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Law No. 816-IX "On Amendments to Certain Legislative Acts of Ukraine Concerning the Reform of Patent Legislation"

18 August 2020

On August 14, 2020, President of Ukraine Volodymyr Zelenskyy has signed the Law No. 816-IX "On Amendments to Certain Legislative Acts of Ukraine Concerning the Reform of Patent Legislation",  which was adopted on July 21, 2020 by the Ukrainian parliament. The purpose of this law is to ensure the fulfillment of Ukraine's obligations in the field of European integration in terms of harmonizing the requirements of the current legislation of Ukraine on the protection of rights to inventions and utility models with the legislation of the European Union.

The main changes in the Law related to inventions and utility models are as follows.

1. The object “the new use of a known product or process” has been removed from the list of the objects that are granted patent protection.

2. The following items have been added in the list of the objects of technologies, which are not a subject to patent protection:

- surgical and therapeutic methods of treating people or animals, as well as methods for their diagnosis;

- processes for the cloning of human beings, processes for modifying the germ line genetic identity of human beings;

- the 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, and also animals resulting from such processes;

- the human body at the various stages of its formation and development, as well as the simple detection of one of its elements, in particular, the sequence or partial of the sequence of a gene;

- a product or process involving a plant or animal, the use of which is limited to a specific plant variety or a specific animal species; a product or process that concerns a natural biological material, but not being isolated from its natural environment, or is not a product of a technical process.

3. The range of objects that can be protected by a utility model has been limited: the utility model protection can be obtained only for device and process.

4. A new requirement for involving an inventive step for some pharmaceutical objects has been introduced; in particular, new forms of a medicinal product including salts, esters, ethers, compositions, combinations and other derivatives, polymorphs, metabolites, pure forms, particle sizes, isomers, which is known from the prior art can be recognized as non-conforming to the specified condition, if they do not differ significantly in effectiveness.

5. The grace period for novelty has been reduced from twelve months to six months.

6. The period for restoring the missed deadline for filing an application for substantive examination has been reduced from twelve months to six months.

7. A new Article regarding division of an application has been introduced.

8. A new Article regarding supplementary protection for pharmaceutical objects in the form of a supplementary protection certificate has been introduced, and according to this Article, the deadline for filing a  request for obtaining supplementary protection is limited, namely, an application for obtaining permission from the competent authority in Ukraine must be submitted within 1 year from the date of filing such request for the first time in any country. Supplementary protection extends to patents, the objects of which are an active substance of a medicinal product, the process of obtaining a medicinal product or the use of a medicinal product, an animal and plant protection agent.

9. The procedure of filing the reasoned objection by the third party during examination has been introduced.

10. There has been the introduction of a provision in the article concerning actions that are not recognized as an infringement of rights, that during the term of supplementary protection the use of the invention for the purpose of export to third countries or for storage six months before expiration of the term of supplementary protection without permission of the Certificate’s holder shall not constitute the infringement of the rights to such an invention.

11. A new Article has been introduced, according to which the recognition of patents as invalid can be carried out by the Appeal Chamber, provided that opposition is filed within nine months from the date of publication of the patent. An application for recognition of the rights to a utility model as invalid can be filed with the Appeal Chamber during the entire period of validity of the rights to a utility model and after their termination. At the same time, the final provision of the Law states that the Appeal Chamber can invalidate previously issued patents as well.

Currently, the publication of the new Law and its entry into force the day after publication is expected. In addition, taking into account significant changes in the patent legislation of Ukraine, bylaws should be developed in order to regulate the new procedures and provide for the introduction of appropriate new fees.

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