[Ip-health] WIPO: IFPMA-WIPO partnership raises conflict of interest concerns

Mirza Alas mirzalas at gmail.com
Tue Oct 10 00:55:39 PDT 2017


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


*WIPO:  IFPMA-WIPO partnership raises conflict of interest
concernsPublished 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.)



More information about the Ip-health mailing list