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 “until the work [has been] completed,” a spokesperson told Intellectual Property Watch. Industry asserts that the WHO will post regulators’ recommendations, but this is not clear.

INNs are generic names of medicine ingredients that “do not belong to the company,” 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

“INNs are non-proprietary names, that is, nobody’s property, selected and assigned to be the absolute antithesis [or] opposite of trademarks,” Ronald Rader of the Biotechnology Information Institute (US) told Intellectual Property Watch. “The 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,” 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, “not so much for us but for the patient,” referring to safety concerns.

If the industry-proposed changes were adopted, however, it could mean “granting unique INNs to each biopharmaceutical product from each company,” 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.

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

“Because 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” Rader said. “They intensively dislike the very idea of biopharmaceuticals being considered generics, as suggested by generic names.”

“This means it cannot be registered as a trademark,” a United Kingdom Patent Office spokesperson said. The office “will object to your application to register such a mark and inform you that it is a ‘reserved word’,” he said.

“Will WHO ignore the united front and arguments from industry?” said Rader.

The Reason for the Proposed Change

But Moll said there is reason for the suggestion. There is concern about so-called “biosimilar medicines,” biological medicinal products that are very similar but not the same. The difference is the basis for the industry request to the WHO to “rethink on what they base their INNs,” 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 “stem,” but to add a suffix or qualifier, such as “alpha” 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).

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

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

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

Tove Gerhardsen may be reached at tgerhardsen@ip-watch.ch.