Patents and Trademarks
All legal aspects surrounding patents & trademarks in Poland. Prepared in association with DLA Piper, a leading law firm in Poland, this is an extract from The Pharma Legal Handbook: Poland, available to purchase here for GBP 75.
1. What are the basic requirements to obtain patent and trademark protection?
An invention (which is patentable) is a new (on a global scale) solution of a technical nature, characterized by a degree of inventiveness (not obvious in prior art), and suitable for industrial application (if, on the basis of the invention a product can be made or a method can be implemented, in any industrial activity, including agriculture).
There are four categories of inventions:
Biotechnological inventions are a special type of invention. A biotechnological invention is an invention relating to a product consisting of or containing a biological material or a method by which a biological material is produced, processed or used. Biotechnological inventions for which patents may be granted are, in particular, inventions: 1) constituting a biological material that is isolated from its natural environment or made by technical means, even if it has previously been found in nature; 2) constituting an element isolated from the human body or otherwise produced by technical means, including the sequence or a partial gene sequence, even if the structure of that element is identical to that of the natural element; 3) concerning plants or animals, if the technical possibilities of using the invention are not limited to a particular plant variety or breed of animal.
A patent lasts for 20 years from the application date. In the case of patents referring to pharmaceutical products and plant protection products, protection for the product implementing a particular solution might be extended up to 25 years by acquiring a Supplementary Protection Certificate (SPC).
An SPC is granted, among other things, for medicinal products. This is a subjective, erga omnes right, separate from the patent, which can be traded as an element of property and business. An additional protection right is granted based on the patent remaining in force, and the term of protection may not exceed five years (with the exception of pediatric medicinal products, for which protection can be extended for a further six months).
SPCs are subject to the same restrictions as the basic patent, upon the expiry of which supplementary protection arises. Like patent exclusivity, protection under an SPC is territorial.
The subject of the SPC has the same rights as those granted for the patent. The scope of protection resulting from an SPC may be narrower or the same as that resulting from the patent – but not wider. In the event of obtaining an additional protection right based on a basic patent for a product, the scope of exclusivity resulting from the additional protection right extends to the medical applications of the protected substance. The authorized person may use the invention to the extent approved by the regulatory authority in the first marketing authorization for a medicinal product. The additional protective right covers the part of the invention covering the product for which the first marketing authorization was granted.
The SPC loses its force with the main patent. If the main patent loses its validity for a reason not affecting the invention which is the subject of the additional patent, the additional patents to the main patent become patents and remain in force for the period for which the main patent was granted.
A trademark is any sign that is capable of distinguishing the goods (or services) of one enterprise from the goods (or services) of another enterprise. Types of signs include:
A trademark right grants the owner the exclusive right to use the trademark in a commercial and professional way in the territory of Poland (or in the EU, based on an EU trademark). A trademark right prohibits any third party from manufacturing, using, offering, marketing or importing and exporting and stocking for these purposes, products marked with an identical, similar or confusingly similar trademark (in the case of renowned trademarks, the level of similarity is lower and does not require that goods marked with such trademarks be identical or very similar).
The right to a registered trademark may last indefinitely if the protection is extended every 10 years.
2. What agencies or bodies regulate patents and trademarks?
All proceedings referring to local patents and trademark registrations are handled by the Patent Office of the Republic of Poland (“Polish Patent Office”).
With respect to foreign trademark and patent registrations which can also cover Polish territory, the following authorities are applicable:
- EU trademarks – European Union Intellectual Property Office (EUIPO);
- International trademarks – World Intellectual Property Organization (WIPO);
- European patents – European Patent Office (EPO);
- International patents: Patent Cooperation Treaty (PCT) and The Visegrad Patent Institute (VPI) – filed with the Polish Patent Office.
3. What products, substances, and processes can be protected by patents or trademarks and what types cannot be protected?
The Polish Patent Office grants patents for inventions that are patentable. This means inventions that are characterized by a set of features defined in legal provisions, whose existence is necessary for the invention to be patentable.
