Patents and Trademarks
The legal lowdown on patents and trademarks in Latvian pharma. Prepared in association with TGS Baltic, a leading law firm in Latvia, this is an extract from The Pharma Legal Handbook: Baltics, available to purchase here for GBP 99.
1. What are the basic requirements to obtain patent and trademark protection?
There are three ways to obtain patent protection in the Republic of Latvia:
- national route: by filing an application directly with the Patent Board (hereinafter the PB) (under the Patent Law of the Republic of Latvia);
- international route: (under the Patent Cooperation Treaty), and;
- regional route: (under the European Patent Convention).
There are three ways to get exclusive rights to a trademark in the Republic of Latvia:
- national route: by filing applications directly with the PB (under the Trademark Law of the Republic of Latvia);
- international route: whereby the protection provided by the international trademark registration is extended to the Republic of Latvia (under the Protocol of the Madrid Agreement Concerning the International Registration of Marks), and;
- European Union trademark protection route: whereby any trademark, registered as European Union trademark with the Register of European Union trademarks, is protected in Latvia (under EU Regulation 2017/1001 of the European Parliament and of the Council of 14 June 2017 on the European Union trade mark).
2. What agencies or bodies regulate patents and trademarks?
In Latvia, patents and trademarks are regulated by the Patent Board of the Republic of Latvia.
3. What products, substances, and processes can be protected by patents or trademarks and what types cannot be protected?
Patents are available for any inventions in all fields of technology, provided that they are new, involve an inventive step, and are capable of industrial application. Where the object of invention is a method, patent protection is also granted with respect to a product made by such method.
The law establishes the list of what should not be considered as inventions, e.g.:
- discoveries, scientific theories, and mathematical methods;
- designs of products;
- schemes, rules, and methods of games, intellectual or economic activities, as well as programmes for computers, etc.
The law also provides a list when patents should not be granted, e.g. patents are not granted for:
- methods for treatment of the human or animal body by surgery or therapy, except where an object of invention is equipment or materials utilised for such methods (please note, that there are exceptions regarding second pharmaceutical use of medicinal products such as “Swiss-type claims” and “European Patent Convention 2000 claims”);
- inventions, the commercial exploitation of which would be contrary to public interests, principles of morality and humanity, such as processes for cloning human beings or uses of human embryos for industrial or commercial purposes.
A trademark is any sign capable of distinguishing the goods or services of one person from those of other persons and capable of being represented graphically.
Trademarks may consist only of the following:
- words, personal surnames, names, artistic pseudonyms, business names of legal persons, slogans;
- •etters, numerals;
- drawings, emblems;
- three-dimensional forms (the shape of products, their packaging, or containers);
- colours or combinations of colours, their compositions;
- any combination of signs specified above;
- special form (sound or light signals and similar).
The law provides that a sign may not be recognised as a trademark and must be refused registration in specific cases, e.g.:
- the sign is devoid of any distinctive character;
- the sign has become customary in the current language or in the bona fide and established practices of the trade;
- the sign is of such a nature as to mislead the public, for instance as to the nature, quality, or geographical origin of the goods and/or services;
- the sign is contrary to accepted principles of morality or public policy, including ethics of society and humanitarian principles;
- the sign consists of the official or traditional (abbreviated) state name of Latvia, of flag or other state heraldic objects or any imitation thereof, etc.;
- it is a sign of high symbolic value, in particular a religious symbol, etc.
4. How can patents and trademarks be revoked?
Surrender of the Patent
The owner of the patent may surrender the patent by a written declaration to the PB. The surrender may be limited to one or more claims of the patent. The PB records the surrender in the Register of Patents and publishes it in the Official Bulletin.
Invalidation of the Patent
At the request of any persons concerned, the court may invalidate a patent on one of the following grounds:
- the invention is not patentable;
- the patent does not disclose the invention in a manner sufficiently clear and complete for it to be carried out by a person skilled in the art;
- the disclosure contained in the patent goes beyond what has been disclosed in the application as filed, or if the patent was granted on a divisional application, which goes beyond what has been disclosed in the initial application as filed;
- the owner of the patent has no right to it.
