Letter from Secretary General
Hello again, I am Sreekar Reddy, a fourth year mechanical engineering student of CBIT, I was introduced to MUNs at CBIT beginning as a director in the 2011 edition and currently serving my second term as Secretary General of this great conference , needless to say it is indeed an honour and a privilege. For two years we have stood up and redefined MUN conferences in India, For two years we have led the way with innovation. We wanted to deliver a phenomenon We wanted to be the difference. For two editions now we have been and done all that but we come back for the third time promising the same and even more. When a team creates something spectacular it leaves a greater responsibility in the hands of the next team, it leaves a legacy, a legacy that must continue. Moving forward with this responsibility on our shoulders we would assure the participants who have supported us since 2011 that the best is yet to come and to those who have missed the last two editions we would like to tell you that it’s never too late to be a part of something that shall become a collection of memories to cherish. To put it simply, hello delegate, welcome to CBITMUN. Sreekar Reddy Secretary General CBITMUN
WORLD INTELLECCTUAL PROPERTY ORGANIZATION INTRODUCTION: World Intellectual Property organization is the most effective and influential body of UN that deals with conflicts of intellectual rights. WIPO was formed in the year 1967 as a successor of a body that was over 50 years old, named BIRPI, which was the French acronym for United International Bureaux for the Protection of Intellectual Property and in 1970 it officially stated that it seeks to "promote the protection of intellectual property throughout the world." In 1974 it officially became a specialized agency that was responsible for the facilitating the transfer of technology and for the promotion of creative intellectual activity in order to speed up economic, social and cultural development. It is currently based in Geneva in Switzerland and consists of 184 UN countries with Francis Gurry as Director General. As an organization, the aim of WIPO is “dedicated to developing a balanced and accessible international intellectual property (IP) system, which rewards creativity, stimulates innovation and contributes to economic development while safeguarding the public interest.” As the topics being discussed in the committee are “disputes relating to drug patents” and “review of international copyrights law”, PARIS CONVENTION and BERNE CONVENTION are significant treaties in regards to these topics. These particular treaties have designed a wide range of rules regarding industrial property. The major payoff of PARIS CONVENTION treaty was that when an applicant files an application for a patent or a trademark in a foreign country member of the Union, the application receives the same treatment as if it came from a national of this foreign country. The substantive provisions of the Convention fall into three main categories: national treatment, right of priority, common rules. And the major turning point of this convention in regards to patent The two major treaties that have had an important relevance upon WIPO are Patent Cooperation Treaty (PCT) and the Patent Law Treaty (PLT) that more or less synchronize global patenting system. The Patent Cooperation Treaty (PCT) concluded in 1970, which makes it possible to obtain patent protection in many nations by filling out just a few forms—the first major step towards Global protection of patents. The second is the Patent Law Treaty (PLT), concluded in 2000, its main aim being “to harmonize and streamline formal procedures in respect of national and regional patent applications and patents, and thus to make such procedures more user-‐friendly.” Thus, making the protection of IP more stringent. The Berne Convention is an international agreement governing copyright. This particular convention set forth, that requires all signatories to protect the artistic property of foreign authors similarly to how they protect their domestic authors. The United States initially refused to become a party to the Convention this led to the UniversalCopyright Convention in 1952 to accommodate the wishes of the United States.
