Patents and Trademarks
The low-down on the situation regarding patents and trademarks in Ukrainian pharma. Prepared in association with Sayenko Kharenko, a leading law firm in Ukraine, this is an extract from The Pharma Legal Handbook: Ukraine, available to purchase here for USD 99.
1. What are the basic requirements to obtain patent and trademark protection?
In order to obtain an invention/utility model/design patent or trademark protection for an object in the field of medicine, it is required to file a trademark or an invention/utility model/design patent application to the State Enterprise “Ukrainian Intellectual Property Institute (Ukrpatent)” (“UAPTO”).
A well-known trademark is protected irrespective of its registration in Ukraine under Article 6bis of the Paris Convention, provided it has been recognized as such either by the Appeal Board of the Ministry of Economic Development and Trade of Ukraine (“MEDT”) or by a competent court. Both authorities will determine the date on which the trademark is deemed to be well-known.
2. What agencies or bodies regulate patents and trademarks?
The MEDT is responsible for the development of general legal frameworks for patents and trademarks, implementing state policy in the field of intellectual property, organizing examination of patent and trademark applications, as well as issuing patents and trademark certificates. The MEDT also maintains state registers with respect to patents and trademarks.
The MEDT’s functions with respect to the examination of applications for inventions/utility models/designs and trademarks, as well as technical administration of state registers with respect to patents and trademarks are delegated to the UAPTO.
3. What products, substances, and processes can be protected by patents or trademarks and what types cannot be protected?
According to Ukrainian law a sign or a combination of signs may be registered as a trademark. Such signs may represent words (including people’s names, if consented), letters, numbers, pictures, colors, 3D objects or any combination of the foregoing. Further to traditional signs, the UAPTO also accepts registration of sounds as a trademark in Ukraine if they can be graphically represented by audio notation. Other non-traditional trademarks (tastes, smells, etc.) are not prohibited for registration in Ukraine but the respective trademark applications are not accepted by the UAPTO due to the technical incapacity to record such trademarks in the trademark register and make them available to the public.
Patent protection concerns inventions, utility models, and designs.
An invention/utility model patent protects new and inventive technical features of products (e.g. a new active ingredient in a medicinal product) and processes (e.g. a manufacturing technique) or advanced use of already known products or processes.
To qualify for patent protection, an invention must be new, involve an inventive step, be industrially applicable, should not be specifically excluded from protection (e.g. methods of medical treatment or diagnostic methods but not the products used in such methods), and should not contravene public order as well as the principles of humanity or morality.
In the framework of patenting inventions, pharmaceuticals, chemical compounds, treatment of the human or animal body are patentable. In its turn, no patent protection shall be granted for processes for:
- Cloning a human being,
- processes for modifying the germ line genetic identity of human beings,
- use of human embryos for industrial or commercial purposes,
- processes for modifying the genetic identity of animals which are likely to cause them suffering without any substantial medical benefit to man or animal, and also animals resulting from such processes;
- scientific theories and mathematical methods,
- solutions relating only to an external appearance of products, rules, and methods of games, intellectual or business methods, computer programs and solutions relating to the presentation of information.
The protection of utility models, as well as industrial designs in the field of medicine, is also available. However, such objects are rarely employed in Ukraine to protect medical solutions.
4. How can patents and trademarks be revoked?
Invalidation and revocation actions should be brought to the court. There are no administrative proceedings including the specific board of the UAPTO/MEDT for invalidation or revocation of patent or trademark.
I. INVALIDATION ACTION
A registered trademark may be invalidated partially or in full by the court if the trademark:
- fails to meet the registration requirements (e.g. the trademark was registered in spite of the existence of absolute grounds for refusal or the trademark is confusingly similar to the trademark previously registered in the name of a third person for the same goods/services);
- a trademark certificate contains elements or goods/services which were not claimed in the trademark application; and/or
- infringes the rights of third parties at the trademark application date.
An invalidation claim may be lodged to the court by any interested party within three years of the date on which that party learned about or could have learned about violation of their own rights arising out of disputed trademark registration.
