Procedures and strategies for pharmaceutical brands: Poland
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.
Selection, clearance and registration
The following legislation applies to the registration and use of trademarks in Poland:
- the EU Community Trademark Regulation (207/2009);
- EU Directive 2015/2436 and its implementing act, the Act on Industrial Property Law 2000; and
- the Act on Combating Unfair Competition 1993.
The following legislation applies specifically to pharmaceutical trademarks – including their authorisation, manufacture and distribution on the Polish market:
- the Pharmaceutical Law 2001;
- the Regulation of the Ministry of Health on Requirements for Marking the Packaging of Medicinal Products and their Leaflets 2009; and
- the EU Directive on the Community Code relating to Medicinal Products for Human Use (2001/83/EC) (since under the Pharmaceutical Law, medicines that have been granted EU marketing authorisation can be marketed in Poland, with certain exceptions).
Naming medicinal products
Article 2(14) of the Pharmaceutical Law states that the name of a medicinal product may be:
- an invented name that cannot be confused with the product’s international non-proprietary name (INN); or
- the product’s INN or scientific name, bearing a trademark or the name of the rights holder.
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. At present, each trademark application is assessed based on absolute grounds as stated in the regulation and the Industrial Property Law. The trademark may not be devoid of distinctive character, generic or established in trade practice.
As of April 15 2016, pharmaceutical trademarks will no longer be examined ex officio for relative grounds for refusal by the Patent Office. Regarding relative grounds for refusal, any degree of similarity to an INN should also be taken into account. According to a communication issued by the president of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products (ORMP), an invented name of a medicinal product must not:
- raise the risk of a handwritten, printed or spoken error through confusion with the name of another medicinal product;
- contain single numeric characters, letters or symbols, as this may mislead patients regarding dosage or duration of treatment;
- contain selective indications or specified places of action which are not listed in the medicinal product characteristics or indications;
- be misleading regarding:
- the therapeutic action or pharmaceutical form of the product and the required method of administration; or
- the composition and effect of the product and the effect of excipients on its pharmacological activity;
- carry any advertising or promotional information; or
- carry any negative associations or be offensive.
Packaging of medicinal products
The outer packaging must include the following information about the medicine:
- its invented name and the common name of its active substance;
- its strength;
- its pharmaceutical form;
- its method of administration and route of administration (if necessary); and
- the name of the marketing authorisation holder.
The information placed on the packaging of a medicine (except for the invented name) must be of an informative character and cannot be registered as a trademark.
Parallel imports and repackaging
The Pharmaceutical Law defines a ‘parallel import’ as any action within the meaning of Article 72, Section 4 that involves importing medicinal products from EU or European Economic Area member states, provided that the conditions specified in the law are met.
Parallel import authorisation is issued by the ORMP for five-year periods.
Parallel import of products whose trademark rights have expired is not considered to be infringement. However, the rights of the trademark owner will not be waived if special circumstances allow it to oppose further distribution of goods – in particular, if the condition of the goods is subject to alteration or deterioration following marketing by the parallel importer (Industrial Property Law, Article 155, Section 3). Repackaging is generally acknowledged to be necessary in order to provide Polish consumers with information about a foreign medicine in Polish. Repackaging is understood to involve:
- replacing the external packaging with new packaging in Polish; or
- placing a new, Polish-language label on the original packaging (with the trademark owner’s mark left unmarked or placed anew).
In order to safeguard the legitimate interests of the trademark owner, the new packaging must not affect the original condition of the product inside the packaging and must clearly show which party repackaged the product and the name of the manufacturer. The appearance of the repackaged product must not damage the reputation of the trademark or its owner.
Anti-counterfeiting and enforcement
The Pharmaceutical Law defines a ‘counterfeit medicinal product’ as a medicinal product that has been falsely presented in terms of:
- identity – including packaging, labelling, name or composition (or the strength thereof);
- origin, manufacturer, country of origin or marketing authorisation holder; or
- background – including any data or documents concerning channels of distribution.
Counterfeiting of a pharmaceutical trademark can be combated through the national and EU instruments dealing with trademark infringements.
Apart from these, the specific anti-counterfeiting regulations in Poland include:
- the EU Customs Regulation (608/2013);
- the EU Community Trademark Regulation;
- the Industrial Property Law;
- the Act on Combating Unfair Competition;
- the Civil Code and the Code of Civil Proceedings; and
- the Penal Code and the Code of Criminal Proceedings.
Trademark infringement cases are adjudicated by the district courts. If a trademark is infringed, the trademark owner can initiate court proceedings and apply for an interim injunction. Mediation proceedings may also be instituted.
Two types of preliminary injunction are available under Polish law:
- an injunction to settle reciprocal relations between the parties for the duration of the proceedings (eg, a ban on offering the suspected infringing product for sale for the duration of the proceedings); and
- an injunction permitting one party to obtain information necessary to enforce the claim.
The court can prohibit all actions that infringe a trademark, including:
- using the trademark; and
- offering, putting on the market, importing, exporting or storing products marked with the trademark.
When ruling on infringement, at the claimant’s request, the court may decide on the disposal of unlawfully marked products and publish the verdict both in a specific publication and online.
Monetary remedies are also available – namely, the delivery of profits or compensation of damages.
Criminal proceedings may be instituted against any party that:
- marks goods with a counterfeit trademark for the purpose of placing them on the market; or
- places counterfeit goods on the market.
Numerous actions defined under the Act on Combating Unfair Competition 1993 are also penalised through criminal proceedings.