The World Trade Organization passed the third major piece of legislation—the Agreement on Trade-‐Related Aspects of Intellectual Property Rights (TRIPS) — in 1994. TRIPS, generally considered by scholars and diplomats to be the most significant piece of global legislation protecting intellectual property rights, specify how countries should enforce copyrights and patents. AGENDA 1: DISPUTES RELATING DRUG PATENTS: WHAT IS A PATENT AND WHAT DOES IT DO? A patent is an exclusive right granted for an invention, which is a product or a process that provides, in general, a new way of doing something, or offers a new technical solution to a problem. In order to be patentable, the invention must fulfill certain conditions. A patent provides protection for the invention to the owner of the patent. The protection is granted for a limited period, generally 20 years. Patent protection means that the invention cannot be commercially made, used, distributed or sold without the patent owner's consent. These patent rights are usually enforced in a court. A patent owner has the right to decide who may -‐ or may not -‐ use the patented invention for the period in which the invention is protected. The patent owner may give permission to, or license, other parties to use the invention on mutually agreed terms. The owner may also sell the right to the invention to someone else, who will then become the new owner of the patent. Once a patent expires, the protection ends, and an invention enters the public domain, that is, the owner no longer holds exclusive rights to the invention, which becomes available to commercial exploitation by others. WHAT CAN AND NOT -‐BE PATENTED? An invention must, in general, fulfill the following conditions to be protected by a patent. • It must be of practical use; • It must show an element of novelty, that is, some new characteristic which is not known in the body of existing knowledge in its technical field. • This body of existing knowledge is called “prior art". The invention must show an inventive step which could not be deduced by a person with average knowledge of the technical field. • Finally, its subject matter must be accepted as "patentable" under law. SCOPE OF PATENTS
The patented invention or the extent of protection is defined in the claims of the granted patent. In other words, the terms of the claims inform the public of what is not allowed without the permission of the patent holder. Patents are territorial, and infringement is only possible in a country where a patent is in force. For example, if a patent is filed in the United States, then anyone in the United States is prohibited from making, using, selling or importing the patented item, while people in other countries may be free to make the patented item in their country. The scope of protection may vary from country to country, because the patent is examined by the patent office in each country or region and may have some difference of patentability, so that a granted patent is difficult to enforce worldwide. INTRODUCTION TO THE DISPUTE Intellectual property (IP) protection has become an important component of national economic policies. Governments have options as to how they would want their IP system to be, thatbest serves their policy objectives. Each country decides as to whether to offer patent protection within its borders.The WIPO-‐ administered Patent Cooperation Treaty (PCT) provides for the filing of a single international patent application which has the same effect as national applications filed in the designated countries. An applicant seeking protection may file one application and request protection in as many signatory states as needed.In general, an application for a patent must be filed, and a patent shall be granted and enforced, in each country in which you seek patent protection for your invention, in accordance with the law of that country. ISSUE: “The debate over global drug pricing is one of the most contentious issues between developed countries and the developing world. While poorer nations maintain they have a moral obligation to make cheaper, generic drugs available to their populations — by limiting patents in some cases — the brand name pharmaceutical companies contend the profits they reap are essential to their ability to develop and manufacture innovative medicines.” With the growing globalization, the markets of developing countries are often in unfair competition to the strong markets of the industrialized world. Private companies, backed by their governments, are trying to increase their income all over the world. Many times the third world has nothing or little room for reaction, because of their dependence on western aid. The population simply can’t afford many high expensive necessary treatments. We have to find a way, to make a compromise between the involved parties which promotes further research while making it affordable for those who need it the most. The Indian Supreme Court ruled that Indian makers of generic drugs can continue producing copy-‐cat versions of Gleevec, a drug made by Novartis that provides effective treatment for some forms of Leukemia. Being the most important provider of inexpensive medicines, India maintains its role fighting deadly diseases on a global scale by cutting the prices.The Delhi High Court recently reserved its verdict on an appeal filed by US pharma company Merck Sharp and
Dohme (MSD) challenging a court order refusing to stop Indian pharma firm Glenmark from making anti-‐diabetes drugs allegedly violation its patent.MSD said it made anti-‐diabetes patented drugs Januvia and Janumet, whose composition was allegedly copied by Glenmark. This implies several problems the all Nations are facing and we are trying to discuss and explain some of them. • Research oriented pharmaceutical companies mostly in developed countries that have provided us with products to fulfill the need of treating complex diseases that were untreatable years ago who are now afraid that they might lose their profit to the generic drug companies. • Middle income countries that focus on producing generics which account for most of the low cost drugs available in the poor underdeveloped countries.India and China together produce more than 80 percent of the active ingredients of all drugs used in the United States. • Although the World Trade Organization’s (WTO) Agreement on Trade Related Aspects of Intellectual Property Rights (TRIPS Agreement) obliges all WTO members, including India, to grant patents on medicines, nothing obliges developing countries to replicate the patent systems of wealthy countries. An important flexibility in this respect is the right of WTO Member States to define what deserves a patent, and what doesn’t, in accordance with their particular national priorities. This is precisely what India did when it amended its patent law in 2005(section 3(d)). • In the United States, companies can get a new patent for a drug by altering its formula or changing its dosage. The companies contend that even minor improvements in medicines — changing a pill dosage to once a day instead of twice a day — can have a significant impact on patient wellness. But critics say a majority of drug patents given in the United States are for tiny changes that often provide patients few meaningful benefits but allow drug companies to continue charging high prices for years beyond the original patent life. • If generic competition on many crucial medicines ends, then prices for these medicines will increase, across the developing world. This would have a devastating impact on not only people MSF(Médecins Sans Frontières) treats, but also on people over the world who rely on affordable medicines manufactured in India and China. • Glenmark Pharmaceuticals said its US-‐based group company has settled a patent dispute with GlaxoSmithKline over the launch of a generic version of anti-‐malaria drug Malarone.Under the terms of the settlement agreements, Glenmark will be able to market and distribute its atovaquone/proguanil 250mg/100mg tablets under a royalty-‐ bearing licence from GSK in the third quarter 2011, or earlier under certain circumstances, it said.The settlement agreements are still subject to review by the Federal Trade Commission and the Department of Justice, Glenmark said. • Manufacturers of brand-‐name drugs and manufacturers of generic drugs are traditionally fierce competitors, making it noteworthy that both have lobbied for the legality of a controversial practice: “pay for delay” settlements to resolve drug-‐patent lawsuits.
