...Novartis V. Union of India & Others – A Landmark Judgement on Indian Patent Law & Pharmaceutical Industry: A Report The Supreme Court judement on the Novartis v. Union of India & Others is a landmark decision on the issue of pharmaceutical patent in India. The decision taken after a seven year long litigation fought by pharmaceutical major Novartis is based on a case pertaining to grant of Indian patent on a compound called Imatinib Mesylate in Beta Crystalline Form (referred as Imatinib hereinafter as convenience of brevity). The Supreme Court decided that Imatinib, the substance for which Novartis sought patent does not qualify the test of invention as laid down in section 2(1)(j), section 2(1)(ja) and the test of efficacy under section 3(d) of the Indian Patent Act, 1970. The decision generated widespread discussion and debate on affordability of life saving drugs in India for public good and impact on R&D for further innovation in pharmaceutical industry. The report covers following contents. 1. Background of the Novartis Case ❖ Fact of the case ❖ Underlying legal provisions 2. Overview of patent law in India with special focus on pharmaceutical industry 3. Supreme Court Decision in Novartis Case 4. Impact of the Supreme Court Judgement ❖ On affordability of life saving drugs ❖ On innovation for future improvement and development ❖ Overall impact on pharmaceutical industry...
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...was registered as a public limited company in Mumbai. Khwaja Abdul Hamied, the founder of Cipla (Chemical, Industrial & Pharmaceutical Laboratories) was gave the company all his patent and proprietary formulas for several drugs and medicines, without charging any royalty. * 1941–As the Second World War cuts off drug supplies, the company starts producing fine chemicals, dedicating all its facilities for the war effort and helped British with drugs during World War II to create goodwill so that after war we India can request for freedom * 1952– Sets up first research division for attaining self–sufficiency in technological development. * 1960– Starts operations at second plant at Vikhroli, Mumbai, producing fine chemicals with special emphasis on natural products. * 1960- Cipla began manufacturing a new, patented drug, propranolol, and when the drug's patent holder, ICI, protested to the Indian government, the CEO of Cipla successfully lobbied the government of Indira Gandhi to change India's patent laws to eliminate patents that directly covered drugs, and instead to allow only patents that covered methods to make drugs. This change made propranolol and other patented drugs, generic and led to criticism of both India's patent laws and Cipla. India reinstated patents on drugs in 2005 * 1968– Cipla manufactures ampicillin for the first time in the country. * 1972–Starts Agricultural Research Division at Bangalore, for scientific cultivation of medicinal...
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...Patent for Imatinib had already been obtained by Novartis on April 2, 1993. Novartis claimed that this invention involved two aspects: 1. Selecting an example from the Zimmermann patent and then choosing methane sulphonic acid addition salt of the free base Imatinib, which was called Imatinib Mesylate. 2. Making the invention suitable for oral consumption and use. This led to the formation of the beta-crystalline form of the above drug. Opponents of the patent filed by Novartis charged saying that the first invention had merely been picked up from the Zimmermann patent and couldn’t actually be classified as an invention and that the claims by Novartis were false[3]. Hence, the SC had to first determine the veracity of the claims made by the company. For this, the bench studied the relevant clauses of the Zimmermann patent in detail. It was found that Novartis had indeed disclosed both Imatinib and Imatinib Mesylate in the Zimmermann patent and had also directed Natco Pharma to stop selling their drug Veenat, in Europe [4]. Veenat involved the use of Imatinib Mesylate and was infringing upon their European equivalent of the Zimmermann patent[4]. Hence, the court declared that only the second invention of the formation of the beta-crystalline form could be actually termed as an “invention”. Once this was done, Novartis had to pass the bar of calling its invention a “patent”. Section 3(d) of the Act clearly states that discovery of a new form of a known substance must...
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...Monday, April 21, 2008 Roche vs CIPLA: The Rhetoric of Patent Busting Roche, a multinational pharma company and CIPLA, a generic manufacturer from India. CIPLA brazenly defied Roche's patent over an anticancer drug, Tarceva and went ahead and introduced a generic version at 1/3rd the price. It claimed that the patent ought not have been granted in the first place. CIPLA's counsel, Arun Jaitley argued very persuasively in court that Roche's drug did not meet the requirements of section 3(d), a unique section introduced into India's patent regime in 2005 to prevent a phenomenon widely known as "evergreening". Under section 3(d), derivatives of existing pharmaceutical substances would not merit patent protection, unless such derivative was more "efficacious" than the earlier existing pharma substance. The section was challenged by Novartis as being violative of TRIPS and of the Indian constitution CIPLA also stressed that since the price differential between the patented drug and the generic version sold by CIPLA was extremely high, "public interest" demanded that no injunction be granted in favour of Roche. In a remarkably sophisticated and well researched judgment, Justice S Ravindra Bhat of the Delhi High Court ruled in favour of CIPLA. The matter is now under appeal. Unless Roche is able to demonstrate empirically that CIPLA's lower prices for Tarceva (the lung cancer drug in issue) does not really translate to increased access to poor patients, it is difficult...
