Sector: Pharmaceuticals

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Foreword

Over the past year, attention has turned to the pharmaceutical patent cliff, with a range of companies adapting to – or preparing for – the post-patent commercial reality. In such an environment, branding and trademark rights play a critical role in guarding and extending market share. Yet establishing and protecting those brands is a complex process – strict controls at both the national and international levels mean that rights holders and their advisers must have detailed knowledge of the regulatory regimes that exist in parallel to the standard registration systems. To assist counsel in this competitive market, World Trademark Review is pleased to present the fourth edition of Pharmaceutical Trademarks – A Global Guide.

23 September 2013

European Union

The European Medicines Agency (EMA) isresponsible for the scientific evaluationof applications for European marketingauthorisations for human and veterinarymedicines.

23 September 2013

France

Pharmaceutical products, and consequently, pharmaceutical trademarks, are highly regulated in France. Both national and EU laws and regulations govern various aspects of the development and commercialisation of pharmaceuticals, including the intellectual property deriving therefrom.

27 January 2012

South Africa

South African trademark law is governed by the Trademarks Act (194/1993). Section 10 of the act provides absolute and relative grounds for refusal. Sections 10(1) and 10(2) provide that a mark shall not be registered if:• it does not constitute a trademark; • it is not capable of distinguishing within the meaning of Section 9;• it consists exclusively of a sign or an indication which may serve, in trade, to designate the kind, quality, quantity,intended purpose, value, geographical origin or other characteristics of the goods or services, or the mode or time of production of the goods or of rendering of the services; or• it consists exclusively of a sign or an indication which has become customary in the current language or in the bonafide and established practices of the trade.

27 January 2012

Hungary

The following trademarks may enjoy protection in Hungary:• national trademarks filed with the Hungarian Intellectual Property Office (HIPO);• international trademarks – an international trademark application on the basis of the Madrid Agreement and/or Madrid Protocol shall be filed with HIPO and forwarded to the World Intellectual Property Organisation; and• Community trademarks (CTM) – the protection of a registered CTM extends to the territory of Hungary as an EUmember state. A CTM trademark application is to be filed with the Office for Harmonisation in the Internal Market.

27 January 2012

Mexico

Trademarks in Mexico are regulated under the Industrial Property Law and its regulations. Industrialists, merchants and service providers can use trademarks in industryand 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 TrademarkOffice (IMPI).

27 January 2012

Romania

Prior to placing a medicine on the Romanian market, a marketing authorisation must be obtained either by following the national procedure or in accordance with the EUcentralised procedure. The state authority responsible for issuing the marketing authorisations is the National Medicine and Medical Devices Agency (NMMDA).

27 January 2012

India

The manufacture, distribution, labelling, packaging, sale or stocking of any drug in India is regulated by the Drugs andCosmetics Act 1940. Under the act’s provisions, a penalty can be imposed for the manufacture, sale, stocking, exhibition or distribution of drugs without a valid licence.

27 January 2012

Israel

Israel became party to the Madrid Protocol on September 1 2010. Accordingly, it is possible to designate Israel as a member state in the framework of an internationaltrademark application/registration. As of September 1 2010, multi-class trademark applications are also available inIsrael.

27 January 2012

Finland

In Finland, pharmaceutical trademarks are governed by national trademark legislation and relevant EU directives and regulations. In addition, international trademark registrations designating Finland must comply with the Madrid Protocol, to which Finland acceded on April 1 1996. Pharmaceutical trademarks must also comply with pharmaceutical legislation and some sector-specific regulations.

27 January 2012

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