Article 197. Enforcement of Protection
The Parties shall enforce the protection provided for in Articles 194 to 196 of this Agreement by appropriate action by their authorities including at the customs border. They shall also enforce such protection at the request of an interested party.
Article 198. Temporary Measures
Products which were produced and labelled in conformity with national law before 1 January 2016 but which do not comply with the requirements of this Agreement, may continue to be sold until stocks run out.
Article 199. General Rules
1. The importation, exportation and commercialisation of any product referred to in Articles 192 and 193 of this Agreement shall be conducted in compliance with the laws and regulations applying in the territory of the Party in which the products are placed on the market.
2. Any matter arising from product specifications of registered geographical indications shall be dealt with in the GI Sub-Committee established pursuant to Article 201 of this Agreement.
3. The registration of geographical indications protected under this Agreement may only be cancelled by the Party in which the product originates.
4. A product specification referred to in this Sub-section shall be that which is approved, including any amendments also approved, by the authorities of the Party in whose territory the product originates.
Article 200. Cooperation and Transparency
1. The Parties shall, either directly or through the GI Sub-Committee established pursuant to Article 201 of this Agreement, maintain contact on all matters related to the implementation and functioning of this Agreement. In particular, a Party may request from the other Party information relating to product specifications and their modification, and contact points for control provisions.
2. Each Party may make publicly available the product specifications or a summary thereof and contact points for control provisions corresponding to geographical indications of the other Party protected pursuant to this Agreement.
Article 201. Sub-Committee on Geographical Indications
1. The Sub-Committee on Geographical Indications (GI Sub-Committee) is hereby established. It shall report on its activities to the Trade Committee in accordance with Article 404(5) of this Agreement. The GI Sub-Committee shall consist of representatives of the UK and Ukraine with the purpose of monitoring the development of this Agreement and of intensifying their co-operation and dialogue on geographical indications.
2. The GI Sub-Committee shall adopt its decisions by consensus. It shall determine its own rules of procedure. It shall meet at the request of either of the Parties, alternatively in the UK and in Ukraine, at a time and a place and in a manner (which may include by videoconference) mutually determined by the Parties, but no later than 90 days after the request.
3. The GI Sub-Committee shall also see to the proper functioning of this Sub- section and may consider any matter related to its implementation and operation. In particular, it shall be responsible for:
(a) amending Annex XVII-A Part A to this Agreement, as regards the references to the law applicable in the Parties;
(b) amending Annex XVII-A Part B to this Agreement, as regards the elements for registration and control of geographical indications;
(c) amending Annex XVII-B to this Agreement, as regards the criteria to be included in the objection procedure;
(d) modifying Annexes XVI-C and XVI-D to this Agreement as regards geographical indications;
(e) exchanging information on legislative and policy developments on geographical indications and any other matter of mutual interest in the area of geographical indications;
(f) exchanging information on geographical indications for the purpose of considering their protection in accordance with this Agreement.
Subsection 4. DESIGNS
Article 202. Definition
For the purposes of this Agreement:
(a) "design" means the appearance of the whole or a part of a product resulting from the features of, in particular, the lines, contours, colours, shape, texture and/or materials of the product itself and/or its ornamentation (32);
(b) "product" means any industrial or handicraft item, including inter alia parts intended to be assembled into a complex product, packaging, get-up, graphic symbols and typographic typefaces, but excluding computer programs;
(c) "complex product" means a product which is composed of multiple components that can be replaced, permitting disassembly and reassembly of the product.
Article 203. Requirements for Protection
1. The United Kingdom and Ukraine shall provide for the protection of independently created designs that are new and have individual character.
2. A design applied to or incorporated in a product which constitutes a component part of a complex product shall only be considered to be new and to have individual character:
(a) if the component part, once it has been incorporated into the complex product, remains visible during normal use of the latter; and
(b) to the extent that those visible features of the component part fulfil in themselves the requirements as to novelty and individual character.
3. A design shall be considered to be new if no identical design has been made available to the public:
(a) in the case of an unregistered design, before the date on which the design for which protection is claimed has first been made available to the public;
(b) in the case of a registered design, before the date of filing of the application for registration of the design for which protection is claimed, or, if priority is claimed, the date of priority.
Designs shall be deemed to be identical if their features differ only in immaterial details.