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...A “Calibrated Approach”: Pharmaceutical FDI and the Evolution of Indian Patent Law Web version: August 2007 Authors: Katherine Connor Linton and Nicholas Corrado1 Abstract India has charted its own intellectual property (IP) path over the last 35 years, attempting to foster the growth of a domestic pharmaceutical industry and access to medicine while, more recently, also addressing the requirements of the international IP regime. Multinational companies (MNCs) have responded to India’s movement towards compliance with the W TO intellectual property agreement, TRIPS, by increasing the quantity and quality of foreign direct investment (FDI) in the areas of pharmaceutical research and development (R&D) and manufacturing. By contrast, MNCs have adopted a more cautious attitude toward the patenting and commercialization of new pharmaceutical products in India, waiting to see how Indian courts and patent offices interpret the new laws, and awaiting the enactment of longdebated data protection legislation. The ultimate success of the Indian “calibrated approach” to fostering the domestic industry and access to medicine while also addressing international IP requirements remains to be seen. 1 Katherine Connor Linton (katherine.linton@usitc.gov) is the International Trade Analyst for Intellectual Property and Nicholas Corrado was a law student intern in the Office of Industries of the U.S. International Trade Commission (USITC). The views expressed are those of Ms. Linton and...
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...MARIAM LIANA Introduction This paper explores the impact of pharmaceutical patent laws on Anti-AIDS drug, substantial controversy which has been generated around the globe on ethical grounds. Pharmaceutical patents on Anti-AIDS drug availability in the third world countries, focusing on an ethics of the Trade Related Aspects of Intellectual Property Rights (TRIPs) Agreement. It highlights the value of essential drugs and generic production in developing countries, using India, Cipla as a case study. It also explores global ways to deal with unethical grounds to TRIPs. History of Cipla, Indian Pharmaceutical Company Cipla is one of the world's largest producers of generic medicines.Cipla is one of India's top five pharmaceutical manufacturers. Although Cipla's primary market is India, the company sells its products worldwide. Cipla's lines of more than 400 drugs include anti-asthmatic, anti-cancer, anti-inflammatory, anti-depressant and anti-AIDS medications. Over the years, the company has developed strong research and marketing capabilities. In recent times, Cipla has attracted considerable media attention because of its efforts to offer AIDS drugs globally at very low prices. But in its quest to capture this market, Cipla faces the might of global multinational corporations, who are doing all they can to protect and enforce their patent rights. The case deals with all these issues in detail. World Trade Organization’s (WTO) The World Trade...
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...granted patent in both the US and Europe. Beginning with Imatinab in its base form. 4. Novartis claims to have developed Beta Crystalline form of Imatinab in a two-stage process and a direct process, with obtaining Imatinab Mesylate in amorphous form as an output in the stage one of the two-stage process. 5. An application was filed for the patent of the beta crystalline form of Imatinab Mesylate in India claiming that the newly invented form had more beneficial flow properties, thermodynamic stability and a lower hygroscopicity than the original Imatinab. 6. Further, they claimed it has better storage properties and that it was easier to process than the Imatinab in basic form. 7. However it was also claimed in the application for patent that all the inhibitory and pharmacological effects of the beta crystalline form of Imatinab Mesylate were also found in the base form of the compound. Novartis: Law Points and Development of the Case 1. When the application was filed for patent in the year 1995,the patent laws in India were under transition phase and as a result the application held in a dormant mode. 2. Later in March 2002, the applicant makes another application for Exclusive Marketing Rights (EMR) of the product under the section 24A of Indian Patent Acts 1970, which now stands deleted following the amendments to the Indian Patent Act, and in the due course, the EMR for the product was granted to the applicant. 3. However during the period of EMR, the drugs sold...