When a decision of the court to invalidate a patent becomes final, the court sends it to the PB, which records data on the invalidation in the Register of Patents and publishes it in its Official Bulletin.
Invalidation of Trademark Registration
Upon request by any interested person, the registration of a trademark may be invalidated by the court on the grounds that the said trademark does not comply with the Law on Trademarks. When a decision of the court to invalidate a trademark becomes final, the court sends it to the PB, which removes the trademark from the Register of Trademarks.
Revocation of Trademark Registration
Upon the request of any interested party, the court may revoke the registration of a trademark, if:
- the trademark has become the common name for goods and/or services, for which it is registered, as a result of the treatment of the trademark as a common name by the proprietor or of his inactivity or due to such treatment of the trademark by the others;
- in consequence of the use made of it by the proprietor of the trademark, the trademark is liable to mislead the public, particularly as to the nature, quality, or geographical origin of those goods and/or services;
- within a period of five years after the issue of the registration certificate, a genuine use of the trademark has not been started by the proprietor of the trademark in Latvia.
5. Are foreign patents and trademarks recognized and under what circumstances?
European patents granted by the European Patent Office and validated in the Republic of Latvia are recognised as national patents.
International trademarks are recognised and protected in Latvia after the notification from the World Intellectual Property Organisation on the extension of the protection of international trademarks in the Republic of Latvia and the decision of the PB to grant the protection.
All European Union trademarks registered in the Register of European Union trademarks are also valid in Latvia.
6. Are there any non-patent/trademark barriers to competition to protect medicines or devices?
Regulatory data protection
There are additional barriers for receiving a marketing authorisation for a generic (similar) medicinal product without performing full clinical testing.
Referenced (original) medicinal products are being granted:
- a data exclusivity period of twenty years from the initial authorisation;
- additional five to 10 years of market exclusivity;
- additional one year in case of certain new indications.
This practice is based on Article 39(3) of the TRIPS which states that Members of the TRIPS shall: “[..]as a condition of approving the marketing of pharmaceutical [..] the submission of undisclosed test or other data, the origination of which involves a considerable effort, shall protect such data against of unfair commercial use.” The barrier may be additionally strengthened by the referenced (original) medical product manufacturer/marketing authorisation holder withdrawing the product from the market – then the generic (similar) medicinal product manufacturer cannot receive marketing authorisation based on the initial authorisation and without performing clinical testing.
Supplementary protection certificates
Supplementary protection certificates (SPCs) are an intellectual property right that serve as an extension to a patent right. They apply to specific medicinal products that have been authorised by regulatory authorities. Due to the lengthy registration process of medicinal products (medicinal products cannot be marketed right after patent protection is granted as for example, it is possible for mobile phones) SPC’s aims to offset the loss of patent protection. An SPC can extend a patent right for a maximum of five years. The SPC is granted to the holder of the patent, not to a licensee or a manufacturer that is not also the patent holder.
Evergreening, follow-up patent or lifecycle management is defensive strategy and shall be understood as an umbrella term, as it involves different approaches and measures to extend the patent protection of invention owned by the pharmaceutical companies. Evergreening can include lawful as well as unlawful activities. Evergreening is mostly used to improve the competitiveness with the generic medicinal product companies and strengthening the market position without offensively protecting established rights. Evergreening could be defined as development of new uses, creating patent clusters, making reverse payments, registering “pseudo-generics”, using marketing strategies to hold the dominant position, etc.
7. Are there restrictions on the types of medicines or devices that can be granted patent and trademark protection?
No, there are no restrictions, explicitly stated in laws, on the types of medicines or devices that can be granted patent and trademark protection, except for the general restrictions as provided in Question No. 3.
8. Must a patent or trademark license agreement with a foreign licensor be approved or accepted by any government or regulatory body?
Only in cases when one is willing to be able to use a licence agreement against third parties, a patent or trademark licence agreement with any licensor (both local and foreign) must be duly recorded with the PB, and the data of such agreements must be entered in either the Register of Patents of the Republic of Latvia or the Register of Trademarks of the Republic of Latvia.