...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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...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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...United States gives inventors the exclusive right to sell an invention for up to 20 years before others may copy and sell it.” (page 3) Most pharmaceutical patents only last for 10 years however. This protects an inventor’s rights and allows them to profit from their idea before others are able to copy it. In the case of pharmaceutical companies, patents prohibit other companies from making generic versions of a drug that is still under patent. Pharmaceutical companies can extend their patents by seeking new patents on specific compounds such as single versions of drugs which can exist in both “left-handed” and “right-handed” forms. (Apotex) Every time a new patent is granted, the patent time starts over. This process is known as “evergreening” and can extend the amount of time a drug is under a patent for years. Pharmaceutical companies invest huge amounts of money into developing new drugs. Without patents other companies would be able to copy their drug without investing all of the money into research. Then they could probably sell the same drug at a lower price since they do not have to cover the cost of researching it. Without patent protection companies would not be willing to invest the substantial amounts of money into research if they knew that another company could copy their product. So more drugs are probably being created because a company knows that they can protect their invention with a patent which also protects their income source. As Hubbard says...
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...GlaxoSmithKline and AIDS Drugs for Africa GlaxoSmithKline Pharmaceuticals Ltd Trimester 1 Project – Division D Prepared By (Group 4) :Nakul Agarwal Sanket Guhagarkar Tanvi Gupta Piyush Jain Saurabh Jain (D004) (D020) (D026) (D029) (D030) Table of Contents Company Overview....................................................................................................................... 1 HIV / AIDS in Africa ................................................................................................................... 1 Core interest of GSK in Africa .................................................................................................... 1 Criticism of GSK ......................................................................................................................... 1 Access to Medicine (ATM) Outlook ............................................................................................ 2 Governance .................................................................................................................................... 2 Management Structures....................................................................................................... 3 Performance Management & Incentives ............................................................................. 3 Stakeholder Engagement..................................................................................................... 4 Innovation in General Access to Medicine...
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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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...EXPANDING THE FRONTIERS OF ABUSE OF DOMINANCE THE ASTRAZENECA CASE AND ITS IMPLICATIONS FOR SOUTH AFRICA Neil Mackenzie and Stephen Langbridge1 On 6 December 2012 the European Court of Justice decided the case of AstraZeneca v Commission2. The ECJ upheld the European Commission’s finding of a novel abuse of dominance - by strategic misuse of regulatory procedures, AstraZeneca impeded the entry by marketers of generic pharmaceutical products into various European markets. The company was found to have made misleading representations to patent regulatory agencies in order to procure unwarranted extensions to existing patents, and to have strategically withdrawn the market authorisations ordinarily relied upon by generic producers to sell their products. What is novel about this? Abuse of dominance laws are typically applied to what might be described as conduct in the market. What we mean by this is the manner in which the dominant firm provides its goods or services to the market, and engages with its suppliers, customers and competitors. The AstraZeneca case applies abuse of dominance law to ‘non-market’ conduct in this case conduct in the course of engaging with regulatory authorities. This previously unchartered species of anti-competitive behaviour could be described as a ‘regulatory abuse’. This case appears, therefore, to have expanded the frontiers of European abuse of dominance law. Its implications may well be profound for the enforcement activities of competition authorities...
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...BUS 393 – Final Review Chapter 2 – TORTS: * Tort: (private wrong = not criminal) an act that causes harm such as physical harm, harm to property or reputation, & gives the right to sue and to seek remedies (damages to compensate for loss) * Intent: it is not the intent to injure or harm but whether you deliberately intended the conduct or act that caused the injury (damages greater if can prove intent – includes punitive damages) * Vicarious Liability: you did not intend the harm but is responsible for someone else who did the harm – intentional or not (ex. Employers) * INTENTIONAL TORTS: * Battery: form of trespass to person – intentional physical interference – actual physical contact * Assault: threat to harm another (immediate & possible to carry out) * Defense: consent or self-defense * False imprisonment: complete restraint (physical or no physical = handcuffs) without authority – wrongdoer must have been caught committing a crime then private citizen can arrest. No false imprisonment where authority to arrest (ex. police) * Trespass: voluntary conduct without authority (ex. On land, someone throws something on land, building structure) * Nuisance: person using their property in a way to interfere with a neighbor’s use of property (ex. Fumes, noise, water) – must be reasonably foreseeable * Defamation: derogatory false statement – must clearly refer to the person suing – must be published (heard or read...
