In the most recent case of compulsory licensing in india, lee pharma, a hyderabadbased indian pharma company, filed an application for a compulsory licence 29 june 2015 for the patent covering astrazenecas diabetes management drug saxagliptin. A series of legislative changes, including the recent music modernization act, has made the compulsory music licensing regime increasingly inconsistent and ill equipped to handle new forms of music dissemination. Cipo pandemic response and canadas new compulsory patent. A decade and a half ago the use of flexibilities contained in the world trade organization agreement on trade related aspects of intellectual property rights, in particular compulsory licensing, was seen as a mechanism to respond to highprice medicines for the treatment of hivaids. Controller awarded compulsory license on a cancer drug nexavar patented by bayer to generic drug maker natco pharma. Erectile dysfunction is often characterized as a nonlife. And now, its connected to the adobe document cloud. Richard tren, free industry, not the drugs, wall st. On march 11, the world health organization who declared covid19 a global pandemic. Compulsory licensing and innovation historical evidence.
Thus, depending on whose perspective one takes, compulsory licensing could be viewed as either a harmful or beneficial policy measure. The compulsory license mechanism is broken and will not bring drug access to the worlds poorest nations. In particular, it deals with the grounds for compulsory licensing. One might also see possible effects on the level of innovation within the countries that use the. Compulsory licensing for patents, when the authorities license companies or individuals other than the patent owner to use the rights of the patent to make, use, sell or import a product under patent i.
If the owner is no longer at the address or refuses to accept delivery if the notice of intention to obtain a compulsory license is. Compulsory licensing of patents during pandemics by sapna. Essentially compulsory licensing provide that owners may only exercise the exclusive rights granted to them under law in a certain way and through a certain system. Since the virus first emerged at the end of 2019, pharmaceutical companies have been ramping up efforts to develop new medicines and vaccines to address the pandemic, but concerns regarding fair access to medicines and vaccines accompany. Compulsory licensing of technology and the essential. Existing language still raises a number of questions about the process, however, including questions about whether a compulsory license could be granted before judicial decisions or appeals. Chapter xvi of the indian patents act 1970 and the agreement on traderelated continue reading what is compulsory. In a recent issue of the antitrust law journal, a symposium of articles considers possible legal remedies to. A compulsory license is an authorization given by a national authority to a natural or legal person for the exploitation of the subject matter protected by a patent. Circular 73 compulsory license for making and distributing.
Compulsory licensing practical experiences and ways forward. Mar 01, 2004 compulsory licensing is the remedy which has evolved, but this is a relatively recent development and the appropriate terms of such licensing have not yet been subject to detailed economic analysis. Compulsory licensing in europe full version pdf, 1. This circular provides a general overview of the compulsory license, also known as the 115 license or mechanical license. Compulsory licensing is covered in the trips agreement by. In recent years, however, policymakers have begun to lose sight of this accessencouraging role.
In particular, it deals with the grounds for compulsory licensing, procedure involved, decisions on compulsory. Compulsory licensing in europe provides a countryby. Compulsory license for making and distributing phonorecords 3 3 file with the owner or authorized agent of the owner a detailed annual statement of account, certified by a certified public accountant. The decision of a government to grant compulsory licenses may lead to the loss of foreign direct investment. However according to article 31 of the trips agreement, a patent can be used by the government or third. Compulsory licensing practical experiences and ways. Compulsory licenses may be required to import or produce a given product, or to use a patented technology for research.
Jun 28, 2017 the challenge of providing access to highpriced patented medicines is a global problem affecting all countries. Jun 27, 2019 recently, interest in compulsory licensing of pharmaceuticals has been growing regardless of a countrys income level. Compulsory license can be granted in india at any time after the expiration of three years from the date of the sealing of a patent, any person interested can make an. World trade organization economic research and statistics division. This group of scholars came together to analyse how the international conventions on intellectual property may be interpreted and to explore the doctrinal groundwork surrounding compulsory patent licensing and beyond in order to show that the cl scheme could be transformed into a truly workable mechanism facilitating the speedy use and dissemination of innovation and other subject. There must be an incentive to invent because commercialization of new ideas involves money and effort 8. Section 1 elaborates on the relevant international and national legal provisions for compulsory licensing. Multiple candidates laid out plans for presidential oversight of drug pricing. Next, i will discuss the policy and practical issues raised by compulsory licensing, particularly in the nonmerger, nonconsent context. This paper uses an exogenous event of compulsory licensing after world war i under the trading with the enemy act to examine the long run effects of compulsory licensing on domestic invention. Reconceptualizing compulsory copyright licenses stanford.
Compulsory licensing of patents inquiry report pdf 2181 kb compulsory licensing. Essentially compulsory licensing provide that owners may only exercise the exclusive rights granted to them under law in. Section 2 cites global instances where compulsory licensing has been used in the posttrips era. Canadas parliament, as part of the covid19 emergency response act, has now added health emergency compulsory licensing legislation to canadas patent act. Whether compulsory licensing must be considered as a last resort or whether alternative remedies are available 6. The global alliance for patient access explains how shortcuts like compulsory licensing can hurt patients in the long run. Compulsory license for making and distributing phonorecords. By means of legal and economic reasoning this master thesis argues that the 30. Vishal gupta, a mathematical approach to benefitdetriment analysis as a solution to compulsory licensing of pharmaceuticals under the trips agreement, cardozo j. The first compulsory licensing of patents and copyright by. When a compulsory license can be used what activities are covered by the compulsory license. As a point of structure, i will turn first to the history of the compulsory licensing remedy in the us and the eu. Compulsory licensing allows firms in developing countries to produce foreignowned inventions without the consent of foreign patent owners.
