Polish IP & IT law » medicinal product

Archive for: medicinal product

Advertising of pharmaceuticals, case VI SA/Wa 2110/09

March 17th, 2010, Tomasz Rychlicki

On June 2009, the Polish newspaper Gazeta Wyborcza published an article (sort of an advertorial) containing images that depicted packagings of Stoperan and Septolete medicines, together with a note instructing that the leaflet attached to these products should also be read.

The Main Pharmaceutical Inspector (MPI) ordered the immediate cessation of such actions in a decision of 4 September 2009, case no. GIF-P-R-450-81-4/JD/09, PDF file. The MPI has fund that the publication did not meet the requirements set in the Polish pharmaceutical law with regard to advertising of medicinal products. It was not commissioned by the responsible entity and it did not contain the detailed characteristics of the products or the required and established warnings.

Agora S.A., the owner of Gazeta Wyborcza, filed a complaint to the Voivodeship Administrative Court (VAC) in Warsaw. The VAC in a judgment of 11 MArch 2010, case file VI SA/Wa 2110/09, ruled that medicines are dangerous products and therefore the strict requirements and regulations for advertising of such preparations were introduced, and they do not allow for the so-called hidden advertising. The Court agreed with MPI’s findings that the article published by Gazeta Wyborcza contained information about two medicinal products and that could encourage the use of these preparations, which is contrary to article 52(1) of the 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.

Advertising a medicinal product shall mean any activity consisting in informing about and encouraging to use the medicinal product

This judgment is not yet final. A cassation complaint may be filed to the Supreme Administrative Court.

See also my posts entitled “Polish regulations on pharmaceutical trade marks” and “Polish case law on advertising of pharmaceuticals“.

Advertising of pharmaceuticals, case II GSK 461/09

March 14th, 2010, Tomasz Rychlicki

The Main Pharmaceutical Inspector (MPI) found that Polish Federation for Women and Family Planning (in Polish: Federacja na rzecz Kobiet i Planowania Rodziny) is publishing the names of contraceptives on its Internet website, and therefore the Federation advertises these products. The MPI ordered the immediate cessation of such actions because it may encourages the use and prescription of such medical preparations and public advertisement of medicinal products as contraceptives, that are issued only on prescription, is prohibited by provisions of article 52(1) of the 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.

Advertising a medicinal product shall mean any activity consisting in informing about and encouraging to use the medicinal product

The Federation filed a complaint to the Voivodeship Administrative Court (VAC) in Warsaw. The VAC in a judgment of 3 March 2009, case file VII SA/Wa 2108/08, has overturned the decision of the MPI, but only because the incomplete material was submitted. The VAC agreed that MPI’s decision was justified with regard to cessation of public advertisement of contraceptives. The Federation filed a cassation complaint.

The Supreme Administrative Cort (SAC) in a judgment of 10 March 2010, case file II GSK 461/09, ruled that the provisions of article 52 are legible and obvious, but they must relate to the circumstances of a particular case and to all reasons of actions taken in order to inform about the medicinal product. According to the SAC these circumstances were not considered and the VAC also omitted the statutory objectives of the Federation. The major role of the Polish Federation for Women and Family Planning is to inform of the various methods of family planning. Publishing the name of contraceptives, cannot be treated as an encouragement for its use. The information does not come from the responsible entity, and the publication of characteristics of medicinal products is not considered as advertising. If the order issued by the MPI was sustained, such information could not be published at all.

Therefore, the SAC annulled the questioned judgments of the Voivodeship Administrative Court and returned the case to the VAC for reconsideration.

Trade mark law, case II GSK 214/09

March 3rd, 2010, Tomasz Rychlicki

This is a continuation of the story described in a post entitled “Trade mark law, VI SA/Wa 1000/08“. Les Laboratoires Servier from France filed a cassation complaint. The Supreme Administrative Court in a judgment of 16 December 2009, case file II GSK 214/09, ruled that the sign GLAZIDE is representing a creative transformation of the name of an active ingredient (AI) called gliclazidium (gliclazide) that was proposed by the WHO. GLAZIDE has the distinctive character because it is a fanciful sign and it does not constitute either a name of a generic product, or the International Nonproprietary Name of the active substance of the Latin Gliclazidum (English: Gliklazide, Polish: Gliklazyd), nor does it directly inform about the characteristics (properties) of goods. Therefore, the SAC rejected the complaint.