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...FACTORS AFFECTING PERFORMANCE OF COMMERCIAL BANKS IN KENYA BY MAURICE MUIRURI KAARIUKI A RESEARCH PROPOSAL SUBMITTED TO THE SCHOOL OF BUSINESS IN PARTIAL FULFILLMENT OF THE REQUIREMENTS FOR THE AWARD OF MASTERS IN BUSINESS ADMINISTRATION, DEGREE OF KENYATTA UNIVERSITY. JULY, 2014 DECLARATION Declaration by the Researcher This research is my original work and has not been presented for a degree in any other University. No part of this study may be reproduced without prior authority of the author and/or Kenyatta University. Signature……………………………………………………… Date………………………. Maurice Muiruri Kariuki Declaration by the Supervisor This research proposal has been submitted for examination with my approval as the university supervisor. Signature……………………………………………………… Date………………………. Name (PhD.) School of Business ACKNOWLEDGEMENT I take this opportunity to express my gratitude and regards to Professor name (PhD.) for his guidance. I am indebted to all the persons and institutions that offered support, encouragement and prayers to me during the entire research. Lastly, I thank almighty, my parents, brother, sisters and friends for their constant encouragement without which this assignment would not be possible. ABSTRACT The study seeks to investigate the factors affecting performance of commercial banks in Kenya. The Background of the study reveals that there has been continued globalization and economic cooperation among the...
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...Determinants of NPAs in the Indian Public Sector Banks: A Critique of Policy Reforms Dr. Pradip Kumar Biswas* and Ashis Taru Deb** The paper analyzes the process leading to formation and perpetuation of high levels of NPAs in Indian Public Sector Banks (PSBs). It distinguishes between random and non-random reasons of NPA formation in PSBs. It points out that a high degree of arbitrariness is involved in defining NPAs as it fails to capture diversity in terms of the seasonal and cyclical nature of the economic activities in India. The study conceptualizes random reasons for default in a simplified framework of a Poisson process. It then argues that the non-random reasons go beyond the conventional paradigm of interim, ex-ante and ex-post information asymmetries and incomplete contracts. It points out that the financial notion of NPA as a mere risk phenomenon is inadequate, because a number of reasons leading to non-random generation of NPA are related to the dimension of uncertainty. It highlighted that the use of a secondary asset market may take care of NPA problem, but it requires a number of conditions for its use, which hardly exist in India. The study observes a number of reasons for generation of NPAs which are important and peculiar to India. This is followed by a critical evaluation of the series of policy measures that have been adopted to improve the NPA scenario since liberalization. While one set of policies granting greater autonomy to the PSBs are proved to be quite...
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...What are the trends in growth, inflation, unemployment, and debt? Over the last ten years Japan had a tremendous growth. It is no surprise for a country like Japan to have an increase in GDP among the last ten years; it had a GDP of $4.3 trillion in 2004 and kept increasing till it reached $5.96 trillion in the end of 2013 (Trading Economics, 2013). This significant increase in in the GDP is due to the increase in the net exports, since nowadays Japan is known as the world’s second largest developed economy. Japan exports a lot of automobiles because it is one of the leading countries in the production of automobiles that are spread all over the world. Moreover, Japan is the largest creditor nation while running an annual trade surplus. The GDP per capita increased from $29369.49 in 2004 to $31425.49 in 2013 (Trading Economics, 2013) meaning that the economy is vigorous since people are earning more so they have more disposable income to spend which vitalities the economy and the services thus leading the economy to thrive. All these conditions led the growth rare to increase from 0.1% in 2004 to 0.3% in 2013 (Trading Economics), however it is still considered low since it only increase 0.2%. In general we can come to a conclusion that the Japanese economy is healthy and is experiencing a positive growth. Since we already know that the economy in Japan is booming it would be rational to say that there are new opportunities for new positions in the market, the demand for workers...
