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Pharmaceutical Patents in India

Pharmaceutical patents for inventions resulting from combination of previously known active ingredients face higher level of scrutiny from the patent examiner as patent office does not generally allow the patent owners to extend the life of existing patents by filing new patents for substantially same or similar inventions, without any novelty or inventive step (non-obviousness).… Continue reading Pharmaceutical Patents in India

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BioSpectrum Asia – Compulsory License of Bayer’s Nexavar

BioSpectrum Asia - Debate over compulsory licensing of Bayer's Nexavar  Originally published here. Full Article: India allows compulsory licensing of Bayer’s Nexavar In March 2012, the Indian Patent office granted first compulsory license to NATCO pharma to make anti-cancer drug sorafenib for the India market. However, the compulsory license is subject to certain conditions, such… Continue reading BioSpectrum Asia – Compulsory License of Bayer’s Nexavar

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LawAsia Publication – Patent Opposition in India

Full Article: Patent Opposition in India: Recent Trends Overview of patent opposition in India, the two-stage patent opposition process and how it affects the industry, as the patent applicants are now vulnerable to multiple pre-grant oppositions filed by competitors, or even by a single competitor, since there is nothing to stop a party which has filed a pre-grant… Continue reading LawAsia Publication – Patent Opposition in India

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International Bar Association – Patent Enforcement in India

Asia Pacific – Regional Forum News – Newsletter of the International Bar Association Legal Practice Division Full Copy of Publication: Local working requirements and enforceability of patents: an Indian perspective of challenges and opportunities surrounding a granted patent This article provides a basic overview regarding local working requirements of granted patents in India in light of… Continue reading International Bar Association – Patent Enforcement in India

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BioSpectrum – Regulatory Challenges For APAC Businesses – Biotech in Asia Pacific

By 2020, according to Frost & Sullivan, healthcare expenditure in the APAC will increase 151 percent over 2010 figure, to $2927 billion at a compound annual growth rate of 9.2 percent. Factors such as increasing population, per capita income, prevalence of lifestyle diseases due to rapid urbanization, apart from cost factors, are aiding growth. However,… Continue reading BioSpectrum – Regulatory Challenges For APAC Businesses – Biotech in Asia Pacific

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Global Legal Post – Indian Patent Office Backlog

Global Legal Post Publication Before US visit, PM Modi announced to resolve one the most crucial issues daunting the Indian Patent Office, i.e. clearing the huge backlog. Originally published here. Full Article: 1,000 backlog beaters for Indian patent office Rahul Dev, Partner at the law firm of Tech Corp Legal LLP, is a patent attorney and international… Continue reading Global Legal Post – Indian Patent Office Backlog

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Swissinfo – Novartis Patent Case – Indacaterol – Onbrez Delhi High Court Judgement

Swissinfo is Swiss Government's International Publication Service managed by Swiss Broadcasting Corporation (SBC). Originally published here. Views on Delhi High Court's ruling in Novartis patent dispute: "the ruling is totally in line with existing laws, rules and judicial precedents. For example, the Indian patents act provides provisions for revocation of patent rights in case such… Continue reading Swissinfo – Novartis Patent Case – Indacaterol – Onbrez Delhi High Court Judgement

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Regulatory Challenges and FDA Approval of Biosimilars – An Overview

Biosimilars are generic versions of biologics, medicinal products with active drug component being made (or derived) from a living organism. It is complicated and cost intensive to manufacture biologics, and hence regulatory approval of biosimilars is very challenging. Originally published here. //storify.com/rdpatentlawyer/fda-approval-of-biosimilars-regulatory-challenges/embed//storify.com/rdpatentlawyer/fda-approval-of-biosimilars-regulatory-challenges.js[View the story "FDA Approval of Biosimilars - Regulatory Challenges" on Storify] About the… Continue reading Regulatory Challenges and FDA Approval of Biosimilars – An Overview

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Pharmaceutical Patents in India – Compulsory Licensing, Health Emergency & Affordable Healthcare – Patent Laws in India

India is facing tremendous pressure from US for enforcement of Intellectual Property Rights (IPR) since last few months, specifically with regards to concerns over violations of pharmaceutical patents in India. Originally published here. Recent Issue – Dasatinib [Bristol-Myers Squibb (BMS)’s Cancer drug] Dasatinib, an anti-cancer drug produced by pharma major Bristol-Myers Squibb (BMS), is used… Continue reading Pharmaceutical Patents in India – Compulsory Licensing, Health Emergency & Affordable Healthcare – Patent Laws in India