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22 September 2010

The Pharmaceutical Trade Marks Group – defining an industry role

There is a considerable history behind the Pharmaceutical Trade Marks Group (PTMG) and some major traditions to be upheld. Reflecting the pace of change in the pharmaceutical trademark sector and the challenges facing trademark counsel, the PTMG cannot stand still, but needs to progress, learn, grow and develop. The PTMG has to manage change and rise to new challenges, while at the same time remaining true to its essential nature.

22 September 2010

Israel

Before filing trademark applications, it is recommended that applicants conduct a clearance search to verify the availability of the proposed mark in Israel and assess the possible risk of trademark infringement. If the applicant wishes to search for common law marks in order to avoid other possible risks based on unregistered marks, this will involve an investigation of the actual products in the Israeli market and, in particular, a search of relevant websites and databases.

22 September 2010

Canada

In Canada, prescription drugs can be sold only once they have successfully completed the drug review process and a notice of compliance (NOC) and drug identification number (DIN) have been issued. The Therapeutic Products Directorate of Health Canada will assess the safety, efficacy and quality of a drug; if it concludes that the benefits outweigh the risks, the drug will be issued an NOC and DIN.

22 September 2010

Japan

Under the Pharmaceutical Affairs Law, sellers must obtain approval from either the Ministry of Health, Labour and Welfare or the prefecture in order to market pharmaceutical products, including drugs (defined in Article 2(1) of the law). Approval must be obtained for each product.

22 September 2010

India

The drug controller general of India approves new chemical products introduced into the country. The manufacture, distribution, sale or stocking of any drug requires a licence issued by the authorities established under the Drugs and Cosmetics Act 1940. Under these provisions, a penalty can be imposed for the manufacture, sale, stocking, exhibition or distribution of drugs without a valid licence.

22 September 2010

Foreword

It is a pleasure to welcome you to the second edition of Pharmaceutical Trademarks – A Global Guide. Building on the success of the inaugural edition, Pharmaceutical Trademarks 2010/2011 provides trademark professionals with comprehensive guidance on the key issues involved in the protection, enforcement and marketing of pharmaceutical brands. Written by experts from leading firms across the globe, the guide is designed to help the busy practitioner to make an international comparison of the practices and procedures governing pharmaceutical marks. To achieve this, this year’s edition presents analysis from 18 key jurisdictions, with a regional chapter investigating the particular challenges arising from similarities between pharmaceutical trademarks in the European Union. Although the chapters in this book offer valuable insight on law and practice governing pharmaceutical trademarks, they do not seek to provide specific legal advice and should not be read as such. However, only those firms and organisations with specialist expertise in the field of pharmaceutical trademarks were invited to contribute, and the authors raise a number of critical points that rights holders and their advisers should take into consideration when constructing an international pharmaceutical protection strategy. I am grateful to all of the authors for their commitment to and participation in this valuable project, and would also like to thank the Pharmaceutical Trade Marks Group for all its assistance during the production of Pharmaceutical Trademarks 2010/2011.Trevor LittleManaging editor

22 September 2010

United Kingdom

The principal legislation governing trademarks in the United Kingdom is the Trademarks Act 1994. Regulation and enforcement of the rules governing the pharmaceutical industry are carried out by the Medicines and Healthcare Products Regulatory Agency. In instances where EU-wide approval is required, the relevant regulatory authority is the European Medicines Agency.

22 September 2010

Sweden

In Sweden, pharmaceutical trademarks are governed by trademark law and also, to some extent, by sector-specific regulation. Primarily, the bodies dealing with the registration of pharmaceutical trademarks are those involved in granting registrations for all kinds of trademark.

22 September 2010

Indonesia

Indonesia’s rapidly growing domestic market presents significant opportunities for pharmaceutical companies seeking to do business in the country. However, its geography and unique socioeconomic conditions also present a challenge. Success is possible through a robust strategy, as well as strict and transparent compliance with Indonesia’s regulatory regime.

22 September 2010

Mexico

Trademarks in Mexico are regulated under the Industrial Property Law and its regulations. Industrialists, merchants and service providers can use trademarks in industry and commerce, or for the services that they provide (Article 87 of the law). The exclusive right to use a trademark is obtained by registering the mark with the Trademark Office.

22 September 2010

Poland

The Pharmaceutical Law is almost entirely based on the principles of EU law. All Community regulations and judgments of the Court of Justice of the European Union relating to pharmaceutical issues – including trademarks, repackaging and parallel imports – are directly applicable in Poland.

22 September 2010

Germany

Pharmaceutical trademarks must be selected carefully, as patient safety is at stake. Prescription errors due to similarities between trademarks must be minimised. In Germany, the Federal Institute for Drugs and Medical Devices is the competent authority within the Federal Ministry of Health to authorise medicinal products on the basis of the Medicines Act.

22 September 2010

Luxembourg

Pharmaceutical trademarks are regulated by the general trademark legislation – namely, the 2006 Law Approving the Benelux Convention on Intellectual Property – and by national legislation on medicines and IP rights.

22 September 2010

South Africa

South African trademark law is governed by the Trademarks Act (194/1993). Section 10 sets out the criteria for registering trademarks, including both absolute and relative grounds for refusal. In addition, applicants for pharmaceutical trademarks should be aware of the regulatory environment for medicines in South Africa.

22 September 2010

China

A drug can have three names in China: the generic name, the trade name and the trademark. Generic names and trade names are administrated and approved by the State Food and Drug Administration, while trademarks are registered with the China Trademark Office (CTMO) and administrated by both the CTMO and the local administrations for industry and commerce.