Ukraine - EU AGreement: IP and Health Care. Presented by Oksana Kashyntseva, Ukraine.

1. Ukraine - EU Association
Agreement:
IP and Health Care
Oksana Kashyntseva
Head of the Center for Harmonization of Human Rights and Intellectual Property Rights,
Scientific and Research Institute of Intellectual Property
of National Academy of Law Sciences of Ukraine
Marrakesh, 2018

2. Historical Retrospective of IP
and Pharmaceutical Market in Ukraine
TRIPS-plus & TRIPS-flex
1. It was strategically important to Ukraine to possess a membership in WTO. From 2008
Ukraine is a member of WTO.
2. Ukraine signed TRIPS Agreement on the basis of TRIPS-plus provisions.
3. The legal collision of TRIPS-plus provisions and Human Rights is obvious for Ukrainian
Society.
4. Until the present time we had not political will to implement TRIPS-flexibility provisions
into the national legislation.

3. Percent index of patents in Health Care in 2001 – 2015 in Ukraine:
Pharmaceuticals – 5, 09 % from the total amount of granted patents;
Medicine – 8, 22 % from the total amount of granted patents.
http://www.wipo.int/ipstats/en/statistics/country_profile/profile.jsp?code=UA

4. Percent index of patents 2001 – 2015 of the close to Ukraine countries:
Georgia: Moldova:
pharmaceuticals – 6,96 % pharmaceuticals -10, 24%
medicine –13,33 % medicine – 3,80 %

5. Percent index of patents 2001 – 2015 in EU:
Austria: Germany:
pharmaceuticals – beyond others (less than 3 %) pharmaceuticals – 3,60
medicine – 3,89 % medicine – 4,10 %
medicine – 3,89 %

6. Patents granted in the sphere of Health Care:
Patents in Health Care
Ukraine Georgia Moldova Austria

7. Intellectual Property Institute
of National Academy of Law
Sciences of Ukraine
In 2012 it was founded the Center for Harmonization of Human Rights and Intellectual Property Rights of Scientific and Research
Institute of Intellectual Property of NALS of Ukraine.
After the signing of Ukraine - EU Association Agreement our experts are the members of WGs.

8. Ukraine - EU Association Agreement and
National Reform of IP System in Ukraine
Capacity of Committee in Trade Configuration
as an executive body to lead reforms in the Economic sphere
and IP
The main spheres of reforms under the Ukraine - EU Association Agreement:
- patents, biotechnological patents, supplementary protection certificates;
- geographical names;
- Trade Marks (well-known, common TM);
- Copyrights and Neighboring Rights;
- IP Court.

9. UA - EU Association vs. TRIPS-flexibilities:
is it manipulation? Yes!
Article 219
Patents and public health
1.The Parties recognize 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 paragraph 6 of the
Doha Declaration.

10. Association Agreements of
EU and Georgia and EU and Moldova
have the same norms
Article 185 Patents and Public Health
1. The Parties recognise the importance of the
Declaration of the Ministerial Conference of the WTO
on the TRIPS Agreement and Public Health adopted
on 14 November 2001.
2. The Parties shall respect the Decision of the WTO
General Council of 30 August 2003 on paragraph 6 of
the declaration referred to in paragraph 1 of this Article
and shall contribute to its implementation.
Article 313 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 by the Ministerial
Conference of the World Trade Organisation. In
interpreting and implementing the rights and obligations
under this Chapter, the Parties shall ensure
consistency with the Declaration.
2. The Parties shall respect the Decision of the WTO
General Council of 30 August 2003 Paragraph 6 of the
Declaration on the TRIPS Agreement and Public
Health, and they shall contribute to its implementation.

11. High-Level Political Dialog
on IP and Access to Medicines
October 25, 2017
Kyiv
WHO Experts:
Dr. Marthe Everard, WHO representative to Ukraine
Peter Beyer, WHO HQ
Ellen ‘t Hoen, WHO consultant
Boyan Konstantinov, UNDP
Hans Georg Bartels, WIPO
Ukrainian Experts from:
Ministry of Health of Ukraine,
State Exp. Center,
Ministry of Economic Development and Trade of Ukraine
Antimonopoly Committee of Ukraine
State Patent Office
Scientific and Research Intellectual Property Institute of
National Academy of Law Sciences of Ukraine

12. WHO recommendations presented in
Political Dialog in Kyiv
October 25, 2017
Flexibilities of TRIPS
TRIPS scope of obligation (Article 1)
Protection against TRIPS-plus
Parallel import (exhaustion of rights, Article 6)
TRIPS objectives and principles (Article 7&8)
Basic standards for patentability and a limited list of exceptions to patentable
subject matter (Article 27)
Exceptions to patent rights (Article 30)
www.medicineslawandpolicy.org

13. Draft Law On Amendments to Certain Legislative Acts of Ukraine
On Improvement of the Legal Protection of Inventions and Utility Models
of October 17, 2017
1. Introducing more stringent patentability criteria with regard to pharmaceutical
inventions.
2. Excluding from the patentability objects of patenting methods of diagnostic,
treatments and surgery.
3. Implementing of pre-granting and post-granting patent opposition procedures in the
State Patent Office (Ukrpatent).
4. Implementation of the non-commercial use with public health purposes, also known
as governmental use.
5. Limiting the applicability of registration data exclusivity.
6. Implementing the mechanism of approving the patents on medicines granting by
Patent Office by the State Expert Center of Ministry of Health of Ukraine.
7. Implementation of the Bolar regulatory exclusion provision.
8. Limiting the possibility to extend patent duration.

