Rationale of compulsory licensing of pharmaceutical. Compulsory licensing of patents, an indian outlook. The report is entitled, compulsory licensing in europe. Compulsory licensing of copyright in india intepat ip. 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. Recent examples of the use of compulsory licenses on patents1. The south africa aids controversy a case study in patent. Evaluating the options article pdf available january 2009 with 348 reads how we measure reads. Compulsory licencing is one of several safeguards in the.
Uscbc believes that the call for comments represents a positive and constructive effort by the. For more information on compulsory licensing of patents in india please write to us at. Compulsory licensing provisions are a feature of many patent laws around the world, and are included in international agreements to which australia is a party. Compulsory licenses differ from ordinary licenses in. Compulsory licensing, price controls, and access to patented foreign products. This paper investigates whether compulsory licensing which allows governments to license patents without the consent of patentowners discourages. Compulsory licensing of pharmaceutical patents in developing countries by changsik min a thesis submitted in partial fulfillment of the requirements for the degree of doctor of juridical science s. This report presents background information for an inquiry on the compulsory licensing provisions of the patents act 1990 cwlth. Comments on draft measures for the compulsory licensing. These difficulties persist despite relevant efforts made by some world trade organization wto members. Compulsory licensing may also be used to protect the public interest, especially dur ing public health emergencies, or to act as a safeguard against abuses that might arise from the monopoly rights conferred by patents. Compulsory licensing sometimes becomes unavoidable as to save lives of the populace by ensuring accessibility of the products at affordable rate.
The patents act, 1970 was amended three times in 1999, 2002, 2005 respectively to include the concept of compulsory license and these are given in the sections 8492 of the indian patents act, 1970. A countrybycountry overview pdf, and was published in january. A compulsory licence suspends the monopoly effect of a patent and allows others than the patent holder to produce and supply the product. Many developing countries are giving importance to the compulsory licensing because of the unavailability and unaffordability of the medicines, and they are continuously granting more and more compulsory licenses. The term compulsory license refers to the grant of permission for an enterprise seeking to use anothers intellectual property without the consen t of its proprietor. Compulsory licensing often did not produce lower prices for. A compulsory license shall not be granted if, at the date of the request, the patent owner. In addition to a voluntary license, patents may be subject to a compulsory license. The bayernatco case on 9th march 2012 the indian controller of patents granted the first compulsory licence in india. Compulsory patent licences may be issued to meet the demand for a patented product in a domestic market, to enhance competition by aiding the growth of domestic competitors, or to facilitate the development or establishment of a domestic market. Compulsory licensing is defined generally as the granting of a license by a government to use a patent without the patent holders permission. Compulsory licensing of patents a comparative analysis of.
Compulsory licensing of patents inquiry report pdf 2181 kb compulsory licensing of patents inquiry report by chapters wordzip. Compulsory licensing of pharmaceuticals and trips wto. Compulsory licencing is one of several safeguards in the patents act 1990 patents act that allow a patented invention to be used without the authorisation of its owner. Compulsory licensing of patents background a compulsory licence is an order for a patentee to grant a licence to another party, allowing that party nonexclusive rights to exploit the patented invention. Many low and middleincome countries experience difficulty in using compulsory licensing as a measure to balance patent protection and access to medicines.
Draft measures for the compulsory licensing of patents the uschina business council uscbc and its member companies appreciate the opportunity to submit comments on the draft measures for the compulsory licensing of patents, issued on october 12, 2011. Questioning the frequency and wisdom of compulsory. Epo compulsory licensing in europe european patent office. Furthermore, the threat of compulsory licensing has no e. What are compulsory licenses under the patents act. Mar 20, 2020 today, the education, culture, science and technology commission of the national assembly in ecuador approved a resolution asking the minister of health to issue compulsory licenses over patents related to coronavirus technologies. Compulsory licenses and patents chennai3rd floor, creative enclave, terms and conditions of compulsory license section 90 1148150, luz church road, mylapore, chennai 600 004. Intellectual property rights and the use of compulsory licenses. Patents provide monopoly rights to patent owners to manufacture, sell, and import the product resulting in overpricing of the patented products. Indias first ever compulsory license was granted by the patent office on march 9, 2012, to hyderabadbased natco pharma for the production of generic version of bayers nexavar, an anticancer agent used in the treatment of liver and kidney. Without patents, the inventors and innovators can neither be adequately compensated for their costs of research nor be encouraged or motivated for further research to develop new and improved products. Compulsory licensing evidence from the trading with the enemy act. The european patent office has published a report detailing differences in the laws and procedures of european countries for the granting of compulsory licences. Licensing of related patents section 94 of the act deals with termination of compulsory license, it provides that on an application made by the patentee or any other person deriving title or interest in the patent, a compulsory license granted under section 84 may be terminated by the controller, if and when the circumstances that gave rise to.
