1 Oct
2019

Procedures and strategies for pharmaceutical brands: Romania

Cabinet M Oproiu

Selection, clearance and registration

In Romania, pharmaceutical trademarks are governed by the same national legislation and relevant EU directives and regulations as other trademarks. However, when selecting trademarks to register, and in contentious matters, some specific elements must be taken into account.

Pharmaceutical trademarks can be registered through various channels:

  • as national trademarks, by filing directly with the Romanian Patent and Trademark Office (OSIM);
  • as international registrations designating Romania through the Madrid Protocol and Agreement (Romania is a member of both); and
  • since 1 January 2007, as EU trademarks (formerly known as Community trademarks) – Community trademarks with an earlier filing date shall be valid in Romania only from that date, which is when Romania acceded to the European Union.

The Trademark Law (84) does not distinguish between prescription drugs and over-the-counter (OTC) drugs.

The Trademark Law was fully amended in March 2019, in order to align it with the EU Harmonisation Directive (2015/2436).

OSIM is the body responsible for granting trademark protection in Romania. The Trademark Law was most recently amended in May 2010 in order to harmonise it fully with the EU directives and bring it into line with the EU Community Trademark Regulation regarding examination criteria.

According to the Trademark Law, OSIM does not carry out examinations on relative grounds, just as in the case of Community trademarks. However, in recent practice OSIM has sent reports to the holder of the earlier right if a similar junior mark is filed.

The examining division carries out examinations on absolute grounds, such as descriptive character or a misleading mark in respect of the origin or the product. Some manufacturers, in particular newer companies, tend to select names that are quite close to the international common denomination in the hope that consumers will retain such names as trademarks. In most cases, OSIM correctly denies registration of such marks.

Relative grounds are used as a reason for rejection in opposition, appeal and cancellation proceedings. On the merits of the case, relative grounds are similar to those mentioned in the EU Trademark Regulation – namely, the later mark shall not be registered if:

  • it is identical to the earlier mark and the goods or services for which registration is sought are identical to the goods or services of the earlier mark; or
  • it is identical or similar to the earlier mark for identical or similar goods and services and a likelihood of confusion exists on the part of the public that includes the likelihood of association with the earlier trademark.

The Trademarks Law is under imminent revision due to the obligation set by EU Directive 2015/2436 (16 December 2015) to approximate the laws of the member states relating to trademarks.

The evaluation of the risk of confusion for the purpose of registration of the marks does not usually take into consideration the distinction between drugs whose price is reimbursed by the social security authority and others, nor the distinction between original medicinal products and generic products.

Other elements to be taken into consideration in evaluating the risk of confusion, including the risk of association, relate to the list of goods of the marks in conflict, as well as the therapeutic indications and normal channels of distribution of the drugs. The more specialised the drug and the more restricted the channels of distribution, the lower the risk of confusion, and vice versa.

Thin line between pharmaceuticals and food supplements

Food supplements are in the same class as pharmaceutical preparations (Class 5). Their composition is usually similar to that of vitamins. The main difference between them is the chain of authorisation and the chain of distribution.

Pharmaceutical preparations undergo a strict approval process at national or EU level, whereas food supplements undergo a simplified process. Pharmaceutical preparations can be sold only in authorised places such as pharmacies or distributed in hospitals and health centres; whereas food supplements can be sold in many places, including pharmacies, supermarkets and drugstores.

As the chain of distribution and the composition partially overlap, food supplements are similar to pharmaceutical products for the purpose of registering the marks.

In recent years there has been an increase in the registration of marks for food supplements at national level. There was some confusion at the OSIM level, as the body responsible for the registration of marks, when it comes to assessing the similarity of marks when referring to a food supplement. Recent trends indicate that OSIM has now reached a degree of consistency in assessing the similarity of food supplements and vitamins, which are considered similar products.

National regulations for selecting brand names

A March 2012 decision of the Council of the National Drugs Agency aims to regulate the registration and use of ‘umbrella-type’ commercial denominations.

Specifically, according to the decision:

  • a proposed umbrella-type brand name shall not be accepted for medicines for human use if such umbrella already exists in the brand name of a food supplement, cosmetic product or medical device sold by the same company; and
  • it is prohibited to maintain an umbrella-type commercial denomination approved for a medicine from the moment of approval by the same company of a food supplement, cosmetic product or medical device whose denomination includes the umbrella.

The regulations do not distinguish between OTC drugs and prescription drugs.

Parallel imports and repackaging

The requirements relating to the manufacture and distribution (including import) of medicines are set out in Title XVII – Medicinal Products of the Health Reform Law (95/2006). Pursuant to Articles 700(1) and (2) of the law, a pharmaceutical product can be put on the market only after having obtained a marketing authorisation at national level or following the centralised procedure at EU level.

Parallel import occurs when a product placed on the market in one country is bought by a party which exports it to another country without the permission of the marketing authorisation holder. Parallel importing is permitted between EU member states based on the principle of free movement of goods. The requirements relating to parallel imports are described in the European Commission Communication on Parallel Imports (COM (2003) 839 Final).

According to the principle of exhaustion of rights, the rights holder loses its right to control the distribution of the goods once the medicinal product has been put on the market in any EU or European Economic Area member state, so that the product can be traded freely by authorised wholesalers in any of these countries. This principle was introduced in Article 38 of the Trademark Law: “The right conferred by the trade mark is exhausted and the holder cannot forbid other persons the use of the mark for products that were put on the market in the EU and the European Economic Area under this mark by the owner or with his consent.”

National law provides for an exception to the exhaustion of rights – namely, justified reasons for which the owner of the mark is entitled to forbid other persons from using the mark in parallel imports, “especially when the state of the products is modified or altered after having put them on the market”.