To assess the patentability of an invention, it is necessary that:
- the invention is presented clearly and comprehensively so that a person skilled in the art can implement it;
- the patent application explains what is to be protected in a clear and concise manner and is fully supported by the description of the invention.
According to Polish law, “patents are granted – regardless of the field of technology – for inventions that are new, have a degree inventiveness, and are suitable for industrial use.”
Patentability testing by the Polish Patent Office requires first to determine whether the subject of the application can be considered as an invention. It should be borne in mind that, above all, an invention is a technical solution. Only after determining the existence of an invention is it possible to check whether the invention meets the statutory conditions required to obtain a patent.
An invention is considered new if it is not part of the state of the art. The state of the art is understood as anything which, prior to the date on which priority is given to obtaining a patent, has been disclosed to the public in the form of a written or oral description, by application, display or otherwise. To assess whether an invention is new, the fact of its being shared (disclosed) is significant – not whether anyone has become acquainted with it.
The disclosure of an invention is deemed to be such a representation of the nature of the invention that one skilled in the art may be able to implement it.
The above criteria regarding the novelty of an invention do not exclude the possibility of granting a patent for an invention concerning a new substance or mixtures forming part of the state of the art for use in a strictly defined manner in methods of treatment or diagnosis, provided that such use is not part of the state of the art.
Legal provisions do not exclude the possibility of granting a patent for an invention if its disclosure occurred not earlier than six months before the date of filing the application and was caused by an obvious abuse in relation to the applicant or its legal predecessor.
An invention is considered to have a degree of inventiveness if the invention is not obvious to a person skilled in the art. The state of the art taken into account when assessing the degree of inventiveness is understood in the same way as when assessing novelty. The difference is that it does not include information contained in the patent applications of inventions or utility models using an earlier priority, not disclosed to the general public, provided that they are announced in the manner specified by law.
An invention is considered to be suitable for industrial use if, as a result of the invention, a product or method can be obtained, in a technical sense, in any industrial activity.
An invention can be considered adaptable if it can be used (implemented) in a reproducible manner with identical effect. Such an invention must contain all technical means possible for its application and must be suitable for use. It must pursue a specific goal of practical importance and satisfy a practical need.
Not all inventions can be granted protection. Patents cannot be granted for:
- inventions, the use of which would be contrary to public policy or decency; using an invention that is prohibited by law is not automatically considered to be contrary to public policy;
- plant varieties or animal breeds and purely biological methods of plant or animal breeding, as well as products obtained by such methods; this does not apply to microbiological or other technical methods or to products obtained by such methods, unless they are plant varieties or animal breeds;
- methods of treating humans and animals by surgical or therapeutic methods and methods of diagnosis used on humans or animals; this does not apply to products, in particular substances or mixtures, used for diagnosis or treatment.
According to Polish law, biotechnological inventions, the use of which would be contrary to public policy or decency or public morals, include: methods of human cloning, ways of modifying the human germline genetic identity, the use of human embryos for industrial or commercial purposes, and ways of modifying the genetic identity of animals that may cause them suffering without bringing any significant medical benefit to humans or animals.
Polish law provides for several circumstances under which trademark protection cannot be granted. The most significant are marks that:
- cannot constitute a trademark;
- are not capable of distinguishing, in trade, the goods for which they have been applied;
- consist exclusively of elements which may serve, in trade, to designate, in particular, the type of goods, their origin, quality, quantity, value, intended use, manufacturing process, composition, function, or usefulness;
- consist exclusively of elements which have entered everyday speech or are customarily used in fair and well-established trade practices;
- consist of only a shape or other property of a product, arising from the very nature of the product, necessary to achieve a technical effect or increase significantly the value of the product;
- have been applied for in bad faith;
- are contrary to public policy or morals;
- incorporate an officially recognised sign adopted for use in trade, in particular a safety, quality, or verification mark, insofar as this could mislead the public as to the nature of such a sign, unless the applicant proves that it is authorised to use such a sign.
It should be noted that all absolute grounds for rejection are assessed ex officio.
