The Intellectual Property Law of Vietnam (the “IP Law”) brings pharmaceutical products within its scope of protection as patentable subjects. This means that any pharmaceutical invention may be granted and protected under the title of patent in Vietnam, so long as it meets the following requirements1: • it is novel; • comprises of an inventive step; • it is susceptible to industrial application. In situations where an invention fails to satisfy the second requirement, but is deemed novel and susceptible to industrial application, it may obtain protection in the form of a utility solution patent2. In addition, all applied inventions, including pharmaceutical inventions, must satisfy the disclosure requirement. Accordingly, the specifications of the claimed pharmaceutical patent must include information of its fundamental characteristics, i.e.: ingredients and structures of the pharmaceutical product, effects, method of testing the effect (in vitro and in vivo), the relationship between the test results and the actual effect of the product, dose, use, side effect, etc. A pharmaceutical invention must describe experimental samples proving the effect of substance(s) or compound(s) in the pharmaceutical products, thereby demonstrating industrial application of the invention. The samples must include information about (i) experimental substance(s) or compound(s); (ii) applied experiment methods/systems; (iii) experimental subjects; (iv) experimental results; (v) the relationship between the obtained experiment result and practical application of the product for prevention, treatment and diagnosis. Protection for pharmaceutical products is stipulated not only by the IP Laws, but also by the Pharmaceutical Laws. Accordingly, for the purpose of obtaining approval for a new drug circulation, related clinical test data 1 Article 58.1 of Intellectual Property Law 2005, amended 2009 2 Article 58.2 of Intellectual Property Law 2005, amended 2009 April 2015 www.bakermckenzie.com/bmvn BMVN International LLC Unit 1002, 10th Floor, Indochina Plaza Hanoi, 241 Xuan Thuy Street, Cau Giay District, Hanoi Vietnam Tel: +84 4 3936 9409 E-mail: email@example.com 2 Public Health: Bolar Exemptions and Compulsory Licenses in Vietnam | April 2014 BMVN International LLC is exclusively protected during a period running from the date of data submission, to five years from the date of approval. Bolar Exemption and Compulsory License in Vietnam Generally speaking, an owner of a patented invention has the exclusive right to prevent others from registering, using or exploiting his/ her invention. In the pharmaceutical sector, companies put a lot of time, research and investment into drug research and development, which poses many risks. In order to promote the development of pharmaceuticals, patent registration systems in most countries of the world accept pharmaceutical inventions for patentability. However, pharmaceutical products relate directly to human health and wellbeing, so patent protection systems have also been devised to balance the interests of patent owners with those of the public. Thus, the Bolar Exemption and Compulsory License are incorporated into the laws of most jurisdictions, including Vietnam. a) Bolar Exemption In Vietnam, the Bolar Exemption is provided for in both the IP Laws and The Pharmaceutical Laws. Article 125.2.a of the IP Law 2005, as amended in 2009, states that “the owners of protected IP subjects are not entitled to prohibit others from using protected inventions, industrial designs or semiconductor integrated circuits for personal needs or non-commercial purposes, or for evaluations, analysis, research or teaching, testing, pilot production or for collecting information to carry out procedures for license of production, importation or marketing of products”. Meanwhile, Article 14.2 of the Circular 44/2014/TT-BYT dated 25 Nov 2014 of the Ministry of Health provides that “Within a period of two years before the expiration date of a patented drug invention, pharmaceutical companies are entitled to submit a request for approval for a generic drug in attached documents evidencing that the protection for the patented drug invention is going to expire” Taking the above into consideration, generic drug producers may enter their products into the market immediately after the patent has expired. Also according to Circular 44/2014/TT-BYT, the time limit for the relevant authorities, i.e the Drug Administration Department, to consider the approval of a new drug is a maximum of 6 months from the filing date of the request. Meanwhile, the period for a generic drug company to submit a request for approval is within two years before the expiration date of the drug patent. These provisions facilitate generic drug companies to prepare and sell their generic drugs right after the patent of the relevant drug has expired. b) Compulsory License As a contracting member of the TRIPS Agreement, Vietnam has incorporated provisions of TRIPS on compulsory licensing into its domestic IP Laws. Article 7 of The IP Law 2005, which was amended in Public Health: Bolar Exemptions and Compulsory Licenses in Vietnam | April 2014 3 BMVN International LLC 2009, provides for limitations of IP rights. Accordingly, the Government may prohibit or limit rights holders from performing their IP rights, or request that the rights holders permit others to use some of their IP rights subject to certain conditions. Additionally, Article 145 of The IP Law 2005, as amended in 2009, lists out circumstances in which the compulsory license can be granted: • For the purposes of public or non-commercial use, national security or defence, disease prevention or treatment, or other urgent situations; • The owner of a patent fails to produce the patented product, or apply the patented process for the purpose of national security or defence, disease prevention or treatment, or other urgent situations; • The licensee and the licensor cannot reach an agreement on the use of a patented subject matter, after a reasonable time period for negotiation has elapsed; • The owner of a patent has conducted an anti-competitive act. Any compulsory license has a time limit and is non-exclusive and nonassignable, except for the case it is assigned as a part of the enterprise transfer. The patent owner shall be paid adequate remuneration depending on the circumstances of each case.3 In practice, although Vietnam, as a developing country, is faced with many social problems, particularly health issues, the price of drugs and medicine far exceeds what is affordable for many poor people. Although compulsory license provisions of international treaties have been incorporated into domestic laws, Vietnam has not granted any such licenses so far, as in practice the production of generic drugs is very difficult to accomplish in developing countries. As the development capacity of licensed companies in Vietnam is limited, the implementation of compulsory license provisions, by themselves, are not sufficient to promote the introduction of these drugs to the market. Furthermore, compulsory licenses have major impacts on the interests of pharmaceutical companies. Thus governments are inevitably faced with strong opposition from such companies in respect of granting compulsory licenses. 3 Article 146 of Intellectual Property Law 2005, amended 2009 © 2015 BMVN International LLC. All rights reserved. BMVN International LLC, a member of Baker & McKenzie. This publication is copyrighted. Apart from any fair dealing for the purposes of private study or research permitted under applicable copyright legislation, no part may be reproduced or transmitted by any process or means without prior written permission. The material in this publication is of the nature of general comment only. It is not offered as advice on any particular matter and should not be taken as such. The firm and the contributing authors expressly disclaim all liability to any person in respect of anything and in respect of the consequences of anything done or omitted to be done wholly or partly in reliance upon the whole or any part of the contents of this publication. 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