Patents and Trademarks
A brief overview of the situation regarding patents and trademarks in Romanian Pharma. Prepared in association with Mușat & Asociații, a leading global law firm, this is an extract from The Pharma Legal Handbook: Romania, available to purchase here for GBP 119.
1. What are the basic requirements to obtain patent and trademark protection?
As a rule, a patent or a trademark protection can only be obtained by registration with the State Office for Inventions and Trademarks (“OSIM”), based on the specific provisions stipulated by the Romanian Trademark Law no. 84/1998, respectively by the Romanian Patent Law no 64/ 1991.
The invention must:
- Show an element of novelty, meaning the new characteristic which is not known in the existing knowledge of its technical field. The existing knowledge is called “prior art”.
- Involve an “inventive step” or “non-obvious”, which means that it could not be obviously deduced by a person having ordinary skill in the relevant technical field;
- Have an industrial application, meaning that it must be capable of being used for an industrial or business purpose beyond a mere theoretical phenomenon, or be useful. Its subject matter must be accepted as “patentable” under law. In this respect, scientific theories, aesthetic creations, mathematical methods, plant or animal varieties, discoveries of natural substances, commercial methods, methods for medical treatment (as opposed to medical products) or computer programs are generally not patentable;
Be disclosed in an application in a manner sufficiently clear and complete to enable it to be replicated by a person with an ordinary level of skill in the relevant technical field.
The Romanian trademark system is based on the first-to-file principle and registration is possible without preliminary use.
Romania is a party to the following international trademark treaties:
- the Paris Convention for the Protection of Industrial Property;
- the World Intellectual Property Organisation Convention;
- the Madrid Agreement on the International Registration of Marks;
- the Madrid Protocol;
- the Nice Agreement on the International Classification of Goods and Services;
- the Vienna Agreement Establishing an International Classification of the Figurative Elements of Marks; and
- the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPs).
The right to a national trademark shall be acquired and protected by registration with OSIM, a European trademark with the European Union, and an international trademark with WIPO, were Romania is a designated country.
The first step to registration is filing a trademark application, which will allow the TM Office to verify the basic requirements for granting the requested protection:
➢ If the requested trademark consist in a sign able to be represented in the Trademarks Registry, in such a way as to enable the authorities and the public to clearly and precisely determine the subject-matter of the protection conferred on their proprietor;
➢ if the sign is distinctive;
➢ if the sign is available and lawful;
➢ if the applicant provides with the proof of payment of the filing and examination fee, in the amount prescribed by the law.
There is no requirement to use a mark in order to acquire trademark rights. The Romanian trademark system is based on the first-to-file principle and registration is possible without preliminary use. If a trademark is refused registration for lack of distinctive character, this can be overcome by showing that the mark has acquired distinctive character through use prior to its application date.
The protection afforded to unregistered marks is limited to well-known trademarks. In order for a trademark to be considered well-known, it must be widely known in Romania among the relevant segment of consumers of the goods or services to which the trademark is applied.
Supplementary Protection Certificate
A particular type of protection, under specific conditions, is expressly stipulated in the field of medicines, in addition to the protection granted by a patent, so called supplementary protection.
A Supplementary Protection Certificate (“SPC”) is granted only for medicines and phytopharmaceutical products and is limited to the active ingredient or the combination of the active ingredients, for which the marketing authorization was granted. Therefore, the subject matter of the SPC is not the same with the subject matter of the patent covering the related medicines/ phytopharmaceutical products.
The SPC could be obtained if the holder/ the basic patent or his successor in title meets the following requirements stipulate by the law:
➢ the product is protected by a basic patent in force;
➢ a valid marketing authorisation (to place the product on the market as a medicinal product) has been granted in accordance with Directive 2001/83/EC or Directive 2001/82/EC, as appropriate;
➢ the marketing authorisation referred to in the previous point is the first authorisation to place the product on the market as a medicinal product;
➢ the product has not already been the subject of a certificate;
➢ the application for the SPC is lodged within six months of the date on which the said marketing authorisation was granted/ on which the patent is granted (in hypothesis when the patent is granted after the marketing authorisation);
Once granted, the SPC extends the patent protection in respect of the active ingredient/ combination of active ingredients as to enjoy an overall maximum of 15 years of exclusivity from the time the medicinal product in question first obtains authorization to be placed on the market in the European Union. Taking into account that the pharmaceutical sector is a complex and sensitive one, the SPC shall not be granted for a period exceeding five years, except specific cases of medicinal products approved for a new, second use or for paediatric use, assuming that the legal requirements are fulfilled..
