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On August 16, 2020, the Law of Ukraine No. 816-IX came into force, which improves the protection of intellectual property rights to inventions and utility models and adapts patent legislation to EU law.
In particular, the document expands the list of rights and obligations of subjects of rights to inventions / utility models and the list of technology objects that are not subject to legal protection. It also provides for the possibility of filing applications in electronic form and provides the right to file objections to applications for inventions after their publication.
In addition, the procedure for granting additional protection of rights to inventions of medicines is being clarified. Also, by this law, Section VI of the Law of Ukraine "On the Protection of Rights to Inventions and Utility Models" was supplemented by a new Article 27-1, which regulates additional protection of rights to inventions.
This article provides that the owner of a patent for an invention, the object of which is the active substance of a medicinal product, the process of obtaining a medicinal product or using a medicinal product, an animal protection product, a plant protection product, the introduction of which in Ukraine is provided by the competent authority in accordance with the legislation of Ukraine, has the right to extend the period of validity of intellectual property rights to such an invention (additional protection), which is certified by a certificate of additional protection. The Supplementary Protection Certificate is issued at the request of the patent owner with payment of a fee.
Rights to additional protection are limited to a product (active substance or a set of active pharmaceutical ingredients of a medicinal product), the introduction of which into circulation in Ukraine is permitted by the competent authority, and its use in accordance with the quality of the medicinal product, animal protection products, plant protection products within the scope of the rights granted the relevant patent on the day of filing the application for a subsidiary protection certificate, and are valid subject to the validity of such permission.
The owner of a patent for an invention, the object of which is a medicinal product, animal protection product, plant protection product, has the right to extend the period of validity of intellectual property rights in the event that an application for obtaining permission from the competent authority for the introduction of a medicinal product, animal protection product, protection product plants for civil circulation in Ukraine were filed within one year from the date of filing such an application for the first time in any country.
The article also establishes that the term of supplementary protection is equal to the period between the date of filing an application with the institution and the date of receipt by the patent holder of the first authorization from the competent authority, reduced by five years. The term of supplementary protection may not exceed five years. For an invention, the object of which is an active substance of a medicinal product, in respect of which studies have been carried out in the field of use for children, the terms of additional protection shall last for six months.
A person who intends to manufacture a product or a medicinal product containing a product using a patented invention during the period of supplementary protection shall notify the institution and the holder of the supplementary protection certificate of such intention in writing no later than three months before the start of the use of the invention. The applicant's message shall indicate his address, methods of using the invention and the purpose of such use, the number and date of issue of the subsidiary protection certificate.
In the case of the manufacture of a product or a medicinal product containing a product for the purpose of export, the message shall also indicate the number of the authorization of the competent authority of the third country in which the export is planned. The institution ensures the publication of the information contained in the message.
The amendments also provide that the manufacturer of a product or medicinal product containing a product is obliged to obtain written guarantees from all persons who, on his order, store, export or perform other actions that are not recognized as a violation of the rights to an invention, that such a product or the medicinal product containing the product will not be used otherwise than for export or storage in accordance with the established procedure.
The law also provides for an administrative procedure for invalidating the right to an invention or utility model (post grant opposition), which will quickly stop the activity of unfair patent holders, the so-called "patent trolls".
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On July 5, 2020, Law No. 644-IX "On Amending Certain Laws of Ukraine Regarding the Elimination of Artificial Bureaucratic Barriers and Corruption Factors in the Health Care Sphere" entered into force.
This law makes it possible to carry out all procedures related to the registration of generics during the patent protection of the original drug.
Among other things, this law introduces the so-called "Bolar rule", according to which it is considered a violation of the rights arising from a patent, the import into the customs territory of Ukraine in the manner prescribed by law of goods manufactured using the invention (utility model) for research and / or use of the invention (utility model) in studies conducted with the aim of preparing and presenting information for the registration of a medicinal product. It is expected that this norm will help accelerate the process of introducing generic medicines to the Ukrainian market. Also, Law No. 644-IX improves the prohibition of the export of donated blood and its components outside Ukraine.
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Dear partners, colleagues and friends!
We congratulate you on the holiday of the bright Resurrection of Christ - Easter!
May this holiday bring us all peace, health, grace, prosperity and love. Let your houses always be filled with light and warmth, and the business will always be successful and bring a steady income. We wish that our cooperation always bears fruit and lasts a long time.
Christ is risen!!!
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The «Biofoodpharm» team congratulates the company's partner, Nataliya Khomenko, on receiving the "Lawyer of the Year 2019" award in the category "Medical and Pharmaceutical Law". The award ceremony was timed to coincide with the lawyer's day and was organized by the Ukrainian Bar Association and was held in Kiev at the Hyatt Regency Kyiv Hotel.
We are proud of you and wish you further victories!!!
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"Biofoodpharm" company took part in the 28th Healthcare International Medical Exhibition, which was held in Kiev from October 1 to 3, 2019 at the International Exhibition Center.
The Healthcare Exhibition is the first in Ukraine and the fourth in Europe event of an international level and is a full member of UFI (World Association of the Exhibition Industry).
Every year, Healthcare gathers more than 300 leading manufacturers and distributors of equipment, services, medicines, medical devices from Ukraine and other countries. For more than two decades, the exhibition has helped expand the market and strengthen partnerships with companies from Germany, the Czech Republic, Latvia, Lithuania, Italy, China, India, Singapore, the United Kingdom, the Netherlands, USA, Belarus, Poland, Turkey, Austria, Moldova and Ukraine.