The time for pharmaceutical compulsory licensing has expired. Compulsory licensing of a drug product allows the government to issue the license of manufacturing the drug to a. A compulsory licence is a licence or authorisation issued by the government to an applicant for making, using and selling a patented product or employing a patented process without the consent of the patentee. The amount of royalties set by the state granting a compulsory license cannot. Constitutionality of the provisions on compulsory and.
Compulsory licensing is a provision that contradicts patents issued and an attempt is made in bringing awareness. To access the html version and the elearning module or download the pdf. Compulsory licensing of patents inquiry report pdf 2181 kb compulsory licensing of patents inquiry report by chapters wordzip. The effect on the life and health of social or economic minority 4. Compulsory licensing provisions further the same goal of general 4 as the united states supreme court recently stated, compulsory licensing is a rarity in our patent system, and we decline to manufacture such a requirement.
The contribution of this article to the literature on trips compulsory licensing is twofold. Trends in compulsory licensing of pharmaceuticals since the. Pdf an overview of compulsory licensing in pharmaceuticals. Thus, the request for grant of the compulsory licence was refused. Compulsory licensing of patented pharmaceutical inventions. The current paper discusses the various issues and challenges of indias first compulsory licensing case. Compulsory licensing of patents inquiry report pdf 2181 kb compulsory licensing of patents inquiry report by chapters wordzip 1898 kb. Also examine if providing compulsory licensing to generic pharma companies is in violation of wto rules. Adobe acrobat reader dc software is the free global standard for reliably viewing, printing, and commenting on pdf documents. Compulsory licensing of pharmaceuticals and trips wto. Trends in compulsory licensing of pharmaceuticals since.
Importance of the intellectual property system in attempting. Oct 04, 2017 this lecture is a part of a nptel course on patent law for engineers and scientists. Jan 10, 2012 more than half the compulsory licensing episodes occurred in uppermiddleincome countries including brazil and thailand. Under the auspices of the max planck institute for intellectual property and competition law now the max planck institute for innovation and competition.
Comments on draft measures for the compulsory licensing of. Section 111 statutory license for secondary transmissions. Ever since compulsory licensing has emerged as a statutory obligation, it has been debated around the balance of. Indian government has issued its first compulsory license in 2012 for the drug nexavar, an anticancer drug. Moreover, the growth of local industry in developing countries is heavily dependent on investment that comes from outside the country. Inquiry report compulsory licensing of patents productivity. An overview of compulsory licensing regimes across the 38 epc contracting. Finally, most compulsory licensing episodes occurred between 2003 and 2005. It is shown how the compulsory licensing regime could be transformed into a truly workable. The term compulsory license refers to the grant of permission for an enterprise seeking to use anothers intellectual property to do so without the consent of its proprietor. We aim to investigate the use of compulsory licensing as a legitimate part of the patent system and tool for the government to utilize by demonstrating that countries with a mature patent system were more likely to utilize compulsory licensing of pharmaceuticals. Whether the compulsory licensing application was filed against a patent for an orphan drug 3.
Download fulltext pdf download fulltext pdf read fulltext. There was a smaller peak of activity in the months leading up to the doha conference, but after 2006 activity declined substantially. The main question is whether the compulsory licensing system as prescribed in the recent decision is an ample means of improving access to patented aids medicines in the developing world. Compulsory licensing must meet certain additional requirements.
Compulsory licensing of drug products in developing. One aspect common throughout the world, but virtually absent in the united states, is compulsory licensing. Does the compulsory licensing of pharmaceuticals hurt. Aug 01, 2017 through its exposition and analysis of the first five distinct compulsory licensing regimes, some concluding observations are made about the triggers for the first compulsory licences and the conditions that might help predict the desirability of compulsory licensing as a matter of modern public policy in any given setting. Compulsory licensing of drug products is a very hot issue in todays pharmaceutical world. Pdf of report is available for download along with the press release. Unlike developed nations, developing countries have rarely used the compulsory license as an instrument of public policy. It seems likely that the special nature of information goods might require licensing fee structures that differ from those used for access pricing. Evaluating the usefulness of compulsory licensing in developing countries. It also establishes the requirements governing the form, content of the filing of these semiannual statements, and submission of statutory royalty payments. Compulsory licensing, price controls, and access to. Compulsory licensing of pharmaceutical patents in developing.
The license prescribes various conditions under which cable systems may obtain a compulsory license to retransmit ed works, including the filing of statements of account forms. Why broad compulsory licensing is not a viable solution to the access to medicine problem introduction rectile dysfunction, cancer, and hivaids are not generally thought of as falling within the same class of medical illness. Many other countries like, malaysia, indonesia, china, taiwan, mozambique, zambia, zimbabwe, etc. Both cases involved the compulsory licensing of hivaids drugs. Data exclusivity exceptions and compulsory licensing to. Compulsory licensing may be established through negotiating licenses that provide terms within the parameters of the compulsory license. Using compulsory licenses to facilitate access to medicines. Country experiences in using trips safeguards world health. Dec 18, 2020 prescription drug prices, and means by which the executive branch might lower them absent legislative action, were a hot topic during the 2020 election, particularly during the democratic primary. Whether compulsory licensing must be considered as a. Compulsory licensing in canada and thailand wiley online library. Compulsory licensing to cut drug costs could harm public.
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