Parallel imports are regulated by Decision 2/2007 of the Scientific Council of the National Drugs Agency, issued in March 2007 and amended in 2009. According to this decision, parallel imported goods can be sold under a different brand and can be repackaged and relabelled.

Any distributor that is not the holder of the marketing authorisation and wishes to import a medicinal product from an EU member state (ie, a parallel importer) must notify its intention to the authorisation holder and the National Drug Agency. The authorisation holder cannot oppose the grant of the secondary licence unless it has justified reasons, as set out above.

The regulations do not distinguish between OTC drugs and prescription drugs.

Anti-counterfeiting and enforcement

Romania joined the European Union on 1 January 2007. Consequently, the responsibility of Romanian Customs to protect the external borders of the European Union increased considerably, as Romania shares major borders with non-EU countries. Pharmaceutical goods are not among the top 10 types of product most commonly seized, according to information provided by the National Customs Authority.

As of 1 January 2014, the EU Customs Regulation (608/2013) replaced former EU Regulation 1383/2003. The new regulation is also directly applicable in Romania and is supplemented by national legislation, the Customs Intervention Law (344/2005), which applies to applications based on national trademarks. The national legislation goes beyond the EU legislation as Customs interprets the legal provisions rather liberally, so that when it seizes goods for another reason (eg, an issue with the documents), it checks whether there is also a rights infringement.

The regulations do not distinguish between OTC drugs and prescription drugs.

Advertising

The advertising of pharmaceutical products is specifically regulated in Title XVII of the Health Reform Law.

Pursuant to Article 798, advertising is prohibited for medicines that do not have valid marketing authorisation in the Romanian territory. The information contained in the advertising material must correspond to that contained in the leaflet, and the advertising must encourage patients to use the medicine sensibly through an objective presentation and without exaggeration of the properties. Most importantly, the advertising must not be deceptive.

Advertising to the public is permitted only for medicines that, due to their composition and therapeutic indication, can be used without a doctor having to diagnose the medical condition and for which it is sufficient to ask the pharmacist’s advice (OTC drugs). Advertising to doctors is also allowed.

Prescription medicines, as well as medicines comprising substances defined as narcotic and psychotropic drugs by international conventions, cannot be advertised to the public. Neither can medicines that are prescribed and used within the social security system, with the exception of vaccination campaigns initiated and approved by the Ministry of Health.

The direct sale or distribution of medicinal products to the public for advertising purposes is prohibited.

Generic substitution

Generic substitution is allowed. There are two key issues:

  • patent infringement; and
  • reimbursement of the price of the product by the social security authorities.

In respect to patent infringement, the rule is straightforward: the generic product must not infringe any valid patent.

A decision was just given in a peculiar case regarding a generic medicine product. In 2003, Company A – the manufacturer of the original medicine product – sued Company B – a manufacturer of a generic product – for patent infringement. A preliminary injunction was obtained in 2003, thus removing the generic medicine from the market from 2003 until 2010 when a final decision was ruled. This decision included the cancellation of the patent on which the preliminary injunction was based. From 2010 the manufacturer of the generic product was free to put its generic products back on the market; however, it did not do so. Instead, in 2013 Company B filed a new lawsuit against Company A, claiming that Company A had removed Company B’s products from the market back in 2003, wilfully anticipating that Company B’s patent would at a later point be cancelled. The case went through all stages of procedure, with a decision issued in March 2019 rejecting Company B’s claim. The court’s motivation is not yet released.

In respect to the reimbursement of the price of the product by the social security authorities, the prices of medicine products and the reimbursement policy of the social security authorities are both governed by the principles of Council Directive 89/105/EEC (21 December 1988) relating to the transparency of measures regulating the prices of medicinal products for human use and their inclusion in the scope of national health insurance systems (also known as the Transparency Directive).

The lists approved by the social security authorities is based on the list of international non-proprietary names. Doctors usually prescribe generic substitutes due to their reduced price. It is a matter of patient knowledge to be aware that same-substance original products are available. Manufacturers of original products may be at a disadvantage, due to the limited medical knowledge of a large part of the public.

Online issues

EU Directive 2001/62/EC, amending EU Directive 2001/83/EC on the Community Code Relating to Medicinal Products for Human Use – which aims to prevent the entry into the legal supply chain of falsified medicinal products and which entered into force on 2 January 2013 – established a framework for distance sales (ie, the online sale of medicinal products).

The measures aim to tighten control of e-commerce relating to medicinal products by establishing:

  • an obligation to introduce safety features that allow verification of the authenticity and identification of individual packs and provide evidence of tampering;
  • a common logo with the help of the European Commission which is recognisable throughout the European Union while allowing for the identification of the member state in which the person offering medicinal products for sale at a distance is established;
  • stricter norms for control and inspection of manufacturers of active substances; and
  • measures and criteria for verification of persons authorised to engage in activity as a wholesaler in medicinal products.

Cabinet M Oproiu

Str Popa Savu 42, Ground Floor

PO Box 2-229, Sector 1

Bucharest 011434

Romania

Tel +40 21 260 28 33/34

Fax +40 21 260 28 35/36

Web http://oproiu.ro

Raluca Vasilescu

Partner

[email protected]

Raluca Vasilescu is a patent and trademark attorney, and has been a partner at Cabinet M Oproiu since 1995. She specialises in patent and trademark prosecution, including related appeals and litigation. She has authored numerous articles, as well as the Romanian chapter in Enforcement of Intellectual Property Rights Through Border Measures (Vrins/Schneider, Oxford University Press, 2012). She also contributed to the first edition of commentaries on the EU Community Trademark Regulation and the Community Design Regulation published by CH Beck in Spring 2015; the second edition of both commentaries was published in 2018.