The changes are summarized in the following:
- There has been a significant limitation in the scope of patentable subject-matter.
(i) Surgical or therapeutic methods of treating a person or animal, methods of diagnosing the human or animal body have been excluded from patentability (cf. Art. 6 (3)). This provision does not apply to products (substances or compositions) used in diagnosis or treatment.
(ii) Non-patentable subject-matter now also includes, inter alia processes for cloning human beings; processes for modifying the germ line genetic identity of human beings; uses of human embryos for industrial or commercial purposes; the human body, at the various stages of its formation and development, and the simple discovery of one of its elements, including the sequence or partial sequence of a gene; processes for modifying the genetic identity of animals that are likely to cause them suffering without any substantial medical benefit to man or animal, and also animals resulting from such processes (cf. Art. 6 (3)).
(iii) The expression “as well as the novel use of a known product or process” has been deleted from the definition of the term “invention” of Art. 6 (2), which now reads:
“2. The object of an invention, the legal protection of which is granted in accordance with this law, may be a product (device, substance, strain of a microorganism, culture of plant and animal cells, etc.), a process (method).”
It is still under debate whether said amendment means that the category “use” as such is no longer patentable in the Ukraine. Practice needs to show whether a protection of second medical use will still be possible in the Ukraine, e.g. via other claim categories.
(iv) Pursuant to Art. 7 (7) inventive step of new forms of a compound known from the prior art, including salts, esters, esters, compositions, combinations and other derivatives, polymorphs, metabolites, pure forms, particle sizes, isomers, can be considered as being obvious, if they do not differ significantly in efficacy.
- A new Art. 271) has been introduced codifying the SPC.
(i) An SPC may be granted for patents the subject-matter of which being an active pharmaceutical ingredient of a medicinal product, a process of obtaining a medicinal product or the use of a medicinal product, an animal protection product, a plant protection product.
(ii) A 6-month pediatric extension has been introduced into the Ukrainian Patent law.
(iii) The 6-month time limit for filing an SPC request with the Patent Office (either after patent grant or after obtaining the marketing authorization in the Ukraine), which in practice has been applied already in result of harmonization with European legislation, has been incorporated into the patent law.
(iv) An additional time limit has been introduced: The patent owner is entitled to obtain an SPC only, if a Ukrainian MA is filed within one year after filing the very first MA for this product in any other country.
(v) The following actions of a third party are not deemed to be an infringement of an SPC (cf. also Art. 31 (6):
- manufacture of a product or medicinal product containing a product using a patented invention for the purpose of export to third countries, as well as other actions that, according to this law, are recognized as the use of the invention, if they are necessary for the manufacture of a product or medicinal product containing a product for the purpose of export to third countries
- manufacture of a product or medicinal product containing a product using a patented invention not earlier than six months before the expiration of the additional protection period for the purpose of storing it for introduction into circulation after the expiration of the additional protection period, as well as other actions that, according to this law, are recognized as the use of the invention, if they are necessary for the manufacture of the product or medicinal product containing the product and its storage not earlier than the specified period.
- A Bolar exemption has been introduced into Ukrainian patent law (cf. Art. 31 (5):
The importation into the customs territory of Ukraine in accordance with the procedure established by law of goods manufactured using the invention (utility model) for research and/or the use of the invention (utility model) in research conducted for the purpose of preparing and submitting information for registration of a medicinal product is not recognized as a violation of the rights arising from the patent.
- Pre-grant and Post-grant opposition before the Patent Office has been introduced:
- Pre-grant opposition may be filed within 6 month after publication of the application
- Post-grant opposition may be filed within 9 month after publication of the grant of the patent