Poland: differences in pharmaceutical trade marks

February 17th, 2010, Tomasz Rychlicki

On 4 June 2002, the Polish entrepreneur Wojciech Soszyński from Sopot applied to the Polish Patent Office for the right of protection for OCERIN Z-251142 trade mark in class 5 for goods such as oral pharmaceutical preparations in a form of granulate, drops, capsules, emulsion, herbal blends, pastes, pills, powder, syrup, suspensions, gels, pharmaceutical preparations for mouthwashingin a form of aerosol, chewing gum, capsules, concentrate, drops, pills, pastes, liquids, powder, tablets, suspensions, gels, pharmaceutical preparations for dental purposes in a form of emulsion, paste, liquids, powder, tablets, suspensions, gels, pharmaceutical preparations for inhalation purposes in a form of aerosol, emulsion, gas, ointments, liquid, powder, tablet, suspension, gels, trachea and lung pharmaceutical preparations in a form of powder, solution, suspension, pharmaceutical preparations for skin care applied on skin and percutaneous in a form of medicated bath supplements, emulsion, cataplasm, collodion, concentrate, cream, ointment, dressing, paste, foam, plaster, liquids, powder, shampoo, suspension, gels, pharmaceutical preparations for eyes in a form of drops, creams, ointments, liquids, drops solvent, vaginal pharmaceutical preparations in a form of pills, tampons, vaginal douching suspensions, gels, powder, solvents for gel preparation, rectal pharmaceutical preparations in a form of suppositories, emulsion, capsules, concentrates, creams, ointments, foams, liquids, tablets, tampons, suspensions, gels, vesica and urethra pharmaceutical preparations in a form of washing liquids, powder for liquid preparation, gels, pharmaceutical preparations for ears in a form of aerosol-emulsion, solutions, suspensions, creams, drops, ointments, liquids, powders, rods, tampons, gels, pharmaceutical preparations for nose in a form of aerosol-suspension, liquids, drops, ointments, powders, rods, vaginal pharmaceutical preparations in a form of emulsion for irrigation, intravaginal tablets, intravaginal capsules, intravaginal creams, intravaginal ointments, intravaginal foams.

The Polish Patent Office (PPO) in decision of 21 July 2008 refused to grant a right of protection. The PPO noted that BEIERSDORF AG from Hamburg reported observations as to the existence of grounds that may cause a right of protection to be denied. BEIERSDORF AG argued that OCERIN is similar to its EUCERIN IR 710661 trade mark applied for with the priority of 3 March 1999 for goods in class 5 such as cosmetics for medical purposes prepared in the form of creams, gels and lotions, all for the protection of dry skin, dermatologic preparations for prevention of allergy and skin ills, medical preparations for care, washing and beauty of hair, medical preparations for shower and bath purposes, medical sun tanning preparations, medical preparations against aging of skin, prevention skin preparations against UV radiation, and another word-figurative trade mark EUCERIN IR 765927.

The PPO found that the greater part of the opposed signs is identical and differs only in the beginning. Taking into account the specificity of goods in Class 5, the consumer may think that this is a variation of a single product or products with a similar purpose. It cannot be excluded that the consumer will shift the similarity (in the core and the ending of a sign) to the origin of goods, nor that differences in the beginning of a sign, will be shifted to the differences between the products, rather than differences in terms of their origin. Thus, in both cases, the signs causes the consumer the confusion as to the origin of goods.

The PPO also noted that both signs have no particular meaning in the Polish language. Consumers may try, or not, to give them some meaning. The PPO pointed out that it is very often in the market of pharmaceuticals that endings of signs or whole signs refer to the active substances. However, the average recipient has no knowledge of chemistry and pharmacy. Therefore, one may not know what components produce the substance or whether they are derivatives, and how it translates on the naming. The similarity of words is all, what is available to consumers and on such basis, they have to decide on the origin of goods. A large part of products listed in both lists of goods are those that are available without any prescription, and thus the support of pharmacist during its purchase cannot always be assumed. These products are also offered in hypermarkets and drugstores, where you cannot always count on the help of a sales assistant. But even if the pharmacist may give an advice on the composition of a product, it still does not determine the lack of the association between entrepreneurs. The assumption on the association between entrepreneurs should be concluded from minor differences in signs or other indications on the packaging and labeling, and such a situation, while comparing the signs, cannot be presumed, since the mark must indicate the origin of the goods itself.