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Before most generic drugs can be marketed, the generic manufacturer must initiate a legal proceeding against the brand-‐name manufacturer that seeks to invalidate patents protecting the product or prove that the generic version does not infringe those patents.However, in the past several years, settlements that leave the patents intact and the generic version off the market have become increasingly common.Several such settlement agreements have been widely publicized. 1. In one case, a generic manufacturer agreed not to market its version of extended-‐release diltiazem(an antihypertensive drug), in exchange for annual payments of $40 million from the brand-‐name manufacturer. 2. In 2006, a proposed settlement between brand-‐name manufacturer Bristol-‐ Myers Squibb and generic manufacturer Apotex regarding the antiplatelet drug clopidogrel (Plavix) was rejected because of an undisclosed (and illegal) side agreement between the companies. Apotex then launched its version of clopidogrel at a substantially reduced price. After losing more than $500 million in sales in 5 days,2 Bristol-‐Myers Squibb won an injunction preventing additional generic sales and then successfully defended the challenged patents in court, preserving its market exclusivity to the present day. Ø The Federal Trade Commission (FTC), the regulatory body that enforces antitrust laws to promote market competition, has pressed Congress and the courts to make certain pay-‐for-‐delay settlements presumptively illegal •
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The current controversy over pay-‐for-‐delay settlements arose from a combination of unique features of the pharmaceutical market and the Hatch– Waxman Act of 1984. It created an Abbreviated New Drug Application (ANDA) process that allows generic manufacturers to seek Food and Drug Administration (FDA) approval by submitting proof that the active ingredient is bioequivalent to the brand-‐name version. The ANDA process requires the generic manufacturer to certify that it will market the generic drug only when all patents on the brand-‐name version have expired, or to certify that the brand-‐name manufacturer's patents are invalid or are not infringed by the generic product. Brand-‐name drugs are rarely protected by a single patent on the underlying active ingredient; drugs are instead covered by multiple patents, many of which cover less innovative aspects, such as the coating or different formulations of the drug. These secondary patents usually protect relatively minor innovations, but they can extend beyond the patent term for the underlying active ingredient. 1. For example, the patent on the underlying active ingredient in the proton-‐pump inhibitor omeprazole (Prilosec) expired in 2001, whereas patents on other properties, such as the coating of the pill, lasted until 2007 and later.
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2. In the case of the selective serotonin-‐reuptake inhibitor fluoxetine (Prozac), a federal court found that key parts of a later-‐issued patent lasting until 2006 were duplicative, opening the way for a generic competitor to enter the market shortly after the expiration of a patent on the underlying ingredient in 2001. The Patented Medicine Regulations are regulations under Canada’s Patent Act that apply only topharmaceutical products.They give pharmaceutical patentees, i.e. brand-‐name drug companies, extra remedies in a patent dispute, far beyond the normal remedies available to patentees in other industries. Ø The Regulations allow brand-‐name drug companies to keep ageneric competitor out of the market automatically for 24 months,without a court hearing, merely by starting a court case assertingthat a patent, or several patents, would be infringed by the genericproduct. Ø The Regulations have enabled many abusive strategies, which allow patentees to prolong their market monopolies at the expense of all purchasers of prescription medicines in Canada, including provincialgovernments, employers that sponsor drug plans and the public. Ø The Regulations give patentees every incentive to litigate patents aslong as possible, keeping non-‐infringing, lower-‐cost generic pharmaceutical products off the market. Generic drug companies win mostof the cases eventually, but only after years of delays. Ø Pharmaceutical products with annual sales totaling nearly $1-‐billion in Canada have had their market monopolies extendedby evergreening strategies under the Patented Medicines Regulations.
