Responsibility for a company’s trademark portfolio is frequently placed in the hands of a few specialists. Often, this is not the only task carried out within the department, or even by those tasked with this responsibility. However, the legal protection of trademarks requires a high degree of specialisation in a field in which few lawyers and others are experienced.
Udo Pfleghar and Michael Best
The Brazilian Patent and Trademark Office (BPTO) examines pharmaceutical trademarks more stringently than it does ordinary trademarks. Public health concerns come into play which must be weighed against the private interests of applicants. This can result in greater flexibility in the permitted proximity between trademarks during the examination process.
Sweeping amendments were made to the Trademarks Act two years ago, most of which will likely be implemented by 2018. These amendments will bring both benefits and challenges to applicants in all industries, and the pharmaceutical industry is no exception.
Susan J Keri, Jennifer McKenzie and Meghan Dillon
One of the most important and widely discussed topics in the life sciences sector over the last few years has been healthcare compliance – in particular, for pharmaceutical companies in Germany. Cooperation between the pharmaceutical industry and other members of the healthcare sector – such as doctors – must comply with statutory laws (eg, criminal law and competition law). This is particularly true regarding invitations to congresses, sponsorship, gifts and donations.
Oliver Nilgen, Andreas Kabisch and Stephan Held
Like all trademarks, pharmaceutical trademarks are subject to general trademark rules regarding validity and use. A trademark must be capable of distinguishing the goods or services of one undertaking from those of others. It serves as a guarantee of origin for the goods or services at hand. In this regard, the shapes of products have been the subject of heated debate. For a shape to be registered as a trademark, it must not be determined solely by the nature or function of the product in question.
Pharmaceutical trademark owners face a variety of issues that are not seen in other sectors, including health regulatory requirements, linguistic marketing issues and political factors. Finding an effective and acceptable pharmaceutical brand name can thus be an intense and sometimes complex procedure.
Julia Holden, Lia Puntieri and Giulia Cellerini
The exclusive right to a trademark is obtained through registration with the Mexican Institute of Industrial Property (IMPI). All visible signs can be protected, provided that they are sufficiently distinctive and can distinguish the goods or services to which they apply from others in the same class (Article 89 of the Industrial Property Law). Once Parliament has enacted the amendments required by the TPP, non-traditional trademarks will be recognised.
Victor Ramirez and Erwin Cruz
Norway has no separate rules for pharmaceutical trademarks (as opposed to other trademarks), but the practice of the Norwegian Intellectual Property Office (NIPO) highlights certain points to take into account. Eligibility depends on the rules set out in the Trademark Act, which is largely based on the EU Trademarks Directive (89/104/EC). For registration eligibility, the mark must have distinctive character, be non-descriptive and not conflict with the public interest. If it contains elements relating to the characteristics or functions of the pharmaceutical product, it is likely to be rejected as descriptive.
Kristoffer Weltzien, Kathrine Kjendlie and Thomas Gaarder-Olsen
The Law on Circulation of Drugs 2015 regulates the procedure and requirements for registering a pharmaceutical product for the purposes of import, production, advertisement or sale. The procedure and requirements for registering a trademark are regulated by Part IV of the Civil Code. Under the Law on Circulation of Drugs, drugs can be manufactured, sold and used in Russia only if they are registered with the Ministry of Health.
Acquiring trademark protection for pharmaceutical products is standard practice, not only for the word element of a drug’s name, but also for graphic elements and packaging. Regarding non-traditional trademarks, the rules set out in the amended Community Trademark Regulation apply. Since the regulation has been amended to remove the requirement for graphic representation of trademarks (from October 1 2017), new applications for trademarks consisting of shapes, tastes or smells are likely to appear in the coming years.
Helena Gajek and Magdalena Maksimowska
The Intellectual Property Office of the Republic of Serbia is the competent body for the registration of all trademarks in Serbia, including pharmaceutical trademarks. Trademark registration is governed by the Law on Trademarks (104/2009, as amended). The Medicines and Medical Devices Agency of Serbia regulates the registration, market approval, commercialisation, packaging, labelling and advertising of medicines.
Katarina Kostic and Natalija Popović
Pharmaceutical trademarks, like all other trademarks, are governed by Decree-Law 556 on the Protection of Trademarks. Before filing a trademark application, an availability search for the phrase to be filed should be conducted in the official database of the Turkish Patent Institute (TPI) to eliminate or reduce the risk of refusal or infringement.
Barış Kalaycı, Hande Hançer and Pınar Arıkan
A pharmaceutical product can be marketed in Ukraine only after state registration and issuance of marketing authorisation. The legal framework for the manufacture, distribution and authorisation of pharmaceuticals in Ukraine is established by the Law on Pharmaceuticals 1996, as amended.
Antonina Pakharenko-Anderson and Alexander Pakharenko
Trademark protection may be obtained through the registration of a national trademark or through an EU trademark. UK national trademarks are governed by 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 (MHRA). EU-wide approvals are regulated by the European Medicines Agency (EMA).
John Olsen and Ellen Hughes-Jones
Drug makers face unique challenges when selecting and clearing trademarks for new drugs. Care must be taken to select a name that can be registered at the US Patent and Trademark Office (USPTO) and will meet the Food and Drug Administration’s (FDA) stringent approval process. USPTO registration and FDA approval are independent and typically proceed along different timelines.
Robert D Litowitz and Lynn M Jordan
Regarding the regulatory legal framework for pharmaceutical trademarks, the Pharmaceutical Products Review Board of the National Institute of Hygiene has established several standards for packaging, labelling, advertising, promotion and branding. The Pharmaceuticals Law establishes the general rules governing the commercialisation, manufacture, production, distribution, import and export of pharmaceutical products.
Sebastián González Yanes
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