The complaint to the Voivodeship Administrative Court (VAC) in Warsaw was brought by Oceanic S.A., legal successor of Wojciech Soszyński’s trade mark application. The VAC in a judgment of 7 October 2009, case file VI SA/Wa 1176/09, ruled that the risk of misleading the public as to the origin of goods decides whether the two signs are similar. The questions does not concern a personified trader/entrepreneur but it is all about the sign which has always to mark and indicate that the goods originate exclusively from the same trader. The unacceptable misleading of public as to the origin of goods is created by the similarity of goods and the similarity of signs.

Therefore, any doubts should be decided in favor of the proprietor of the trade mark with an earlier priority. This rule is a consequence of the belief that the entrepreneur who, for the same type of goods, chooses a sign that is similar to the trade mark with earlier priority, acts at its own risk and all uncertainty should be decided against him. A comparison of the lists of goods for EUCERIN and OCERIN trade marks indicates that these goods are similar. In the midst of these products are both cosmetics and pharmaceutical preparations of cosmetic and medicinal characteristics.

This judgment is not yet final. A cassation complaint may be filed to the Supreme Administrative Court.

See also my posts entitled “Polish regulations on pharmaceutical trade marks” and “Polish case law on advertising of pharmaceuticals“.

Pharmaceutical trade marks, case VI SA/Wa 844/09 – GESTROL is not always similar to GESTROLTEX

February 2nd, 2010, Tomasz Rychlicki

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.

2. A right of protection for a trademark shall not be granted, if the trademark:
(…)
(ii) is identical or similar to a trademark for which a right of protection was granted or which has been applied for protection with an earlier priority date (provided that the latter is subsequently granted a right of protection) on behalf of another party for identical or similar goods, if a risk of misleading the public exists, in particular by evoking associations with the earlier mark,

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.

See also my posts entitled “Polish regulations on pharmaceutical trade marks” and “Polish case law on advertising of pharmaceuticals“.

Advertising of pharmaceuticals, case II GSK 199/08 – illegal incentives

June 30th, 2008, Tomasz Rychlicki

In the article entitled “Zabronione zachęty w folderze leków“, the Polish newspaper Rzeczpospolita reports a recent judgment of the Supreme Administrative Court (SAC) regarding the commercial promotion and advertising of medicinal products.

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 that

Advertising a medicinal product shall mean any activity consisting in informing about and encouraging to use the medicinal product

and article 53(1-2) 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.

See also my posts entitled “Polish regulations on pharmaceutical trade marks” and “Polish case law on advertising of pharmaceuticals“.

Advertising of pharmaceuticals, case VII SA/Wa 556/08

June 19th, 2008, Tomasz Rychlicki

In the article entitled “Nie można mówić, że lek, który zwalcza objawy, leczy“, the Polish newspaper Rzeczpospolita reports a recent judgment of the Voivodeship Administrative Court (VAC) in Warsaw regarding the commercial promotion and advertising of medical products.

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.

Article 55
Advertisements of medicinal products should not be misleading, should objectively present a medicinal product and inform of its rational application.
(…)
Advertisements of a medicinal product addressed to the general public also cannot include any contents that would:
(…) assure that taking a given medicine guarantees an appropriate effect, it is not accompanied by any undesirable effects or that effect is better or the same as in the case of another method of treatment or treatment with the use of another medicinal product;
(…)
Article 56
It shall be prohibited to advertise medicinal products:
1) not authorized to turnover on the territory of the Republic of Poland;
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.

See also my posts entitled “Polish regulations on pharmaceutical trade marks” and “Polish case law on advertising of pharmaceuticals“.

Poland: trade marks for medicines

April 30th, 2008, Tomasz Rychlicki

All readers who are going to apply for trade mark registration for medicines in the Republic of Poland should consider not only the Act on Industrial Property Law and its related Regulations but also the procedure and requirements set by the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products (OFROMPMDABP — now that’s an abbreviation) if they want to avoid any headache.

OFROMPMDABP is a government agency competent for matters related to evaluation of quality, efficacy and safety of medicinal products, medical devices and biocidal products. Trade mark owners should be aware of the existence of the announcement (this is a PDF file in Polish language) issued by the President of the Office on 12 March 2008. This document applies to the process of medicinal product naming and the substitution of names that were already issued.

New name of a medicine product should differ from earlier registered product’s name in at least 3 letters and the new name can not include the sequence of more then two of the same letters. The applicant is required to issue a justified written statement in case of seeking a waiver from the above mentioned rules.
New name can not lead to likelihood on confusion (in print, spelling and pronunciation) with regard to earlier registered name.
New name can not give any promotion or advertising information related to application process.
Signs such as ® and “TM” can not be a part of a new name.

Categories: Class46 post | Polish law | medicinal product | trademark law.