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...Corporate Development Strategies Faculty 02 – Economics and Business Administration Johann Wolfgang Goethe-University Frankfurt Industry analysis of the pharmaceutical industry Written assignment Submitted by: Heiko Kreuz, 4897736, s5706079@stud.uni-frankfurt.de Janine Seelinger, 4896818, s1010710@stud.uni-frankfurt.de Dana Winkler, 4497800, s1099437@stud.uni-frankfurt.de Supervisor: Prof. Dr. Lars Schweizer November 6, 2015 Table of contents 1 Introduction...........................................................................................................................1 2 Theoretical framework of Porter’s Five Forces ........................................................1 3 Industry analysis by means of Porter’s Five Forces ................................................2 3.1 Competitive rivalry ................................................................................................... 2 3.2 Bargaining power of suppliers.................................................................................. 2 3.3 Bargaining power of buyers ..................................................................................... 2 3.4 Threat of substitutes ................................................................................................. 3 3.5 Threat of new entrants .............................................................................................. 3 3.6 The regulators ............................
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...American Business Law Journal Volume 45, Issue 2, 283–330, Summer 2008 The Impact of Compulsory Licensing on Foreign Direct Investment: A Collective Bargaining Approach Robert Birdn and Daniel R. Cahoynn I. INTRODUCTION The need to facilitate access to essential medicines for those with lifethreatening or fatal diseases like HIV, tuberculosis, and malaria has generated significant interest. Yet, an inevitable tension exists between the need for pharmaceutical companies to profit from their patented inventions and the desire to provide access for impoverished persons. Developing nations have attempted to resolve this tension through the issuance of patent compulsory licensesFauthorizations for government-approved generic copies1Fso that those in need of the n Assistant Professor of Business Law, School of Business, University of Connecticut. This article received the Holmes-Cardozo Award for Outstanding Submitted Conference Paper as well as the Ralph J. Bunche Best Paper Award at the Academy of Legal Studies in Business Annual Meeting, Indianapolis, IN, August 2007. Our thanks for comments and support go to Jayashree Watal, Peter Yu, Douglas Lippoldt, and the other participants at the University of Connecticut’s Center for International Business Education and Research Conference, ‘‘The Impact of Intellectual Property Rights on Innovation, Knowledge Diffusion, and Foreign Direct Investment in the Global Economy,’’ Storrs, CT, May 2007. Additional thanks to Anthony Kwasnica and...
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...intends to answer the six questions related to the In-Depth Integrative Case 1.2 and highlight the global rights conflict of between a developing country’s fight to confront the AIDS epidemic and intellectual property protection. Delicate Balance Of Intellectual Property And Access To Medication Introduction When the South African Medicines Act was introduced it quickly resulted in battle lines being drawn between patent rights and public health. While all parties acknowledged the scope of the AIDS crisis, how to go about solving the problem became the subject of significant moral and legal debate (Halbert, 2012). Case Study Review In the case study Pharmaceutical companies, intellectual property, and the global AIDS epidemic, there are a number of questions to review. First, do pharmaceutical companies have responsibility to distribute drugs for free or at low cost in developing countries? What are the arguments for and against such an approach? There are socio-economic responsibilities of businesses and pharmaceutical companies have responsibility to distribute drugs for free or at low cost to developing countries. The products pharmaceutical companies make help save people lives. For that, they should be helping to save lives in developing countries that cannot afford medication. In contrast, pharmaceutical companies need to balance goodwill and profit in order to satisfy investors and used for more research for better medications. AIDS activists around the...
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...Rights of patentees (1) Subject to the other provisions contained in this Act, a patent granted before the commencement of this Act, shall confer on the patentee the exclusive right by himself, his agents or licensees to make, use, exercise, sell or distribute the invention in India. (2) Subject to the other provisions contained in this Act and the conditions specified in section 47, a patent granted after the commencement of this Act shall confer upon the patentee - where the patent is for an article or substance, the exclusive right by himself, his agents or licensees to make, use, exercise, sell or distribute such article or substance in India; Where a patent is for a method or process of manufacturing an article or substance, the exclusive right by himself, his agents or licensees to use or exercise the method or process in India. Term of Patent (1) Subject to the provisions of this Act, the term of every patent granted under this Act shall - in respect of an invention claiming the method or process of manufacture of a substance, where the substance is intended for use, or is capable of being used, as food or as a medicine or drug, be five years from the date of sealing of the patent, or seven years from the date of the patent whichever period is shorter; and in respect of any other invention, be fourteen years from the date of the patent. (2) A patent shall cease to have effect notwithstanding anything therein or in this Act on the expiration of the period prescribed...
