TWN Info Service on Intellectual Property Issues (Oct17/03)
9 October 2017
Third World Network

WIPO:  IFPMA-WIPO partnership raises conflict of interest concerns
Published in SUNS #8547 dated 6 October 2017

Geneva, 5 Oct (K. M. Gopakumar*) - The partnership between the International Federation of Pharmaceutical Manufacturers & Associations (IFPMA) and the World Intellectual Property Organisation (WIPO) to create a database of patent information on medicines raises concerns of conflict of interest.

The Patent Information Initiative for Medicines (Pat-INFORMED) provides patent information on small molecule products in oncology, hepatitis C, cardiovascular, HIV, diabetes and respiratory therapy areas as well as any medicine on WHO's Essential Medicines List which do not fall into the above therapeutic categories. Currently, 20 IFPMA member companies are participating in the initiative.

Pat-INFORMED was launched on 3 October 2017 at the WIPO Headquarters in Geneva, on the sidelines of the 57th Meetings of the WIPO Assemblies.

IFPMA and WIPO issued a joint press release and background note explaining the details of the initiative. This database is projected as a tool to help medicines procurement agencies check the patent status of the medicines concerned in different jurisdictions and to expedite decision-making on procurement.

The joint press release quotes WIPO Director-General Mr. Francis Gurry: "Pat-INFORMED will make it easier for the procurement experts to assess the patent status of medicines, underlining how a well-designed and implemented patent system incentivizes innovation while making available and accessible key information about patented inventions". Further, Mr. Gurry said, "this initiative ... responds to real needs in the public health community".

Reinforcing the utility of Pat-INFORMED, Thomas Cueni, the director-general of IFPMA, said, "Helping ease access to patent information for public health authorities can help them establish smarter procurement strategies, one building block of improved global health".

The background note terms the initiative as a global version of the US Orange Book. [The Orange Book is the US Food and Drug Administration's database which provides the details of molecules that have obtained marketing approval. Annex F of the Orange Book provides the details of various patents on the molecule and their expiry date.]

The Pat-INFORMED database provides the International Non-proprietary Names (INN) of the products, dose, treatment indications, patent information in various countries and contact details for further queries. However, the database does not include information on patent applications that have been rejected or withdrawn, or where patent oppositions have been filed.

Since patentability criteria is nationally determined, countries increasingly are reviewing their pharmaceutical patent scope and patentability criteria to be rigorous in terms of novelty and inventive step, and such national level information is crucial for procurement agencies.

The Pat-INFORMED database also does not provide information on prices of the products. An IFPMA staffer told TWN that it is impossible to include prices in the database.

There are serious concerns that such a patent database that claims to be a tool to facilitate procurement may create an opposite effect.

National or international procurement agencies may be intimidated by the existence of multiple patents and may choose to be cautious and avoid procuring generic medicines which may not even infringe the patents listed.

The information deficit as described above reinforces these concerns. In an ideal situation such a database containing comprehensive information on patent status as well as on prices could be useful inputs for the procurement agencies and ministry of health authorities to consider using various options such as compulsory licenses to source medicines at an affordable cost.

As it stands, Pat-INFORMED with its contact details of the companies that hold the patents listed in the database risk furthering the commercial interest of those companies by facilitating price negotiations for patented originator products instead of facilitating options to procure generic medicines at far more competitive prices.

A question and answer in the background note furthers this fear. It reads: "Will Pat-INFORMED provide freedom to operate guarantee to procurement agencies? If not, why?

"No. It will identify patents that Pat-INFORMED participants have the right to enforce and may be relevant to the supply of generic products. It cannot provide - and must not be seen as providing - any guarantee of freedom to operate for a number of reasons".

This implies that even if there is no entry in the database of a patent with regard to a particular medicine, it does not mean that the procurement agencies can source the generic version without worries over possible patent barriers. Or if there are patents listed in the database this list may not be complete with regard to a particular medicine.

At the 3 October launch, TWN raised the possibility that patent information in such a database could help governments to identify possible TRIPS flexibilities, such as compulsory license, that can be used. However, both the Secretariat and IFPMA did not provide a clear answer on this point.

The idea for such database is one of the recommendations of the UN Secretary-General's High Level Panel on Access to Medicines (UNHLP), whose report recommended: "Governments should establish and maintain publicly accessible databases with patent information status and data on medicines and vaccines".

In this regard, the UNHLP further recommended: "This information should be periodically updated and consolidated by WIPO in collaboration with stakeholders to develop an international, easily searchable database which should include: (1) standard international common names for biological products; (2) international non-proprietary names for products, either as known at the time of application or after the granting of a patent; and (3) dates of grant and expiry".

Instead of stakeholders, WIPO collaborated with only one stakeholder, i.e. the pharmaceutical industry. During the interactive session, Chile expressed its concern over the non-involvement of national patent offices in this project.

Chile recalled its Memorandum of Understanding with the Medicines Patent Pool (MPP) for sharing Chile's data for the patent and licenses database MedsPaL.

[The MPP's MedsPaL database is a public searchable database of relevant patent and pending patent applications, along with details of inclusion of countries in voluntary licenses and data exclusivity status in relation to HIV, TB, Malaria and Hepatitis medicines.]

During the discussion, Brazil asked the WIPO Secretariat specifically for the reason for the exclusion of MPP from the partnership. Brazil also cited Recommendation 9 of the WIPO Development Agenda for the exclusion of national patent offices for the database project.

Recommendation 9 states: "Request WIPO to create, in coordination with Member States, a database to match specific intellectual property-related development needs with available resources, thereby expanding the scope of its technical assistance programs, aimed at bridging the digital divide".

The Secretariat cited Sustainable Development Goal (SDG) 17, which stresses multi-stakeholder partnerships to achieve the SDG targets, to justify its partnership with IFPMA.

There was also no answer to the TWN's question on whether the Secretariat has carried out any due diligence to identify conflict of interest involved in the partnership and steps taken to avoid such conflict of interest.

(* With inputs from Chee Yoke Ling.)