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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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...At the Intersection of Health, Health Care and Policy Cite this article as: Henry G. Grabowski, Joseph A. DiMasi and Genia Long The Roles Of Patents And Research And Development Incentives In Biopharmaceutical Innovation Health Affairs, 34, no.2 (2015):302-310 doi: 10.1377/hlthaff.2014.1047 The online version of this article, along with updated information and services, is available at: http://content.healthaffairs.org/content/34/2/302.full.html For Reprints, Links & Permissions: http://healthaffairs.org/1340_reprints.php E-mail Alerts : http://content.healthaffairs.org/subscriptions/etoc.dtl To Subscribe: http://content.healthaffairs.org/subscriptions/online.shtml Health Affairs is published monthly by Project HOPE at 7500 Old Georgetown Road, Suite 600, Bethesda, MD 20814-6133. Copyright © 2015 by Project HOPE - The People-to-People Health Foundation. As provided by United States copyright law (Title 17, U.S. Code), no part of Health Affairs may be reproduced, displayed, or transmitted in any form or by any means, electronic or mechanical, including photocopying or by information storage or retrieval systems, without prior written permission from the Publisher. All rights reserved. Not for commercial use or unauthorized distribution Downloaded from content.healthaffairs.org by Health Affairs on February 29, 2016 at UNIV OF CALIFORNIA Intellectual Property & Innovation By Henry G. Grabowski, Joseph A. DiMasi, and Genia Long 10.1377/hlthaff...
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...The Indian Banking Sector On the Road to Progress G. H. Deolalkar G. H. Deolalkar is formerly Managing Director of State Bank of India. 60 A STUDY OF FINANCIAL MARKETS Overview of Banking and Financial Institutions The Banking Sector The banking system in India is significantly different from that of other Asian nations because of the country’s unique geographic, social, and economic characteristics. India has a large population and land size, a diverse culture, and extreme disparities in income, which are marked among its regions. There are high levels of illiteracy among a large percentage of its population but, at the same time, the country has a large reservoir of managerial and technologically advanced talents. Between about 30 and 35 percent of the population resides in metro and urban cities and the rest is spread in several semi-urban and rural centers. The country’s economic policy framework combines socialistic and capitalistic features with a heavy bias towards public sector investment. India has followed the path of growth-led exports rather than the “exportled growth” of other Asian economies, with emphasis on self-reliance through import substitution. These features are reflected in the structure, size, and diversity of the country’s banking and financial sector. The banking system has had to serve the goals of economic policies enunciated in successive fiveyear development plans, particularly concerning equitable income distribution, balanced...
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...M UM B A I S I L I C O N VA L L E Y BANGALORE S I NG A P ORE M UM BA I -BK C NEW DELH I M UNI CH Intellectual Property Law in India December 2013 © Copyright 2013 Nishith Desai Associates www.nishithdesai.com Intellectual Property Law in India About NDA Nishith Desai Associates (NDA) is a research based international law firm with offices in Mumbai, Bangalore, Silicon Valley, Singapore, New Delhi, Munich. We specialize in strategic legal, regulatory and tax advice coupled with industry expertise in an integrated manner. We focus on niche areas in which we provide significant value and are invariably involved in select highly complex, innovative transactions. Our key clients include marquee repeat Fortune 500 clientele. Core practice areas include International Tax, International Tax Litigation, Litigation & Dispute Resolution, Fund Formation, Fund Investments, Capital Markets, Employment and HR, Intellectual Property, Corporate & Securities Law, Competition Law, Mergers & Acquisitions, JVs & Restructuring, General Commercial Law and Succession and Estate Planning. Our specialized industry niches include financial services, IT and telecom, education, pharma and life sciences, media and entertainment, gaming, real estate and infrastructure. IFLR1000 has ranked Nishith Desai Associates in Tier 1 for Private Equity (2014). Chambers & Partners has ranked us as # 1 for Tax, TMT and Private Equity (2013). Legal Era, a prestigious Legal Media Group...
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...Pharmaceuticals and Life Sciences Global pharma looks to India: Prospects for growth Table of contents Introduction 03 Background 04 A fast growing economy An expanding pharmaceutical market Government-provided healthcare improving, but private healthcare dominates Domestic market overview 09 Background Consolidation underway, despite challenges Contract manufacturing Vaccines Over the counter market holds significant potential Reaching the untapped rural market Growing Research & Development 15 Overview Clinical trials Biotech and biosimilars on track for growth Other growth areas Bioinformatics 20 Stem cell research Medical devices Global Pharma’s evolving business models and options in India 23 Background Export-oriented business (Contract Research and Manufacturing Services) Licensing Franchising Joint ventures Wholly-owned subsidiaries Practical concerns 27 Infrastructure Tax environment Counterfeiting Intellectual property Conclusion 30 Related reading: Pharma 2020 31 References 32 Acronyms 38 Introduction The pharmaceutical industry’s main markets are under serious pressure. North America, Europe and Japan jointly account for 82% of audited and unaudited drug sales; total sales reached US$773 billion in 2008, according to IMS Health. Annual growth in the European Union (EU) has slowed to 5.8%, and sales are increasing at an even more sluggish rate...
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