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...FOREIGN TRADE UNIVERSITY HCMC ---------***-------- MIDTERM PROJECT SUBJECT: INTELLECTUAL PROPERTY RIGHTS Major: External Economics IP AND THE PROMOTION OF BIODIVERSITY AND TRADITIONAL KNOWLEDGE AND BENEFIT SHARING WITH PROVIDERS COMMUNITIES Class: K53CLC3 – Group 6 Lecturer: Pham Thi Mai Khanh Ho Chi Minh City, February 2016 I GROUP MEMBERS No 1 2 3 4 5 6 Name Khúc Thị Kiều Thương Phạm Mỹ Tiên Trương Thủy Tiên Nguyễn Hoàng Minh Trâm Lương Gia Vĩ Ngô Nhật Vy ID 1401025125 1401025128 1401025129 1401025133 1401025159 1401025162 II TABLE OF CONTENTS INTRODUCTION ............................................................................................................................. 1 A. BACKGROUND ........................................................................................................................... 2 I. Overview of Intellectual Property ............................................................................................... 2 II. Overvew of Biodiversity ............................................................................................................ 2 III. Overview of Traditional Knowledge ....................................................................................... 4 B. CURRENT SCENERIO ................................................................................................................. 5 I. Intellectual Property in Today World ..........................
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...trade secrets. Unlike patents which require the secret to be inventive or non-obvious, things such as customer lists, equations, and compilation of data (which aren't eligible for copyright or patent protection) can be protected through a trade secret. Granted, though, that the company assumes the costs associated with protecting the said secret. Whereas patents expire after 20 years, and all the designs/specifications are consequently available to the public domain, trade secrets can be protected for longer; this depends on the secret holders ability to adequately establish a framework to maintain secrecy and thereby protect the intellectual property. In the cases of Coca-Cola and KFC, the process of keeping trade secrets has benefited them greatly. Granted, though, they also use a symbiotic or symphonic combination of patents, trademarks, and copyrights to protect their overall product; no competitor has been able to completely replicate their products because the processes making the syrup (for Coca-Cola) or the method of mixing the spices (for KFC) has been a closely guarded trade secret. Had these companies patented these processes, they would have received initial protection for 20 years from anyone replicating it, but would have had these processes disclosed to the public after that. Whereas these companies have been in existence for a longer time, a patent for the processes wouldn't have been in their best long-term interest. Whereas patents (while valid) disallow...
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...Critical Review 1 In recent years, patents, copyrights and trademarks have become more and more prevalent. Nowadays, people are trying and in some instances succeeding in trademarking things such as human genes, scents, and even phrases such as Donald Trump’s “You’re Fired”. Kembrew Mcleod in his article titled, “Freedom of Expression: Overzealous Copyright Bozos and Other Enemies of Creativity” analyzes the effects that patents and copyrights have on our society today. Mcleod uses numerous examples and anecdotes to emphasize his main point that patents and copyrights are getting out of hand and restricting our freedom of expression. Mcleod presents a very convincing argument in this article and does a great job explaining how trademark holders are going to the extreme to protect their property. Mcleod believes that our freedom of expression is being eroded because of the expansion of the patent law in the last quarter of the century. As a result, many things are becoming privatized. In the article, Mcleod discusses an incident regarding a man named Moore, who had his spleen removed to treat his leukemia. The doctor that did the procedure patented a cell line taken from his organ without Moore’s consent. The doctor went on to develop a drug from the patent and Moore did not reap any of the benefits of the success of the drug because of the doctor’s patent. This example proves that what some people are patenting these days is getting out of hand. In the article, Mcleod...
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...as opposed to low costs in India and new regulations that opened Indian market to foreign investments (up to 51%) created tempting conditions to enter one of the emerging huge markets of the world. Alliance with Ranbaxy was a smart strategy for Eli Lilly to establish its presence in India. Ranbaxy was the second largest manufacturing company of bulk drugs and generics with domestic market share of 15% in India with established distribution network and the second largest exporter to different countries, including Russia (which Eli Lilly was attempting to reach), with capital cost 50-75% lower than those of comparable US plant and R&D expenses of 2-5% of sales. Besides, Ranbaxy developed its own process for Eli Lilly's patented drug Cefaclor. Since Eli Lilly's product patent for Cefaclor expired in 1992 and the firm was expecting to protect its monopoly with process patents which were due to expire only in 1994, this gave great scope for a mutually advantageous agreement between the two companies. There was also possibility to conduct cheap clinical trials in India. Although the joint venture ran into problems because of weak patent laws in the country, which prevented the American partner from sharing its research expertise, Eli Lilly obviously, realized the benefits of an arrangement with Ranbaxy in sourcing low-cost basic research from India. Question 2: Evaluate the three successive IJV leaders. Identify the...
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