Source: http://rychlicki.net/en/issue/polish-law/polish-act-on-pharmaceutical-law/
Timestamp: 2019-04-19 01:04:06+00:00

Document:
On 4 February 2004, the Polish company Przedsiębiorstwo Farmaceutyczne LEK-AM Sp. z o.o. from Zakroczym filed to the Polish Patent Office (PPO) a trademark application for word sign GESTROL Z-275787 for the goods in class 5, cancer drugs. In a decision of 11 April 2008 the PPO refused to grant the right of protection. The PPO found that GESTROL is similar to the earlier registered trade mark (with priority date of 6 February 2003) – GESTROLTEX R-192945 registered for BIOTON S.A. from Warsaw, for goods in class 5, pharmaceutical preparations. Article 132(2)(ii) of 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, served as the basis for the decision to refuse to grant a right of protection.
LEK-AM filed a request for re-examination of the matter. The company argued that the sign applied for is intended to mark the anticancer drug. The active substance in this preparation is a chemical compound of the generic name (INN) megestrol. Under the decision of the Polish Minister of Health, GESTROL as a medicinal product received authorization for marketing. The Minister of Health has not found confusing similarity between GESTROL and GESTROLTEX. LEK-AM pointed out that both trade marks will be identified in the course of the highly specialized medical personnel. The PPO rejected the request and LEK-AM filed a complaint before the Voivodeship Administrative Court (VAC) in Warsaw.
The Court in a judgment of 12 October 2009, case file VI SA/Wa 844/09, ruled that the recipient, to whom the association between the marks GESTROL and GESTROLTEX may arise, is not only a person who is reasonably well informed and reasonably observant and circumspect, but it is also a person with high qualifications. Anticancer drugs are not bought and ordained without the intermediary of a doctor. For this reason, evaluation of other state administrative body, namely the Office for Registration of Medicinal Products, Medical Devices and Biocides and it is the ORMP who sets procedures and requirements for registration of signs for medicinal products, must be considered not only as a medical evaluation of the effects of the medication but also as the situation where the ORMP does not allow for the existence of two medicinal products with the same or similar name, which would prevent the identification of the product and the source of its origin at the medicinal products market. Of course, the court agreed with the PPO’s argument that the registration of the name of the medicinal product in the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products at the Ministry of Health does not create an individual right to a specific drug name. Such a right exists from the time the right of protection for trademark is granted the IPL. It was obvious that the trade mark examination/registration proceedings before the PPO are independent of the proceedings before the ORMP, but it must be borne in mind that the earlier findings of one of the official bodies of Polish state cannot be neglected by another official body.
The VAC came to the conclusion that the contested decision of the PPO did not comply with the requirements of the 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. According to article 107 §3 of the APC, the reasons for the administrative decision should include in particular: facts that the PPO considered proven, the evidence on which it relied and the reasons why the credibility of other evidence were denied the probative value, and the legal justification for the decision should be explain the legal basis for the decision, quoting the law. The VAC held the Polish Patent Office has not give sufficient reasons for, why it has refused to grant protection for a GESTROL trade mark.
The VAC annulled both contested decisions, and ruled them unenforceable. This judgment is not yet final. The party unsatisfied with the ruling may file a cassation complaint to the Supreme Administrative Court.
Categories: Art. 107 §3 APC | Art. 132(2)(ii) IPL | distinctive character | likelihood of confusion | Main Pharmaceutical Inspector | medicinal product | pharmaceutical law | Polish Act on Industrial Property Law | Polish Act on Pharmaceutical Law | Polish Administrative Proceedings Code | Polish courts | Polish law | Polish Patent Office | similarity of signs | trademark law | Voivodeship Administrative Court.
Apteka przy Ratuszu – Centrum Farmaceutyczne (the pharmacy) in Białystok had published a brochure titled “Megaextracharges” (Megadopłaty) in which it has provided information about promotional prices of medicinal products that were available in “Apteka przy Ratuszu”. The Main Pharmaceutical Inspector (MPI) – the central organ of the Polish administration which has the authorithy to supervise compliance with the regulations of Pharmaceutical Law in the scope of advertisements – has ruled that such advertising is prohibited by the Polish Pharmaceutical Law and has ordered the owners of the pharmacy to cease distribiution of brochures and leaflets.
Article 52 of the Polish Act on Pharmaceutical Law – PHL – (in Polish: ustawa prawo farmaceutyczne) of 6 September 2001, published in Journal of Laws (Dziennik Ustaw) of 2008, No 45, item 271, with later amendments provides definition of advertising.
Article 53(1-2) of the PHL allows for limited advertising.