4. How can patents and trademarks be revoked?
Under Polish law, a patent may be revoked -as a whole or in part – if the statutory conditions required to obtain a patent have not been met – in particular with respect to novelty or suitability for industrial use. Invalidation may also occur if an objection is raised against the final decision of the Polish Patent Office on granting the exclusive right. The decision to revoke exclusive rights is issued by the Polish Patent Office in a litigation procedure.
Any legal entity that has a legal interest may apply to the Polish Patent Office for the revocation of a trademark protection right. To achieve the revocation of a protection right, two basic conditions arising from the Polish provisions must be met. First, the applicant must show that it has a legal interest in seeking the revocation of the protection right. Secondly, the applicant must prove that one of the statutory conditions for granting the protection right has not been met.
The grounds for revoking a trademark include:
- Granting the rights to the trademark in violation of the absolute grounds of protection, as described above, and
- Collision with an earlier mark – meaning that the trademark was similar to another trademark to which rights were granted earlier. If the basis for the application for a declaration of invalidity is an earlier right, then the earlier right can only be invoked by its holder.
The application may concern the annulment of the right of protection for a trademark as a whole or in part. Due to the binding limitations of the invalidation application, the Polish Patent Office cannot invalidate an exclusive right to a wider extent that goes beyond the applicant’s request. However, an exclusive right can be invalidated in a narrower scope if the result of the evidence proceedings supports such a decision.
There are also certain restrictions applicable to the invalidation of trademark rights. In particular, an application for a declaration of invalidity may not be submitted in the following circumstances:
- in the case of collision with an earlier mark or in violation of the applicant’s personal or property rights – if, for a period of five consecutive years of the registered mark being used, the applicant, being aware of its use, did not oppose it;
- if the trademark was granted a right of protection in breach of the requirement of having a distinctive character – if, by the day of submitting the application, the mark acquired, as a result of its use, a distinctive character in ordinary trading conditions;
- in the case of a collision with a well-known trademark – if, for a period of five consecutive years of the registered trademark being used, the holder of the well-known trademark, being aware of its use, did not oppose it.
5. Are foreign patents and trademarks recognized and, if so, under what circumstances?
Patent law is territorial in nature and limited by the geographical borders of the country or region in which protection was granted.
The protection of an invention or a utility model in the territory of Poland can be obtained via national European, or international procedures.
A national procedure is a procedure carried out directly before the patent office of the country in which protection is sought. The applicant submits an application to the patent office of the country in which he/she wants to apply for patent protection for his/her invention. The protection thus obtained is only valid in the territory of that country. If the applicant wants to extend the protection, he/she may, based on the Paris Convention, submit an application in other countries. If the applicant decides to do so, he/she must, within 12 months of the date of the original application, submit an application in each of the additional countries based on the priority resulting from the initial application.
The essence of the regional (European) procedure is to obtain a European patent. This procedure is carried out before the European Patent Office (EPO) in accordance with the principles set out in the Convention of 5 October 1973 on a European Patent (known as the Munich Convention). The decision of the European Patent Office has such effects in the signatory countries designated by the applicant as if national patents were granted there by way of separate proceedings before the competent offices of those countries. When filing a European patent application, the applicant does not designate the specific countries in which the invention should be protected – all states that are parties to the Munich Convention are designated automatically. After obtaining a European patent in the EPO, in order to secure protection in the territory of Poland, the applicant must submit a translation of the European patent into Polish to the Polish Patent Office within three months of the date on which the EPO publishes information on the granting of the European patent. The deadline for submitting a translation cannot be extended.
International patent applications are defined in the PCT procedure. Applications are filed at receiving offices, which are national patent offices or international organizations. This procedure is carried out based on the principles arising from the Patent Cooperation Agreement. The guiding principle of the PCT system is that the applicant, applying for a patent in several countries, submits one application, which is subject to the so-called international procedure prior to its transfer to the national patent offices. . An application for a patent may be filed through the Polish Patent Office. When submitting an international PCT application, the applicant does not designate the countries in which he/she wants his/her invention to be protected. At the time of filing the international application, all states that are parties to the PCTare designated automatically. The PCT procedure consists of two main phases. It begins with an international application – the so-called the international phase, and ends (in the case of a positive result) with the granting of a national or regional patent – the so-called national phase or regional phase.