II. REVOCATION ACTION
A trademark may be revoked partially or in full by the court in cases involving the existence of at least one of the following circumstances:
- non-use of a trademark during three consecutive years.
The most recent court practice in this regard suggests use of the five-year term stipulated by the EU-Ukraine Association Agreement instead of the three-year term stipulated by Ukrainian Trademark Law.
- a trademark has become a generic name for a product or service for which it is registered and the owner has not taken sufficient measures to prevent this.
Ukrainian Patent Law envisages the following grounds for invalidating an invention patent partially or in full:
- a patented solution does not meet the patentability requirements as prescribed by the law (e.g. lacks novelty, inventive step or industrial applicability);
- a claim of the patent extends beyond the content of the filed application;
- it infringes the rights of third parties at the invention patent application date; and
- an applicant has failed to file an international patent application for a Ukrainian invention with the UAPTO first.
Although there are specialized chambers within the commercial courts and specialized judges within the civil courts for IP cases who have been additionally trained and usually hear IP disputes, most of IP disputes regarding trademarks and patents still tend to fall under the category of disputes which require special knowledge.
5. Are foreign patents and trademarks recognized and under what circumstances?
When applying for trademark registration, an applicant may rely on foreign trademark application to claim a priority in Ukraine. Priority may be claimed within six months from the prior application submission date with the trademark authority of a member state of the Paris Convention provided that the priority on the prior application was not claimed. A copy of the priority document certified by registration body of the prior trademark shall be submitted to the UAPTO within three months from the date of filing a Ukrainian trademark application.
The priority of the trademark that was initially shown at an official or officially recognized international exhibition in the territory of the Paris Convention member state may be determined by the date of opening of the exhibition if the application is filed within six months from the respective date.
An applicant may claim priority of the prior application relating to the same invention within the 12 months that follow the filing date of the prior application with the patent authority of a member state of the Paris Convention provided that no priority has been claimed with regard to the prior application. In order to claim priority, the applicant should submit the respective motion to the UAPTO accompanied by a copy of the priority materials within three months from the date of filing the Ukrainian patent application for the invention. The respective three-month term may be extended upon the applicant’s motion in certain cases.
Where the UAPTO decides it to be necessary, it may request the applicant to furnish a translation of the previous materials into Ukrainian. The translation shall be furnished to the UAPTO within a period of two months.
The applicant may claim priority for the whole application or for one of the claims of the invention or the priority of several earlier applications.
Priority shall apply only to those claims which have been mentioned in the prior application for which priority is claimed.
6. Are there any non-patent/trademark barriers to competition to protect medicines or devices?
Apart from patent/trademark barriers, Ukrainian legislation envisages data exclusivity as an instrument to protect medicines. In this context, Ukrainian laws prescribe that if an original medicine is registered for the first time in Ukraine then the registration of another medicine containing the same active pharmaceutical ingredients may be performed in 5 years from the date of the original medicine registration. The 5-year data exclusivity period may be extended to 6 years when a state body governing healthcare in Ukraine will determine such medicine as one having particular advantages compared to other medicines within three years upon registration of the original medicine.
7. Are there restrictions on the types of medicines or devices that can be granted patent and trademark protection?
The relevant Ukrainian law does not stipulate limitations on obtaining patent or trademark protection for any types of 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?
Generally, Ukrainian laws do not impose an obligation to approve or accept a license agreement with a foreign licensor by any government or regulatory body. The parties to a license agreement may voluntarily submit it for registration with the MEDT. In practice, the parties usually apply for license agreement registration.
As a party to the TRIPS Agreement, Ukraine has undertaken to introduce compulsory licensing of medical inventions aimed at therapy of socially dangerous diseases. More specifically, Ukrainian law stipulates that the Ukrainian government may grant a license (approval) to a third party to use medical invention with mandatory royalty payments to a patent holder if the latter fails to serve a demand of patented medicines and refuses to grant a license to the third party willing to use the invention.