Disincentives against using compulsory licensing by. On checking, we found that it was true a compulsory licence application has been filed. 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. The amount of royalties set by the state granting a compulsory license cannot. Feb 16, 2016 trips covers compulsory license in detail. Compulsory licensing must meet certain additional requirements. 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. A compulsory license is a statutory licensing agreement in which a licensing fee is paid for the use of a work subject to u. Recently, interest in compulsory licensing of pharmaceuticals has been growing regardless of a countrys income level. Compulsory licensing to generic drugs a lifeline to a. 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. Next, i will discuss the policy and practical issues raised by compulsory licensing, particularly in the nonmerger, nonconsent context. Compulsory licensing of a drug product allows the government to issue the license of manufacturing the drug to a third person.
Compulsory licensing allows firms in developing countries to produce foreignowned inventions without the consent of foreign patent owners. The north american free trade agreement nafta has its own provisions for compulsory licensing of patents, which are somewhat more restrictive than those in. 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. What is the concept of compulsory license under the patents. Flexibilities in international intellectual property rules and local production of pharmaceuticals for the. Frequently asked questions about compulsory licenses. The basic thesis of this report is that the adoption of compulsory licensing will aggravate the problems associated with distant signal importation. Section 111 statutory license for secondary transmissions.
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 normal circumstances, an individual needs permission from a owner to reproduce, perform, or distribute a ed work. This paper reports on a number of recent examples of the use of compulsory licenses. Compulsory licensing in the united states chapter iii. 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. Uscbc believes that the call for comments represents a positive and constructive effort by the. Create a license agreement to control viewing of pdf files. The licensing division offers fillable pdf forms for both the short and longform statements of account to submit via mail. In 2006 thailand granted a compulsory license on two antiretroviral drugs, efavirenz and clopidogrel. 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. Part i of this article starts with a discussion of the status of. Compulsory licensing of drug products in developing countries. The consequences of filing form pctib382 in countries with compulsory licensing provisions are unclear, but are worth considering. 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.
Questioning the frequency and wisdom of compulsory licensing. 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. 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. In the last 20 years, german courts have developed a sophisticated approach to compulsory licensing of patents.
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. In this way, the compulsory licensing system minimizes the transactional costs for using these phonorecords, benefiting creativity and the economy. Global perspective on compulsory licensing this phenomenon of compulsory licensing is a hugely debated issue. Recent examples of the use of compulsory licenses on patents1. 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. 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. Compulsory license is not a remedy or a drug to be taken daily, argues guimaraes. 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. 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. Using compulsory licenses to access pharmaceuticals uio duo. 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, drugs and pharmaceuticals, trips agreement, doha declaration, indian patents act. Compulsory license is an action of a government forcing an exclusive. The compulsory licensing provisions have been a feature of the australian patents system since the.
Compulsory licensing is defined by the wto as compulsory licensing is when a government allows someone else to produce the. 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. It often relates to pharmaceutical patents and other intellectual property ip. 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. 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. After doha declaration many countries aggressively amended their patent regime for purpose of compulsory licensing. The compulsory and statutory license for secondary transmissions by cable systems. Other countries could cite such an action as the basis for imposing broad and onerous compulsory licensing requirements upon united states patentees. Oct 01, 2010 in particular, it deals with the grounds for compulsory licensing, procedure involved, decisions on compulsory licensing and trips compliance issues. 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. Introduction in india, it is very well established at all statutory, administrative and judicial levels that intellectual property is very.
Pdf compulsory license of pharmaceutical products in the trade related aspects of intellectual property rights trips agreement attempts to balance. For better or for worse, the done deal lies in the balance article pdf available in journal of intellectual property rights 171 january 2012 with 314 reads. Compulsory licensing, price controls, and access to patented. To begin, you need to create a pdf file with layers, which is possible with a program such as adobe indesign. Compulsory licensing of copyright in india intepat ip. Compulsory licensing to generic drugs a lifeline to a patient. Intellectual property rights and the use of compulsory licenses. 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 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.
Sam can take the necessary action to have little jimmys compulsory license revoked and prevent his version of the recording from being distributed or. 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. Compulsory licensing allowed was for the use of protected without prior permission of the owner of the right. Later, little jimmy, a punk rap star, acquires a compulsory license and records sams song but changes the words and eliminates the melody. 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. This paper reports on a number of recent examples of the use of compulsory licenses, in both developed and developing economies. 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. Essentially compulsory licensing provide that owners may only exercise the exclusive rights granted to them under law in. Compulsory licensing of drug products is a very hot issue in todays pharmaceutical world.
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 licence application filed over astrazenecas. Compulsory license definition of compulsory license by. Statutory license for secondary transmissions by cable. 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.
Compulsory licensing, price controls, and access to. This file may not be suitable for users of assistive technology. Compulsory licensing is covered in the trips agreement by. Indeed, there is no requirement that compulsory licenses be limited to cases involving health care problems at all. Natco files compulsory license against bayers nexavar. These examples,althoughoflessrelevancetoour model, indicate the increasingly wider use of compulsory licensing. The trips provides for compulsory licenses of patents in article 31, but also provides a number of restrictions on the use of compulsory licenses. Earlier today, we received an anonymous tipoff that an application for a compulsory license had been filed last week for the patent covering saxagliptin.
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. In particular, it deals with the grounds for compulsory licensing, procedure involved, decisions on compulsory licensing and trips compliance issues. There must be an incentive to invent because commercialization of new ideas involves money and effort 8. Envisioning a compulsorylicensing system for digital samples through emergent technologies by christopher r.
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. Compulsory licensing is a governmentgranted authorization given without the patent holders permission. While use of compulsory licenses is controversial, countries have traditionally. 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. On checking, we found that it was true a compulsory licence application has been filed over astrazenecas diabetes management drug saxagliptin. Circular 73 compulsory license for making and distributing. A person may by complying with the provisions of this section obtain a compulsory license to make and distribute phonorecords of a nondramatic musical work, including by means of digital phonorecord delivery. Compulsory license for maing and distributing phonorecords 5 the licensing division will acknowledge receipt of the filing. Patent fundamentals the patent system is grounded in article i, section. Compulsory licensing is a major intellectual property issue effecting international business today, and will continue to do so for the foreseeable future. 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.
Questioning the frequency and wisdom of compulsory. 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. The grant of such a patent licence tends to fulfill one. Patents provide monopoly rights to patent owners to manufacture, sell, and import the product resulting in overpricing of the patented products. What is the concept of compulsory license under the. Comments on draft measures for the compulsory licensing of. Of course, for the option to invoke compulsory li censing to matter, compulsory licensing need not actually be used. As a point of structure, i will turn first to the history of the compulsory licensing remedy in the us and the eu. Compulsory license for making and distributing phonorecords. Compulsory licensing of pharmaceuticals and trips wto. Escalating pressure emanating from the entertainment, pharmaceutical, and hightech industries ultimately helped with the push towards a new international trade policy, culminating in the adoption of the trips regime. Compulsory licensing may be established through negotiating licenses that provide terms within the parameters of the compulsory license. Compulsory licences under competition law are of particularly high relevance. Individuals and businesses can safely reuse creative content without worrying about liability, so long as.
1060 109 278 1271 1300 1297 1110 1408 1063 1091 342 1529 471 1007 1437 785 255 1401 544 193 1038 1125 1237 795 1122 1403 1349 416 56 1421 1483 168 314 70 1120 157