Archive for: Directive 2001/83/EC

Polish regulations on pharmaceutical trade marks

February 1st, 2010, Tomasz Rychlicki

I. The law
The main sources of binding laws in the Republic of Poland are the Constitution of 2 April 1997, acts passed by the Parliament, ratified international treaties and regulations issued, for example, by the Prime Minister or the Council of Ministers – Polish government. Regulations are issued for the purpose of implementation of acts.

I.A. Substantive law

  • The Polish Act of 30 June 2000 on Industrial Property Law – IPL – (in Polish: ustawa Prawo własności przemysłowej) of 30 June 2000, published in Journal of Laws (Dziennik Ustaw) of 2001 No 49, item 508, consolidated text of 13 June 2003, Journal of Laws (Dziennik Ustaw) No 119, item 1117, with later amendments, defines the requirements for obtaining trademark protection in the Republic of Poland. There are related regulations that are issued for the purpose of implementation of the IPL.
  • The Polish Act of 16 April 1993 on Combating Unfair Competition – CUC – (in Polish: ustawa o zwalczaniu nieuczciwej konkurencji), Journal of Laws (Dziennik Ustaw) No 47, item 211, with later amendments.
  • The Polish Act on Pharmaceutical Law – PHL – (in Polish: ustawa prawo famraceutyczne) of 6 September 2001, published in Journal of Laws (Dziennik Ustaw) of 2008, No 45, item 271, with later amendments, defines pharmaceutical/medicinal product. Of course, there are several related regulations to the PHL and the case-law of Polish courts. The PHL is almost entirely based on EU principles.

I.B. Procedural law

  • Administrative Proceedings Code – APC – (in Polish: Kodeks postępowania administracyjnego) of 14 June 1960, Journal of Laws (Dziennik Ustaw) No 30, item 168, consolidated text of 9 October 2000, Journal of Laws (Dziennik Ustaw) No 98, item 1071 with subsequent amendments.
  • Act on proceedings before administrative courts – PBAC – (in Polish:Prawo o postępowaniu przed sądami administracyjnymi) of 30 August 2002, Journal of Laws (Dziennik Ustaw) No 153, item 1270, with later amendments.
  • Civil Proceedings Code – CPC (in Polish: Kodeks Postępowania Cywilnego) of 17 November 1964, Journal of Laws (Dziennik Ustaw) No 43, item 296, with later amendments.
  • Act on Patent Attorneys – APAT – (in Polish: ustawa o rzecznikach patentowych) of 11 April 2001, Journal of Laws (Dziennik Ustaw) No. 49, item 509, with subsequent amendments.

I.C. Case law
See “Polish case law on advertising of pharmaceuticals“.

I.D. EU law
Moreover, all EU regulations and the judgements of the Court of Justice (COJ) of European Union relating to pharmaceutical issues are directly applicable in the Republic of Poland.

II. National bodies and procedures concerning pharmaceutical trade marks
The right of protection for a sign being capable to be registered as a trade mark is granted by the Patent Office of the Republic of Poland (PPO), while the Polish Ministry of Health controls the registration process and approval procedure for medicinal products. Registration of signs for medicinal products is governed by the procedure and requirements set by the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products (ORMP), a government agency competent for the evaluation of the quality, efficacy and safety of medicinal and biocidal products, as well as medical devices.

The Main Pharmaceutical Inspector (MPI) is the central organ of public administration, executing her/his duties with the assistance of the Main Pharmaceutical Inspectorate and the MPI is authorized to ensure compliance with pharmaceutical regulations in the context of advertising. Main Pharmaceutical Inspector is the appeal institution in matters connected with executing tasks and competences of Pharmaceutical Inspection (the institution of second instance with regard to decisions of the provincial pharmaceutical inspector). Appeals against MPI’s decisions are filed before the Voivodeship Administrative Court (VAC) in Warsaw. Further appeal should be brought in the form of a cassation complaint with the Supreme Administrative Court (SAC).

An entity seeking to produce or import medicinal products must file an application for approval with the Inspectorate. The application must specify the medicinal name of the product and any other commonly used names (INN).

See also “Administrative, civil and criminal proceedings in trade mark cases in Poland“.

III. Names of medicinal products and trademarks
A trade mark under the Polish law can be any sign capable of being represented graphically, provided that such signs are capable of distinguishing the goods of one undertaking from those of other undertaking. The following, in particular, may be considered as trademarks: words, designs, ornaments, combinations of colours, the three-dimensional shape of goods or of their packaging, as well as melodies or other acoustic signals. Rights of protection will not be granted for signs which are a subject of absolute or relative grounds for refusal.

