could be sustainably produced”.3

In order to provide further information on patenting activity related to influenza viruses with pandemic potential, the WHO, based on resolution WHA60.28, requested WIPO to prepare a working paper on Patent Issues Related to Influenza Viruses and Their Genes.4 In 2010, upon request from WHO member states, WIPO presented a patent search report on PIP-related patents to the WHO Open-Ended Working Group of Member States on Pandemic Influenza Preparedness: Sharing of Influenza Viruses and Access to Vaccines and other Benefits (see Box 3.18).

3. The PIP Framework

The PIP Framework was adopted by the 64th World Health Assembly in 2011. The Framework provides a global approach to the sharing of influenza viruses with pandemic potential for risk assessment and response, and the sharing of benefits derived from such viruses. The scope of the Framework is limited to influenza viruses with pandemic potential. The Framework defines the materials covered under it as “PIP Biological Materials”.

The PIP Framework contains a Standard Material Transfer Agreement (SMTA 1) applicable to all GISRS laboratories. SMTA 1 specifies terms and conditions for transferring viruses both within the GISRS and to entities outside the system. Among others, SMTA 1 states that members of the GISRS should not seek to obtain IPRs on PIP biological materials.

Under the PIP Framework, recipients of PIP biological materials, such as influenza vaccine manufacturers, play a critical role in supporting global pandemic preparedness and response. This includes the payment of an annual partnership contribution and the negotiation and signing of benefit sharing agreements with the WHO. A model benefit sharing agreement or “SMTA 2” is contained in Annex 2 of the PIP Framework. It sets out a list of options for benefit sharing from which recipients are required to choose. One such option is the granting of royalty-free licences to manufacturers in developing countries on IPRs for the production of pandemic influenza vaccines, adjuvants, antiviral products or diagnostic materials needed in a pandemic. A similar provision allows the WHO to receive licences that may then be sublicensed to manufacturers in developing countries under appropriate terms. In this manner, the Framework provides opportunities for IP holders to share IP related to pandemic influenza preparedness or response. It does not, however, compel them to do so.

1. WHA, Resolution: WHA60.28: Pandemic influenza preparedness: sharing of influenza viruses and access to vaccines and other benefits.. back to text

2. Source: WIPO (2011c).. back to text

3. See www.who.int/influenza/resources/technical_studies_under_resolution_wha63_1_en.pdf. See also www.who.int/.. back to text

4. See www.who.int/influenza/resources/documents/ wipo_ipdoc/en/.. back to text