[Ip-health] IP-Watch: Proposal Could Create New Biotech Benefits In WHO Public Medicine System

[Thiru Balasubramaniam]

27/11/2006

Proposal Could Create New Biotech Benefits In WHO Public Medicine System

By Tove Iren S. Gerhardsen

The biotechnology industry has proposed to change the international
generic naming of medicine ingredients, which at the moment are public
property, into unique names for each medicine, making it harder to
substitute them with cheaper versions, and linking them to trademarks,
sources say.

A powerful industry coalition submitted a joint position at a World
Health Organization (WHO) stakeholder meeting on 13 November, according
to sources, at which the generics industry also submitted its position,
according to Nathalie Moll of EuropaBio, the European association for
biotechnology industries. Industry argues that patient safety is at
stake, as dissimilar medicines are treated as substitutes under the
current system. There is no danger of the names being trademarked, she
said.

At issue is the International Nonproprietary Names (INN) system managed
by the WHO to facilitate the identification of pharmaceutical active
ingredients.

Dr. Raffaella Balocco-Mattavelli of the INN unit at the WHO told
Intellectual Property Watch that the WHO has consulted with regulators
and industry on this issue. She said industry papers will be posted on
the Internet, and recommendations made by the regulators also will be
posted if all the stakeholders agree to it, she said.

A WHO INN expert group (to which a source said members are appointed in
their personal capacity) is discussing this issue and met on 14-15
November, according to sources.

One source said that the European regulators were hesitant about
posting their recommendations. The group has been working on the issue
for several years, and developed guidelines. But a source from the
European Medicines Agency declined to comment on the discussions =93until
the work [has been] completed,=94 a spokesperson told Intellectual
Property Watch. Industry asserts that the WHO will post regulators=92
recommendations, but this is not clear.

INNs are generic names of medicine ingredients that =93do not belong to
the company,=94 Moll said. They are based on the active pharmaceutical
ingredient or substance of a medicine, and the same INN generic name
applies internationally to all medicines belonging to a certain group.

The INN system was initiated in 1950 by a World Health Assembly
resolution (WHA3.11). The cumulative list of INNs now stands at over
7,000 names designated since that time, and this number is growing
every year by some 120-150 new INNs, according to WHO.

Confusingly Close to Trademarks

=93INNs are non-proprietary names, that is, nobody=92s property, selected
and assigned to be the absolute antithesis [or] opposite of
trademarks,=94 Ronald Rader of the Biotechnology Information Institute
(US) told Intellectual Property Watch. =93The whole idea is to design and
select unique names that belong to no one, not trademarked anywhere, so
everyone can use them without any concern or conflicts with trademarks
or other drug names,=94 he said.

Separately from this, medicines also have brand names and as these are
particular for each individual medicine, the names are protected by
trademarks. But now the biotechnology companies want a system of unique
INNs for their products, Moll said, =93not so much for us but for the
patient,=94 referring to safety concerns.

If the industry-proposed changes were adopted, however, it could mean
=93granting unique INNs to each biopharmaceutical product from each
company,=94 Rader said. This could mean that pharmacies would not be able
to substitute one biotechnology product with another, based on the
common INN name, which often is being done with other drugs to save
money, sources said.

Moll said that the new INN names would be non-proprietary and companies
would not be able to trademark them. But others argue there is still a
trademark concern.

=93[T]here will be a close association between unique INNs and
trademarks,=94 Rader said. He raised areas of concern, especially for
patients who could end up paying more for drugs.

=93Because INNs are not unique [but] generic, referring to the active
agent, that is why the trade associations want to make INNs unique to
fit their view of each biopharmaceutical being unique and
non-interchangeable in terms of prescriptions=94 Rader said. =93They
intensively dislike the very idea of biopharmaceuticals being
considered generics, as suggested by generic names.=94

=93This means it cannot be registered as a trademark,=94 a United Kingdom
Patent Office spokesperson said. The office =93will object to your
application to register such a mark and inform you that it is a
=91reserved word=92,=94 he said.

=93Will WHO ignore the united front and arguments from industry?=94 said
Rader.

The Reason for the Proposed Change

But Moll said there is reason for the suggestion. There is concern
about so-called =93biosimilar medicines,=94 biological medicinal products
that are very similar but not the same. The difference is the basis for
the industry request to the WHO to =93rethink on what they base their
INNs,=94 for these products, she said. The issue is that no two
biological products are the same, and they cannot therefore have the
same INN or be substituted, Moll said.

For some of these biological products, the WHO has chosen to use the
same base, or =93stem,=94 but to add a suffix or qualifier, such as =93alph=
a=94
at the end, Moll said. The concern is not about distinguishing original
from copy medicines, but rather distinguishing each individual medicine
from that of other companies, she added.

Other members of the industry coalition are: the European Federation of
Pharmaceutical Industries and Associations, the International
Federation of Pharmaceutical Manufacturers and Associations,
Pharmaceutical Research and Manufacturers of America, European
Biopharmaceutical Enterprises, and the Biotechnology Industry
Organization (US).

INNs Discussed at WIPO Meeting

INNs were also on the agenda at the 13-17 November meeting of the World
Intellectual Property Organization (WIPO) Standing Committee on the Law
of Trademarks, Industrial Designs and Geographical Indications (SCT).

=93The SCT agreed on a number of proposals for making information on INNs
available to trademark administrations of interested countries,=94 WIPO
said in a press release. =93With the growing number of INNs and
trademarks, the possibility of conflicts between them has gradually
increased,=94 it said.

Among the suggestions discussed was the circulation of cumulative lists
of INNs on CDs, which WIPO would do in cooperation with WHO, it said.

A participant told Intellectual Property Watch that =93discussions were
about better ways to make information on INNs available to members so
as to avoid collision between INNs and trademarks, i.e., reject
trademarks for INNs.=94

=93The main source of conflict is usually an attempt by a manufacturer to
propose a new trademark containing =91stems=92 which are word elements
established in the INN system to demonstrate the relationship between
pharmacologically related substances,=94 WIPO said.

Separately, the SCT also took note of a =93non-exclusive list of
customary names used in Brazil associated with biodiversity,=94 which has
the aim of preventing misuse of these names in trademarks, WIPO said
(IPW, Biodiversity, 4 August 2006).


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Thiru Balasubramaniam
Geneva Representative
CPTech
voice +41.22.791.6727
fax +41.22.723.2988
mobile +41 76 508 0997
thiru@cptech.org