The Code of Criminal Proceedings stipulates that once a rights holder has filed a motion for prosecution, criminal proceedings are conducted ex officio by the police or public prosecutor. The rights holder may act as a subsidiary prosecutor.
The conditions and procedures for customs authorities to deal with suspected infringing goods are established in the Customs Regulation. Customs may suspend or detain suspected infringing goods at the border; these actions are undertaken by Customs at the request of an interested party or ex officio. Infringements can be combated by instituting civil or criminal proceedings, or by way of a simplified procedure (ie, through which the goods will be destroyed, provided that the holder of the seized goods agrees to their destruction).
The advertisement of medicines is governed by the Pharmaceutical Law. The law lists examples of activities that are considered to be advertising and defines the activities that are excluded from that definition. Advertising can be addressed to the public, doctors or pharmacists. Activities include:
- visits by sales and medical representatives to doctors and pharmacists;
- provision of samples of medicinal products to doctors and pharmacists; and
- sponsorship of promotional meetings and conferences.
However, the law excludes from the category of advertising:
- information placed on the packaging and included with the packaging in accordance with the marketing authorisation;
- information not intended for the public; and
- trade catalogues and price lists, provided that they contain only the legally specified information.
The law specifically prohibits advertising that:
- promises or offers any benefits in exchange for purchasing a medicinal product;
- is aimed at children;
- is aimed at the public, with any content suggesting that:
- failure to take the advertised medicine may be detrimental to health;
- a therapeutic effect can be achieved without consulting a physician; or
- the advertised medicine is a foodstuff or a cosmetic;
- is aimed at the public and suggests that:
- the advertised medicine produces no side effects; or
- the effect of the advertised medicine is better than or identical to that of another medicinal product;
- is for medicinal products that:
- may not be marketed in Poland; or
- contain information that is inconsistent with the medicinal product characteristics; or
- is aimed at the public and is for:
- prescription-only medicines on the list of reimbursed drugs; or
- drugs with names that are identical to those of prescription-only medicines on the list of reimbursed drugs (even over-the-counter (OTC) drugs).
The rules for conducting marketing activities (not only in relation to medicinal products) are also laid down in the Act on Combating Unfair Commercial Practices 2007 and the Act on Combating Unfair Competition. The Pharmaceutical Law also regulates comparative advertising in detail. Such advertising is permitted, provided that it:
- is not misleading;
- fairly and objectively compares the goods or selected characteristics thereof; and
- does not:
- cause confusion in distinguishing between the advertiser and its competitor;
- discredit goods, trademarks, company marks or any other distinctive marking;
- unfairly use the reputation of a trademark; or
- present goods as an imitation of goods or services bearing a protected trademark.
The rules and responsibilities of pharmacists regarding generic substitution are regulated by the Act on the Reimbursement of Medicines, Foodstuffs Intended for Particular Nutritional Uses and Medical Devices 2011.
The act requires pharmacists to inform consumers of the option to purchase a reimbursable generic medicine instead of the prescribed medicine, provided that it:
- has the same INN, dosage, pharmaceutical form and therapeutic indication;
- does not produce therapeutic differences; and
- has a lower retail price than the prescribed medicine.
A pharmacy must ensure the availability of such generic substitute where possible. Further, the pharmacy must place information indicating that consumers have the right to generic substitution in a visible, easily accessible place.
A pharmacist dispensing a reimbursable medicine must provide a cheaper substitute at the request of the consumer. However, the right to substitution does not apply where the physician has included a special note on the prescription prohibiting substitution of the medication prescribed. In practice, consumers do not always choose the cheaper medication – particularly if they are unfamiliar with the proposed substitute or do not trust it.
The above consumer rights and obligations of the pharmacist apply not only to medicines, but also to foodstuffs intended for particular nutritional uses and medical devices.
The Pharmaceutical Law allows mail-order sales by public pharmacies and limited service pharmacies of OTC medicines only, provided that there are no age restrictions on the drug.
The ‘mail-order sale’ of a medicine is understood to be an agreement of sale concluded without both parties being present, where the order is placed using any available means of electronic communication.
Offering a medicine through electronic order, where the medicine is collected in person, does not fall under the definition of ‘mail-order sales’. In this situation, no agreement is concluded remotely and the consumer is considered to purchase the product directly at the pharmacy. The Regulation of the Minister of Health on Mail-Order Sales of Medicinal Products 2015 provides detailed rules for mail-order sales, precisely defining:
- the conditions for mail-order sales of OTC medicines;
- required delivery methods;
- the conditions to be met by pharmacies and limited service pharmacies conducting mail-order sales; and
- the minimum scope of information to be made available on websites that offer medicines.
The Polish top-level domain is ‘.pl’, governed by the domain name registry NASK.
According to the ‘.pl’ domain name regulations, domain name disputes are resolved either by any common court or by one of the existing arbitration courts:
- the Arbitration Court at the Polish Chamber of Information Technology and Telecommunication;
- the Court of Arbitration at the Polish Chamber of Commerce; and
- the World Intellectual Property Organisation Arbitration and Mediation Centre (resolving only disputes in which both parties are registered or resident outside Poland).
The above tribunals adjudicate based on all possible legal measures granting proprietary rights to a party. In particular, the proceedings enable trademark owners to prevent third parties from using domain names that are identical or confusingly similar to their trademarks.
A legally valid decision of an arbitration court or a common court verdict stating that the subscriber has infringed the trademark owner’s rights will form the basis for NASK to terminate its agreement with the infringing subscriber and register the domain name with the plaintiff.
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