A medicinal product is defined as a substance or mixture of substances presented as having properties for treating or preventing disease in humans or animals, or given to make the diagnosis or to restoring, improving or modifying physiological functions through the pharmacological, immunological or metabolic effect. The the provisions of the PHL also apply to products that meet the criteria for both medicinal product and another type of product, in particular dietary supplement or cosmetic (as defined by separate regulations).

Pharmaceutical trade marks not only need to comply with the provisions of the IPL, but also need to meet the requirements regarding names of pharmaceutical products contained in the PHL. Pursuant to these regulations, a pharmaceutical name can be:

  • an invented name, as long as it does not cause confusion with a common name (i.e., an international non-proprietary name (INN) recommended by the World Health Organization or, if such name has not been attributed to a given product, a common chemical name) or
  • a common, or scientific name accompanied by a trademark, a company name or the name of the marketing authorization holder.

Obtaining an authorization for the release of a medicinal product under a given name does not exempt an entity from liability if the name violates third-party trademark rights. Applicants must therefore also keep in mind the provisions of the IPL and the CUC.

See also:
– “Trade mark law, case II GSK 210/06“.
– “Pharmaceutical trade marks, case VI SA/Wa 844/09“.
– “Pharmaceutical trade marks, case VI SA/Wa 1176/09“.

An announcement of the president of the ORMP issued on March 12 2008 gives further guidance on the process of naming medicinal products and the substitution of names that have already been granted. It sets out the following instructions:
– The new name of a medicinal product should differ from an earlier registered product name in at least three letters and the new name cannot include a sequence of more than two of the same letters. An applicant is required to provide a justified written statement when seeking a waiver from these rules.
– The new name cannot result in the likelihood of confusion (in print, spelling and pronunciation) with an earlier registered name.
– Signs such as ® and ™ cannot form part of the new name.
– The name of a medicinal product cannot contain personal names and surnames, including the name of the inventor. Further, it must not contain:
1. Names of abstract persons that are used together with scientific titles, aliases or pseudonyms.
2. Expressions which bring to mind religious, geographical or historical associations.
3. Names of natural objects.
4. Obscene words or words suggesting obscene content.
– The name of the medicinal product must also be placed on the packaging in the Braille system.

The evidence of registration of a medicinal product name with the ORMP can act as evidence of use of the sign as at that date when attempting to protect the name as an industrial property right.

IV. Parallel imports and repackaging
Parallel importation into Poland of a pharmaceutical product from other EU member states or members of the European Economic Area (EEA) is acceptable provided that it meets all of the following conditions:

  • The parallel-imported medicinal product must have the same active ingredient(s) as the product authorized for marketing in the territory of the Republic of Poland (i.e., the same indications at least up to the third level of the Anatomical Therapeutic Chemical (ATC) or the ATC veterinary.
  • The parallel-imported product must have the same strength and administration route as the authorized product, as well as the same or similar form. Slight differences in form cannot lead to any therapeutic differences between the products.
  • Where the product authorized for marketing in Poland is a brand name pharmaceutical, the parallel import must also be the brand name product. Similarly, where the authorized product is a generic, the parallel-imported pharmaceutical must also be a generic.

A parallel importation licence is available on application to the Polish Health Minister. The licence is issued on the basis of an assessment report prepared by the president of the ORMP. The application must include a sample of the packaging and the product information leaflets. A licence is granted for a period of five years.

According to article 21a(9) of the PHL, a parallel importer is allowed place the pharmaceutical product on the market in the Republic of Poland under:

  • the name used in Poland,
  • the name used in the EU/EEA member state of origin, or
  • the common name (INN) or scientific name together with the trademark or name of the parallel importer.

A parallel importer intending to put a medical product on the Polish market must inform the holder of the marketing authorization in Poland as to the expected date of entry onto the market at least 30 days before such date.

In order to place a product on the market, the parallel importer must alter the packaging thereof to adhere to local standards. The packaging must comply with that approved in the import licence. Polish authorities generally require the repackaging of parallel-imported medical products into new boxes that contain informational leaflets for patients in Polish. The informational leaflet must also be consistent with the parallel import licence.

The first parallel-imported medical products were placed on the Polish market in November 2005. As of the end of March 2008, over 200 parallel import licences had been granted in Poland.

The process of repackaging frequently causes disputes between parallel importers and mark owners. However, there is no case law in Poland with regard to this issue at present.