14. Article 220 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.

15. TRUVADA case for Ukraine
In the case of Truvada, the patent which was the subject of the SPC is the basic patent claiming
tenofovir, but the market authorisation relates to Truvada, which is the combination of tenofovir and
emtricitabine. Tenofovir alone was approved in Feb. 2002, but Gilead could not obtain a patent
extension for its tenofovir patent based that authorisation which was too early, so they applied for the
SPC based on Truvada's approval instead. This case is under challenge in several European
countries and at the ECJ.
600 51-55 / Ukraine – 7 000 UAH (200 mg -№ 30)

16. Art. 27-1 of Draft Law
1. The owner of a patent to an invention, the subject of which is an active substance of a medicinal product, a product
for animal protection, a product for plant protection, which may be introduced into the civilian circulation in Ukraine
upon the permission of the competent authority, has the right to extend the validity period of intellectual property
rights to such invention (supplementary protection), which is certified by the supplementary protection certificate.
2. The rights to supplementary protection are limited to the product authorized by the relevant competent authority and
its use, respectively, as a medicinal product, a product for animal protection, a product for plant protection, within the
rights granted by the corresponding patent at the time of applying for the issuance of a supplementary protection
certificate, and are valid if such market authorization is effective.
3. The term of additional protection equals the period between the date of filing an application to the Office and the
date of receipt by the owner of the patent of the first permit of the competent authority, reduced by 5 years. The term
of supplementary protection can not be more than 5 years.
4. For an invention the subject of which is the active substance of a medicinal product and for which pediatric
investigation has been carried out and the results of which are reflected in the product information that has been
authorized by the relevant competent authority, the terms of the supplementary protection specified in paragraphs 1
and 2 of this part are increased by six months.
5. The application must reach the Office within 6 months from the date of publication of the information on the state
registration of the invention or from the date of issue of the first permit of the relevant competent authority, whichever
is later. The application must be accompanied by documents confirming the right of the holder of the patent for
additional protection…

17. The efforts to balance between the Art. 220 of UA –
EU Association Agreement and TRIPS-flexibilities
1. To use the experience of EU countries implement the definition of “basic
patent”.
2. The supplementary protection shall be granted only to the inventions on
basic patent.
3. Only the owner of basic patent could apply for SPC and only if the
application on marketing authorization has been provided in Ukraine
within one year from the date of first marketing authorization in the
world.
4. The real term of supplementary protection shall no exceed the term of
the procedure of marketing autorotation and not more then five years.
Currently we have discussion around the working out the most effective
mechanism of balancing between the EU demands and TRIPS-flex

18. The public reply to the Draft Law
Positive
UNDP
WHO
Committee of Medical and
Pharmaceutical Law and
Bioethics of National Bar
Association of Ukraine
Negative
European Business Association
American Chamber of
Commerce
Ukraine International Chamber
of Commerce

19. The most disputable issues of
Draft Law
1. Excluding from the protection of the new forms of a
known from the state of the art medicinal product,
including salts, esters, complex ethers, compositions,
combinations and other derivatives, polymorphs, metabolites,
pure forms, particle sizes, isomers, new dosage forms, or any
new property or a new use of a known medicinal product,
except those that lead to a significant increase in the
therapeutic efficacy of the medicinal product, as evidenced by
the research results.
2. Supplementary protection rights to invention (calculation of
the reasonable period).

20. New challenge for Ukraine:
Harmonization of IP Law, Unfair Competition Law and Right
on Access to Medicines
In EU the compulsory licensing in Health Care Sphere is basing on the Antitrust Legislation and Protection of the
Consumers' Rights demonstrate the perspectives in such field in Ukraine as well. Using the experience of the EU
draft the changes and amendments to legislation of Unfair Competition and Antitrust legislation on the
pharmaceutical market for the protection of patients’ rights on medicines.

21. Our further steps in Patent Reform under the
UA - EU Association Agreement
1. Strengthen the patentability criteria and implement them into
the Rules of examination of application on invention of
pharmaceutical products to avoid “evergreening patents”.
2. Work out the Compulsory License Procedure, Government
Use and realize them in practice.
3. Exclude Patent linkage from the pharmaceutical legislation.
4. Work out antitrust legislation and IP instrument to avoid the
overuse of patent rights.

22. Art. 68 Law On Industrial Property of Poland
The holder of the patent or license may not abuse his right, in particular by preventing the
third party from using the invention if it is necessary to satisfy the needs of the domestic
market, in particular when the public interest so requires and the product is not available to
the public in sufficient quantity or quality or at excessively high prices.
Uprawniony z patentu lub z licencji nie może nadużywać swego prawa, w szczególności
przez uniemożliwianie korzystania z wynalazku przez osobę trzecią, jeżeli jest ono
konieczne do zaspokojenia potrzeb rynku krajowego, a zwłaszcza gdy wymaga tego interes
publiczny, a wyrób jest dostępny społeczeństwu w niedostatecznej ilości lub jakości albo po
nadmiernie wysokich cenach.

23. • "The idea of a better ordered World is one in which medical
discoveries will be free of patents and there will be no
profiteering from life and death…"
Indira Gandhi
World Health Assembly, 1982

24. On behalf of Intellectual Property Institute of National Academy of Law
Sciences of Ukraine and of the members of Working Group in IP
Reforming we highly appreciate the support of:
UNITAID, ITPC, All-Ukrainian Network of PLWH
UNDP, OSF
Ministry of Health of Ukraine,
Ministry of Economic Development and Trade of Ukraine
Oksana Kashyntseva
kashyntseva@ukr.net