Volynets I. Intellectual property rights protection from unfair competition on the pharmaceutical market

Українська версія

Thesis for the degree of Doctor of Philosophy (PhD)

State registration number

0822U100358

Applicant for

Specialization

  • 081 - Право. Право

14-01-2022

Specialized Academic Board

ДФ 26.501.004

Scientific research institute of intellectual property of National academy of law of Ukraine

Essay

The dissertation is devoted to complex research of features of intellectual property rights protection from unfair competition on the pharmaceutical market. The principle conclusion of the investigation presupposes that unfair competition on the pharmaceutical market consists of the actions or inaction of business entities aimed at misleading of consumers, business reputation intervention, violation of trade and other fair customs and regulations in the field of competition, including illegal actions regarding the results of intellectual and creative activity, that are subject to protection of intellectual property rights. Forms of unfair competition on the pharmaceutical market are defined, namely infringements in the field of intellectual property, which include: intentional extension of pharmaceutical companies' patent protection of medicines, i.e. abuse of patent rights by creating an "evergreen" patent; patent trolling; intentional non-registration of trademarks for medicines; change of the form and/or route of administration of the developed and sold medical product, unless the corresponding changes do not lead to the improvement of the pharmaceutical efficacy of the medical product, etc. The dissertation arguments the concept of "protection of intellectual property rights from unfair competition on the pharmaceutical market". The main problems (economic, social and legal), arising on the pharmaceutical market and affecting the legal regulation of relations in this area are underlined, which include the following: demand for medicines depends on their pricing policy; protection of medicines by patents, which make it impossible to produce generics; lack of alternative generic copies in many original drugs (including orphan); rising prices for medicines due to the consistent monopoly of leading pharmaceutical companies, etc. The investigation formulates the concept of "pharmaceutical market". It is investigated the peculiarities of medicines protection forms in the system of intellectual property rights under copyright, patent law and protection of trademark rights. The work determines that the production of generics (in advance of the expiration of the patent term), the granting of compulsory licenses for medicines, as well as the import of medicines through parallel imports cannot be characterized as forms of unfair competition. The conclusion of the dissertation contemplates among other about possible negative consequences of the ban on medicines advertising on television and radio, as well as in other media. In particular, the lack of advertising on television for demonstration of packaging, trademarks and names of medicines can increase the number of infringements of intellectual property rights of pharmaceutical manufacturers and the spread of unfair competition. The position on the providing the mechanism for the protection of intellectual property rights to trademarks in the administrative procedure "post-grant opposition" in the Chamber of Appeal of the National Intellectual Property Authority is substantiated. The paper provides the arguments on expanding the competence of the High Court on intellectual property issues due to the establishment of the Judicial Chamber for the Protection of Intellectual Property Rights and Economic Competition. It is underlined the urgency of enhanced oversight of the activities of market participants in medicinal products by government agencies, which must react on the forms of unfair spread of misleading information, containing false, inaccurate statements, minimizing product risks, exaggerating efficiency, containing unproven, unreasonable or unjustified comparison goods with another. It is noted that the change of legislation in the field of comparative advertising of medicines allows to use trademarks without the consent of the owner, however, in contrast to US and EU legislation, Ukrainian legislation does not restrict the use of a competitor's trademark, comparing criterions are absent, as well principle prescriptions, necessary in the comparative advertising of the presented goods, namely: warnings about side effects, allergic reactions, etc. At the same time, comparative advertising may not discredit a competitor, contain incomplete/ inaccurate/ false information about a competitor's medicinal product and other allegations. It is proposed to define the concept of "corrective advertising of medicines" as advertising that corrects (amends) already published advertising of medicines (on television, radio or other media and otherwise) and eliminates allegations that mislead consumers, contain incomplete/ inaccurate / false information about the medicinal product, as well as eliminate infringements of intellectual property rights. It is determined that the legislative enshrinement of the term "corrective advertising".

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