2. What agencies or bodies regulate patents and trademarks?
OSIM is the sole administrative authority in Romania entrusted with the protection of industrial property.
OSIM is a specialized body of the central public administration, subordinated to the Government, having, inter alia, the following main powers and duties:
- to elaborate the strategy for developing the protection of industrial property in Romania and to apply the Governmental policy in the field;
- to register and examine applications in the field of industrial property;
- to issue protection titles granting exclusive rights on Romanian territory to their holders;
- to administer the national registers related to industrial property rights.
3. What products, substances, and processes can be protected by patents or trademarks and what types cannot be protected?
Products, substances or processes can be protected by patents. None of these can enjoy protection also as trademarks. Protection conferred by a trademark can however be obtained for tri-dimensional forms (especially a product’s form or the form of its packaging), provided that such protection is not for the product/ packaging itself.
Patents can be granted in order to protect products, including substances, or processes which meet the conditions of novelty, inventive step and industrial applicability.
Specific provisions are stipulated in the field of biotechnology. Assuming that general said requests are met, patents in this field shall be granted if inventions relate to:
- a biological material which is isolated from its natural environment or produced by any technical process;
- plants or animals, if not limited to a specific plant variety or animal breed;
- a microbiologic process or other technical process or product obtained by this process, other than a plant variety or an animal breed;
- an isolated element of the human body or otherwise produced by a technical process, including a sequence or a partial sequence of a gene, even though the structure of that element is identical with the structure of a natural element.
In particular, being of major interest for the pharma sector, the products consisting in substances or compositions to be used in treatment and diagnosis methods are able to gain protection by patent. Also, any substance or composition which is already part of the state of the art is patentable for use in relation to a treatment or diagnosis method for humans or animals if such use is not in the state of the art (patents for second medical use).
Products and processes excepted from patentability are expressly provided by the law:
- Discoveries, scientific theories and mathematical methods;
- Aesthetic creations;
- Schemes, rules, methods for performing mental activities, in relation to games or economic activities, as well as computer programs;
- Mere presentations of information;
- Inventions the commercial exploitation of which would be contrary to the public order or morality, including those harmful to the health and life of humans, animals or plants and able to seriously affect the environment;
- Plant varieties, animal breeds and essentially biological processes for the production of plants or animals, except for microbiological processes and products of them;
- Inventions having as object the human body in its various formation and development stages and the mere discovery of one of its elements, including the sequence or partial sequence of a gene;
- Treatment methods of the human or animal body, by surgery or therapy, and diagnosis methods performed on the human or animal body, except for products, in particular substances or compositions for use in any of these methods.
4. How can patents and trademarks be revoked?
The registration of a trademark can be invalidated or revoked by filing an application with the competent court – the BucharestTribunal. As of 14 January 2023, the TM Office will also have the jurisdiction to settle the invalidation and or revocation requests..
The trademark invalidity application can be filed at any time during the protection period, based on any of the following grounds:
- Breaching the legal provisions regarding the registration requirements;
- The trademark application was filed in bad faith;
Invalidity has retroactive effects and can be requested to the Bucharest Tribunal. As of 14 January 2023, cancellation claims can also be filed with OSIM, in administrative procedures.
A revocation action of a trademark can be filed at any time during the protection period, based on the following grounds:
- Non-use for an interrupted period of 5 years, without justification;
- The trademark has become either generic or deceptive;
- The trade mark has been registered by a person who is not the applicant or holder.
After the registration of a patent, an interested party has an administrative remedy, by filing a revocation request with the OSIM (A) and a judiciary remedy, by requesting the annulation before the competent court, namely the Bucharest Tribunal (B).
A. The revocation of a patent can be sought within six months from publication of patent grant, if:
a. the subject-matter of the invention is not patentable;
b. it does not disclose the invention clearly enough so that a person skilled in the art can carry it out;
c. it extends protection beyond the contents of the filed application;
B. A patent can be annulled in the three above situations and also if:
d. the patent protection has been extended;
e. the patent holder is not entitled to the patent.
The patent annulment application can be filed at any time during the validity of the patent, except when it is based on the reasons mentioned at points a-c, where it can be filed at any time during the validity of the patent, but only after the expiry of the deadline for revocation.
The revocation or the annulment can be granted only partially where the grounds for revocation or annulment are valid only with regard to part of the patent.