4. A design shall be considered to have individual character if the overall impression it produces on an informed user differs from the overall impression produced on such a user by any other design which has been made available to the public:
(a) inthe case of an unregistered design, before the date on which the design for which protection is claimed has first been made available to the public;
(b) in the case of a registered design, before the date of filing of the application for registration of the design for which protection is claimed, or, if priority is claimed, the date of priority.
In assessing individual character, the degree of freedom of the designer in developing the design shall be taken into consideration.
5. This protection shall be provided by registration and shall confer exclusive rights upon their holders in accordance with the provisions of this Article. Unregistered designs made available to the public shall confer the same exclusive rights, but only if the contested use results from copying the protected design.
6. A design shall be deemed to have been made available to the public if it has been published following registration or otherwise, or exhibited, used in trade or otherwise disclosed, except where these events could not reasonably have become known in the normal course of business to the circles specialised in the sector concerned, operating within the territory in which protection is claimed, before the date of filing of the application for registration or, if priority is claimed, the date of priority. In the case of unregistered design protection, a design shall be deemed to have been made available to the public if it has been published, exhibited, used in trade or otherwise disclosed in such way that, in the normal course of business, these events could reasonably have become known to the circles specialised in the sector concerned, operating within the territory in which protection is claimed.
A design shall not, however, be deemed to have been made available to the public for the sole reason that it has been disclosed to a third person under explicit or implicit conditions of confidentiality.
7. Disclosure shall not be taken into consideration for the purpose of applying paragraphs 3 and 4 of this Article if a design for which protection is claimed under a registered design right has been made available to the public:
(a) by the designer, his/her successor in title, or a third person as a result of information provided or action taken by the designer, or his/her successor in title; and
(b) during the twelve-month period preceding the date of filing of the application or, if priority is claimed, the date of priority.
8. Paragraph 7 of this Article shall also apply ifa design has been made available to the public as a consequence of an abuse in relation to the designer or his/her successor in title.
Article 204. Term of Protection
1. The duration of protection available in the United Kingdom and Ukraine following registration shall amount to at least five years. The right-holder may have the term of protection renewed for one or more periods of five years each, up to a total term of 25 years from the date of filing.
2. The duration of protection available in the United Kingdom and Ukraine for unregistered designs shall amount to at least three years as from the date on which the design was made available to the public in the territory of one of the Parties.
Article 205. Invalidity or Refusal of Registration
1. The United Kingdom and Ukraine may only provide that a design is refused for registration or declared invalid after registration on substantive grounds in the following cases:
(a) if the design does not correspond to the definition under Article 202(a) of this Agreement;
(b) if it does not fulfil the requirements of Article 203 and Article 207 (paragraphs 3, 4 and 5) of this Agreement;
(c) if, by virtue of a court decision, the right-holder is not entitled to the design;
(d) if the design is in conflict with a prior design which has been made available to the public after the date of filing of the application or, if priority is claimed, the date of priority of the design, and which is protected from a date prior to the said date by a registered design or an application for a design;
(e) if a distinctive sign is used in a subsequent design, and the law of the Party concerned governing that sign confers on the right-holder of the sign the right to prohibit such use;
(if the design constitutes an unauthorised use of a work protected under the copyright law of the Party concerned;
(g) if the design constitutes an improper use of any of the items listed in Article 6ter of the Paris Convention or of badges, emblems and escutcheons other than those covered by the said Article 6ter and which are of particular public interest in the territory of a Party.
This paragraph is without prejudice to the right of the Parties to set formal requirements for design applications.
2. A Party may provide, as an alternative to invalidity, that a design, which may be invalidated for the reasons set out in paragraph 1 of this Article, may be limited in its use.
Article 206. Rights Conferred
The holder of a protected design shall at least have the exclusive right to use it and to prevent third parties not having his/her consent from using it, in particular to make, offer, put on the market, import, export or use a product in which the design is incorporated or to which it is applied, or stocking such a product for those purposes.
Article 207. Exceptions
1. The rights conferred by a design right upon registration shall not be exercised in respect of:
(a) acts done privately and for non-commercial purposes;
(b) acts done for experimental purposes;
(c) acts of reproduction for the purposes of making citations or of teaching, provided that such acts are compatible with fair trade practice and do not unduly prejudice the normal exploitation of the design, and that mention is made of the source.
