[Ip-health] Third World Network WIPO: Generic industry calls for review of WIPO involvement in Pat-INFORMED

K.M. Gopakumar kumargopakm at gmail.com
Tue Apr 16 21:59:03 PDT 2019


*WIPO: Generic industry calls for review of WIPO involvement in

Geneva, 16 April (TWN): A medicines patent database set up by transnational
originator pharmaceutical companies with the involvement of the World
Intellectual Property Organization (WIPO) has come under criticism by the
generic industry.

The International Generic and Biosimilar Medicines Association (IGBA), an
international association of generic medicine manufacturers has called for
the reassessment of WIPO’s involvement in the Patent Information Initiative
for Medicines (Pat-INFORMED), a database of patent status of medicines.

Pat-INFORMED was launched in September 2018 as a partnership between WIPO
and the International Federation of Pharmaceutical Manufacturing
Associations (IFPMA), an international associations of pharmaceutical TNCs.
It 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.

IGBA expressed their concern in a letter to WIPO Director-General Dr.
Francis Gurry dated 6th February 2019. The letter says: “Given the many
issues the IGBA has identified with respect to its potential impact on
pharmaceutical competition, procurement and public health, we believe WIPO
should reassess its involvement in this initiative and whether the
inclusion of a link to the database on its website is appropriate for a
United Nations agency”.

The letter expresses concerns “that (Pat-INFORMED) could unnecessarily
delay patient access to more affordable medicines”. The letter contains
three concrete concerns with regard to Pat INFORMED viz. patent linkage,
lack of a verification mechanism to ensure accuracy of information, and the
propriety of a UN agency to be part of such an initiative.

*Patent Linkage*: According to the letter “Pat-INFORMED is an inappropriate
tool for medicines procurement. A database that purports to link patents
with procurement serves as a tool for patent linkage.” This concern is
raised in the light of the projection of Pat-INFORMED as a database to help
procurement agencies. The press release announcing the launch of the
Pat-INFORMED described it as “an online tool designed to help procurement
agencies better understand the global patent status of medicines.”

IGBA raised doubts about the accuracy of information and states: “There may
be a long list of irrelevant patents in the Pat-INFOMRED database that may
easily mislead procurement agencies and unduly delay access to generic and
biosimilar medicines, providing a disservice to public health.”

[There are often multiple patents granted on a medicine, depending on the
patentability criteria of a country. Many of these patents can be “weak” or
“trivial” thus not meeting the criteria of novelty or inventive step. When
challenged, such patents could be revoked. By listing all patents over a
medicine, Pat-INFORMED could create confusion and misperception resulting
in delays in market entry of generic and biosimilar medicines.]

*Accuracy of Information*: A second concern is the lack of mechanism to
verify the information directly uploaded by the originator companies in the
database. According to the letter, “incorrect information can easily be
uploaded to the database, and outdated information may not be revised or
removed in a timely manner. This could easily mislead public authorities
and delay the opportunity for generic medicines to participate in
competitive tenders.”

The letter cites the example of the Orange Book of the United States Food
and Drug Administration’ (FDA) which provides a mechanism for verification
of patent listings. IGBA states that: “the FDA has established a way to
referee disputes regarding the accuracy of listings in the Orange Book, and
such listings by originator drug companies are made under penalty of
federal law which includes criminal liability for providing false
information to the U.S. government.”

The letter also recalls an earlier meeting with WIPO staff in October 2018
where IGBA had pointed out a mistake in the database with regard to Truvada
(emtricitabine), whereby “on 18 September 2018, the UK Supplementary
Protection Certificate (SPC/GB05/041) was invalidated with no possibility
of appeal by Mr. Justice Arnold of the UK Court”.

*Propriety of engagement*: The letter points out the inappropriateness of
WIPO as a UN agency to be part of an initiative which can prevent
competition in the pharmaceutical market. It states: “the hosting of the
Pat-INFORMED database on the WIPO website provides the public with the
perception that WIPO and the United Nations more broadly views the
information as being accurate and useful, even though the Pat-INFORMED
database can easily be transformed by originator companies into a tool for
anti-competitive delays for generic medicines access world wide as well as
for bio similar medicines, in the event that larger molecules are added to
the database in the future”.

Third World Network also expressed the concern on the adverse impact of
Pat-INFORMED on procurement agencies. A report published on 5 October 2017
on the occasion of the soft launch of the Pat INFORMED stated:

“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”

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