Legislative committee in ecuador approves resolution on. Compulsory licensing of pharmaceutical patents in india. The term compulsory licensing does not appear as such in the trips agreement, however compulsory licensing is covered under article 31 of the agreement. Compulsory licensing is a license issued by a state authority to a government agency, a company or other party to use a patent without the patent holder. Questioning the frequency and wisdom of compulsory licensing for pharmaceutical patents richard a. Compulsory licensing, price controls, and access to. Compulsory licensing, price controls, and access to patented. European patent office report compares compulsory licensing. Compulsory licensing is a part of trips flexibilities that aims to strike a balance between promoting access to existing drugs and promoting research and development. Compulsory licenses are authorizations given to a thirdparty by the controller general to make, use or sell a particular product or use a particular process which has been patented, without.
For instance, a patent on a lifesaving drug may be diluted to the detriment of the patent holder in case of an outbreak of an epidemic. With regard to the iprcompetition interface, compulsory licensing can be granted on the grounds of the existence of. The most important global norm for the use of compulsory licenses is article 31 of the wto trips agreement, which addresses uses of a. Comments on draft measures for the compulsory licensing of. The uk patents act 1977 also provides for the grant of compulsory licences under patents in circumstances where it can be established that there has been an abuse of the monopoly rights in relation to such patents. Like most countries, australia has legislated a system of compulsory licensing so that patent owners can be compelled to license their inventions to others in a limited range of circumstances. A compulsory license provides that the owner of a patent or licenses the use of their rights against payment either set by law or determined through some form of. Compulsory licensing in india intellectual property india. In the most recent case of compulsory licensing in india, lee pharma, a hyderabad based indian pharma company, filed an application for compulsory license dated 29. The term compulsory license is used to describe a number of mechanisms for nonvoluntary authorizations to use patents. Ciprofloxacin and compulsory licensing of pharmaceutical patents.
This concept of compulsory licensing has been given in the chapter xvi of the indian patents act, 1970. The patentee, however, has the right to be heard in the compulsory licensing application process. Patent fundamentals the patent system is grounded in article i, section 8, clause 8 of the u. After doha declaration many countries aggressively amended their patent regime for purpose of compulsory licensing. Compulsory license can be issued to a generic company on different grounds to fulfill the patient need and to improve quality of life. Compulsory licensing of pharmaceutical patents in developing. Compulsory licensing may be established through negotiating licenses that provide terms within the parameters of the compulsory license. Before doha declaration, big pharmaceutical companies are continuously taking the advantages to earn money by sustaining monopoly because of the rigid patent protection. Scott kieff many advocates for using compulsory licensing cl for pharmaceutical patents in developing countries like thailand rest their case in part on the purported use of cl in the united states.
Despite criticism and drawbacks of compulsory licensing, the right of sovereign states to grant a compulsory license has. Compulsory patent licensing and local drug manufacturing. Compulsory licensing of patented pharmaceutical inventions. A compulsory license is a term generally applied to a statutory license to do an act covered by an exclusive right without the prior authorization of the right owner. Ciprofloxacin and compulsory licensing of pharmaceutical. This file may not be suitable for users of assistive technology. Patent, compulsory licensing, trips, doha declaration, access to drugs patents vest monopoly rights in the creator to manufacture, use and sell a product.
The compulsory license was issued to natco pharma ltd. The forfeiture of the patent would only apply where a compulsory license proved to be ineffective as a means of addressing the nonworking of a patent article 5a. It also helps to break the monopolies and cartel which are some of the abuses of patent rights. The productivity commission the commission released its final report to government into the compulsory licensing provisions of the patents act 1990 cth the act on 28 march 20. Relevance and objectives of the study in 2012, india issued its first compulsory license for patents. The relevant national legislation as indicated in the answers provided by the respondents is listed in table 1. Vivekanandan the trips agreement has brought a basic universal common denominator on various intellectual property segments among the member states of world trade organization.
Scott kieff many advocates for using compulsory licensing cl for pharmaceutical patents in developing countries like thailand rest their case. The fourth part of the paper considers reasons for granting patent monopolies and how compulsory licenses a. Compulsory licensing of patented inventions every crs report. In some cases, national authorities may license companies or individuals other than the patent owner to use the rights of the patent without the consent of the patent owner. Compulsory licensing may also increase invention indirectly as it encourages investments in scientific training and other skills, which in turn facilitate invention e. This report is a descriptive one that explores the system of compulsory licensing in india. This provision art 1 was inserted as long ago as the berlin revision of 1908, where it reflected a. The grant of a compulsory patent license typically requires the sanction of a governmental entity and provides for compensation to the patent. Of course, for the option to invoke compulsory licensing to matter, compulsory licensing need not actually be used. Health care reform in south africa south africa, a country about twice the geographical size of texas, has approximately fortytwo million inhabitants, 75.