QARMA: Ø To find a solution to separate the cost of the drug and the profit because innovation makes the prize higher and is therefore preventing the poor from getting necessary drugs? Ø Whether a patent should be allowed on an already existing drug with slight changes in their salt forms? Ø Should the Rights of governments to promote public heath are respected and efforts of pharmaceutical companies and rich countries for stronger IP ignored? Ø Should laws of countries made more stringent on the matters relating to evergreening? And should it be made clear as to what is considered as “NOVELTY”? Ø Do the problems which we face due to mandatory acceptance of TRIPs pre-‐date it?
AGENDA 2: REVIEW OF INTERNATIONAL COPYRIGHT LAWS: WHAT IS A COPYRIGHT AND WHAT DOES IT DO? Copyright is a legal term which refers to the rights granted to authors, artists and other creators for their literary and creations, generally referred to as “works”. Under this system of rights, creators are assured that their works can be disseminated without fear of unauthorized copying or piracy. Works covered by copyright include, but are not limited to: Literary works such as novels, poems, plays, reference works, newspapers and computer programs; databases; films, musical compositions, and choreography; Artistic works such as paintings, drawings, photographs and sculpture; architecture; and advertisements, maps and technical drawings. Copyright protection extends only to expressions and not to ideas, procedures, and methods of operation or mathematical concepts as such. This principle has been confirmed by the Agreement on Trade-‐Related Aspects of Intellectual Property Rights (TRIPS Agreement) of the World Trade Organization (WTO) as well as the WIPO Copyright Treaty. RIGHTS PROVIDED BY COPYRIGHT: The original creators of works protected by copyright, and their heirs and successors, have certain basic rights under copyright laws. They hold the exclusive right to use or authorize others to use the work on agreed terms. The right holder(s) of a work can authorize or prohibit: Its reproduction in various forms, such as printed publication or sound recording; Its public performance, such as in a play or musical work; Its recording (“fixation”), for example, in the form of compact discs or DVDs; Its broadcasting, by radio, cable or satellite;
Its translation into other languages; and Its adaptation, such as a novel into a film screenplay. Creators often sell the rights to their works to individuals or companies better able to market the works in return for compensation in the form of payments and/or royalties. According to the Berne Convention for the Protection of Literary and Artistic Works, copyright protection is obtained automatically without the need for registration or other formalities. However, many national copyright offices and some laws provide for registration of works. DISPUTE AT HAND: A common misconception about copyrights is that they are enforceable only if an author publishes a work. The life of a copyright actually begins the moment the work is “fixed” into a tangible medium, meaning the moment an author writes a poem or the instant a musician records a song. Most legal debates over copyrights involve a concept known as the fair use FAIR USE: is a limitation and exception to the exclusive right granted by copyright law to the author of a creative work. The ambiguity of the fair use doctrine provides a degree of legal tension between a party that seeks copyright protection and one that seeks fair use. Political leaders and academics who argue that forcing developing countries to adopt strict copyright laws is contradictory to their economic progress and will only widen the gap between developed and undeveloped states. Although most countries respect and effectively protect copyrights, some states, despite regulations, fail at enforcing their copyright laws. This presents an interesting global conflict because every country has a piece of its economy at stake. In a rapidly changing global economy, many leaders feel traditional copyrights are no longer necessary. Some argue that copyrights discourage creative growth by limiting people’s ability to build on previously published work.