1. Advertising of a medicinal product must not be misleading, it shall show the medicinal product objectively and it shall inform about its rational application.
2. Advertising of a medicinal product can not consist of offering or promising of any benefits, in direct or indirect way, in exchange for product’s purchase or delivery of proofs that the product was purchased.
The owners filled a complaint before the Voivodeship Administrative Court (VAC) in Warsaw. The Court overruled the MPI’s decision and held that the disputed brochures provided information only about the possibility to buy cheap medicines which, in consequence, did not fulfil the definition of “advertising of a medicinal product” as provided in Article 52 of the PPL. The VAC did not find any circumstances of “encouragement to buy” in those promotional materials.
The MPI filled a cassation complaint before the Supreme Administrative Court. The SAC agreed with the Main Pharmaceutical Inspector and held that the lower court should assess not only the visual incentive to buy, but also the “actual intention”, while testing the differences between information and advertising.
The Supreme Administrative Court in a judgment of of 26 June 2008, case file II GSK 199/08 clearly noted that prices promotions encouraging to medicinal products purchases in a specific pharmacy are the advertising of a medicinal product and a company which applies it.
Categories: advertising law | Art. 52 PHL | Art. 53 PHL | medicinal product | pharmaceutical products advertising | Polish Act on Pharmaceutical Law | Polish courts | Polish law | Polish Supreme Administrative Court | trademark law | Voivodeship Administrative Court.
US Pharmacia has commissioned a TV spot for Stoperan – a diarrhoea drug. The ad’s message promised an immediate effect and cure. The Main Pharmaceutical Inspector – the central organ of the Polish administration which has an authorithy to supervise compliance with the regulations of Pharmaceutical Law in the scope of advertisement, has ruled that this advertising spot was contrary to the charactersitics of the drug, because Stoperan works in 1-3 hours and achieves a therapeutic effect after 48-72 hours. In short, it does not cure, though it overcomes the cause.
US Pharmacia has appealed against the MPI’s decision, claiming that it has ceased the broadcasting and screening of the contested ads. The new version had the questioned parts removed and replaced by other to which the MPI did not submit any objections.
However, the Voivodeship Administrative Court has ruled that the MPI had the right to order the cessation of a medicinal product’s advertisement where it was contrary to the current legal regulations and US Pharmacia has violated the provisions of article 55 and 56 of the Polish Act on Pharmaceutical Law – PHL – (in Polish: ustawa Prawo farmaceutyczne) of 6 September 2001, published in Journal of Laws (Dziennik Ustaw) of 2004 No. 53, item 533, with later amendments.
Advertisements of medicinal products should not be misleading, should objectively present a medicinal product and inform of its rational application.
2) containing information inconsistent with the approved Characteristics of the Medicinal Product.
The judgment of the Voivodeship Administrative Court in Warsaw of 17 June 2008, case file VII SA/Wa 556/08 is not final. The parties have a right to file a cassation complaint to the Supreme Administrative Court.
Categories: advertising law | Art. 55 PHL | Art. 56 PHL | medicinal product | pharmaceutical law | pharmaceutical products advertising | Polish Act on Pharmaceutical Law | Polish courts | trademark law | Voivodeship Administrative Court.
The Voivodeship Administrative Court in Warsaw in its judgment of 3 October 2007 case file VII SA/Wa 1157/07 held that a given activity is deemed as the advertising of pharmaceutical product, if it involves the transfer of information on the product while encouraging its use – i.e., it must be information describing the medicinal product in a way to encourage its use, information that is passed to increase the number of prescriptions, the supply of pharmaceutical product or its sale or consumption.
Categories: advertising law | Art. 55 PHL | Art. 57 PHL | Main Pharmaceutical Inspector | pharmaceutical law | pharmaceutical products advertising | Polish Act on Pharmaceutical Law | Voivodeship Administrative Court.
The Voivodeship Administrative Court in Warsaw in its judgment of 29 December 2005 case file I SA/Wa 584/05 held that the important element of pharmaceutical product advertising is the intention of the advertiser to cause a specific reaction of potential customers. Therefore any activity, regardless of its specific, individual way and method of its performance and measures used for its implementation should be considered as the advertising of a medicinal product if the goal of this activity is to increase sales of the advertised product.
Categories: Art. 55 PHL | Main Pharmaceutical Inspector | pharmaceutical products advertising | Voivodeship Administrative Court.

References: §3
 Art. 107
 §3
 Art. 132
 Art. 52
 Art. 53
 Art. 55
 Art. 56
 Art. 55
 Art. 57
 Art. 55