Celebrating 20 Years of IP Excellence

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Examining the Origins of Section 3(d) in India’s Patents Act and Its Connection to EU SPCs

Section 3(d) of The Patents Act 1970 has been the subject of much research interest due to its connection with preventing evergreening in pharmaceutical patents. This section was introduced after the TRIPS agreement, and may have been inspired by a similar provision in the E.U.’s Supplementary Protection Certificates regulation. It requires any patent for a new form of an active ingredient to demonstrate enhanced therapeutic efficacy. Continue Reading Examining the Origins of Section 3(d) in India’s Patents Act and Its…

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Revisiting Supplementary Protection Certificates of the European Union

Supplementary Protection Certificates (SPCs) are a form of additional patent protection for pharmaceuticals and plant protection products, granting up to 5 years of extra market protection beyond the standard 20 year patent period. The E.U has established regulations to ensure uniformity across member countries in the grant of SPCs, and over 20000 SPCs have been granted since 1993. Further study is needed to identify when and where SPCs are necessary to ensure they are used responsibly and do not unreasonably…

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Profiting from the Patent Cliff

Profiting from the Patent Cliff: What Drug Manufacturers Need to Know about Secondary Patents

Learn about the patent cliff and how Novartis’ heart failure drug Vymada (Entresto®) will expire its patent protection in 2023. Find out more about secondary patents that can extend market exclusivity of Entresto® until 2033. Continue Reading Profiting from the Patent Cliff: What Drug Manufacturers Need to Know about Secondary Patents

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This image depicts Tablets and Capsules of various colors. This image is relevant as the topic is about Final Guidelines for Examination of Pharmaceuticals Published. Click on the image for more information

Revised Draft Guidelines for Examination of Patent Applications in the Pharma Industry

This post was first published on 22nd August, 2014.   The Controller General of Patents, Designs and Trademarks (CGPDTM) published the revised draft guidelines for the examination of patent applications in the field of Pharmaceuticals on August 12, 2014. The main intention of said guidelines was to bring in a uniform practice for the examination of patent applications relating to the Pharmaceutical field. Earlier in the month of February, the CGPDTM had published the draft guidelines with regard to this and had…

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Special Report

Demystifying the Evergreen myth

This post was first published on 19th May, 2014.   Evergreening, known in the politically-correct-circles as “Life Cycle management” of a drug, is the concept of extending the exclusivity term rendered to a pharmaceutical patent through legal and business measures. Contrary to existing myths and notions, Evergreening does not stop an interested party from exploiting the invention of an expiring patent. It is purely a business strategy to introduce and position newer products (sometimes patented) into the market so as to prolong…

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Patent Linkage – An Overview

This post was first published on 5th March, 2011. Authored by Mr. Vijaykumar Shivpuje. Abstract: Patent Linkage with regulatory approval procedure is a sensitive issue for Indian pharmaceutical industry which includes mainly generic companies. This essay discusses the implications of patent linkage and the current scenario in India. Further, the recent developments related to patent linkage including the Bayer v/s Cipla decision and India-EU free trade agreements are discussed. Introduction: Patent Linkage refers to…

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Extension of Waiver for Pharma Patents until 2033 A.D.

After intense negotiations between the United States and the Group of Least-Developed Countries, the World Trade Organization committee on intellectual property rights finally decided to extend a waiver allowing LDCs from applying and enforcing IP rights on pharmaceutical products until 2033. The consensus among the World Trade Organisation (WTO) members over extension of waivers in respect of pharmaceutical patents for the least developed countries (LDCs) is being held as a major breakthrough in the world of pharmaceutical patents. Following the…

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Compulsory Licensing in India

  Mark Twain once said “Get your facts first, then you can distort them as you please”. How is this relevant to this Compulsory Licensing post here? You need to read on to discover that.   The history of Compulsory Licensing can be traced back to the UK Statute of Monopolies in 1624, which ruled out monopolies associated with patent, and stated that grants should not be mischievous to the State‘ or hurt trade. The UK recognized compulsory licensing in terms of…

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The featured image shows many strips of tablets and a thermometer on a grey background. The post is regarding the trademark dispute between Cadila health care and Sun Pharma . To know more please click here.

The 3D Effect of Novartis Case on Genetic Inventions

  The Novartis decision of the Indian Supreme Court rejecting patentability of the cancer drug, Imatinib Mesylate in its beta crystalline form (commonly called 'Glivac'), has been commended for its outlook on public interest and access to health. It was in fact an important decision for cancer patients as it removes the last possible hurdle to access the drug at one-tenth of its cost, which was around Rs. 1, 20, 000/- per month. The main issue in the case revolved around…

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