Copyright infringement is the use of works under copyright, infringing the copyright holder's exclusive rights, such as the right to reproduce, distribute, display or perform the copyrighted work, or to make derivative works, without permission from the copyright holder, which is typically a publisher or other business representing or assigned by the work's creator. Another major setback of copyright laws is in regard to foreign treatment of a copyright, as a copyright's terms may not be recognized in other nations or upheld by international copyright law. Some of the various copyright disputes • Apple Computer, Inc. v. Microsoft Corporation, was a copyright infringement lawsuit in which Apple Computer, Inc. (now Apple Inc.) sought to prevent Microsoft and Hewlett-‐ Packard from using visual graphical user interface (GUI) elements that were similar to those in Apple's Lisa and Macintosh operating systems. In the midst of the Apple v. Microsoft lawsuit, Xerox also sued Apple alleging that Mac's GUI was heavily based on Xerox's. 1. Apple lost all claims in the Microsoft suit except for the ruling that the trash can icon and folder icons from Hewlett-‐Packard's NewWavewindows application were infringing. The lawsuit was filed in 1988 and lasted four years; the decision was affirmed on appeal in 1994,[2] and Apple's appeal to the U.S. Supreme Court was denied. • In other incident, Apple had not secured the proper permissions from the three writers before selling their books in Apple's App Store. The books were apparently uploaded by a third party and sold without the proceeds going to the authors or their publishers.Further, Apple was only fined $118,000, a figure too small to prod other large companies into hiring the additional personnel they'd need to verify each title that comes through their servers. • Samsung's legal woe in patent infringement cases versus Apple has been quite a debatable issue since the launch of various tablets by Samsung. 1.It was found that Samsung infringed all but one of the seven patents at issue in the case— a patent covering the physical design of the iPad. They found all seven of Apple's patents valid—despite Samsung's attempts to have them thrown out. They also decided Apple didn't violate any of the five patents Samsung asserted in the case. 2. Many have questioned whether such complex cases can be decided by juries, while a federal judge recently threw out a high-‐profile case between Apple and Motorola, saying the patent system was in "chaos." Lawyers and judges warn that mounting patent litigation—including cases that encompass everything from smartphones to videogame consoles, will mean mounting costs for consumers. 3.Different types of intellectual property claims that are rarely combined in one case have been brought together in this particular case (apple vs. Samsung): patents that
cover software features, hardware design and high-‐speed communication features, as well as "trade dress," a claim to the overall look and feel of a device. • Sony Corp. of America v. Universal City Studios, Inc. (1984) 1. Universal City Studios unsuccessfully sued Sony Corp in a U.S. court for copyright infringement over Sony's video cassette recorders. 2. The studio alleged that because consumers used recorders manufactured by Sony to record material copyrighted by Universal, Sony was liable for the copyright infringement. 3. The suit resulted in the Sony Doctrine, a principle which states that distributors of copying technology that is capable of commercially significant noninfringing use are shielded from liability for infringement committed by user, unless the distributors had knowledge of infringement and failed to act. • A&M Records, Inc. v. Napster, Inc. (2001) 1. In the first major case involving file sharing sites, record companies represented by the Recording Industry Association of America successfully sued online music file sharing site Napster for copyright infringement in a civil case. 2. The case ultimately led to Napster being ordered to remove music created by most mainstream U.S. musicians from its site. In September 2001, Napster agreed to pay $26 million to musicians and songwriters. • MGM Studios, Inc. v. Grokster, Ltd. (2005) 1. The U.S. Supreme Court ruled that peer-‐to-‐peer file-‐sharing service Grokster could be held liable for copyright infringement in a lawsuit brought by a group of U.S. entertainment companies led by MGM Studios. 2. Many files shared through Grokster contained copyrighted material. The company cited the Sony Doctrine to argue its innocence, and said it was not responsible for controlling file downloads because none of the files passed through its computers. 3. The court disagreed, saying Grokster was different from Sony because it knowingly promoted its service as a way to infringe copyright. Grokster shut down the site in November 2005. • Fair Use: Libraries that provided a search engine company (Google) with books to scan were protected by fair use when the libraries later used the resulting digital scans for three purposes: preservation, a full-‐text search engine, and electronic access for disabled patrons who could not read the print versions. 1. Important factors: The three purposes for which the scans were used were transformative. The court also did not find any evidence of financial harm and labeled as circular logic, any claims of lost license revenue. • Not a fair use: A biographer paraphrased large portions of unpublished letters written by the famed author J.D. Salinger. Although people could read these letters at a university library, Salinger had never authorized their reproduction. In other words, the first time that the general public would see these letters was in their paraphrased form in the biography. Salinger successfully sued to prevent publication. 1. Important factors: The letters were unpublished and were the “backbone” of the biography–so much so that without the letters the resulting biography was
unsuccessful. In other words, the letters may have been taken more as a means of capitalizing on the interest in Salinger than in providing a critical study of the author. • Fair use: The Washington Post used three brief quotations from Church of Scientology texts posted on the Internet. 1. Important factors: Only a small portion of the work was excerpted and the purpose was for news commentary. • Not a fair use: Entire publications of the Church of Scientology were posted on the Internet by several individuals without Church permission. 1. Important factors: Fair use is intended to permit the borrowing of portions of a work, not complete works. QARMA: Ø Could more lenient intellectual property laws encourage creative expression? Ø What should be expected of developing nations in terms of enforcing copyrights? Ø How can agreements like TRIPS be strengthened to better combat piracy and Counterfeiting? Ø Should there be guidelines as to what can be considered as “fair use”? Ø What changes should be made in the copyright law in order to cut down on copyright infringement?