It is one of the flexibilities in the field of patent protection included in the wtos agreement on intellectual property the trips traderelated aspects of intellectual property rights agreement. Compulsory license is the term generally applied to a statutory license to do an act covered by an exclusive right without the prior authorization of the right owner. Indeed, there is no requirement that compulsory licenses be limited to cases involving health care problems at all. Intellectual property rights and the use of compulsory licenses. Compulsory licensing of pharmaceuticals and trips wto. Introduction in india, it is very well established at all statutory, administrative and judicial levels that intellectual property is very. Where a patent is endorsed licences of right, any person is entitled to a licence under the patent. Patent fundamentals the patent system is grounded in article i, section 8, clause 8 of the u. Compulsory license for making and distributing phonorecords. Using compulsory licenses to access pharmaceuticals uio duo. Obstacles created by the present compulsory licensing law even after the clarification issued during doha declaration and the subsequent decision, law on compulsory licensing suffers from many drawbacks, preventing the effective use of this law for access to drugs. If one of the grounds for compulsory licensing is established, the comptroller may order the grant of a licence on such terms as the comptroller decides or endorse the patent licences of right. There must be an incentive to invent because commercialization of new ideas involves money and effort 8. Compulsory licenses came into force when the developing countries couldnt afford the cost of technology to produce medicines and high price of the patented medicines.
The compulsory licensing provisions have been a feature of the australian patents system since the. Compulsory license, drugs and pharmaceuticals, trips agreement, doha declaration, indian patents act. Comments on draft measures for the compulsory licensing of. Compulsory licensing of copyright in india intepat ip. Compulsory licensing is a major intellectual property issue effecting international business today, and will continue to do so for the foreseeable future. Compulsory licensing allows for the use of protected in this case, ed material without the prior permission of the owner of the right.
In this blog post, bhavneet vohra, a student of vivekananda institute of professional studies, delhi, and pursuing his diploma in entrepreneurship administration and business laws from nujs, kolkata, provides an overview on compulsory licensing in india. To begin, you need to create a pdf file with layers, which is possible with a program such as adobe indesign. Compulsory license for maing and distributing phonorecords 5 the licensing division will acknowledge receipt of the filing. Compulsory license for maing and distributing phonorecords 2 identifiable reproduction by or for a recipient, regardless of whether the digital transmission is also a public performance of the sound recording or any underlying nondramatic musical work. As a point of structure, i will turn first to the history of the compulsory licensing remedy in the us and the eu. Sam can take the necessary action to have little jimmys compulsory license revoked and prevent his version of the recording from being distributed or played any further. Of course, for the option to invoke compulsory li censing to matter, compulsory licensing need not actually be used. A compulsory license is a statutory licensing agreement in which a licensing fee is paid for the use of a work subject to u. Individuals and businesses can safely reuse creative content without worrying about liability, so long as. A compulsory license obtained under subsection b1 to make and distribute phonorecords includes the right of the maker of such a phonorecord to distribute or authorize distribution of such phonorecord, other than by means of a digital phonorecord delivery, by rental, lease, or lending or by acts or practices in the nature of rental, lease, or lending. 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. Compulsory licensing of drug products in developing countries.
On checking, we found that it was true a compulsory licence application has been filed over astrazenecas diabetes management drug saxagliptin. The compulsory and statutory license for secondary transmissions by cable systems. Statutory license for secondary transmissions by cable. Recent examples of the use of compulsory licenses on patents1. Compulsory licensing may be established through negotiating licenses that provide terms within the parameters of the compulsory license. 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. Compulsory license is an action of a government forcing an exclusive. Envisioning a compulsorylicensing system for digital samples through emergent technologies by christopher r.
Compulsory licensing, price controls, and access to. Compulsory license is not a remedy or a drug to be taken daily, argues guimaraes. 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. Next, i will discuss the policy and practical issues raised by compulsory licensing, particularly in the nonmerger, nonconsent context. Earlier today, we received an anonymous tipoff that an application for a compulsory license had been filed last week for the patent covering saxagliptin. An overview on compulsory licensing in india ipleaders. Later, little jimmy, a punk rap star, acquires a compulsory license and records sams song but changes the words and eliminates the melody.
Natco files compulsory license against bayers nexavar. Reinaldo guimaraes, who agrees that the price of the treatment of hepatitis c is too costly, believes instead that reapplying the measure of compulsory license is not the solution. 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. Pdf compulsory license of pharmaceutical products in the trade related aspects of intellectual property rights trips agreement attempts to balance. Section 111 statutory license for secondary transmissions. The grant of such a patent licence tends to fulfill one. The consequences of filing form pctib382 in countries with compulsory licensing provisions are unclear, but are worth considering. The licensing division offers fillable pdf forms for both the short and longform statements of account to submit via mail. Compulsory licensing is when a government allows someone else to produce a patented product or process without the consent of the patent owner or plans to use the patentprotected invention itself. Part i of this article starts with a discussion of the status of.