2. In addition, the rights conferred by a design right upon registration shall not be exercised in respect of:
(a) the equipment on ships and aircraft registered in another country when these temporarily enter the territory of the Party concerned;
(b) the importation by the Party concerned of spare parts and accessories for the purpose of repairing such craft;
(c) the execution of repairs on such craft.
3. A design right shall not subsist in features of appearance of a product which are solely dictated by its technical function.
4. A design right shall not subsist in features of appearance of a product which must necessarily be reproduced in their exact form and dimensions in order to permit the product in which the design is incorporated or to which it is applied to be mechanically connected to or placed in, around or against another product so that either product may perform its function.
5. A design right shall not subsist in a design which is contrary to public policy or to accepted principles of morality.
Article 208. Relationship to Copyright
A design protected by a design right registered in a Party in accordance with this Sub-section shall also be eligible for protection under the law of copyright of that Party as from the date on which the design was created or fixed in any form. The extent to which, and the conditions under which, such protection is conferred, including the level of originality required, shall be determined by each Party.
Subsection 5. PATENTS
Article 209. Patents and Public Health
1. The Parties recognise the importance of the Declaration on the TRIPS Agreement and Public Health, adopted on 14 November 2001 (hereinafter referred to as the "Doha Declaration") by the Ministerial Conference of the WTO. In interpreting and implementing the rights and obligations under this Chapter, the Parties shall ensure consistency with the Doha Declaration.
2. The Parties shall contribute to the implementation of, and shall respect, the Decision of the WTO General Council of 30 August 2003 on the implementation of paragraph 6 of the Doha Declaration.
Article 210. Supplementary Protection Certificate
1. The Parties recognise that medicinal and plant protection products protected by a patent in their respective territory may be subject to an administrative authorisation procedure before being put on their market. They recognise that the period that elapses between the filing of the application for a patent and the first authorisation to place the product on their respective market, as defined for that purpose by the relevant legislation, may shorten the period of effective protection under the patent.
2. The Parties shall provide for a further period of protection for a medicinal or plant protection product which is protected by a patent and which has been subject to an administrative authorisation procedure, that period being equal to the period referred to in paragraph 1, reduced by a period of five years.
3. Inthe case of medicinal products for which paediatric studies have been carried out, and the results of those studies are reflected in the product information, the Parties shall provide for a further six-month extension of the period of protection referred to in paragraph 2 of this Article.
Article 211. Protection of Biotechnological Inventions
1. The Parties shall protect biotechnological inventions under national patent law. They shall, if necessary, adjust their patent law to take account of the provisions of this Agreement. This Article shall be without prejudice to the obligations of the Parties pursuant to international agreements, and in particular the TRIPS Agreement and the Convention on Biological Diversity of 1992 (hereinafter referred to as the "CBD").
2. For the purposes of this Sub-section:
(a) "biological material" means any material containing genetic information and capable of reproducing itself or being reproduced in a biological system;
(b) "microbiological process" means any process involving or performed upon or resulting in microbiological material.
3. For the purposes of this Agreement, inventions which are new, which involve an inventive step and which are susceptible of industrial application shall be patentable even if they concern a product consisting of or containing biological material or a process by means of which biological material is produced, processed or used.
Biological material which is isolated from its natural environment or produced by means of a technical process may be the subject of an invention even if it previously occurred in nature.
An element isolated from the human body or otherwise produced by means of a technical process, including the sequence or partial sequence of a gene, may constitute a patentable invention, even if the structure of that element is identical to that of a natural element. The industrial application of a sequence or a partial sequence of a gene must be disclosed in the patent application.
4. The following shall not be patentable:
(a) plant and animal varieties;
(b) essentially biological processes for the production of plants or animals;
(c) 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.
Inventions which concern plants or animals shall be patentable if the technical feasibility of the invention is not confined to a particular plant or animal variety. Subparagraph (b) of this paragraph shall be without prejudice to the patentability of inventions which concern a microbiological or other technical process, or a product obtained by means of such a process.
5. Inventions shall be considered unpatentable where their commercial exploitation would be contrary to public policy or public morality; however, exploitation shall not be thus deemed contrary merely because it is prohibited by law or regulation. The following, in particular, shall be considered unpatentable:
(a) processes for cloning human beings;
(b) processes for modifying the germ line genetic identity of human beings;
(c) uses of human embryos for industrial or commercial purposes;
(d) 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.