Compulsory licensing of patents a comparative analysis of japanese and indian practices invited researcher. Inquiry report compulsory licensing of patents productivity. The permission of the patent owner is not required. In practice though, compulsory licences are rarely applied for in the uk. This article analyses the soundness of the decision in the light of global practices dealing with compulsory licensing which is reflected in international agreements, the indian patent law provisions and the conduct of the indian patent office in subsequent applications for such licences. Jun 08, 2015 this article analyses the soundness of the decision in the light of global practices dealing with compulsory licensing which is reflected in international agreements, the indian patent law provisions and the conduct of the indian patent office in subsequent applications for such licences. Compulsory licensing allows for the use of protected in this case, ed material without the prior permission of the owner of the right. Subsequently, the paris convention in 1883 stipulated. What is the concept of compulsory license under the patents. Although no universally accepted definition exists, the term compulsory license implies that anyone who meets certain statutory criteria may use the patented invention. Questioning the frequency and wisdom of compulsory licensing. Compulsory licenses in the patent system most often relate to.
Compulsory licensing of patents a comparative analysis. Markus nolff, compulsory patent licensing in view of the wto ministerial conference declaration on the trips agreement and public health, 84 j. Compulsory licensing has been widely suggested as a legal mechanism for bypassing patents to introduce lowercost generic antiretrovirals for hivaids in developing countries. In certain cases, however, patents may be subject to a compulsory license, which allows another person to practice the invention without the consent of the patent holder.
Even though compulsory licensing is permitted under trips, it has not been used that often by developing countries. Compulsory licensing of patents inquiry report pdf 2181 kb compulsory licensing of patents inquiry report by chapters wordzip 1898 kb. The first compulsory licensing of patents and copyright by. The indian patents act, 1970 incorporates compulsory licensing in sections 84 to 94 and rules 96. The patent act, 1970 has been amended thrice in 1999, 2002, 2005 in relation to the inclusion of the concept of compulsory license. Compulsory licenses do not deny patent holders the right to act against nonlicensed parties. Monopoly is often coupled with possibilities of abuse of patent rights. This paper proposes to look key issues of the public interest foundation of the patent system, the conditions for monopoly grants, abuse of.
On march 9, 2012, indias first compulsory license cl was granted by the patent office to natco pharma ltd. Compulsory licensing in europe provides a countrybycountry overview of compulsory licensing regimes across the 38 epc contracting states including possible grounds. With the implementation of the trips agreement and inclusion of pharmaceutical products. Article 31f of the trips agreement provides that prod ucts made under a compulsory licence shall be predominantly. Compulsory licenses require the sanction of a governmental entity and the payment of compensation to the patent holder. 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. The model is also able to shed light on the nature of interaction between a price con trol and compulsory licensing.
A patent shall be subject to compulsory licensing if the owner exercises his rights therein in an abusive manner or if he uses it to abuse economic power under the terms of an administrative or judicial decision. The interface between competition and intellectual property ip policies. 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 allows firms in developing countries to produce foreignowned inventions without the consent of foreign patent owners.
Part two examines the trips agreement, and then part three evaluates the legality of issuing compulsory licenses under trips. Compulsory licensing must meet certain additional requirements. Compulsory licensing in europe provides a countrybycountry overview of compulsory licensing regimes across the 38 epc contracting states including possible grounds for grant, procedural framework and jurisprudence. Pdf compulsory licensing of patented pharmaceutical. Compulsory licensing and the anticompetitive effects. Indian patent act, 1970 as well as the international legal agreement between all member nations of wto the trips traderelated aspect of intellectual property rights cover the provision of compulsory licensing. The situation in underdeveloped countries with little or no resources for contingency management was a watershed in the history of compulsory licensing.
The boards chief prabha sridevan in an open court on march 4, 20 dictated the order upholding the controllers decision for grant of compulsory license on bayers patented drug, sorafenib tosylate. Compulsory licensing sections of brazils patent law. Index terms access to drugs, compulsory licensing, pharmaceutical patents, trips flexibilities. Note that compulsory licenses in the prc are available only. The indian patents act, 1970 and the trips talk about the provisions for compulsory licensing. In particular, it examines the historybackgroundrationale of the present compulsory licensing. Global perspective on compulsory licensing this phenomenon of compulsory licensing is a hugely debated issue. On 19 march, israel issued compulsory patent licences related to lopinavir ritonavir brand name kaletra, which is an hiv medicine currently being tested, including in combination with other products, for effectiveness in the treatment of covid19. Compulsory licensing evidence from the trading with the. May 08, 2017 the indian patents act, 1970 and the trips talk about the provisions for compulsory licensing.
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