5. Are foreign patents and trademarks recognized and under what circumstances?
European Union trademarks are fully protected in Romania, in the same way as national trademarks.
International trademarks are also protected in Romania to the same effect as national trademarks, provided that Romania or the European Union are designated territories and that an application of extending the trademark protection is filed, according to the Madrid Agreement concerning the international registration of marks (the “Madrid Agreement”) and to the Protocol adopted at Madrid relating to the Madrid Agreement (the “Madrid Protocol”).
Generally, OSIM will proceed to examine such application, according to the national legislation, as in the case of a national application. Exception to this rule is provided for in article 6 quinquies of the Paris Convention, where a trademark registered in a member state of the Paris Convention shall be admitted tale quale, provided that it does not affect prior acquired rights, is distinctive, not contrary to the public moral or order and it is not capable of deceiving the public.
Another form of recognition of foreign rights is the possibility of claiming priority.
A trademark application filed in a foreign country which is member state of the Paris Convention or of the World Trade Organization may be invoked within 6 months from its deposit date in order to claim priority in Romania.
A priority claim can be translated as a request to receive for the Romanian application the deposit date of a foreign application.
Patents registered under the Patent Cooperation Treaty (“PCT”) and European patents validated in Romania are protected in Romania in the same way as national patents.
Also, OSIM is the receiving office for international applications, responsible with the verification and transmission of the application to the International Office according to the PCT.
For the purposes of the validation, the applicant has to file a form for opening the national phase – in case of international applications – and/or an application for extending the protection in the territory – in case of European applications – following to which the application shall be subject to the procedures provided by the national laws, exactly as a regular national application. The submission of the translation of the relevant documents with the OSIM is mandatory in order to be published in the Industrial Property Official Bulletin so as the patent could have full effects in Romania.
An international or a European application designating Romania will have the same deposit date in Romania as the deposit date of the prior application. Accordingly, the national application will take into consideration the priority claims invoked by way of international or European procedure.
The applicant has the possibility to limit its international or European application and continue the national phase only for a part of it.
An international application shall not have effects in Romania if the applicant has withdrawn the application or the application is deemed to be withdrawn according to the PCT, if a national phase or a regional phase before EPO has not been opened or in the regional phase opened before EPO does not designate Romania.
Other forms of recognition of foreign patents and applications are the state of art and the priority claim.
The state of art also includes the international applications for which the national phase has opened and the European applications designating Romania.
A proprietor can also enjoy the priority claim. A patent application filed in a foreign country which is member state of the Paris Convention or of the World Trade Organization may be invoked within 12 months from its deposit date in order to claim priority in Romania.
6. Are there any non-patent/trademark barriers to competition to protect medicines or devices?
With regard to patents, the law adds a protection based on data and marketing exclusivity (A).
A. Without contradicting the applicable laws on patents and trademarks, the Health Law grants a marketing exclusivity period for the innovative medicines, equal to 10 years from the first authorization, during which the commercialization of the related generic medicines is prohibited. This period can be prolonged by maximum 1 year if new therapeutic indications for the medicines are discovered and authorized in the first 8 years from the first authorization.
Furthermore, the Health Law grants an 8 years period of protection for data exclusivity in connection with innovative medicines, during which the data resulted from the pre-clinical and clinical trials conducted in relation to the innovative medicines cannot be referenced in the filings for the related generic medicine, for the same substance.
Additionally to these 8 and 10 years of data and marketing exclusivity, a period of 1 year of exclusivity is granted for applying for a new indication of a substance with pre-established use, if significant clinical and preclinical trials have been conducted for the new indication.
7. Are there restrictions on the types of medicines or devices that can be granted patent and trademark protection?
Apart from the restrictions described at point 3., no other limitations regarding types of medicines or devices are provided by the Romanian laws.
8. Must a patent or trademark license agreement with a foreign licensor be approved or accepted by any government or regulatory body?
Any license concerning a Romanian patent or trademark, regardless of the nationality of the licensor or of the licensee, must be registered with the OSIM in order to be ostensible towards third parties. Note should be made that the validity of the license is not conditioned by such registration.
The license must be registered in the Register administered by OSIM, with payment of an administrative fee, following to which the grant shall be published in the Official Bulletin of Industrial Property. As of the date of this publication, the license shall be enforceable against third parties.
However, enforceability against third parties can also be proven by a direct notice to the third parties conveyed by the licensor or licensee.