The Visegrad Patent Institute (VPI) began its operations on 1 July 2016. It is an international organization founded by the four countries of the Visegrad Group – the Czech Republic, Poland, Slovakia and Hungary. The VPI, like the European Patent Office, acts as the International Searching Authority and the International Preliminary Research Body. Tasks related to conducting international searches and international preliminary examinations are performed by the national offices of VPI member states – each office dealing with entities from its own country, thus enabling the procedure to be carried out in the local language. By choosing the VPI, Polish applicants have the option of filing an international application with the Polish Patent Office in Polish; however, the applicant will be required to provide a translation into one of the 10 languages of publication specified in the PCT regulations within 14 months of the priority date.
In Poland there are three regimes of registered trademark rights: national trademarks (registered by the Polish Patent Office); international trademarks (registered by the World Intellectual Property Organization and approved by the Polish Patent Office); and EU trademarks (registered by the EU Intellectual Property Office).
In Poland, a person wishing to seek protection of his/her designation (sign) does not have to register the trademark through any office. This person may benefit from an unregistered trademark right based on unfair competition law on the basis of prior use on the market. The Polish Industrial Property Law Act also confers certain rights on the owners of non-registered but well-known trademarks commonly used in Poland (a high degree of recognition by the relevant public is required).
6. Are there any non-patent/trademark barriers to competition to protect medicines or devices?
Devices and medicines which are patentable, and also those which do not meet the conditions to obtain patent protection, can be protected as a trade secret.
A trade secret is understood as technical, technological and organizational information (know-how) of an enterprise, or other information of economic value, which, as a whole or in the precise configuration and assembly of its components, is not generally known among persons who normally deal with the kind of information in question or is not readily accessible to such persons, and provided that the person entitled to use or dispose of the information (e.g. licensee) has taken, with due care, steps to maintain its confidentiality. Thus, in order to be regarded as a trade secret, the information should be (i) confidential, (ii) not disclosed and (iii) protected.
A trade secret is protected as long as the information is kept confidential and remains of economic value. This often provides a significant advantage to patentable inventions, as patent protection is time-limited.
With respect to trademarks, a trade name or a logotype can be protected against infringement on the basis of unfair competition laws. In parallel with the protection resulting from the registration of the trademark, but also after its expiry or even when it never existed, it is possible for a person to be protected under competition law as long as the following occur: an act of imitation that results in consumers being misled as to the origin of the goods or name or designation of the enterprise, or the use of another person’s reputation in a dishonest manner.
7. Are there restrictions on the types of medicines or devices that can be granted patent and trademark protection?
Apart from the general restrictions described above, with regard to the limitation of the monopoly of the patent holder of a biotechnological invention, the provisions stipulate that the patent does not extend to biological material obtained by a single reproduction of biological material marketed by the patent holder or with its consent, if reproduction is an indispensable consequence of the use of the biological material.
The patent for an invention regarding a manufacturing method also includes products obtained directly by this method. The patent for an invention regarding the use of a substance forming part of the state of the art to obtain a product having a new use also includes products specially prepared in accordance with the invention for such use.
A patent for a biological material having the characteristics specified in the claims resulting from the invention includes any biological material obtained from a given biological material by reproduction in an identical or different form and having the same characteristics.
A patent for a method that allows the production of biological material having the characteristics of the invention as defined in the claims also includes biological material obtained directly by this method and any other biological material derived from biological material obtained directly by reproduction in an identical or different form and having the same characteristics. A patent for a product containing or possessing genetic information includes all materials into which the product has been incorporated and in which genetic information has been included that fulfills its function in this material, with the exception of certain materials mentioned by law.
There are no additional rules specific to medicines or devices.
8. Must a patent or trademark license agreement with a foreign licensor be approved or accepted by any government or regulatory body?
From the perspective of Polish intellectual property law, there are no such requirements.