Draft Patents (Amendment), Rules, 2023

The Ministry of Commerce and Industry, under the Department for Promotion of Industry and Internal Trade, has introduced draft amendments to the Patents Rules, 2003. These drafts detail various changes proposed by the Central Government, anchored on section 159 of the Patents Act, 1970. The government seeks to amend the …

The myth of branded generics

The pharmaceutical market in India is unique in that it is dominated by "branded" generics which enjoy a price premium though they are not superior to "unbranded" generics in either pharmacopoeia or therapeutic value. Aggressive marketing of branded generics has led to higher prices, irrational fixed dose combinations and concentration …

From polarization to convergence: need to mend the broken patent system

For more than two hundred years, the world has discussed the issue of whether to continue the process of patenting or whether to do away with it. Developed countries remain polarized for various reasons but nevertheless the pro patent regime continued. The result was a huge volume of patents. The …

Multinationals and monopolies - Pharmaceutical industry in India after TRIPS

In January 2005, drug product patent protection was reintroduced in India to comply with the agreement on Trade Related Aspects of Intellectual Property Rights. How are the multinational pharmaceutical companies responding to the new policy environment? Is India likely to see monopolisation of the industry and high prices, which was …

Geographical indications in India: Hitherto and challenges

Every geographical region has its name and fame. Mostly the qualities and characteristics of certain goods attributable to some geographical locations and reputable to “as produce of certain region” come under Geographical Indications (GI). It is an emerging trend in Intellectual Property Rights. This review provides an overview of the …

Judgement of the Supreme Court of India regarding intellectual property licence agreements on the manufacture of wind turbines, 02/06/2014

Judgement of the Supreme Court of India in the matter of Dr. Aloys Wobben & Others Vs Yogesh Mehra & Others regarding intellectual property licence agreements on the manufacture of wind turbines.

2014 special 301 report on intellectual property rights

The Special 301 Report is the result of an annual review of the state of intellectual property rights (IPR) protection and enforcement in U.S. trading partners around world, which the Office of the United States Trade Representative (USTR) conducts pursuant to Section 182 of the Trade Act of 1974, as …

Implications of drug price competition and Patent term Restoration Act (DPCPTRA) on Indian pharma industry

The Drug Price Competition and Patent Term Restoration Act (DPCPTRA), informally known as the ‘Hatch-Waxman Act’, introduced in 1984, modified the Patent Act of 1952 and Federal Food, Drug, and Cosmetic Act Section 21 U.S.C. 355(j) to simplify approval process of generic drugs by FDA by filing Abbreviated New Drug …

How India can attract more foreign direct investment, create jobs, and increase GDP: The benefits of respecting the intellectual property rights of foreign pharmaceutical producers

As the effective application of new technologies has become increasingly important to most nations’ economic growth and development, the significance of intellectual property (IP) rights has also increased. Most technological innovations come from the world’s most advanced countries; and the transfers of those technologies to developing nations, mostly through the …

Patenting trends among the SAARC nations: comparing the local and international patenting intensity

An attempt has been made in this study to present an overview of the patenting intensity of South Asian Association for Regional Cooperation (SAARC) countries. Patent data originating from SAARC countries from 1995 to 2011, filed through World Intellectual Property Organization (WIPO), European Patent Office and United States Patent and …

Trials and TRIPS-ulations: Indian patent law and Novartis ag v. Union of India

When pharmaceutical company Novartis challenged the rejection of its patent application for the leukemia drug Gleevec in Novartis AG v. Union of India, it became the first major legal challenge to India’s newly amended patent law. In 2005, India purportedly made the final changes required to bring its intellectual property …

Overview of changes to the Indian copyright law

The Copyright Amendment Act, 2012 has been enacted by the Government of India bringing changes to the Copyright Act, 1957. The amendments make Indian copyright law compliant with the Internet Treaties, WIPO Copyright Treaty (WCT) and WIPO Performances and Phonograms Treaty (WPPT). The amendments grant performers’ rights to performers. While …

Policy reforms in the Indian pharmaceutical sector since 1994 - Impact on exports and imports

Liberalisation measures in the pharmaceutical sector have brought about major changes in the industrial licensing policy, import restrictions, foreign direct investment and production controls. It was feared that firms would shift from indigenous production to imports, especially of bulk drugs, and this concern was aggravated with the change in the …

Ranbaxy sell-out: Reversal of fortunes

The Ranbaxy sale to Daiichi Sankyo could herald a new phase in the evolution of the Indain pharmaceutical industry. In order to cope in a world after the agreement on Trade-related Aspects of Intellectual Property Rights came into force, some of the larger Indian firms pursued the two strategies of …

The political origins of health inequity: prospects for change

Despite large gains in health over the past few decades, the distribution of health risks worldwide remains extremely and unacceptably uneven. Although the health sector has a crucial role in addressing health inequalities, its efforts often come into conflict with powerful global actors in pursuit of other interests such as …

Charting the course: GIPC International IP index 2014

The second edition of the GIPC International IP Index, entitled Charting the Course, is a snapshot of where 25 countries’ IP environments are today, and can help provide a road map for those countries wanting to improve their IP environment. This year’s Index builds upon the inaugural edition, Measuring Momentum, …

Judgement of the Delhi High Court regarding infringement of Indian patent No. 203937 and damages, rendition of accounts and delivery up, 11/10/2013

Judgement of the Delhi High Court in the matter of Bristol Myers Squibb Company & Others Vs. V.C. Bhutada & Others dated 11/10/2013 regarding infringement of Indian patent No. 203937 and damages, rendition of accounts and delivery up. Original Source: http://lobis.nic.in/dhc/SMD/judgement/11-10-2013/SMD11102013IA104032013.pdf

Patients win Patent War

It's double trouble for global pharma companies in India. On April 1, a Supreme Court bench comprising Judges Aftab Alam and Ranjana Desai dismissed Swiss drug major Novartis AG's seven-year-old plea seeking patent protection for its blood cancer drug Imatinib Mesylate, sold as Glivec. The court held that Glivec was …

Drugs (Prices Control) Order, 2013

Drugs (Prices Control) Order, 2013 has directions to manufacturers of active pharmaceutical ingredients or bulk drugs or formulations and it states that the Government may, - with a view to achieve adequate availability and to regulate the distribution of drugs, in case of emergency or in circumstances of urgency or …

India: access to affordable drugs and the right to health

Nearly 2 billion people (a third of the world's population) lack access to essential medicines. In low-income and middle-income countries, drugs account for 20

HFC: A lesson on how companies make money to save the world

Industrialised countries should phase out HFC says Sunita Narain, Director-General, CSE in this presentation at CSE Annual South Asian Media Briefing Workshop on Climate Change, 2013 held from September 18-19, 2013. HFC: A lesson on how companies make money to save the world - Presentation by Sunita Narain, Director-General, CSE …

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