This paper reports on a number of recent examples of the use of compulsory licenses, in both developed and developing economies. Compulsory licensing in the united states chapter iii. Questioning the frequency and wisdom of compulsory. These examples,althoughoflessrelevancetoour model, indicate the increasingly wider use of compulsory licensing. Compulsory licensing of a drug product allows the government to issue the license of manufacturing the drug to a third person. While use of compulsory licenses is controversial, countries have traditionally. 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. This file may not be suitable for users of assistive technology. Compulsory licensing of drug products is a very hot issue in todays pharmaceutical world. Compulsory licensing is a governmentgranted authorization given without the patent holders permission. Compulsory licensing, price controls, and access to patented. The basic thesis of this report is that the adoption of compulsory licensing will aggravate the problems associated with distant signal importation. In the authoring program, show the agreement layer and hide the content layer, then export to pdf.
Uscbc believes that the call for comments represents a positive and constructive effort by the. Compulsory licensing chennai3rd floor, creative enclave, compulsory licenses are licenses that are granted by a148150, luz church road, mylapore, government to an individual or company seeking to use chennai 600 004. Sam can take the necessary action to have little jimmys compulsory license revoked and prevent his version of the recording from being distributed or. Flexibilities in international intellectual property rules and local production of pharmaceuticals for the. 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. This paper uses an exogenous event of compulsory licensing after world war i under the trading with the enemy act to examine the effects of compulsory licensing on domestic invention. What is the concept of compulsory license under the. Circular 73 compulsory license for making and distributing. Compulsory license is the term generally applied to a statutory license to do an act covered by an exclusive right without the prior authority of the right owner.
Compulsory licensing must meet certain additional requirements. Compulsory license definition of compulsory license by. Create a license agreement to control viewing of pdf files. The north american free trade agreement nafta has its own provisions for compulsory licensing of patents, which are somewhat more restrictive than those in the trips. In the last 20 years, german courts have developed a sophisticated approach to compulsory licensing of patents. Compulsory licences under competition law are of particularly high relevance. What is the concept of compulsory license under the patents. Patents provide monopoly rights to patent owners to manufacture, sell, and import the product resulting in overpricing of the patented products. In 2006 thailand granted a compulsory license on two antiretroviral drugs, efavirenz and clopidogrel. Other countries could cite such an action as the basis for imposing broad and onerous compulsory licensing requirements upon united states patentees. 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. Compulsory licensing allows firms in developing countries to produce foreignowned inventions without the consent of foreign patent owners. Compulsory licensing is covered in the trips agreement by. Compulsory licensing to generic drugs a lifeline to a.
The appearance of a united states government agency imposing a compulsory patent license, especially a royaltyfree compulsory license, must be avoided except in response to egregious conduct. To confirm receipt, the licensing division will email an acknowledgement of receipt and, later, a digitallysigned and stamped pdf copy of the electronic form to the cable operator, using the email address designated in space n of the form. Feb 16, 2016 trips covers compulsory license in detail. On january 8, 2005, essential inventions, a nonprofit, asked the cameroon minister of public health to approve compulsory licenses for patented arvs in the country. The amount of royalties set by the state granting a compulsory license cannot. Given the recent transition of india to a pharmaceutical product patent regime, it is expected that a number of generic companies are actively looking to exploit the compulsory licensing windows. Compulsory licensing allowed was for the use of protected without prior permission of the owner of the right. Questioning the frequency and wisdom of compulsory licensing. Recently, interest in compulsory licensing of pharmaceuticals has been growing regardless of a countrys income level. This move by natco has placed the ball in bayers courtbayer now needs to decide whether to hold its ground or capitulate and reduce the price of nexavar for india and the policy guidelines that come out as a result of this application would be interesting for both patentees and generic drug manufacturers. In normal circumstances, an individual needs permission from a owner to reproduce, perform, or distribute a ed work. Individuals and businesses can safely reuse creative content without worrying about liability, so long as they are willing to follow these rules and pay the license fee. Essentially compulsory licensing provide that owners may only exercise the exclusive rights granted to them under law in.
Compulsory licensing to generic drugs a lifeline to a patient. This paper reports on a number of recent examples of the use of compulsory licenses. It often relates to pharmaceutical patents and other intellectual property ip. In countries that allow for compulsory licenses, filing form pctib382 could be seen as a commitment or preliminary agreement on the part of the patent applicant to license its technology in that country. Disincentives against using compulsory licensing by. Patent fundamentals the patent system is grounded in article i, section. Global perspective on compulsory licensing this phenomenon of compulsory licensing is a hugely debated issue. Compulsory licensing is defined by the wto as compulsory licensing is when a government allows someone else to produce the. Oct 01, 2010 in particular, it deals with the grounds for compulsory licensing, procedure involved, decisions on compulsory licensing and trips compliance issues. In particular, it deals with the grounds for compulsory licensing, procedure involved, decisions on compulsory licensing and trips compliance issues. A person may obtain a compulsory license only if the primary purpose in making phonorecords of the musical work is to distribute them to the. In this way, the compulsory licensing system minimizes the transactional costs for using these phonorecords, benefiting creativity and the economy. Jul 01, 2012 compulsory licensing chennai3rd floor, creative enclave, compulsory licenses are licenses that are granted by a148150, luz church road, mylapore, government to an individual or company seeking to use chennai 600 004. Compulsory licences sections 48 to 54 of the patents act 1977the actallow the granting of compulsory licences for patents in order to address anticompetitive uses.
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