6. The protection conferred by a patent on a biological material possessing specific characteristics as a result of an invention shall extend to any biological material derived from that biological material through propagation or multiplication in an identical or divergent form and possessing those same characteristics.
7. The protection conferred by a patent on a process that enables a biological material possessing specific characteristics to be produced as a result of an invention shall extend to biological material directly obtained through that process and to any other biological material derived from the directly obtained biological material through propagation or multiplication in an identical or divergent form and possessing those same characteristics.
8. The protection conferred by a patent on a product containing or consisting of genetic information shall extend to all material, save as provided in paragraph 4(c) of this Article, in which the product is incorporated and in which the genetic information is contained and performs its function.
9. The protection referred to in paragraphs 7 and 8 of this Article shall not extend to biological material obtained from the propagation or multiplication of biological material placed on the market in the territory of the Parties by the holder of the patent or with his/her consent, where the multiplication or propagation necessarily results from the application for which the biological material was marketed, provided that the material obtained is not subsequently used for other propagation or multiplication.
10. By way of derogation from paragraphs 7 and 8 of this Article, the sale or any other form of commercialisation of plant propagating material to a farmer by the holder of the patent or with his/her consent for agricultural use implies authorisation for the farmer to use the product of his/her harvest for propagation or multiplication by him/her on his/her own farm. The extent and conditions of this derogation shall correspond to the conditions provided for in the Parties' national laws, regulations and practices concerning plant variety rights.
By way of derogation from paragraphs 7 and 8 of this Article, the sale or any other form of commercialisation of breeding stock or other animal reproductive material to a farmer by the holder of the patent or with his/her consent implies authorisation for the farmer to use the protected livestock for an agricultural purpose. This includes making the animal or other animal reproductive material available for the purposes of pursuing agricultural activity, but not sale within the framework or for the purpose of a commercial reproduction activity. The extent and the conditions of the derogation provided for above shall be determined by national laws, regulations and practices.
11. The Parties shall provide for compulsory cross-licensing in the following cases:
(a) where a breeder cannot acquire or exploit a plant variety right without infringing a prior patent, he/she may apply for a compulsory licence for non-exclusive use of the invention protected by the patent inasmuch as the licence is necessary for the exploitation of the plant variety to be protected, subject to payment of an appropriate royalty. The Parties shall provide that, where such a licence is granted, the holder of the patent will be entitled to a cross-licence on reasonable terms to use the protected variety;
(b) where the holder of a patent concerning a biotechnological invention cannot exploit it without infringing a prior plant variety right, he/she may apply for a compulsory licence for non-exclusive use of the plant variety protected by that right, subject to payment of an appropriate royalty. The Parties shall provide that, where such a licence is granted, the holder of the variety right will be entitled to a cross-licence on reasonable terms to use the protected invention.
12. Applicants for the licences referred to in paragraph 11 of this Article must demonstrate that:
(a) they have applied unsuccessfully to the holder of the patent or of the plant variety right to obtain a contractual licence;
(b) the plant variety or the invention constitutes significant technical progress of considerable economic interest compared with the invention claimed in the patent or the protected plant variety.
Article 212. Protection of Data Submitted to Obtain an Authorisation to Put a Medicinal Product on the Market
1. The Parties shall implement a comprehensive system to guarantee the confidentiality, non disclosure and non-reliance of data submitted for the purpose of obtaining an authorisation to put a medicinal product on the market.
2. For that purpose, when a Party requires the submission of test data or studies concerning the safety and efficacy of a medicinal product prior to granting approval for the marketing of such product, the Party shall not, for a period of at least five years from the date of the first approval in that Party, permit other applicants to market the same or a similar product, on the basis of the marketing approval granted to the applicant which had provided the test data or studies, unless the applicant which had provided the test data or studies has given consent. During such period, the test data or studies submitted for the first approval will not be used for the benefit of any subsequent applicant aiming to obtain a marketing approval for a medicinal product, except when the consent of the first applicant is given.
Article 213. Data Protection on Plant Protection Products
1. The Parties shall determine safety and efficacy requirements before authorising the placing on the market of plant protection products.
