Selection, clearance and registration
Parallel imports and repackaging
Anti-counterfeiting and enforcement
Generic substitution
Domain names
Selection, clearance and registration
The following trademarks may enjoy protection in Hungary:
- national trademarks - such trademarks are filed with the Hungarian Intellectual Property Office;
- international trademarks - an international trademark application on the basis of the Madrid Agreement or Madrid Protocol must be filed with the Hungarian Intellectual Property Office and forwarded to the World Intellectual Property Organisation; and
- Community trademarks - the protection of a registered Community trademark extends to the territory of Hungary as an EU member state. A Community trademark application is to be filed with the Office for Harmonisation in the Internal Market.
Protectable signs
In accordance with Section 1(1) of the Trademarks and Geographical Indications Act (11/1997), trademark protection shall be granted to any signs that are capable of being represented graphically, provided that they are capable of distinguishing the goods or services of one undertaking from those of other undertakings. Signs which may be granted trademark protection include:
- words and combinations of words, including personal names and slogans;
- letters and numerals;
- figures and pictures;
- two or three-dimensional forms, including the shape of goods or of their packaging;
- colours, combination of colours, light signals and holograms;
- sound signals; and
- combinations of the above.
The filing fee for three classes is Ft74,800 (approximately €256); for the fourth and each further class the filing fee is an additional Ft32,000 (approximately €109).
Filing process
The filing date is the date on which the Hungarian Intellectual Property Office receives the application.
If the application meets the requirements for granting a filing date, the Hungarian Intellectual Property Office will examine the formal requirements. It carries out a search of earlier rights and sends its report to the applicant. If a trademark application meets the requirements as to absolute grounds laid down in the Trademarks and Geographical Indications Act, the Hungarian Intellectual Property Office will carry out a substantive examination of the application. After sending the search report to the applicant, the Hungarian Intellectual Property Office will publish the application in the Official Gazette and notify the applicant of this publication. Within three months of the publication of a trademark application, or the modification or division thereof, opposition to registration of the trademark may be submitted by holders of earlier rights based on relative grounds for refusal. Third parties may file observations stating that the designation conflicts with absolute grounds for refusal.
If the trademark application meets all of the requirements, the Hungarian Intellectual Property Office registers the trademark in the Trademark Register and issues a trademark certificate, together with an extract of the register.
Term of protection
Trademark protection lasts for 10 years from the application filing date. Protection can be extended for further periods of 10 years upon the registered owner's request for renewal. The number of renewals is unlimited.
Name of pharmaceutical product
The name of a pharmaceutical product can be an invented name - which may not be liable to cause confusion with a common name - or a common or scientific name accompanied by the trademark or the name of the holder of the marketing authorisation.(1) The name of the pharmaceutical product cannot be identical or confusingly similar to the name of a proprietary pharmaceutical product for which marketing authorisation has already been granted. Such requirement is not affected if an invented name is registered as a trademark. The international non-proprietary name of an active ingredient or a confusingly similar designation cannot be registered as a trademark.
Parallel imports and repackaging
Parallel import
Parallel import activities are governed by the Ministry of Health Regulation on Wholesale and Parallel Import of Pharmaceutical Products (53/2004 (VI 2)), known as the Parallel Import Regulation. Parallel importers must obtain a parallel import licence from the National Institute for Quality and Organisational Development in Healthcare and Medicines (NIP). The following conditions on parallel import activities also apply:
- The imported pharmaceutical product must originate from a member state of the European Economic Area (EEA);
- The product must have obtained marketing authorisation for the EEA member state from which it originates;
- The product must have obtained marketing authorisation for Hungary; and
- The product must be accompanied by a release document issued by a qualified person at the manufacturer confirming that the product complies with the product quality requirements stated in the marketing authorisation.
A parallel import licence is valid for five years from its date of issue.
Repackaging
'Repackaging' refers to an action that results in the stripping or relabelling of the original packaging, or the amendment of the patient leaflet therein while keeping the original packaging, in order to comply with the valid marketing authorisation in Hungary. Pharmaceuticals may be repackaged only in other EEA member states.
Protection of trademarks
The holder of a Hungarian marketing authorisation must be notified 30 days before parallel import. The importer is obliged to repackage the product according to the Hungarian marketing authorisation, keeping adverse effects on the trademark to a minimum. The trademark owner may oppose the repackaging if it goes beyond the specifications of the Parallel Import Regulation. With regard to trademark enforcement in connection with parallel imports, the courts' practice is limited to cases where the product has been imported from a non-EEA country, in which case such parallel import qualifies as trademark infringement. When the parallel import originates in the EEA, the trademark owner can file a lawsuit if the above-mentioned rules are breached because any injury to its trademark rights gives cause to terminate the exhaustion exemption. Proceedings to cancel the parallel import authorisation of illegally repacked pharmaceutical may form part of any legal defence.