V. Anti-counterfeiting and enforcement
The responsibility for combating the trade and distribution of counterfeit medicines in Poland falls on the bodies responsible for the prosecution of crime – the Police, the Custom Service (detection and seizure of imported counterfeit medicines) and the Public Prosecutor’s Office. According to the official data published by the Ministry of Finance, 1,356 counterfeit packages of medicine were seized at the Polish borders in 2007, while 1,700 packages were seized within the first three months of 2008. According to the Main Pharmaceutical Inspectorate, 99% of medicines offered for sale from illegal sources are counterfeit and are hazardous to life or health.

VI. Advertising of pharmaceutical products
The PHL sets out the requirements for advertising pharmaceutical products in Poland. The advertising of medicinal product has also to be made in accordance with the current Regulation of the Minister of Health on the advertising of medicinal products of 21 November 2008, Journal of Laws (Dziennik Ustaw) No 210 item 1327. Advertising a medicinal product shall mean any activity consisting in informing about and encouraging to use the medicinal product, with the purpose of increasing the number of prescriptions, delivery, sale or consumption of the medicinal product.

Among others, the following activities are seen as advertising of pharmaceutical products:

  • Advertising of pharmaceutical products addressed to the public,
  • Advertising of pharmaceutical products addressed to individuals authorized to issue prescriptions or involved in the distribution of pharmaceutical products,
  • The visiting by sales or medical representatives of individuals authorized to issue prescriptions or involved in the distribution of pharmaceutical products,
  • The provision of pharmaceutical product samples,
  • Sponsoring promotional meetings for individuals authorized to issue prescriptions or involved in the distribution of pharmaceutical products
  • Sponsoring scientific conferences, meetings and congresses for individuals authorized to issue prescriptions or involved in the trade of pharmaceutical products.

It should note that the Polish legislature did not apply the correct legislative techniques and thus the PHL includes different concepts with different contents of which makes a mess of the legal terminology. It is also the problem of the European legislator because the same problem also applies to article 86 of the Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use.

Pharmaceutical products may be advertised exclusively by the parties responsible for the products or by persons who have been commissioned by such parties.

An advertisement for a pharmaceutical product cannot be misleading. It should present the product objectively and inform about its rational use. Further, the following types of advertising are prohibited:

  • Advertising offering or promising any advantages in a direct or indirect manner in return for purchasing the product, or providing any evidence of having purchased the product.
  • Advertising addressed to children or containing any element which might be considered as being addressed to children.
  • Advertising of pharmaceutical products that have not been admitted for trade in the territory of Poland or contain information which is inconsistent with the officially approved pharmaceutical product description.

Special restrictions are also imposed on advertising directed to specialists and the public.

VII. Generic substitution
Generic substitution is allowed under Polish law. Generic drug names comprise the name of the company producing the medicine together with its INN or invented name.

VIII. Online issues – e-pharmacies, domain names
The market turnover of medicinal products takes place only under the terms and conditions laid down by the PHL’s regulations. Conducting the sale of medicines is reserved for “public pharmacies”. In addition, the right of the retail resale of certain drugs without a prescription and some prescription drugs is granted to “pharmacy points”. The sale of selected drugs without a prescription can be also conducted by the so-called “out-pharmacy market post”: herbal-medical shops, specialized medical supplies stores, pet shops, herbal/chemists shops/drugstores, and public shops – provided that the staff have appropriate qualifications. The law precisely regulates all features that the public pharmacy should have and the pharmacy point. It already implies the existence of the physical premises open to the public and intended to pursue the sale of drugs. The PHL authorized public pharmacies and pharmacy points to conduct the mail-order sale for public only for medicines purchased without a prescription (article 68 (3) of the PHL). Additionally, the term “pharmacy” is a reserved name that is legally protected under the PHL and criminal law, as well as unfair competition regulations. Any entity wishing to use the term “pharmacy” must meet strict regulatory requirements. Online operators that do not meet the conditions set by the regulations on pharmacies can neither use the term “pharmacy” nor trade in pharmaceutical products.

Where a domain name including a trade mark has been registered by an unauthorized third party, the mark owner can use mediation, alternative dispute resolution (ADR) proceedings or civil court action to obtain the cancellation or transfer of such domain. However, following a recent judgement of the Polish Competition and Consumer Protection Court of 26 December 2006, case act signature XVII AmC 170/05, ADR is unlikely to succeed if the disputed domain name is registered in the name of a natural person.