2. The Parties shall recognise a temporary right to the owner of a test or study report submitted for the first time to achieve a marketing authorisation for a plant protection product. During such period, the test or study report will not be used for the benefit of any other person aiming to obtain a marketing authorisation for a plant protection product, except when the explicit consent of the first owner is given. This right will be hereinafter referred to as "data protection".
3. The Parties shall determine the conditions to be fulfilled by the test or study report.
4. The period of data protection should be at least 10 years starting from the date of the first authorisation in the Party concerned. The Parties may decide to provide an extension of the period of protection for low-risk plant protection products. In such a situation, the period can be extended to 13 years.
5. The Parties may decide that those periods shall be extended for each extension of authorisation for minor uses (33). In such a situation, the total period of data protection may in no case exceed 13 years or, for low-risk plant protection products, 15 years.
6. A test or study shall also be protected if it was necessary for the renewal or review of an authorisation. In those cases, the period for data protection shall be 30 months.
7. Rules to avoid duplicative testing on vertebrate animals will be laid down by the Parties. Any applicant intending to perform tests and studies involving vertebrate animals shall take the necessary measures to verify that those tests and studies have not already been performed or initiated.
8. A new applicant and the holder or holders of the relevant authorisations shall make every effort to ensure that they share tests and studies involving vertebrate animals. The costs of sharing the test and study reports shall be determined in a fair, transparent and non-discriminatory way. A new applicant is only required to share in the costs of information he/she is required to submit to meet the authorisation requirements.
9. Where the new applicant and the holder or holders of the relevant authorisations of plant protection products cannot reach agreement on the sharing of test and study reports involving vertebrate animals, the new applicant shall inform the Party.
10. Failure to reach agreement shall not prevent the Party concerned from using the test and study reports involving vertebrate animals for the purpose of the application of the new applicant.
11. The holder or holders of the relevant authorisation shall have a claim on the new applicant for a fair share of the costs incurred by him/her. The Party concerned may direct the parties involved to resolve the matter by formal and binding arbitration administered under national law.
Subsection 6. TOPOGRAPHIES OF SEMI-CONDUCTOR PRODUCTS
Article 214. Definition
For the purposes of this Sub-section:
(a) "semiconductor product" shall mean the final or an intermediate form of any product:
consisting of a body of material which includes a layer of semiconducting material; and having one or more other layers composed of conducting, insulating or semiconducting material, the layers being arranged in accordance with a predetermined three-dimensional pattern; and intended to perform, exclusively or together with other functions, an electronic function;
(b) the "topography" of a semiconductor product shall mean a series of related images, however fixed or encoded;
representing the three-dimensional pattern of the layers of which a semiconductor product is composed; and in which series, each image has the pattern, or part of the pattern of a surface of the semiconductor product at any stage of its manufacture;
(c) "commercial exploitation" means the sale, rental, leasing or any other method of commercial distribution, or an offer for these purposes. However, for the purposes of Article 217 of this Agreement, commercial exploitation shall not include exploitation under conditions of confidentiality to the extent that no further distribution to third parties occurs.
Article 215. Requirements for Protection
1. The Parties shall protect the topographies of semiconductor products by adopting legislative provisions conferring exclusive rights in accordance with the provisions of this Article.
2. The Parties shall provide for the protection of the topography of a semiconductor in so far as it satisfies the conditions that it is the result of its creator's own intellectual effort and is not commonplace in the semiconductor industry. Where the topography of a semiconductor product consists of elements that are commonplace in the semiconductor industry, it shall be protected only to the extent that the combination of such elements, taken as a whole, fulfils the abovementioned conditions.
Article 216. Exclusive Rights
1. The exclusive rights referred to in Article 215(1) of this Agreement shall include the right to authorise or prohibit any of the following acts:
(a) reproduction of a topography in so far as it is protected under Article 215(2) of this Agreement;
(b) commercial exploitation or the importation for that purpose of a topography or of a semiconductor product manufactured by using the topography.
2. The exclusive rights referred to in paragraph 1 (a) of this Article shall not apply to reproduction for the purpose of analysing, evaluating or teaching the concepts, processes, systems or techniques embodied in the topography or the topography itself.
3. The exclusive rights referred to in paragraph 1 of this Article shall not extend to any such act in relation to a topography meeting the requirements of Article 215(2) of this Agreement and created on the basis of an analysis and evaluation of another topography, carried out in conformity with paragraph 2 of this Article.