Anti-counterfeiting and enforcement
Closed and controlled distributional chain
The Act on Medicinal Products for Human Use creates a strict, closed and controlled pharmaceutical marketing chain in Hungary, which theoretically excludes the risk of counterfeit products being distributed through legally operating dispensaries. Every member of the distribution chain must hold an administrative authorisation issued by the competent Hungarian pharmaceutical supervisory authority or by the pharmaceutical supervisory authority of an EU member state. In addition, their authorised activity is continuously controlled by the competent authority. In accordance with Section 12 of the Medicines Act, the phrase 'supply of medicinal products' covers all activities by which pharmaceutical products are made available directly to users, including the manufacture, production, storage and distribution of pharmaceuticals. Unless otherwise provided by law, pharmaceutical products must be procured and dispensed to patients through pharmacies. Pharmacies may procure pharmaceutical products only from a business entity which is authorised to engage in activities relating to the wholesale distribution of pharmaceutical products.
The NIP and the National Public Health and Medical Officer Service play an important role in controlling the distribution of pharmaceuticals: the former controls pharmaceutical products until they reach the pharmacies, while the latter controls retail distribution.
Investigation and identification
Regarding the investigation of counterfeit pharmaceutical products, the competent authorities are the Hungarian Customs and Finance Guard and the police. Modern techniques and chromatographic and spectrographic devices are used to analyse product quality.
Prevention
The NIP provides information to the public, which recommends purchasing pharmaceutical products from authorised retailers and avoiding unauthorised commercial channels such as street sellers, markets, the Internet and home delivery services. The NIP plays an important role in the international effort to harmonise and enhance the fight against pharmaceutical counterfeiting. It is a member of the Heads of Medicines Agencies; it also sends representatives to the agencies' Working Group of Enforcement Officers.
Generic substitution is not prohibited in Hungary. The NIP publishes a list of pharmaceutical products that are considered bioequivalent and substitutable in the same indication. Generic substitution is governed by the Act on General Rules of Safe and Efficient Supply of Medicinal Products (98/2006) and by the Regulation of the Minister of Health and Social Affairs on Prescription and Dispensing of Pharmaceutical Products (44/2004).
Physician's obligations
In the course of prescribing pharmaceutical products and medical aids, the physician shall inform the patient of:
- any alternative to the pharmaceutical product and medical aid prescribed for the treatment; and
- the difference between the estimated costs to be paid by the patient for pharmaceutical products having the same active ingredient and those of the same fixed subsidy group, as well as bioequivalent pharmaceutical products, and medical aids within the same function group.
The physician may exclude substitution with the consent of the patient and state so on the prescription. The patient is required to verify the receipt of the information by signing the physician's record.
Pharmacist's obligations
In case the physician does not exclude the possibility of generic substitution, the pharmacist shall inform the patient that such substitutes are available at a lower price than the product prescribed. With the consent of the patient, the pharmacist shall replace the prescribed pharmaceutical product with another, cheaper product.
Probable amendments
An amendment proposed by the government would make it possible in the near future for physicians to prescribe active ingredients only, instead of branded pharmaceuticals.
Issues
Physicians usually exclude the possibility of dispensing a generic substitution when, due to the complexity of the disorder or the allergic sensitivity of the patient, the pharmacist may not have appropriate expertise to make the decision. Most physicians oppose the idea that pharmacists may be at liberty to dispense substitutions at all.
In addition, an interesting issue arises with regard to reimbursed pharmaceutical preparations: on the one hand, pharmacists are legally bound to inform patients about the availability of cheaper products, while on the other hand they are interested in making a higher profit, which - due to their legally fixed margin - is achievable only by selling more expensive preparations. This contradiction is left to the pharmacists to resolve when they recommend products to patients, taking all circumstances into account in a given case.
Use as a domain name of the name of a prescription pharmaceutical product or of a pharmaceutical product which is reimbursed by the public healthcare system may be deemed a commercial advertising activity, which is prohibited for such products under the regulations governing advertising of pharmaceutical products. The international non-proprietary name of these products may be registered as a domain name only when the pharmaceutical product cannot be identified on the website and neither the name of the manufacturer nor any identifying reference of the pharmaceutical product is displayed.
For further information on this topic please contact Georgina Busku at Danubia Patent & Law Office LLC by telephone (+36 1 411 8800), fax (+36 1 266 5770) or email ([email protected]).
Endnotes
(1) Section 1(1)13 of the Act on Medicinal Products for Human Use (95/2005), which complies with Article 1(20) of Directive 2001/83/EC.
An earlier version of this update first appeared in Pharmaceutical Trademarks 2012 - A Global Guide, published by the IP Media Group.